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Research ethics board approval: What, why, when, how?

At the BC Medical Journal , we often receive submissions from clinicians who want to share their findings, but they aren’t sure how to approach the subject of research ethics. Here is a brief summary for our readers and prospective authors.

What is a research ethics board?

Research ethics boards (REBs) are “autonomous entities whose primary responsibility is to protect the rights and welfare of human participants taking part in research.”[ 1 ] They can also help to ensure that research is of high quality and is clinically important.[ 2 ] The University of British Columbia has several such boards, including Children’s and Women’s, BC Cancer, Providence Health Care, and the UBC Clinical Research Ethics Board. These committees are composed of individuals from varied backgrounds such as physicians, scientists, researchers, ethicists, and community members. There are also private for-profit ethics boards, which adhere to the same principles and are selected by some researchers for expediency or if the researchers are not affiliated with a university.

Why is research ethics approval necessary?

Involuntary studies on human subjects in the past have had horrendous consequences. The Nuremberg trials exposed the “scientific” evils of the Nazi regime and resulted in the creation of the Nuremberg Code in 1947.[ 3 ] Unfortunately, around the world, including in North America, there were many subsequent occurrences of atrocities committed in the name of research. The World Medical Association Declaration of Helsinki (1964, last updated 2013) was created to further address the ethics and safety of human research and its application to special populations.[ 4 ]

Today, the standards for research involving humans adhere to the Tri-Council Policy Statement (TCPS2 2018), which is a product of Canada’s three federal research agencies.[ 5 ] Applications to UBC’s REBs require all team members to have completed a tutorial on the Tri-Council Policy Statement.[ 6 ] The key principle is informed consent, where research participants are fully informed about the potential risks and benefits of the study.

When does a study need research ethics board approval?

In Canada, any research study involving human participants, human tissue, or human data requires research ethics board approval before commencement. If you are undertaking a quality improvement project, it does not require REB oversight. However, it is important to note that REBs cannot review research that has already been done; if there is any doubt about your project constituting research, it is best to consider the intention of the project before beginning. A sorting tool, available on the PHSA website, can be a helpful first step ( https://rc.bcchr.ca/redcap/surveys/?s=HNWAAKFF97 ). If research ethics appear to be required or you are uncertain, contact your local REB.

At the BCMJ , we also receive submissions of quality improvement projects that have been written up for publication. For example, a medical student was supervised by an attending physician to perform a review of treatment times for different diagnoses in the emergency department. This study represents a retrospective chart review, which involved collecting patient data, de-identifying the information, and analyzing the results. Depending on the nature and specifics of the project, the BCMJ may ask the principal investigator to seek confirmation from a local REB that the project was, in fact, quality improvement and, therefore, did not require REB oversight. If the research would have required REB approval, it cannot be granted retrospectively; therefore, the submission would not be accepted for publication.

How can researchers obtain ethics approval?

Research ethics boards have a standardized application process. UBC uses an online platform called Research Information Systems (RISe) to track applications, amendments, and annual renewals. Ethics boards generally allow for two levels of review depending on the type of study: delegated review (subcommittee review of studies deemed minimal risk) and full review (anything beyond minimal risk). The timeline for review and approval can vary due to committee schedules and the number of revisions required, but it may take anywhere from days to months. Researchers affiliated with UBC can get started at www.rise.ubc.ca/guidance-notes-and-tutorials .

Acknowledgments

Dr Dunne would like to thank Ms Jennie Prasad and Dr Marc Levine of the BC Women’s and Children’s Hospital Research Ethics Board for their editorial input on this article. —Caitlin Dunne, MD, FRCSC

1.    UBC Office of Research Ethics. UBC clinical research ethics general guidance notes. Accessed 22 March 2021. https://ethics.research.ubc.ca/ore/ubc-clinical-research-ethics-general-guidance-notes#A1 .

2.    Hyer CF. What is an IRB, why do we need it, and what is a private IRB? Foot Ankle Spec 2010;3:91-94.

3.    Shuster E. Fifty years later: The significance of the Nuremberg Code. N Engl J Med 1997;337:1436-1440.

4.    World Medical Association. World Medical Association declaration of Helsinki: Ethical principles for medical research involving human subjects. JAMA 2013;310:2191-2194.

5.    Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council. Tri-Council policy statement ethical conduct for research involving humans. 2018. Accessed 21 March 2021. https://ethics.gc.ca/eng/documents/tcps2-2018-en-interactive-final.pdf .

6.    Panel on Research Ethics. TPS2: CORE – tutorial. Accessed 21 March 2021. http://tcps2core.ca/welcome .

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Caitlin Dunne, MD, FRCSC. Research ethics board approval: What, why, when, how?. BCMJ, Vol. 63, No. 4, May, 2021, Page(s) 149 - Editorials .

Above is the information needed to cite this article in your paper or presentation. The International Committee of Medical Journal Editors (ICMJE) recommends the following citation style, which is the now nearly universally accepted citation style for scientific papers: Halpern SD, Ubel PA, Caplan AL, Marion DW, Palmer AM, Schiding JK, et al. Solid-organ transplantation in HIV-infected patients. N Engl J Med. 2002;347:284-7.

About the ICMJE and citation styles

The ICMJE is small group of editors of general medical journals who first met informally in Vancouver, British Columbia, in 1978 to establish guidelines for the format of manuscripts submitted to their journals. The group became known as the Vancouver Group. Its requirements for manuscripts, including formats for bibliographic references developed by the U.S. National Library of Medicine (NLM), were first published in 1979. The Vancouver Group expanded and evolved into the International Committee of Medical Journal Editors (ICMJE), which meets annually. The ICMJE created the Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals to help authors and editors create and distribute accurate, clear, easily accessible reports of biomedical studies.

An alternate version of ICMJE style is to additionally list the month an issue number, but since most journals use continuous pagination, the shorter form provides sufficient information to locate the reference. The NLM now lists all authors.

BCMJ standard citation style is a slight modification of the ICMJE/NLM style, as follows:

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  • There is no period after the journal name.
  • Page numbers are not abbreviated.

For more information on the ICMJE Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals, visit www.icmje.org

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Evidence-Based Practice Group answers clinical questions

Evidence-Based Practice Group answers clinical questions

  • Office of Research Ethics
  • About Human Research Ethics /

Ethics Boards

Research Ethics Boards (REBs) are independent committees established by the University and in partnership with its affiliated hospitals and research institutes.

Acting on behalf of these institutions, REBs are authorized to review the ethical acceptability of research and to approve, reject, propose modifications to, or terminate any proposed or ongoing research involving human participants. 

There are three UBC REBs and three Affiliated REBs. The UBC REBs are the Clinical REB (CREB), the UBC-Vancouver Behavioural REB (BREB), and the UBC-Okanagan REB (BREB). The three UBC Affiliated REBs are BC Cancer REB, Children’s and Women’s REB, and Providence Health Care REB. UBC researchers can submit their ethics applications to any one of these REBs in order to use any of the sites covered by these boards. Multiple ethics approvals are not required

UBC’s REBs are independent of the parent institution(s) in their decision-making, and they are required to operate free of inappropriate influence, including situations of real, potential or perceived conflict of interest. The parent institution(s) may not override REB decisions concerning the ethical acceptability of a study.

UBC’s REBs meet all requisite criteria for an authorized research ethics board, pursuant to the Tri-Council Policy Statement (TCPS2 2014), the International Conference on Harmonization Good Clinical Practice Guidelines (ICH-GCP) and the requirements of the US Department of Health and Human Services, as set out in the Federal Policy for the Protection of Human Subjects, 45CFR Part 46, sub-part A. 

The mandate of the REBs at UBC is:

"To assist the University and its affiliated hospitals and agencies to create a research environment in which human subjects are protected and to ensure responsibilities are discharged according to the relevant ethical standards, by promoting awareness of research ethics amongst faculty, staff and students, by independently reviewing research studies in accordance with the guiding ethical principles of the Tri-Council Policy Statement, and to put into place mechanisms for the protection of human participants in ongoing research conducted under the auspices of the University of British Columbia."

The BREB reviews behavioural and social science/humanities research, and research that may involve the study of patients or health care providers. Behavioural studies do not involve the use of invasive procedures. They do include research involving interviews, observations, and the administration of questionnaires and tests.

Maria Valente,  BREB Research Ethics Review Officer The BREB Review Coordinator advises researchers on BREB policies and expectations, and coordinates the review of applications. 604-827-5112 | [email protected]  

Anita Lillquist, BREB Review Coordinator The BREB Review Coordinator advises researchers on BREB policies and expectations, and coordinates the review of applications. 604-827-5597 | [email protected]

Leah Meanwell,  Jr. Research Ethics Review Coordinator-Behavioural The BREB Jr. Research Ethics Review Coordinator advises researchers on BREB policies and expectations, and coordinates the review of post-approval activities for behavioural applications. [email protected]  

Wendy Bond,  Research Ethics Coordinator, Compliance & Outreach The Research Ethics Coordinator advises researchers on BREB policies and expectations, assists in the review of applications, and maintains the BREB website, in addition to compliance responsibilities. 604-822-4581 |  [email protected]

UBC Behavioural Research Ethics Office #102, Technology Enterprise Facility III 6190 Agronomy Road Campus map Vancouver, BC V6T 1Z3 Fax: 604-822-5093

Reviews research involving clinical interventions such as the testing of drugs, medical devices and rehabilitation exercise programs, and/or the analysis of clinical data obtained from medical records or studies of a clinical nature involving the linkage of data from existing databases.

Reviews clinical research conducted at Vancouver Coastal Health Authority sites, including UBC Hospital, Vancouver General Hospital and GF Strong.

Pia Ganz,  CREB Manager The CREB Manager oversees the functioning of the CREB staff and Board, monitors ethical review process standards, and advises on compliance with ethics policies.  604-875-4149 |  [email protected]

Elmira Chan,  Pre-Post Review Manager The CREB Pre-Post Review Manager is responsible for managing the review of new minimal risk and full board applications and associated deferral/proviso responses, post-approval activities, and general inquiries.  604-875-4111 ext. 68918 |  [email protected]

Freda Tom,  Research Ethics Coordinator The CREB Ethics Review Coordinator is responsible for the review of new minimal risk and full board applications and associated deferral/proviso responses, post-approval activities, and general inquiries.  604-875-4111 ext. 68919 | [email protected]

Sarah Flann,  Research Ethics Coordinator The CREB Ethics Review Coordinator is responsible for the review of new minimal risk and full board applications and associated deferral/proviso responses, post-approval activities, and general inquiries.  604-875-4111 ext. 68919 | [email protected]

Svitlana Franchuk,  Administrative Assistant The CREB Administrative Assistant is responsible for handling incoming general inquiries, minimal risk post-approval activities, SAEs, and fee payment.  604-875-4111 ext. 68917 |  [email protected]

UBC Clinical Research Ethics Office Room 210, Research Pavilion 828 West 10th Avenue  Google Map   Vancouver, BC V5Z 1M9

The Okanagan REB reviews behavioural research conducted by investigators on the Okanagan campus that would otherwise be reviewed by the UBC Behavioural REB. Please check the board website for exact details regarding meeting dates and submission deadlines. 

Lisa Shearer,  Manager, Administration and Compliance The Associate Manager deals with general inquiries regarding research ethics and coordinates the review of applications. 250-807-8289 |  [email protected]

BC Cancer Research Ethics oversees ethical conduct and decision making in clinical and behavioural adult oncology research projects at BC Cancer that use human materials and information. Visit the Board webpage for details on meeting dates and submission deadlines.

Jessica Gagliardi,  Director, BC Cancer Research Ethics Queries relating to compliance with local, national, and international policies and legislation; activities, procedures and direction of Research Ethics administration; ethics or integrity queries or concerns; and training.  604-877-6284 |  [email protected]

The BCC REB Officers respond to queries relating to pre-review of all full board and delegated/minimal risk; and, post-review documentation of all full board REB decisions (e.g., deferrals, provisos, amendments, and renewals). Contact them at  [email protected] .

The UBC Children’s and Women’s REB reviews both clinical and behavioural research taking place at BC Children’s Hospital, BC Women’s Hospital, BC Mental Health and Addiction Services and their affiliated research institutes.  The REB also reviews research taking place under the auspices of PHSA not covered by any of the other UBC REBs.  Visit the Board webpage for details on meeting dates and submission deadlines.

Jennie Prasad,  C&W REB Manager 604-875-2441 |  [email protected] Jennie oversees the functioning of the REB staff and Board, monitors ethical review process standards and advises on compliance with ethics policies.

Farin Meralli,  Research Ethics & Regulatory Specialist Farin is responsible for the review of new full-board and minimal risk applications and associated deferral/proviso responses and general inquiries. 604-875-2000 ext. 5396 |  [email protected]

Talysa Dhahan,  C&W REB Administrative Coordinator  Talysa is responsible for handling incoming general inquiries, post-approval activities, institutional approvals, and fee payment.. 604-875-3103 |  [email protected]

The Providence Health Care REB reviews research being conducted at Providence Health Care sites, including St Paul’s Hospital, Mount Saint Joseph Hospital, St Vincent’s Hospitals, Holy Family Hospital, Youville Residence and Marion Hospice. Visit the Board webpage for details on meeting dates and submission deadlines.

Julie Hadden,  PHC REB Manager, Ethical Reviews Contact Julie for queries relating to policies, standards, REB administration inquiries. 604-682-2344 ext. 63496 |  j [email protected]

Alex Trethewey,  PHC REB Manager, Pre and Post Review Contact Alex for queries relating to pre-review of applications, post-review documentation of REB decisions, post-approval activities and general inquiries.  604-806-8567 |  alex.trethewey@u bc.ca

Paula Piper, Research Ethics Coordinator [email protected]

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Methodology

  • Ethical Considerations in Research | Types & Examples

Ethical Considerations in Research | Types & Examples

Published on October 18, 2021 by Pritha Bhandari . Revised on June 22, 2023.

Ethical considerations in research are a set of principles that guide your research designs and practices. Scientists and researchers must always adhere to a certain code of conduct when collecting data from people.

The goals of human research often include understanding real-life phenomena, studying effective treatments, investigating behaviors, and improving lives in other ways. What you decide to research and how you conduct that research involve key ethical considerations.

These considerations work to

  • protect the rights of research participants
  • enhance research validity
  • maintain scientific or academic integrity

Table of contents

Why do research ethics matter, getting ethical approval for your study, types of ethical issues, voluntary participation, informed consent, confidentiality, potential for harm, results communication, examples of ethical failures, other interesting articles, frequently asked questions about research ethics.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe for research subjects.

You’ll balance pursuing important research objectives with using ethical research methods and procedures. It’s always necessary to prevent permanent or excessive harm to participants, whether inadvertent or not.

Defying research ethics will also lower the credibility of your research because it’s hard for others to trust your data if your methods are morally questionable.

Even if a research idea is valuable to society, it doesn’t justify violating the human rights or dignity of your study participants.

Prevent plagiarism. Run a free check.

Before you start any study involving data collection with people, you’ll submit your research proposal to an institutional review board (IRB) .

An IRB is a committee that checks whether your research aims and research design are ethically acceptable and follow your institution’s code of conduct. They check that your research materials and procedures are up to code.

If successful, you’ll receive IRB approval, and you can begin collecting data according to the approved procedures. If you want to make any changes to your procedures or materials, you’ll need to submit a modification application to the IRB for approval.

If unsuccessful, you may be asked to re-submit with modifications or your research proposal may receive a rejection. To get IRB approval, it’s important to explicitly note how you’ll tackle each of the ethical issues that may arise in your study.

There are several ethical issues you should always pay attention to in your research design, and these issues can overlap with each other.

You’ll usually outline ways you’ll deal with each issue in your research proposal if you plan to collect data from participants.

Voluntary participation means that all research subjects are free to choose to participate without any pressure or coercion.

All participants are able to withdraw from, or leave, the study at any point without feeling an obligation to continue. Your participants don’t need to provide a reason for leaving the study.

It’s important to make it clear to participants that there are no negative consequences or repercussions to their refusal to participate. After all, they’re taking the time to help you in the research process , so you should respect their decisions without trying to change their minds.

Voluntary participation is an ethical principle protected by international law and many scientific codes of conduct.

Take special care to ensure there’s no pressure on participants when you’re working with vulnerable groups of people who may find it hard to stop the study even when they want to.

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Informed consent refers to a situation in which all potential participants receive and understand all the information they need to decide whether they want to participate. This includes information about the study’s benefits, risks, funding, and institutional approval.

You make sure to provide all potential participants with all the relevant information about

  • what the study is about
  • the risks and benefits of taking part
  • how long the study will take
  • your supervisor’s contact information and the institution’s approval number

Usually, you’ll provide participants with a text for them to read and ask them if they have any questions. If they agree to participate, they can sign or initial the consent form. Note that this may not be sufficient for informed consent when you work with particularly vulnerable groups of people.

If you’re collecting data from people with low literacy, make sure to verbally explain the consent form to them before they agree to participate.

For participants with very limited English proficiency, you should always translate the study materials or work with an interpreter so they have all the information in their first language.

In research with children, you’ll often need informed permission for their participation from their parents or guardians. Although children cannot give informed consent, it’s best to also ask for their assent (agreement) to participate, depending on their age and maturity level.

Anonymity means that you don’t know who the participants are and you can’t link any individual participant to their data.

You can only guarantee anonymity by not collecting any personally identifying information—for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, and videos.

In many cases, it may be impossible to truly anonymize data collection . For example, data collected in person or by phone cannot be considered fully anonymous because some personal identifiers (demographic information or phone numbers) are impossible to hide.

You’ll also need to collect some identifying information if you give your participants the option to withdraw their data at a later stage.

Data pseudonymization is an alternative method where you replace identifying information about participants with pseudonymous, or fake, identifiers. The data can still be linked to participants but it’s harder to do so because you separate personal information from the study data.

Confidentiality means that you know who the participants are, but you remove all identifying information from your report.

All participants have a right to privacy, so you should protect their personal data for as long as you store or use it. Even when you can’t collect data anonymously, you should secure confidentiality whenever you can.

Some research designs aren’t conducive to confidentiality, but it’s important to make all attempts and inform participants of the risks involved.

As a researcher, you have to consider all possible sources of harm to participants. Harm can come in many different forms.

  • Psychological harm: Sensitive questions or tasks may trigger negative emotions such as shame or anxiety.
  • Social harm: Participation can involve social risks, public embarrassment, or stigma.
  • Physical harm: Pain or injury can result from the study procedures.
  • Legal harm: Reporting sensitive data could lead to legal risks or a breach of privacy.

It’s best to consider every possible source of harm in your study as well as concrete ways to mitigate them. Involve your supervisor to discuss steps for harm reduction.

Make sure to disclose all possible risks of harm to participants before the study to get informed consent. If there is a risk of harm, prepare to provide participants with resources or counseling or medical services if needed.

Some of these questions may bring up negative emotions, so you inform participants about the sensitive nature of the survey and assure them that their responses will be confidential.

The way you communicate your research results can sometimes involve ethical issues. Good science communication is honest, reliable, and credible. It’s best to make your results as transparent as possible.

Take steps to actively avoid plagiarism and research misconduct wherever possible.

Plagiarism means submitting others’ works as your own. Although it can be unintentional, copying someone else’s work without proper credit amounts to stealing. It’s an ethical problem in research communication because you may benefit by harming other researchers.

Self-plagiarism is when you republish or re-submit parts of your own papers or reports without properly citing your original work.

This is problematic because you may benefit from presenting your ideas as new and original even though they’ve already been published elsewhere in the past. You may also be infringing on your previous publisher’s copyright, violating an ethical code, or wasting time and resources by doing so.

In extreme cases of self-plagiarism, entire datasets or papers are sometimes duplicated. These are major ethical violations because they can skew research findings if taken as original data.

You notice that two published studies have similar characteristics even though they are from different years. Their sample sizes, locations, treatments, and results are highly similar, and the studies share one author in common.

Research misconduct

Research misconduct means making up or falsifying data, manipulating data analyses, or misrepresenting results in research reports. It’s a form of academic fraud.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement about data analyses.

Research misconduct is a serious ethical issue because it can undermine academic integrity and institutional credibility. It leads to a waste of funding and resources that could have been used for alternative research.

Later investigations revealed that they fabricated and manipulated their data to show a nonexistent link between vaccines and autism. Wakefield also neglected to disclose important conflicts of interest, and his medical license was taken away.

This fraudulent work sparked vaccine hesitancy among parents and caregivers. The rate of MMR vaccinations in children fell sharply, and measles outbreaks became more common due to a lack of herd immunity.

Research scandals with ethical failures are littered throughout history, but some took place not that long ago.

Some scientists in positions of power have historically mistreated or even abused research participants to investigate research problems at any cost. These participants were prisoners, under their care, or otherwise trusted them to treat them with dignity.

To demonstrate the importance of research ethics, we’ll briefly review two research studies that violated human rights in modern history.

These experiments were inhumane and resulted in trauma, permanent disabilities, or death in many cases.

After some Nazi doctors were put on trial for their crimes, the Nuremberg Code of research ethics for human experimentation was developed in 1947 to establish a new standard for human experimentation in medical research.

In reality, the actual goal was to study the effects of the disease when left untreated, and the researchers never informed participants about their diagnoses or the research aims.

Although participants experienced severe health problems, including blindness and other complications, the researchers only pretended to provide medical care.

When treatment became possible in 1943, 11 years after the study began, none of the participants were offered it, despite their health conditions and high risk of death.

Ethical failures like these resulted in severe harm to participants, wasted resources, and lower trust in science and scientists. This is why all research institutions have strict ethical guidelines for performing research.

If you want to know more about statistics , methodology , or research bias , make sure to check out some of our other articles with explanations and examples.

  • Normal distribution
  • Measures of central tendency
  • Chi square tests
  • Confidence interval
  • Quartiles & Quantiles
  • Cluster sampling
  • Stratified sampling
  • Thematic analysis
  • Cohort study
  • Peer review
  • Ethnography

Research bias

  • Implicit bias
  • Cognitive bias
  • Conformity bias
  • Hawthorne effect
  • Availability heuristic
  • Attrition bias
  • Social desirability bias

Ethical considerations in research are a set of principles that guide your research designs and practices. These principles include voluntary participation, informed consent, anonymity, confidentiality, potential for harm, and results communication.

Scientists and researchers must always adhere to a certain code of conduct when collecting data from others .

These considerations protect the rights of research participants, enhance research validity , and maintain scientific integrity.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe.

Anonymity means you don’t know who the participants are, while confidentiality means you know who they are but remove identifying information from your research report. Both are important ethical considerations .

You can only guarantee anonymity by not collecting any personally identifying information—for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, or videos.

You can keep data confidential by using aggregate information in your research report, so that you only refer to groups of participants rather than individuals.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement but a serious ethical failure.

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Principles and Practice of Clinical Trials pp 1–22 Cite as

Institutional Review Boards and Ethics Committees

  • Keren R. Dunn 3  
  • Living reference work entry
  • First Online: 06 January 2022

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Institutional review boards (IRBs) are committees established in accordance with US federal regulations to review and monitor clinical trials and other research with human subjects. IRBs evolved from a history of egregious ethical violations in research with human subjects and the ethics codes and declarations that ensued, and were first mandated by US law in 1974, with the passing of the National Research Act. IRBs help to ensure the protection of the rights and welfare of human subjects by applying the ethical principles of the Belmont Report, respect for persons, beneficence, and justice, in their review of research projects. They have the authority to approve, require modifications to, or disapprove proposed research. IRBs review plans to obtain and document informed consent from research participants and can waive the requirements for informed consent in certain circumstances. IRBs may exist within the institution where research is being conducted or institutions can rely on an external IRB with a written agreement. While the term IRB is unique to the USA, clinical trials internationally adhere to the ethical principles of the Declaration of Helsinki, which requires independent review by an ethics committee.

  • Institutional review board
  • Ethics committee
  • Belmont Report
  • Common Rule
  • Informed consent

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Menikoff J, Kaneshiro J, Pritchard I (2017) The common rule, updated. N Engl J Med 375:613–615. https://doi.org/10.1056/NEJMp1700736

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Dunn, K.R. (2021). Institutional Review Boards and Ethics Committees. In: Piantadosi, S., Meinert, C.L. (eds) Principles and Practice of Clinical Trials. Springer, Cham. https://doi.org/10.1007/978-3-319-52677-5_65-1

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Improving the process of research ethics review

  • Stacey A. Page   ORCID: orcid.org/0000-0001-6494-3671 1 , 2 &
  • Jeffrey Nyeboer 3  

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Research Ethics Boards, or Institutional Review Boards, protect the safety and welfare of human research participants. These bodies are responsible for providing an independent evaluation of proposed research studies, ultimately ensuring that the research does not proceed unless standards and regulations are met.

Concurrent with the growing volume of human participant research, the workload and responsibilities of Research Ethics Boards (REBs) have continued to increase. Dissatisfaction with the review process, particularly the time interval from submission to decision, is common within the research community, but there has been little systematic effort to examine REB processes that may contribute to inefficiencies. We offer a model illustrating REB workflow, stakeholders, and accountabilities.

Better understanding of the components of the research ethics review will allow performance targets to be set, problems identified, and solutions developed, ultimately improving the process.

Peer Review reports

Instances of research misconduct and abuse of research participants have established the need for research ethics oversight to protect the rights and welfare of study participants and the integrity of the research enterprise [ 1 , 2 ]. In response to such egregious events, national and international regulations have emerged that are intended to protect research participants (e.g. [ 3 , 4 , 5 ]).

Research Ethics Boards (REBs) also known as Institutional Review Boards (IRBs) and Research Ethics Committees (RECs) are charged with ensuring that research is planned and conducted in accordance with such laws and regulatory standards. In protecting the rights and welfare of participants, REBs must weigh possible harms to individuals against the plausible societal benefits of the research. They must ensure fair participant selection and, where applicable, confirm that appropriate provisions are in place for obtaining participant consent.

REBs often operate under the auspices of post-secondary institutions. Larger universities may support multiple REBs that serve different research areas, such as medical and health research and social science, psychology, and humanities research. Boards are constituted of people from a variety of backgrounds, each of whom contributes specific expertise to review and discussions. Members are appointed to the Board through established institutional practice. Nevertheless, most Board members bring a sincere interest and commitment to their roles. For university Faculty, Board membership may fulfil a service requirement that is part of their academic responsibilities.

The Canadian Tri-Council Policy Statement (TCPS2) advances a voluntary, self-governing model for REBs and institutions. The TCPS2 is a joint policy of Canada’s three federal research agencies (Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council), and institutional and researcher adherence to the policy standards is a condition of funding. Recognizing the independence of REBs in their decision-making, institutions are required to support their functioning. Central to the agreement is that institutions conducting research must establish an REB and ensure that it has the “necessary and sufficient ongoing financial and administrative resources” to fulfil its duties (TCPS2 [ 3 ] p. 68). A similar requirement for support of IRB functioning is included in the US Common Rule (45 CFR 46.103 [ 5 ]). The operationalization of “necessary and sufficient” is subjective and likely to vary widely. To the extent that the desired outcomes (i.e. timely reviews and approvals) depend on the allocation of these resources, they too will vary.

Time and research ethics review

From the academic hallways to the literature, characterizations of REBs and the research ethics review process are seldom complimentary. While numerous criticisms have been levelled, it is the time to decision that is most consistently maligned [ 6 , 7 , 8 , 9 , 10 , 11 ].

Factors associated with lengthy review time include incomplete or poorly completed applications [ 7 , 12 , 13 ], lack of administrative support [ 14 ], inadequately trained REB members [ 15 ], REB member competing commitments, expanding oversight requirements, and the sheer volume of applications [ 16 , 17 , 18 ]. Nevertheless, objective data on the inner workings of REBs are lacking [ 6 , 19 , 20 ].

Consequences of slow review times include centres’ withdrawing from multisite trials or limiting their participation in available trials [ 21 , 22 ], loss of needed research resources [ 23 ], and recruitment challenges in studies dependent on seasonal factors [ 24 ]. Lengthy time to study approval may ultimately delay patient access to potentially effective therapies [ 8 ].

Some jurisdictions have moved to regionalize or consolidate ethics review, using a centralized ethics review of protocols conducted on several sites. This enhances review efficiency for multisite research by removing the need for repeating reviews across centres [ 9 , 25 , 26 , 27 , 28 ]. Recommendations for systemic improvement include better standardization of review practices, enhanced training for REB members, and requiring accreditation of review boards [ 9 ].

The research ethics review processes are not well understood, and no gold standard exists against which to evaluate board practices [ 19 , 20 ]. Consequently, there is little information on how REBs may systematically improve their methods and outcomes. This paper presents a model based on stakeholder responsibilities in the process of research ethics review and illustrates how each makes contributions to the time an application spends in this process. This model focusses on REBs operating under the auspices of academic institutions, typical in Canada and the USA.

Modelling the research ethics review process

The research ethics review process may appear to some like the proverbial black box. An application is submitted and considered and a decision is made:

SUBMIT > REVIEW > DECISION

In reality, the first step to understanding and improving the process is recognizing that research ethics review involves more than just the REB. Contributing to the overall efficiency—or inefficiency—of the review are other stakeholders and their roles in the development and submission of the application and the subsequent movement of the application back and forth between PIs, administrative staff, reviewers, the Board, and the Chair, until ideally the application is deemed ready for approval.

Identifying how a research ethics review progresses permits better understanding of the workflow, including the administrative and technological supports, roles, and responsibilities. The goal is to determine where challenges in the system exist so they can be remediated and efficiencies gained.

One way of understanding details of the process is to model it. We have used a modelling approach based in part on a method advanced by Ishikawa and further developed by the second author (JN) [ 29 , 30 ]. Traditionally, the Ishikawa “fishbone” or cause and effect diagram has been used to represent the components of a manufacturing enterprise and its application facilitates understanding how the elements of an operation may cause inefficiencies. This modelling provides a means of analysing process dispersion (e.g. who is accountable for what specific outcomes) and is frequently used when trying to understand time delays in undertakings.

In our model (Fig.  1 ), “Categories” represent key role actions that trigger a subsequent series of work activities. The “Artefacts” are the products resulting from a set of completed activities and reflect staged movement in the process. Implicit in the model is a temporal sequence and the passage of time, represented by the arrows.

Basic business activity model

Applying this strategy to facilitate understanding of time delays in ethics review requires that the problem (i.e. time) be considered in the context of all stakeholders. This includes those involved in the development and submission of the application, those involved in the administrative movement of the application through the system, those involved in the substantive consideration and deliberation of the application, and those involved in the final decision-making.

The model developed (Fig.  2 ) was based primarily on a review of the lead author’s (SP) institution’s REB application process. The model is generally consistent with the process and practices of several other REBs with which she has had experience over the past 20 years.

Research ethics activity model

What this model illustrates is that the research ethics review process is complex. There are numerous stakeholders involved, each of whom bears a portion of the responsibility for an application’s time in the system. The model illustrates a temporal sequence of events where, ideally, the movement of an application is unidirectional, left to right. Time is lost when applications stall or backflow in the process.

Stakeholders, accountabilities, and the research ethics review model

There are four main stakeholder groups in the research ethics review process: researchers/research teams, research ethics unit administrative staff, REB members, and the institution. Each plays a role in the transit of an application through the process and how well they undertake their role responsibilities affects the time that the application takes to move through. Table  1 presents a summary of recommendations for best practices.

Researchers

The researcher initiates the process of research ethics review by developing a proposal involving human participants and submitting an application. Across standards, the principal investigator is accountable for the conduct of the study, including adherence to research ethics requirements. Such standards are readily available both from the source (e.g. Panel on Research Ethics [Canada], National Institutes of Health [USA], Food and Drug Administration [USA]) and, typically, through institutional websites. Researchers have an obligation to be familiar with the rules for human participant research. Developing a sound proposal where ethics requirements are met at the outset places the application in a good position at the time of submission. Researchers are accountable for delays in review when ethical standards are not met and the application must be returned for revision. Tracking the reasons for return permits solutions, such as targeted educational activities, to be developed.

Core issues that investigators can address in the development of their applications include an ethical recruitment strategy, a sound consent process, and application of relevant privacy standards and legislation. Most research ethics units associated with institutions maintain websites where key information and resources may be found, such as consent templates, privacy standards, “frequently asked questions,” and application submission checklists [ 31 , 32 , 33 ]. Moreover, consulting with the REB in advance of submission may help researchers to prevent potentially challenging issues [ 15 ]. Investigators who are diligent in knowing about and applying required standards will experience fewer requests for revision and fewer stalls or backtracking once their applications are submitted. Some have suggested that researchers should be required, rather than merely expected, to have an understanding of legal and ethics standards before they are even permitted to submit an application [ 19 ].

The scholarly integrity of proposed research is an essential element of ethically acceptable human participant research. Researchers must be knowledgeable about the relevant scientific literature and present proposals that are justified based on what is known and where knowledge gaps exist. Research methods must be appropriate to the question and studies adequately powered. Novice or inexperienced researchers whose protocols have not undergone formal peer review (e.g. via supervisory committees, internal peer review committees, or competitive grant reviews) should seek consultation and informal peer review prior to ethics review to ensure the scientific validity of their proposals. While it is within the purview of REBs to question methods and design, it is not their primary mandate. Using REB resources for science review is an opportunity cost that can compromise efficient ethics review.

Finally, researchers are advised to review and proof their applications prior to submission to ensure that all required components have been addressed and the information in the application and supporting documents (e.g. consent forms, protocol) is consistent. Missing or discrepant information is causal to application return and therefore to time lost [ 7 ].

Administrators

Prior to submission, administrators may be the first point of contact for researchers seeking assistance with application requirements. Subsequently, they are often responsible for undertaking a preliminary, screening review of applications to make sure they are complete, with all required supporting documents and approvals in place. Once an application is complete, the administrative staff assign it to a reviewer. The reviewer may be a Board member or a subject-matter expert accountable to the Board.

Initial consultation and screening activities work best when staff have good knowledge of both institutional application requirements and ethics standards. Administrative checklists are useful tools to help ensure consistent application of standards in this preliminary application review. Poorly screened applications that reach reviewers may be delayed if the application must be returned to the administrator or the researcher for repair.

Reviewers typically send their completed reviews back to the administrators. In turn, the administrators either forward the applications to the Chair to consider (i.e. for delegated approval) or to a Board meeting agenda. In addition to ensuring that applications are complete, administrators may be accountable for monitoring how long a file is out for review. When reviews are delayed or incomplete for any reason, administrators may need to reassign the file to a different reviewer.

Administrators are therefore key players in the ethics review process, as they may be both initial resources for researchers and subsequently facilitate communication between researchers and Board members. Moreover, given past experience with both research teams and reviewers, they may be aware of areas where applicants struggle and when applications or reviews are likely to be deficient or delinquent. Actively tracking such patterns in the review process may reveal problems to which solutions can be developed. For example, applications consistently deficient in a specific area may signal the need for educational outreach and reviews that are consistently submitted late may provide impetus to recruit new Board members or reviewers.

REB members

The primary responsibility for evaluating the substantive ethics issues in applications and how they are managed rests with the REB members and the Chair. The Board may approve applications, approve pending modifications, or reject them based on their compliance with standards and regulations.

Like administrators, an REB member’s efficiency and review quality are enhanced by the use of standard tools, in this case standardized review templates, intended to guide reviewers and Board members to address a consistent set of criteria. Where possible, matching members’ expertise to the application to be reviewed also contributes to timely, good quality reviews.

REB functioning is enhanced with ongoing member training and education, yielding consistent, efficient application of ethics principles and regulatory standards [ 15 ]. This may be undertaken in a variety of ways, including Board member retreats, regular circulation of current articles, and attending presentations and conferences. REB Chairs are accountable to ensure consistency in the decisions made by the Board (TCPS 2014, Article 6.8). This demands that Chairs thoroughly understand ethical principles and regulatory standards and that they maintain awareness of previous decisions. Much time can be spent at Board meetings covering old ground. The use of REB decision banks has been recommended as a means of systematizing a record of precedents, thus contributing to overall quality improvement [ 34 ].

Institution

Where research ethics review takes place under the auspices of an academic institution, the institutions must typically take responsibility to adequately support the functioning of their Boards and promote a positive culture of research ethics [ 3 , 5 ]. Supporting the financial and human resource costs of participating in ongoing education (e.g. retreats, speakers, workshops, conferences) is therefore the responsibility of the institution.

Operating an REB is costly [ 35 ]. It is reasonable to assume that there is a relationship between the adequacy of resources allocated to the workload and flow and the time to an REB decision. Studies have demonstrated wide variability in times to determination [ 8 , 9 , 10 , 22 ]. However, comparisons are difficult to make because of confounding factors such as application volume, number of staff, number of REB members, application quality, application type (e.g. paper vs. electronic), and protocol complexity. Despite these variables, it appears that setting a modal target turnaround time of 6 weeks (±2 weeks) is reasonable and in line with the targets set in the European Union and the UK’s National Health Service [ 36 , 37 ]. Tracking the time spent at each step in the model may reveal where applications are typically delayed for long periods and may be indicative of areas where more resources need to be allocated or workflows redesigned.

As institutions grow their volumes of research, workloads correspondingly increase for institutional REBs. To maintain service levels, institutions need to ensure that resources allocated to REBs match the volume and intensity of work. Benchmarking costs (primarily human resources) relative to the number of applications and time to a decision will help to inform the allocation of resources needed to maintain desired service levels.

Finally, most REB members typically volunteer their Board services to the institution. Despite their good-faith intent to serve, Board members occasionally find that researchers view them as obstacles to or adversaries in the research enterprise. Board members may believe that researchers do not value the time and effort they contribute to review, while researchers may believe the REB and its members are unreasonable, obstructive, and a “thorn in their side” [ 15 ]. Clearly, relationships can be improved. Nevertheless, improving the timeliness and efficiency of research ethics review should help to soothe fevered brows on both sides of the issue.

Upshur [ 12 ] has previously noted that the contributions to research ethics such as Board membership and application review need to be accorded the same academic prestige as serving on peer review grant panels and editorial boards and undertaking manuscript reviews. In doing so, institutions will help to facilitate a culture of respect for, and shared commitment to, research ethics review, which may only benefit the process.

The activities, roles, and responsibilities identified in the ethics review model illustrate that it is a complex activity and that “the REB” is not a single entity. Multiple stakeholders each bear a portion of the accountability for how smoothly a research ethics application moves through the process. Time is used most efficiently when forward momentum is maintained and the application advances. Delays occur when the artefact (i.e. either the application or the application review) is not advanced as the accountable stakeholders fail to discharge their responsibilities or when the artefact fails to meet a standard and it is sent back. Ensuring that all stakeholders understand and are able to operationalize their responsibilities is essential. Success depends in part on the institutional context, where standards and expectations should be well communicated, and resources like education and administrative support provided, so that capacity to execute responsibilities is assured.

Applying this model will assist in identifying activities, accountabilities, and baseline performance levels. This information will contribute to improving local practice when deficiencies are identified and solutions implemented, such as training opportunities or reduction in duplicate activities. It will also facilitate monitoring as operational improvements over baseline performance could be measured. Where activities and benchmarks are well defined and consistent, comparisons both within and across REBs can be made.

Finally, this paper focused primarily on administrative efficiency in the context of research ethics review time. However, the identified problems and their suggested solutions would contribute not only to enhanced timeliness of review but also to enhanced quality of review and therefore human participant protection.

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Acknowledgements

The authors would like to thank Dr. Michael C. King for his review of the manuscript draft.

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The listed authors (SP, JN) have each undertaken the following: made substantial contributions to conception and design of the model; been involved in drafting the manuscript; have read and given final approval of the version to be published and participated sufficiently in the work to take public responsibility for appropriate portions of the content; and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

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SP is the Chair of the Conjoint Health Research Ethics Board at the University of Calgary. She is also a member of the Human Research Ethics Board at Mount Royal University and a member of the Research Ethics Board at the Alberta College of Art and Design. She serves on the Board of Directors for the Canadian Association of Research Ethics Boards.

JN is an Executive Technology Consultant specializing in Enterprise and Business Architecture. He has worked on process improvement initiatives across multiple industries as well as on the delivery of technology-based solutions. He was the project manager for the delivery of the IRISS online system for the Province of Alberta’s Health Research Ethics Harmonization initiative.

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The authors declare that they have no competing interests.

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Research Ethics Board

Our Research Ethics Program is responsible for the ethical and regulatory compliance of research that involves human subjects. We are committed to protecting the rights and welfare of subjects enrolled in its research activities.

As a result, in 2009 the PSI Board of Directors established a Research Ethics Board (REB) to review all human subjects research conducted by us or under our direction.

PSI maintains a Federalwide Assurance (FWA) with the U.S. Department of Health and Human Services’ Office for Human Research Protections (OHRP), and our REB is registered with OHRP.

Submission Information

Our REB accepts complete submissions on a rolling basis. A submission determined to be minimal risk will be reviewed immediately. Those determined to be more than minimal risk will be reviewed by the full board.

Since the overwhelming majority of the submissions to the REB meet the regulatory criteria for expedited approval, our REB convenes on an as-needed basis. If a submission is found to require a full board review, the REB Manager will convene the board within four weeks of submission.

Determining if an activity requires ethical review

Is my activity research? Does my activity require ethical review? We is involved in activity X, but we’re not recruiting participants, do we need ethical review?

These are common questions posed by our staff and researchers. Our Research Ethics Program has developed the following guidance to help staff determine when activities are required to receive ethical review and guidance on questions to consider at this stage of the process.

  • Our guidelines for deciding whether an activity requires REB review
  • Is my activity research? A decision tree
  • Request for determination of research or non research
  • Questions to answer before developing a submission for ethical review

Pre-submission: Understanding the REB review process and preparing a complete package

Understanding our REB review process and elements of a complete submission are key to an efficient and quality review. Our Research Ethics Program developed the following documents to provide detailed explanation on the review process, training requirements for key personnel and how to prepare a complete packet for our REB.

  • Research ethics board review process and timeline
  • Training requirements for key personnel
  • Preparing a complete packet for the REB

REB forms and instructions

The REB requires the completion of the appropriate forms for new submissions, modification requests and continuing review applications.

  • Cover sheet for new submission
  • Instructions for completing the REB cover sheet for new submission
  • Modification form
  • Modification procedures and submission instructions
  • Continuing review form
  • Continuing review procedures and submission instructions
  • Reportable event form
  • Reportable event procedures and submission instructions

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Digitally Signposting to Quality Primary Health Care

Listen to the podcast, better data for stronger health systems, explore our resources, advancing private sector reporting.

In-depth technical brief

Data fragmentation and use

View our short interviews.

In this video, Wycliffe Waweru – Head of Digital Health & Monitoring at Population Services International – outlines three barriers to the use of data for decision-making in health in low- and middle-income countries. For each barrier, Wycliffe proposes some concrete solutions that can help overcome it.

In this video, Dominic Montagu , Professor Emeritus at the University of California, San Francisco, and CEO of Metrics for Management outlines the three levels of data from private healthcare providers in low- and middle-income countries that need to be sequentially integrated into a country’s health information system to assure that governments can manage the overall health system more effectively.

Join us in this illuminating session as we explore the evolution of the STAR self-testing project, sharing insights, challenges, and successes that have emerged over the years. By examining the lessons learned and considering the implications for future healthcare strategies, we hope to foster a deeper understanding of the transformative potential of self-testing in improving healthcare accessibility and patient-centric services.       

This enlightening session promises to  provide  updates from WHO guidelines and share insights on the journey toward viral hepatitis elimination. It will also  showcase outcomes from the STAR hepatitis C self-testing research and discuss how these findings could potentially inform hepatitis B antigen self-testing and the use of multiplex test kits in the   context of triple elimination. Join us in this crucial discussion as we work together to fast-track the global journey toward a hepatitis-free world by 2030.   

In this two-part session,  the Bill & Melinda Gates Foundation, PSI, and Population Solutions for Health will  share lessons and best practices from  rigorous research and   hands-on implementation  experience in Zimbabwe.  The session will  cover important topics  like  client-centered , community-led demand creation,  d ifferentiated  service delivery , sustainable financing, and digital solutions. The sessions will also cover lessons in the program.   

In this session, PSI and PSH will share lessons for optimizing access to comprehensive, culturally sensitive HIV and sexual and reproductive health services. Topics will include enhancing the accuracy and reliability of sex worker population data, improving HIV case finding among men who have sex with men (MSM) through reverse index case testing, and scaling differentiated service delivery models. The session will also cover integrating mental health and substance abuse in key populations (KP) programming and lessons in public sector strengthening.   

Additionally, the session will showcase solutions that MSMs have co-designed, highlighting how this collaboration has improved the consumer care experience. It will demonstrate the critical role of KP communities in establishing strong and sustainable HIV responses, including amplifying KP voices, strengthening community-led demand, and establishing safe spaces at national and subnational levels for KP communities to shape and lead the HIV response.

This enlightening session promises to provide updates from WHO guidelines and share insights on the journey toward viral hepatitis elimination. It will also showcase outcomes from the STAR hepatitis C self-testing research and discuss how these findings could potentially inform hepatitis B antigen self-testing and the use of multiplex test kits in the context of triple elimination. Join us in this crucial discussion as we work together to fast-track the global journey toward a hepatitis-free world by 2030. 

In this two-part session, the Bill & Melinda Gates Foundation, PSI, and PSH will share lessons and best practices from rigorous research and hands-on implementation experience in Zimbabwe. The session will cover important topics like client-centered, community-led demand creation, differentiated service delivery, sustainable financing, and digital solutions. The sessions will also cover lessons in program management. These insights are applicable beyond Zimbabwe and can be used to scale up HIV prevention efforts in the region.

Scaling Digital Solutions for Disease Surveillance

Strong surv eillance systems are essential to detect and respond to infectious disease outbreaks. Since 2019, PSI has worked alongside the Ministries of Health in Cambodia, Laos, Myanmar, and Vietnam to strengthen disease surveillance systems and response. Learn more here.

Misinformation and Vaccine Hesitancy

As COVID-19 spread globally, so did misinformation about countering the pandemic. In response, PSI partnered with Meta to inspire 160 million people to choose COVID-19 preventative behaviors and promote vaccine uptake. Watch the video to learn how.  

The Frontline of Epidemic Preparedness and Response 

Early warning of possible outbreaks , and swift containment action s , are key to preventing epidemics: disease surveillance, investigation and response need to be embedded within the communities. Public Health Emergency Operations Centers (PHEOCs) are designed to monitor public health events, define policies, standards and operating procedures, and build capacity for disease surveillance and response. Learn more here.  

integrating pharmacies and drug shops into the health system

HOW COULD PRIVATE SECTOR PHARMACIES AND DRUG SHOPS ADVANCE PROGRESS TOWARDS UNIVERSAL HEALTH COVERAGE

Private sector pharmacies and drug shops play an important role in improving access to essential health services and products for millions of people living in low- and middle-income countries (LMICs), where healthcare resources are often limited. However, the way in which these outlets are, or are not, integrated into health systems holds significant importance. Do they serve as facilitators of affordable, high-quality care? Or have they become sources of substandard health services and products?

Read the blog  here Read the technical brief here

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The Consumer as CEO

For over 50 years, PSI’s social businesses have worked globally to generate demand, design health solutions with our consumers, and work with local partners to bring quality and affordable healthcare products and services to the market. Now consolidating under VIYA, PSI’s first sexual health and wellness brand and social business, our portfolio represent s the evolution from traditionally donor – funded projects towards a stronger focus on sustainability for health impact over the long term . Across 26 countries, the VIYA model takes a locally rooted , globally connected approach. We have local staff, partners and providers with a deep understanding of the markets we work in. In 2022, we partnered with over 47 ,000 pharmacies and 10,000 providers to reach 11 million consumers with products and services, delivering 1 37 million products . VIYA delivers lasting health impact across the reproductive health continuum, from menstruation to menopause. Consumer insights drive our work from start to finish. Their voices, from product exploration to design, launch, and sales, ensure that products not only meet consumers’ needs but exceed their expectations. The consumer is our CEO.  

In 2019, our human-centered design work in East Africa explored ways that our work could support and accompany young women as they navigate the various choices required for a healthy, enjoyable sexual and reproductive life. Harnessing insights from consumers, VIYA is revolutionizing women’s health by addressing the confusion, stigma, and unreliability surrounding sexual wellness. Across five markets – Guatemala, Kenya, South Africa, Uganda and Pakistan – VIYA utilizes technology to provide women with convenient, discreet, and enjoyable tools for making informed choices about their bodies. The platform offers a wealth of high-quality sexual wellness information, covering topics from periods to pleasure in an accessible and relatable manner. Additionally, VIYA fosters a supportive community where users can share experiences and receive guidance from counselors . In 2023, VIYA will begin offering a diverse range of sexual wellness products and connect users with trusted healthcare providers, ensuring comprehensive care tailored to individual needs.   

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Digitalizing contraceptive counseling to reach rural women and girls in Ethiopia

By: Fana Abay , Marketing and Communication s Directo r, PSI Ethiopia  

In rural Ethiopia, women and girls often face significant barriers in accessing healthcare facilities, which can be located hours away. Moreover, there is a prevailing stigma surrounding the use of contraception, with concerns about potential infertility or the perception of promiscuity. To address these challenges, the Smart Start initiative has emerged, linking financial well-being with family planning through clear and relatable messaging that addresses the immediate needs of young couples—planning for the lives and families they envision. Smart Start takes a community-based approach, utilizing a network of dedicated Navigators who engage with women in their localities. These Navigators provide counseling and refer interested clients to Health Extension Workers or healthcare providers within Marie Stopes International-operated clinics for comprehensive contraceptive counseling and services.   

In a significant development, PSI Ethiopia has digitized the proven counseling messaging of Smart Start, expanding its reach to more adolescent girls, young women, and couples. This approach aligns with the priorities set by the Ethiopian Ministry of Health (MOH) and is made possible through funding from Global Affairs Canada. The interactive and engaging digital messaging has revolutionized counseling services, enabling clients to make informed and confident decisions regarding both their finances and contraceptive choices.  

Clients who received counseling with the digital Smart Start tool reported a higher understanding of their options and were more likely to choose contraception (74 percent) compared to those counseled with the manual version of Smart Start (64 percent). Navigators also found the digital tool more effective in connecting with clients, leading to higher ratings for the quality of their counseling.  

By December 2023, PSI Ethiopia, working in close collaboration with the MOH, aims to reach over 50 thousand new clients by leveraging the digital counseling tool offered by Smart Start. This innovative approach allows for greater accessibility and effectiveness in providing sexual and reproductive health services, contributing to improved reproductive health outcomes for women and couples across the country.  

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Building community health worker capacity to deliver malaria care

By: Christopher Lourenço, Deputy Director, Malaria, PSI Global  

Community health workers (CHWs) are critical lifelines in their communities. Ensuring they have the training, support, and equipment they need is essential to keep their communities safe from malaria, especially in the hardest to reach contexts.  

For example, in Mali, access to formal health services remains challenging, with four in ten people living several miles from the nearest health center, all without reliable transportation or access. In 2009, the Ministry of Health adopted a community health strategy to reach this population. The U.S. President’s Malaria Initiative (PMI) Impact Malaria project, funded by USAID and led by PSI, supports the Ministry with CHW training and supervision to localize health services.  

In 2022, 328 thousand malaria cases were recorded by CHWs ) ; 6.5 thousand severe malaria cases were referred to health centers, according to the national health information system.  

During that time, the PMI Impact Malaria project (IM) designed and supported two rounds of supportive supervision of 123 CHWs in their workplaces in the IM-supported regions of Kayes and Koulikoro. This included developing and digitizing a standardized supervision checklist; and developing a methodology for selecting which CHWs to visit. Once a long list of CHW sites had been determined as accessible to supervisors for a day trip (including security reasons), the supervisors telephoned the CHWs to check when they would be available to receive a visit [as being a CHW is not a full-time job, and certain times of the year they are busy with agricultural work (planting, harvesting) or supporting  health campaigns like mosquito net distribution].  

Supervisors directly observed how CHWs performed malaria rapid diagnostic tests (RDTs) and administered artemisinin-based combination therapy (ACT). They recorded CHW performance using the digitized checklist, interviewed community members, reviewed records, and provided on-the-spot coaching. They also interviewed the CHWs and tried to resolve challenges they expressed, including with resupply of commodities or equipment immediately or soon afterwards.   

Beyond the observed interactions with patients, supervisors heard from community members that they were pleased that CHWs were able to provide essential malaria services in the community. And the data shows the impact.  

In IM-supported areas of Mali, 36% of CHWs in the first round were competent in performing the RDT, which rose to 53% in the second. 24% of CHWs in the first round compared to 38% in the second were competent in the treatment of fever cases and pre-referral counseling. Between both rounds, availability of ACT increased from 80 percent to 90 percent.  

Supportive supervision with interviews and observations at sites improved the basic competencies of CHWs between the first and second rounds, and additional rounds will help to understand the longer-term programmatic benefits.

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Taking a market-based approach to scale sanitation in Ethiopia

By: Dr. Dorothy Balaba, Country Representative, PSI Ethiopia  

In Ethiopia, PSI leads the implementation of USAID Transform WASH (T/WASH) activity with consortium partners, SNV and IRC WASH. Contrary to traditional models that rely on distribution of free or heavily subsidized sanitation products, T/WASH utilizes a market-based sanitation approach. This approach creates sustainable and affordable solutions, by integrating market forces and supporting businesses to grow, while creating demand at the household level. 

During the last six years, T/WASH has worked alongside the private sector and government (Ethiopia’s Ministry of Health, Ministry of Water and Energy, and Ministry of Labor and Skills), among other stakeholders, to increase household access to affordable, quality sanitation products and services. For example, more than 158 thousand households have invested in upgraded sanitation solutions with rapid expansion to come as the initiative scales and market growth accelerates. 

T/WASH has successfully trained more than 500 small businesses, including community masons and other construction-related enterprises, with technical know-how in sanitation product installation, operational capacities, and marketing and sales skills needed to run successful, growing businesses. The Ethiopian government is now scaling the approach to all districts through various national, regional, and local institutions with requisite expertise. T/WASH has also worked the One WASH National Program, Ministry of Health, Ministry of Water and Energy, and Ministry of Labor and Skills to examine policies that influence increased household uptake of basic WASH services, such as targeted sanitation subsidies, tax reduction to increase affordability, and increased access to loan capital for business seeking to expand and households needing help to improve their facilities. 

To share the journey to market-based sanitation, representatives of the Ethiopian Ministry of Health and the USAID Transform WASH team took to the stage at the UN Water Conference in 2023.

“Rather than relying on traditional aid models that often distribute free or heavily subsidized sanitation products, market-based sanitation creates sustainable and affordable solutions, integrating market forces and supporting businesses to grow.”  

— Michael Negash, Deputy Chief Party of T/WASH  

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Promoting self-managed care like Self-testing and Self-Sampling

By: Dr Karin Hatzold, Associate Director HIV/TB/Hepatitis

Building upon the success and insights gained from our work with HIV self-testing (HIVST), PSI is actively applying this approach to better integrate self-care, more broadly, in the health system beginning with Hepatitis C and COVID-19. Self-testing has emerged as a powerful tool to increase access to integrated, differentiated, and decentralized health services, accelerating prevention, care, and treatment for various diseases, while also increasing health system resilience against COVID-19.

Here’s how we got there.

Seven years ago, the landscape of HIV self-testing lacked global guidelines, and only the U.S., the UK and France had policies in place that allowed for HIV self-testing. High disease burdened countries in low-and-middle-income-countries (LMICs) lacked evidence and guidance for HIVST despite major gaps in HIV diagnosis.

However, through the groundbreaking research from the Unitaid-funded HIV Self-Testing Africa (STAR) initiative led by PSI, we demonstrated that HIVST is not only safe and acceptable but also cost-effective for reaching populations at high risk with limited access to conventional HIV testing. This research played a pivotal role in informing the normative guidelines of the World Health Organization (WHO) and shaping policies at the country level. As a result, more than 108 countries globally now have reported HIVST policies, with an increasing number of countries implementing and scaling up HIVST to complement and  partially replace conventional testing services. This became especially significant as nations tried to sustain HIV services amidst the disruptions caused by the COVID-19 pandemic.

By leveraging our expertise, PSI is conducting research to identify specific areas and populations where the adoption of Hepatitis C and COVID-19 self-testing could significantly enhance testing uptake and coverage. This research serves as the foundation for developing targeted strategies and interventions to expand access to self-testing, ensure that individuals have convenient and timely options for testing for these diseases, and are linked to care, treatment and prevention services through differentiated test and treat approaches.

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Using peer coaches to counter HIV stigma in South Africa

By: Shawn Malone, Project Director, HIV/AIDS Gates Project in South Africa, PSI Global

In South Africa, where the HIV response has lagged in reaching men, PSI’s Coach Mpilo model has transformed the role of an HIV counselor or case manager into that of a coach and mentor who provides empathetic guidance and support based on his own experience of living with HIV. Coaches are men who are not just stable on treatment but also living proudly and openly with HIV. Situated within the community and collaborating closely with clinic staff, they identify and connect with men struggling with barriers to treatment and support them in overcoming those barriers, whether that means navigating the clinic or disclosing their HIV status to their loved ones.

PSI and Matchboxology first piloted the model in 2020 with implementing partners BroadReach Healthcare and Right to Care as well as the Department of Health in three districts of South Africa. Since then, the model has been rolled out by eight implementing partners in South Africa, employing more than 300 coaches and reaching tens of thousands of men living with HIV. To date, the model has linked 98 percent of clients to care and retained 94 percent of them, in sharp contrast to the estimated 70 percent of men with HIV in South Africa who are currently on treatment.

Given the success of the program, South Africa’s Department of Health and the United States President’s Emergency Plan for AIDS Relief (PEPFAR) have each embraced the Coach Mpilo model in their health strategy and are embedding it in their strategies and programs. 

“The men we spoke to [while I was traveling to South Africa for a PrEP project with Maverick Collective by PSI] were not only decidedly open to the idea of taking a daily pill…many were willing to spread the word and encourage friends to get on PrEP too. We were able to uncover and support this new way forward because we had flexible funding to focus on truly understanding the community and the root barriers to PrEP adoption. This is the philanthropic funding model we need to effectively fight the HIV epidemic, and it’s beneficial for all sorts of social challenges.”

– Anu Khosla, Member, Maverick Collective by PSI

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simplifying consumers’ journey to care in Vietnam

By: Hoa Nguyen, Country Director, PSI Vietnam

In late 2022, with funding from the Patrick J. McGovern Foundation, PSI and Babylon partnered to pilot AIOI in Vietnam. By combining Babylon’s AI symptom checker with PSI’s health provider locator tool, this digital health solution analyzes symptoms, recommends the appropriate level of care, and points them to health providers in their local area. The main goal is to support people in low-income communities to make informed decisions about their health and efficiently navigate the healthcare system, while reducing the burden on the healthcare workforce. The free 24/7 service saves people time and subsequent loss of income from taking time off work and from having to pay unnecessary out-of-pocket expenses. Under our global partnership with Meta, PSI launched a digital campaign to put this innovative product in the hands of people in Vietnam. By the end of June 2023 (in the nine months since product launch), 210 thousand people accessed the AIOI platform; 2.4 thousand people created personal accounts on the AIOI website, 4.8 thousand triages to Symptom Checker and linked 2.2 thousand people to health facilities.   

Babylon’s AI symptom checker and PSI’s health provider locator tool captures real-time, quality data that supports health systems to plan, monitor and respond to consumer and provider needs. But for this data to be effective and useable, it needs to be available across the health system. Fast Healthcare Interoperability Resources (FHIR) standard provides a common, open standard that enables this data exchange. PSI’s first consumer-facing implementation of FHIR was launched in September 2022 as part of the Babylon Symptom Checker project in Vietnam, enabling rapid alignment between PSI and Babylon’s FHIR-enabled client records systems. PSI already has several other consumer health FHIR implementations under active development in 2023, including PSI’s collaboration with the Kenya MOH to launch a FHIR-enabled WhatsApp national health line for COVID-19 health information. PSI will also look to adopt and scale health workforce-facing FHIR-enabled tools, such as OpenSRP2, which will be piloted in an SRH-HIV prevention project in eSwatini in partnership with Ona by the end of 2023.

— Martin Dale, Director, Digital Health and Monitoring, PSI

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Engaging the private sector for disease surveillance in Myanmar

By: Dr. Zayar Kyaw, Head of Health Security & Innovation, PSI Myanmar

Under a three-year investment from the Indo-Pacific Center for Health Security under Australia’s Department for Foreign Affairs and Trade (DFAT), PSI is enhancing disease outbreak surveillance and public health emergency preparedness and response capacities in Myanmar, Cambodia, Laos, and Vietnam. When PSI conducted a review of existing disease surveillance systems in Myanmar, it identified several gaps: although the Ministry of Health had systems in place for HIV, tuberculosis, malaria and other communicable diseases, they were fragmented, with different reporting formats and reliance on paper-based reporting. In addition, private sector case surveillance data were not routinely captured, yet private clinics and pharmacies are the dominant health service delivery channel in the country. This hindered effective disease prevention and control efforts.

Building on our extensive private sector malaria surveillance work under the BMGF-funded GEMS project in the Greater Mekong Subregion, PSI implemented a case-based disease notification system using social media channels to overcome the limitations of paper-based and custom-built mobile reporting tools. These chatbots, accessible through popular social media platforms like Facebook Messenger and Viber, proved to be user-friendly and required minimal training, maintenance, and troubleshooting. The system was implemented in more than 550 clinics of the Sun Quality Health social franchise network as well as nearly 470 pharmacies. The captured information flows to a DHIS2 database used for real-time monitoring and analysis, enabling rapid detection of potential outbreaks. Local health authorities receive instant automated SMS notifications, enabling them to promptly perform case investigation and outbreak response.

In 2022, private clinics reported 1,440 malaria cases through the social media chatbots, while community mobilizers working with 475 private providers and community-based malaria volunteers reported more than 5,500 cases, leading to the detection of two local malaria outbreaks. Local health authorities were instantly notified, allowing them to take action to contain these surges in malaria transmission. During the same time, pharmacies referred 1,630 presumptive tuberculosis cases for confirmatory testing – a third of which were diagnosed as tuberculosis and enrolled into treatment programs.

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Training health workers in Angola

By: Anya Fedorova, Country Representative, PSI Angola   

The shortage of skilled health workers is widely acknowledged as a significant barrier to achieving Universal Health Coverage. To address this challenge, PSI supported ministries of health to develop a digital ecosystem that brings together stewardship, learning, and performance management (SLPM). The ecosystem enhances training, data-driven decision-making, and the efficiency of healthcare delivery.

Here’s what it looks like in practice.

In July 2020, PSI Angola, alongside the Angolan digital innovation company Appy People, launched Kassai , an eLearning platform that targets public sector health workers in Angola. Through funding from USAID and the President’s Malaria Initiatve (PMI), Kassai features 16 courses in malaria, family planning, and maternal and child health – with plans to expand learning topic areas through funding from ExxonMobil Foundation and private sector companies. A partnership with UNITEL, the largest telecommunication provider in Angola, provides all public health providers in Angola free internet access to use Kassai.

Kassai’s analytics system to follow learners’ success rate and to adjust the course content to learners’ performance and needs. Kassai analytics are integrated with DHIS2 – the Health Management Information System (HMIS) of Angolan MOH, to be able to link learners’ knowledge and performance with the health outcomes in the health facilities.  The analytics track learners’ performance by course and gives visibility by health provider, health facility, municipality, and province. Each course has pre-and post-evaluation tests to track progress of learning, too.

By the end of 2022, there were 6,600 unique users on the Kassai platform and 31,000 course enrollments. PSI Angola’s partnership with UNITEL, the largest telecommunication provider in Angola, allows for free internet access to learn on the Kassai for all public health providers in Angola. Building on its success for malaria training, Kassai now also provides courses in family planning, COVID-19, and maternal and child health. This reduces training silos and provides cross-cutting benefits beyond a single disease.

Implementing the SLPM digital ecosystem brings numerous benefits to health systems. It allows for more strategic and efficient workforce training and performance management, enabling ministries of health to track changes in health workers’ knowledge, quality of care, service utilization, and health outcomes in real time. The ecosystem also supports better stewardship of mixed health systems by facilitating engagement with the private sector, aligning training programs and standards of care, and integrating private sector data into national HMIS. Furthermore, it enables the integration of community health workers into the broader health system, maximizing their impact and contribution to improving health outcomes and strengthening primary healthcare.

WHISTLEBLOWER AND ANTI-RETALIATION

PSI does not tolerate retaliation or adverse employment action of any kind against anyone who in good faith reports a suspected violation or misconduct under this policy, provides information to an external investigator, a law enforcement official or agency, or assists in the investigation of a suspected violation, even if a subsequent investigation determines that no violation occurred, provided the employee report is made in good faith and with reasonable belief in its accuracy.

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Global Code of Business Conduct And Ethics

PSI’s code sets out our basic expectations for conduct that is legal, honest, fair, transparent, ethical, honorable, and respectful. It is designed to guide the conduct of all PSI employees—regardless of location, function, or position—on ethical issues they face during the normal course of business. We also expect that our vendors, suppliers, and contractors will work ethically and honestly.

The Future of Work

With overarching commitments to flexibility in our work, and greater wellbeing for our employees, we want to ensure PSI is positioned for success with a global and holistic view of talent. Under our new “work from (almost) anywhere,” or “WFAA” philosophy, we are making the necessary investments to be an employer of record in more than half of U.S. states, and consider the U.S. as one single labor market for salary purposes. Globally, we recognize the need to compete for talent everywhere; we maintain a talent center in Nairobi and a mini-hub in Abidjan. PSI also already works with our Dutch-based European partner, PSI Europe, and we’re creating a virtual talent center in the UK.

Meaningful Youth Engagement

PSI is firmly committed to the meaningful engagement of young people in our work. As signatories of the  Global Consensus Statement on Meaningful Adolescent & Youth Engagement , PSI affirms that young people have a fundamental right to actively and meaningfully engage in all matters that affect their lives. PSI’s commitments aim to serve and partner with diverse young people from 10-24 years, and we have prioritized ethics and integrity in our approach. Read more about our commitments to the three core principles of respect, justice and Do No Harm in the  Commitment to Ethics in Youth-Powered Design . And read more about how we are bringing our words to action in our ICPD+25 commitment,  Elevating Youth Voices, Building Youth Skills  for Health Design .

Zero Tolerance for Modern-Day Slavery and Human Trafficking

PSI works to ensure that its operations and supply chains are free from slavery and human trafficking.  Read more about this commitment in our policy statement, endorsed by the PSI Board of Directors.

UNITED NATIONS GLOBAL COMPACT

Since 2017, PSI has been a signatory to the United Nations Global Compact, a commitment to align strategies and operations with universal principles of human rights, labor, environment and anti-corruption.  Read about PSI’s commitment to the UN Global Compact here.

Environmental Sustainability

The health of PSI’s consumers is inextricably linked to the health of our planet. That’s why we’ve joined the Climate Accountability in Development as part of  our commitment to reducing our greenhouse gas emissions by 30 percent  by 2030. Read about  our commitment to environmental sustainability .

Affirmative Action and Equal Employment Opportunity

PSI does not discriminate against any employee or applicant for employment because of race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital status, genetic information, disability, protected veteran status or any other classification protected by applicable federal, state or local law.  Read our full affirmative action and equal employment opportunity policy here.

Zero Tolerance for Discrimination and Harassment

PSI is committed to establishing and maintaining a work environment that fosters harmonious, productive working relationships and encourages mutual respect among team members. Read our policy against discrimination and harassment here .

PSI is committed to serving all health consumers with respect, and strives for the highest standards of ethical behavior. PSI is dedicated to complying with the letter and spirit of all laws, regulations and contractual obligations to which it is subject, and to ensuring that all funds with which it is entrusted are used to achieve maximum impact on its programs. PSI provides exceptionally strong financial, operational and program management systems to ensure rigorous internal controls are in place to prevent and detect fraud, waste and abuse and ensure compliance with the highest standards. Essential to this commitment is protecting the safety and well-being of our program consumers, including the most vulnerable, such as women and children. PSI maintains zero tolerance for child abuse, sexual abuse, or exploitative acts or threats by our employees, consultants, volunteers or anyone associated with the delivery of our programs and services, and takes seriously all complaints of misconduct brought to our attention.

Diversity and Inclusion

PSI affirms its commitment to diversity and believes that when people feel respected and included they can be more honest, collaborative and successful. We believe that everyone deserves respect and equal treatment regardless of gender, race, ethnicity, age, disability, sexual orientation, gender identity, cultural background or religious beliefs.  Read our commitment to diversity and inclusion here.  Plus, we’ve signed the CREED Pledge for Racial and Ethnic Equity.  Learn more.

Gender Equality

PSI affirms gender equality is a universal human right and the achievement of it is essential to PSI’s mission.  Read about our commitment to gender equality here.

Engaging the Private Sector

From ministries of health to regulatory bodies and purchasers, we partner with private and public sector players to provide seamless health services to consumers – no matter their entry point to care.

Scaling Digital Health Innovations

Across 40+ countries, we scale digital solutions that make it easier for people to take ownership of their own health, and health systems to use resources efficiently and increase health impact.

Supporting People to be Active Agents in their Healthcare

We support health systems in shaping the policy and regulatory environment for self-care interventions and ensuring self-care is included as an essential part of healthcare services.

01 #PeoplePowered

02 breaking taboos, 03 moving care closer to consumers, 04 innovating on investments, icfp q&a: let's talk about sex.

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Research Ethics Boards

Who is this for?

Information about the University of Toronto (U of T) Research Ethics Boards (REBs) is for the following.

  • Professors/faculty members, postdoctoral fellows, research team members, and students who are conducting human research for submission to an REB
  • Course instructors and undergraduate students conducting course-based human research
  • Researchers with Toronto Academic Health Science Network (TAHSN) hospital REB approvals that involve U of T

What do I need before I can begin?

Carefully review the information in the Ethics in Human Research section to fully understand who is eligible to conduct research at the University of Toronto (U of T) and when review of research by a U of T Research Ethics Board is required.

University of Toronto (U of T) Research Ethics Boards (REBs)

Ethics protocols are reviewed by one of the following University of Toronto (U of T) Research Ethics Boards REBs, depending on the departmental or faculty affiliation of the Principal Investigator (PI).

Health Sciences REB

Social Sciences, Humanities and Education REB

REB Contacts & Affiliations

Chair: Professor Jayne Baker Manager: Dean Sharpe Research from: Faculties of Arts and Science, Information, Music, Education (OISE/UT), and the Toronto School of Theology.  

Chair: Professor Michael Atkinson Manager: Daniel Gyewu Research from: Faculties of Medicine (all departments), Applied Science and Engineering, Nursing, Pharmaceutical Sciences, Social Work, Physical Education & Health, Dentistry, and the Dalla Lana School of Public Health.

Submission Deadlines & Important Dates

The deadline for delegated review is every Monday (or first business day of the week) by 4:00 PM. Investigators are advised to submit well in advance of their anticipated start date, recognizing that approvals must be obtained by supervisors (for student research) and the departmental chair/dean.

Full board submission deadlines and all meetings dates can be found by visiting  Protocol Submission Deadlines & Who to Submit To .

For details on the process of submitting a protocol to an REB, please see  Submit a Human Ethics Protocol.

  • Coordinate, facilitate and manage REB operations

a research ethics board

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Daniel gyewu, kristina miljic (ognjanovic), dean sharpe.

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Research Ethics

a research ethics board

University research is governed by policies and practices that ensure the protection of research participants, researchers (faculty, students and staff members), the university and the public. These policies and practices cover research involving humans, the use of animals, controlled goods and hazardous materials, among others.

Please note that research may not begin before all university approvals/certifications, institutional requirements or governmental authorizations are obtained.

Individual researchers, in addition to being governed by internal policies and procedures, may be governed by external ethical guidelines imposed by professional associations such as the Canadian Psychological Association or the Canadian College of Physicians and Surgeons, as well as the guidelines of Canadian and other regulatory agencies, such as the Health Protection Branch of Health Canada and the U.S. Food and Drug Administration (FDA).

All funded or unfunded research involving humans, animals or controlled goods undertaken at Toronto Metropolitan University facilities and conducted by Toronto Metropolitan University faculty, students and staff is subject to review and approval.

REB Open Office Hours

Every Thursday - 10:00 am to 12:00 pm The TMU REB hosts virtual office hours via Zoom every Thursday between 10 am - 12 pm. 

Join Zoom meeting to attend virtual office hours  (opens in new window) 

Meeting ID: 949 1974 0301 

Please drop in if you have any questions. No appointment necessary.

Office of the Vice-President, Research & Innovation  1 Dundas Street West, 11th Floor Toronto, Ontario M5G 1Z3

Asher Alkoby, LL.B., LL.M., S.J.D. Chair, Toronto Metropolitan University Research Ethics Board 416-979-5000 ext. 552491 [email protected] [email protected]

Todd Girard, PhD Vice-Chair, Toronto Metropolitan University Research Ethics Board 416-979-5000 ext. 552646 [email protected]

Zakiya Atcha, MSW Research Ethics Manager (Ethics, Animal Care, Controlled Goods, Undergraduate Ethics) 416-979-5000 ext. 554841 [email protected]

Bryanna Hines (she/her), MA, MSW, PhD Student Research Ethics Administrator 416-979-5000 ext. 552963  [email protected]

Fabiola Limón Bravo (she/her), MA Research Ethics Administrator 416-979-5000 ext. 552963  [email protected]

Seema Tejani, B.A/B.Ed Research Ethics Administrator  416-979-5000 ext. 552963  [email protected]

To access the online ethics submission and review system, log into your my.torontomu account and go to the "Research" box.

Research Ethics Board

The Research Ethics Board (REB) approves, rejects, proposes modifications to, or terminates any proposed or ongoing research involving humans that is conducted by faculty, staff or undergraduate students of the university, so as to protect research subjects and ensure that research is conducted in an ethical manner. No research on humans shall be undertaken without the prior approval of the REB.

The REB shall:

  • Interpret and apply the Tri-Council Policy Statement and relevant legislation.
  • Establish guidelines and procedures consistent with the Tri-Council Policy Statement and relevant legislation.
  • Facilitate research by consulting with and assisting researchers.

Ex-Officio Members (non-voting)

Faculty and staff representatives, community members, ad hoc / advisors.

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Research Ethics Board: Apply for ethics review

  • About the REB
  • Apply for ethics review
  • Continuing ethics review forms
  • Policies, guidelines and resources
  • Consent process

Applicants must apply for ethics review before the start of the study. Note that the REB cannot retroactively review research involving humans. A letter of approval from the Decisional Authority of Health Canada or PHAC and a Certificate of Ethics Review must be obtained from the REB before the research begins.

Applicants are required to consult the Health Canada-PHAC Privacy Management Division (PMD) to assess whether the research project involves personal information and to assess the risk to privacy. Applicants are advised to contact PMD well before applying to the REB to allow sufficient time for the PMD to complete its assessment.

Important notice for PHAC researchers: PHAC researchers must obtain departmental approval of research involving humans before submitting their application to the REB. For further information and to obtain the necessary form, contact the Office of the Chief Science Officer: [email protected] .

On this page

Pre-submission consultation with privacy management division, application form, application form instructions, research protocol instructions, scientific peer review, evaluation and approval process, meeting and submission deadline dates.

Applicants must consult the Health Canada-PHAC Privacy Management Division (PMD) before submitting an application to the REB.

REB applicants and research staff are ultimately accountable for the management of personal information under their control and for ensuring that it is handled in a manner consistent with the requirements of the Privacy Act and Treasury Board policies. Examples of personal information include opinions, postal code information, age, ethnicity, educational background, employment history, health history, life experience, religion, social status, and human biological material. PMD supports applicants and research staff in meeting these obligations by providing privacy guidance and recommendations.

PMD will conduct an initial assessment of the research proposal to establish whether the project involves personal information that is under the control of Health Canada or PHAC and to determine the preliminary level of privacy risk. The level of privacy risk will dictate the depth of analysis PMD will undertake with respect to the study's collection, use, disclosure, retention and disposal of personal information. PMD will work with the researcher to assess and propose mitigation of privacy risks.

PMD review process

The PMD review consists of two parts:

1. Preliminary privacy risk assessment

The purpose of this assessment is to enable PMD to assess the level of privacy risk associated with an REB application. The level of risk (low, medium or high) is calculated using three variables:

  • The sensitivity of personal information;
  • The type of information; and
  • The third parties involved in the research project.

The assessment is conducted by PMD using information from the research protocol and/or in discussion with the applicant and in consultation with the PMD director to confirm the level of preliminary privacy risk. Depending on the level of risk, PMD may require that a Privacy Protocol Checklist be completed and/or make other recommendations that should be addressed in the research protocol.

2. Privacy Protocol Checklist

The purpose of the Privacy Protocol Checklist is to ensure that Health Canada/PHAC programs handling personal information for non-administrative purposes (e.g., research, audit, evaluation or statistical purposes) are meeting their Privacy Act and Treasury Board requirements.

PMD uses information from the research protocol to complete the Privacy Protocol Checklist, and consults with the applicant as needed to obtain any missing information. PMD will provide an overall privacy assessment and specific recommendations that the applicant must follow. A description of how these recommendations have been implemented must be included as part of the application package to the REB.

Contact PMD

To reach the Privacy Management Division by email:

Individuals applying to the REB must complete the following form:

  • Application for Initial Review of Research Involving Humans (PDF format, 580 KB, 16 pages)

The instructions below provide detailed guidance on how to properly complete the application form for initial review of research involving humans. Incomplete applications will not be accepted for REB review; thus, applicants are strongly advised to follow these instructions carefully to ensure that their application packages are complete and accurate. For questions that are not addressed in these instructions, please contact the REB Secretariat at [email protected] or 613-941-5199.

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1.1 Project title

The title of the project should accurately reflect the nature of the study and should correspond to the title presented on all study materials (i.e., participant information, documents for recruitment, consent forms, etc.). The title should not exceed 200 characters, although it is recommended that the title be as brief as possible while still providing a meaningful description of the project.

1.2 Principal investigator / 1.3 Other investigators and team members

The principal investigator (PI) is the individual who provides overall leadership of the research team and assumes primary responsibility for the execution of the study, including the ethical conduct of the research. If two or more individuals are equally responsible for the project, one should be named as the PI who will be the primary point of contact for administrative issues, and the others should be listed as co-PIs.

The PI can be from HC/PHAC or external to HC/PHAC, depending on who is leading the project. When approval is being sought for HC/PHAC researchers to join an externally led project that has already begun under the authority of an external REB, the lead HC/PHAC researcher should be listed as the PI and the lead external investigator as co-PI. If it is unclear who should be named as the PI, contact the REB Secretariat for guidance.

Other investigators and team members who should be listed here are individuals who (in the PI's judgment) make a significant contribution to the intellectual direction of the research and who play a key role in the conduct and execution of the study. Collaborators whose involvement is more limited need not be named here, but should be included in Section 5 (Third Party Involvement). A drop-down menu is provided to specify the role of each individual (i.e., co-PI, co-investigator, and community partner). If none of these options is appropriate, select "other." If there is insufficient space to list all other investigators/team members, continue the list on an additional page and attach it to the application.

Information - place of work

  • For researchers external to HC/PHAC: Provide the name of your institution (e.g., university, hospital, research centre, organization) and department, if appropriate.
  • For HC/PHAC researchers: Provide the name of your branch, office or bureau (e.g., Health Products and Food Branch, National Microbiology Laboratory) and indicate whether you are with Health Canada or PHAC.

Current CVs must be submitted for the PI and all other investigators/team members listed in this section. The REB uses this information to assess whether the research team has the appropriate training and expertise to carry out the research. A relatively short CV (approx. 10 pages or fewer) describing only the most relevant contributions and experience is sufficient (e.g., following the format of the CIHR Biosketch or the NIH Biosketch). It is not necessary to provide an exhaustive record of each researcher's professional and academic background. CVs are not required for collaborators listed in Section 5.

1.4 Health Canada/PHAC contact person

For projects where the PI is external to HC/PHAC, the contact person is typically the HC/PHAC project authority, project officer, funding officer, research coordinator, or another relevant HC/PHAC employee associated with the project. This section may also be used when the PI is from HC/PHAC, to designate another contact person in addition to the PI. If the contact person is a member of the core research team and listed in Section 1.3, please name her/him here as well. If there is no contact person to name, enter "N/A" in the 'name' field.

1.5 Role of Health Canada/PHAC in the project

Provide a brief description explaining HC/PHAC's involvement in the project. If the project involves one or more HC/PHAC researchers as co-investigators/collaborators on an externally led project, it is particularly important to clearly describe the HC/PHAC component or contribution so that the REB can focus its review appropriately. Examples could include conducting sample analysis, providing access to specialized equipment or training in a specific technique, administering surveys to HC/PHAC employees, etc.

The role of funder should be selected when HC/PHAC is providing funding to an external researcher in the form of a grant or contribution, or if the research project is being conducted under contract to HC/PHAC. For HC/PHAC research supported by internal funding, the role of funder should not be selected, even if external parties will receive funding to conduct portions of the research project. Details on any contracts and funding agreements should be provided in Section 5 (Third Party Involvement).

1.6 Proposed study period

The start date refers to the intended or expected commencement of participant recruitment, or analysis in the case of secondary use. The end date is the point at which data collection and analyses have been completed in order to answer the original research question(s). If the exact start and/or end dates are not known, provide an estimate with a note that the dates are approximate.

If HC/PHAC researchers are joining an externally led project that has already begun under the authority of another REB, indicate the dates at which the HC/PHAC involvement will begin and end.

1.7 Other REB approval

Research involving multiple institutions or jurisdictions may require review by more than one REB. For projects that have already been approved by another REB, provide the date of the initial review and a copy of the most recent ethics certificate or decision letter. For projects pending review by another REB or that will be submitted in the near future, indicate the review date if known, and submit a copy of the decision letter to the REB Secretariat once available.

1.8 Additional approvals

Some research projects may require approval or authorization from other organizations and bodies. It is the applicant's responsibility to obtain the necessary approvals and demonstrate these approvals to the REB. List the additional approvals required and their status (e.g., pending, received). Letters of support from community leaders and other partners or collaborators should also be included here.

Information - clinical trial research

Clinical trial sponsors are required to submit a clinical trial application to Health Canada for authorization to conduct a clinical trial in Canada. For more information, consult the Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications .

Note that it is not necessary to list internal departmental approvals (e.g., senior management, ADM) or Privacy Management Division approval (covered in Section 4).

1.9 Funding information

The REB requires details on the funding for the research to assess the project's feasibility and the relationship between the funder and the researcher. Be sure to provide details on each funding source (including name of funding organization, grant number, amount and duration of funding) in the text box in part (b). If funding has been applied for but not yet been secured, indicate the anticipated funding source and timeframe for obtaining funding. A study budget sheet must be included with the application detailing how the funding will be allocated for the research.

2.1 Plain language summary

Provide a brief summary of the research that uses clear, plain language and that can be easily understood by those without prior knowledge of the subject. The summary should be under 300 words and not exceed the size of the text box provided. The summary should describe the significance of the project (i.e., why the research is being conducted), the hypothesis/research question and major objectives of the project, the methods or procedures to be followed, and the expected outcomes/impact of the work.

Refer to the Public Service Commission Style Guide for tips on writing in plain language.

2.2 Key words

Provide up to five key words that relate to your research. Key words should describe the subject area and any distinctive elements of the project, including the methodology and study population (e.g., "biobank," "artificial intelligence," "HIV/AIDS," "genome-wide association study," "nutrition research," "air pollution").

2.3 Detailed research protocol

Researchers must attach a detailed description of the proposed research project to the application. For additional information and guidance, please refer to the research protocol instructions on the REB website. A formal protocol previously prepared for another purpose (e.g., project planning, program approval, grant proposal) may be submitted for the REB's review so long as it is current and includes all the necessary information outlined in the research protocol instructions.

2.4 How does the research involve human participants

Research involving human participants includes research with living individuals, human remains, human biological materials, and/or information from or about humans. Research may involve studies on information or biological materials initially selected for a different purpose (secondary use). Select the category or categories that best apply to your research project.

Information - categories

Categories that may be unclear are explained in more detail below. For additional guidance concerning the other categories, please contact the REB Secretariat.

  • Human cell lines : Research involving human cells that are maintained in culture, including both primary and immortalized cell lines, falls within the TCPS 2 definition of "research involving humans." As such, it is subject to review by an REB ( TCPS 2, Article 2.1 ).
  • Physical measures: Examples include the measurement of height, weight, heart rate, blood pressure, respiration, body temperature, energy expenditure, eye movement, etc.
  • Personal information: As defined in the Privacy Act , personal information is "information about an identifiable individual that is recorded in any form." Details on the types of personal information can be found in TCPS 2, Chapter 5, Part A .
  • Other: Examples include studies in which human participants are recruited but the information or data comes from other non-human sources (e.g., the participants' pets, participants' homes or workplaces for environmental monitoring including air, water and food sources).

2.5 Study population

Select the category or categories that best describe the research study population. The emphasis should be placed on the population specifically recruited or targeted for the study, and not on subgroups that may happen to be part of that population but were not specifically targeted. For example, if a study population includes a cross-section of the adult population in a particular region, only select "females" and "males" even though the population may happen to include other subgroups such as pregnant women, Indigenous people, specific population groups, sexual and gender minorities, etc.

  • Specific population (ethnic) groups: Where participants are specifically recruited based on ethnicity (e.g., White, South Asian, Chinese, Black, Filipino).
  • Adults with diminished decision-making capacity: As stated in TCPS 2, "Decision-making capacity refers to the ability of prospective or actual participants to understand relevant information presented about a research project and to appreciate the potential consequences of their decision to participate or not participate." Refer to TCPS 2, Chapter 3, Part C , for more information.
  • Other: Examples may include prisoners, homeless persons, persons with specific medical conditions or disabilities, other vulnerable/marginalized groups, and official language minority communities. If working with human cell lines (see Section 2.4(a)), select this category and provide any available details on the individuals from whom the cells were derived.

2.6 Collection of samples/data/personal information

Research involving humans cannot begin without a certificate of REB review and approval from the HC/PHAC Decisional Authority. For most applications, it is expected that sample/data collection related to the proposal in question will begin only after HC-PHAC REB approval has been granted, unless the research involves secondary use of previously collected material.

For certain externally led projects, another REB may have already approved the project, and primary sample collection for the project has begun or been completed. In such cases, HC-PHAC REB approval must be obtained before the HC/PHAC researchers begin working on the project. Wherever possible, applicants in this situation are strongly encouraged to submit their application to the HC-PHAC REB as early as possible in the project lifecycle, and preferably at the same time it is submitted to the external REB, so that any recommendations from the HC-PHAC REB can be incorporated into the project's design.

Applicants are reminded that REB approval must be obtained prior to the start of the study (or the start of HC/PHAC involvement in an externally led project). The REB cannot provide retroactive approval for research involving humans. For more information about when to apply to the HC-PHAC REB, please contact the REB Secretariat.

2.7 Study attributes

Select the category or categories that best describe the research project's attributes. Note that these attributes will not necessarily apply to all studies. Thus, if none is relevant to the current proposal, select "none of the above".

  • Creation of a biobank: A collection of human biospecimens and associated data compiled for research purposes. For more information on the storage and banking of human biological materials, refer to TCPS 2, Chapter 12 .
  • Clinical trial: An investigation in respect of a drug or device for use in humans that involves human subjects and that is intended to discover or verify the clinical, pharmacological or pharmacodynamic effects of the drug/device, identify any adverse events in respect of the drug/device, study the absorption, distribution, metabolism and excretion of the drug, or ascertain the safety or efficacy of the drug/device. See TCPS 2, Chapter 11 , for more information.
  • Human genetic research: As stated in TCPS 2, Chapter 13 , "Human genetic research involves the study of genetic factors responsible for human traits and the interaction of those factors with each other, and the environment. Research in this area includes the identification of genes that comprise: the human genome; functions of genes; the characterization of normal and disease conditions in individuals, biological relatives, families, communities and groups; and studies involving gene therapy."
  • Biomonitoring: The measurement of substances such as parent compounds, their metabolites or their reaction products in human tissues and fluids.

2.8 Independent scientific peer review

To be ethically acceptable, research involving humans must be methodologically sound and meet the scholarly standards of the relevant research discipline. The REB relies on independent scientific peer review in assessing the methodological rigour and validity of the proposed research. Reviewers should not be directly associated with the research project team and should have no real, potential or perceived conflicts of interest concerning the research. Reviewers should also be highly knowledgeable and experienced in the relevant field, and sufficiently qualified to provide an expert assessment of the scientific merit and quality of the proposed research.

Two independent scientific peer reviews must be attached to the application. Applicants must also indicate how they have addressed the reviewers' comments in the research proposal and associated documents (e.g., consent forms). This can be done by preparing a separate document listing the reviewers' comments along with a brief description of whether and how the research proposal was changed. Alternatively (or additionally), the changes can be indicated in the relevant documents using track changes and/or comment boxes. If the reviewers had no specific comments to address and therefore no changes were made to the proposal, check the corresponding box in Section 2.8(b).

Information - peer review

  • Guidance on what constitutes a conflict of interest in peer review can be found in the Conflict of Interest and Confidentiality Policy of the Federal Research Funding Organizations and the CIHR Peer Review Manual .
  • If the research has already undergone independent scientific review by a granting agency, internal board, steering committee, advisory board, thesis committee, etc., these reviews may be sufficient for the REB's purposes. Please submit the reviews along with sufficient details of the review process for the REB to assess the quality and independence of the reviews (e.g., organization that oversaw/solicited the reviews and for what purpose, names and/or qualifications of the reviewers).
  • In certain cases where the proposed research poses no more than minimal risk to the participants, the REB Secretariat may waive the requirement for peer reviews. Applicants should contact the REB Secretariat before submitting their application if they wish to seek an exemption. If an exemption is granted, or if for some reason it is not possible to provide peer reviews, explain this in the text box provided.
  • For situations in which acceptable peer reviews of the proposed research have not already been obtained, the REB Secretariat has created a template for scientific peer reviews that applicants are encouraged to use when soliciting reviews to accompany their REB application.

3.1 Compensation/incentives

If participants will be recruited for the research project and compensation or incentives will be offered, the REB needs to assess the potential impact of the compensation or incentives on voluntariness of participation (see TCPS 2, Chapter 3 , for more information). Specify the nature and amount of any compensation or incentives, including whether and how the compensation/incentives will be affected if the participant withdraws before completing the study.

If the research project does not involve recruitment of human participants, select "N/A".

3.2 Obtaining consent/assent

A copy of the documents used to obtain consent or assent from participants must be included within the application for ethics review. If consent/assent is being obtained verbally, include a copy of the verbal consent script and explain how consent/assent will be documented.

As outlined in TCPS 2, Chapter 3 Part B , it is permissible in certain specific situations to conduct research without obtaining consent of the participants. Applicants who are seeking an exception to the requirement to seek prior consent are advised to consult with the REB Secretariat before submitting their application. Provide the rationale for not obtaining consent from participants in the space provided on the application form.

Information - consent requirements

TCPS 2 provides additional information on the consent requirements for the following types of studies:

  • Research that involves an alteration to the consent requirements ( TCPS 2, Article 3.7A )
  • Use of identifiable information for secondary use without consent ( TCPS 2, Article 5.5A )
  • Research that relies exclusively of secondary use of non-identifiable information without consent ( TCPS 2, Article 5.5B ).

In all cases, the applicant must demonstrate that the requirements set out in the relevant article have been satisfied.

If the research project does not involve recruitment of human participants, select "No" and enter "N/A" in the text box.

4.1 Privacy Management Division (PMD) review

All applicants to the HC-PHAC REB must consult the HC-PHAC Privacy Management Division (PMD) to obtain an assessment of privacy risks. The review consists of two parts:

  • Preliminary privacy risk assessment: streamlined review to assess the overall level of privacy risk (low, medium or high) and to determine the need for completing a privacy protocol checklist
  • Privacy protocol checklist: only required for high risk and certain medium risk proposals

The results of the preliminary privacy risk assessment and the privacy protocol checklist (if applicable) should be included with the application. In some cases, the consultation with PMD and the review by the HC-PHAC REB may be conducted concurrently; however, the ethics certificate will generally be issued only after the PMD review has been completed and the REB Secretariat has received the results. For more information, contact the REB Secretariat.

It is not necessary for applicants external to HC/PHAC to consult with PMD, as long as no HC/PHAC employees are part of the research team and HC/PHAC will not have control of any personal information associated with the research. If this is the case, or if PMD has confirmed that a preliminary privacy risk assessment is not required for any other reason, provide details in the text box provided and attach any relevant correspondence from PMD to the application.

Information - control of personal information

In determining whether a record is under the control of a government institution, some of the factors to be considered include whether:

  • it is held by the institution, whether at headquarters or at a regional, satellite or other office, either within or outside Canada, or at an off-site location such as a private storage facility or a federal records centre (records storage facility administered by Library and Archives Canada containing records that remain under the control of institutions);
  • it is held elsewhere on behalf of the institution (e.g., records maintained by agents, consultants or other contracted service providers); and
  • the institution is authorized to grant or deny access to the record, to govern its use and, subject to the approval of the National Archivist, to dispose of it.

If there is any uncertainty around control, contact PMD for assistance.

Information - contacting PMD

[email protected] or [email protected]

5.1 Third party implications

If there are any individuals and/or organizations not listed in Section 1 who are involved in carrying out the research project, list them here with a brief explanation of their role. The REB requires this information to assess the nature and scope of their involvement for any ethical concerns. Examples of third parties that should be listed include:

  • Individuals who are collaborating with the core research team to provide a specific service (e.g., access to equipment, provision of specific reagents, training in a specialized technique, statistical analysis, access to a patient population). The terms of the collaboration are typically informal but may be defined through a collaboration agreement.
  • Organizations and/or individuals who are formally engaged through a service contract or research agreement to conduct specific activities related to the research project (e.g., provide access to datasets and/or perform data analysis, develop and/or deliver participant surveys, conduct specialized laboratory services such as sample analysis or DNA sequencing, provide translation or transcription services).

If it is unclear whether an individual or organization should be listed in this section, contact the REB Secretariat for direction.

5.2 Contract/agreement Information

For research that involves third parties external to HC/PHAC, contracts and agreements are typically established to define those third party relationships. It is important for the REB to review these agreements as part of the ethics review process in order to have a full understanding of the scope of the research and to help assess issues like privacy of the human participants and protection of personal information. Examples of documents to include in this section include:

  • Contracts or contribution agreements from HC/PHAC to external PIs to fund the research
  • Any agreements between members of the study team and/or with third parties listed in Section 5.1, such as research or collaboration agreements; service contracts; data-sharing or material transfer agreements; and memoranda of understanding (MOUs) or memoranda of agreement (MOAs)

The REB recognizes that it can take time to finalize agreements and that in some cases parties cannot enter into agreement until HC-PHAC REB approval has been obtained for the research. Thus, if there are any agreements still in development at the time of submission, provide details in the space provided and attach draft copies of the agreements wherever possible. Depending on the nature and importance of the agreement, the REB may withhold approval until the agreement has been finalized.

If it is unclear whether a particular document should be included in this section, contact the REB Secretariat for assistance.

6.1 Declaration of conflicts

Conflicts of interest (real, potential or perceived) arise when an individual in a position of trust has competing professional or personal interests. Such competing interests may influence their professional judgment, objectivity and independence and can potentially influence the outcome of a decision, for personal benefit. As noted in TCPS 2, Chapter 7 , it is always preferable to avoid or prevent being in a position of conflict of interest. When it is not possible to avoid a conflict of interest, the conflict must be disclosed and procedures put in place to manage and/or mitigate the conflict. In such cases the REB will assess the information and determine the appropriate steps to manage the conflict of interest.

Information - Other applicable policies

HC/PHAC employees are subject to the Values and Ethics Code for the Public Sector and the HC-PHAC Scientific Integrity Policy, which include directives regarding the avoidance and management of conflicts. REB approval of a conflict of interest management plan does not absolve HC/PHAC researchers of their obligations under either of these policies.

Information - obtaining and submitting signatures

Digital signatures are accepted and encouraged. If any signatures are not obtained electronically, print Section 7 and obtain all necessary signatures in hard copy. Once Section 7 is complete, scan the signed pages and include them in the application package, along with an electronic copy of the completed application in PDF format and all other supporting documents as required.

7.1 Health Canada / PHAC departmental approval

  • PHAC departmental approval must be obtained prior to submission of an REB application. Applications that do not include a completed and signed PHAC Departmental Approval of Research Involving Humans form will be rejected. The form can be obtained by contacting PHAC's Office of the Chief Science Officer . Note that the PHAC Departmental Approval form is not required for projects led by external applicants funded through PHAC contributions. In such cases, the signed copy of the contribution agreement (as requested in Section 5.2) serves as evidence of approval.
  • For HC projects, sign-off is required from the PI's supervisor (manager-level or above) with Section 34 authority. If the PI is external to Health Canada, the HC contact person should sign. The signature should normally be obtained prior to submitting the application to the REB. If the signatory is not available to sign the application before the application deadline, contact the REB Secretariat to determine if an exception can be made.

7.2 Attestation of principal investigator and other investigators/team members

Signatures from the principal investigator and all other investigators/team members (as listed in Sections 1.2 and 1.3) should be obtained prior to submitting the application to the REB. If this is not possible, contact the REB Secretariat to discuss. If an exception is granted, all necessary signatures must be obtained prior to approval from the REB and the HC/PHAC Decisional Authority.

Attachments can be submitted in any standard format including Word documents, PDF files, images (JPEG, TIFF, etc.), Excel spreadsheets, and PowerPoint documents. Filenames should include the section of the application to which the document relates and a brief description of the content (e.g., "1-CV_Einstein," "2-Research protocol"). If the application includes attachments not indicated in the list, or if additional pages were required due to insufficient space on the application form, select "Other" and list the attachments in the text box provided.

Separate files for each attachment are preferred, rather than a single document containing multiple or all attachments. If certain attachments are contained within another document (e.g., if the study budget sheet is included within the research protocol rather than as a separate attachment), please explain in the text box provided.

The research protocol is a critical component of the REB application. The REB relies on the protocol to obtain a complete and accurate picture of the work that will be undertaken, and in particular how human participants will be involved in the research. Because of its central importance to the ethics review process, the research protocol must be readily understandable by each REB member. Applicants are reminded that the REB members come from a wide variety of backgrounds, and not all will necessarily be familiar with the field of study or methodology for the proposed research. Thus, care should be taken to ensure that the protocol is understandable to an intelligent non-expert. Applicants are welcome to include figures and tables where appropriate, as these can be helpful tools to organize and present information.

The instructions provided below describe the elements that must be addressed in the research protocol. Applicants are encouraged to structure their protocols according to this outline and to number the pages for ease of reference. It is also acceptable to use a research protocol that has been prepared for another purpose (e.g., to apply for funding, to obtain internal approval), as long as it addresses all the elements described below and it accurately reflects the research for which REB approval is being sought.

This section should explain the purpose and rationale for conducting the research. It should include the hypothesis or research questions the project is intended to answer, and briefly describe the expected knowledge that will be generated and the anticipated outcomes of the research.

This section should provide the context for the proposed work and identify the knowledge gaps that the research intends to fill. Applicants should explain how the research will build on what is already known and how it will add to the body of existing knowledge. It is important to demonstrate that there is a sound theoretical basis for the proposed work, and that the research will fill a significant knowledge gap.

If the protocol builds on a pilot study or a related research study, describe the results of the previous work and indicate how they have informed the design of the current protocol.

This section should describe how the proposed research will be conducted. Recognizing that not all REB members will necessarily be familiar with the field of study, the description of the methods should avoid excessive technical or scientific jargon while still providing a sufficient level of detail for the REB to critically assess the scientific validity of the proposed approach. The following elements should be included in this section, to the extent that these are applicable to the proposed research:

  • The major procedural steps that will be followed and the activities that will be undertaken in conducting the research
  • Timeline and key milestones for the research
  • Where the research activities will take place
  • Activities for which each member of the research team will be responsible, and whether any activities will be conducted by third parties outside of the research team (provide details on the nature of the arrangements and copies of contracts or research agreements where applicable)
  • Nature and source of the samples/data/information that will be studied
  • Techniques and instruments that will be used to collect the samples/data/information (i.e., questionnaires, interview scripts, focus group guides, physical monitoring, blood collection, etc.)
  • How the samples/data/information will be used and analyzed

Important - supplemental materials

All data collection materials must be included with the research protocol in an appendix or separate attachment (i.e., surveys, questionnaires, telephone scripts, focus group discussion guides, interview scripts, etc.).

If human participants will be recruited to take part in the research study, the following information should be provided:

  • Recruitment strategy, including the target population(s), recruitment methods and materials (e.g., radio or print ads, social media posts)
  • Study population, including sample size, inclusion/exclusion criteria, and sex and gender considerations (with appropriate justification and rationale)
  • How research participants will be involved in the study, what they will be asked to do, and the expected time commitment
  • Whether participants will be offered incentives and/or compensated for their participation in the research, and in what form (e.g., cash, gift cards, meals)
  • Justification for any incentives offered as part of the recruitment strategy and their potential impact on voluntariness of participation

All recruitment materials must be included with the research protocol in an appendix or separate attachment (i.e., invitation letters and emails, telephone recruitment scripts, flyers, brochures, social media posts, etc., in the language(s) understood by the participants).

The importance of free, informed and ongoing consent of human participants in research is central to research ethics review. As described in TCPS 2, Chapter 3 , the core ethics principle of respect for persons implies that individuals who participate in research should do so voluntarily, understanding the purpose of the research, and its risks and potential benefits, as fully as reasonably possible. Thus, this section of the research protocol should clearly explain:

  • How consent/assent will be obtained and documented
  • How consent/assent will be maintained throughout the research project
  • How participants will be informed of their right to withdraw from the study, to what extent participants will be able to review and withdraw their information, and how their samples/data/information will be managed following withdrawal (i.e., whether they will be destroyed, kept for a specific period of time, etc.)
  • How participants will be informed of the potential harms and benefits of participating in the study
  • If vulnerable populations (including participants with diminished decision-making capacity) will be recruited, what additional steps (if any) will be taken to protect the participants' interests (including the use of authorized third parties to make a consent decision)?
  • If minors will be recruited, how will their assent or consent be obtained, and what role will their parents or guardians play in the consent process?
  • If participants will be recruited from different linguistic groups, what is the plan for translating information and consent documents and/or providing access to interpreters?
  • If there is the potential for future use of participants' samples/data/information, what steps will be followed to inform participants and obtain their consent?
  • If the research involves partial disclosure or deception, why is it warranted, and what is the plan for debriefing participants and for offering them the possibility of refusing consent and/or withdrawing their samples/data/information from the study?
  • If participant consent will not be sought, a clear rationale must be provided

All participant information and consent materials must be included with the research protocol in an appendix or separate attachment. Consent materials must be in the language(s) understood by the participants, written in plain language at an appropriate reading level (i.e., grades 6 to 8).

As part of the ethics review process, the REB must decide whether the harms anticipated to research participants, their families and communities can be justified ethically in terms of the potential benefits to the participants, to others and to society as a whole. Thus, this section should describe:

  • All known and reasonably anticipated harms which might be expected to occur, with estimates as to their potential seriousness and frequency (note that harms may be social, behavioural, psychological, physical or economic in nature)
  • The approaches taken to minimize or mitigate the potential harms
  • Known or potential benefits to research participants, their families, communities or society as a whole (note that compensation or incentives for participating are not considered a benefit and should not be listed as such)

For some research projects, it may be true to say that no potential harms and/or benefits can be identified. If applicable, this should be stated and justified.

Researchers have an ethical and legal obligation to respect and protect the privacy and confidentiality of human participants in research. Thus, a key element of the REB's evaluation is to examine how participants' privacy and confidentiality will be addressed by the researchers. Research protocols are also examined by the Health Canada-PHAC Privacy Management Division (PMD) to ensure that any personal information is handled appropriately and all requirements of the Privacy Act are met. PMD will assess whether the research project involves personal information and if the project does determine the preliminary level of privacy risk.

To assist both the REB and PMD in their reviews, the following elements should be addressed in the research protocol, as appropriate to the nature of the research being proposed:

Nature of the samples/data/information

  • What information about the participants is being collected, and in what format (e.g., paper, computer files, online, audio/video recordings, physiological measures, photographs)?
  • Highly sensitive (e.g., information with a serious risk of harm or discrimination such as banking information or illicit drug use)
  • Sensitive (e.g., medical information such as physical disabilities or medical conditions)
  • Contextually sensitive (e.g., information related to a sensitive Health Canada or PHAC program such as the Office of Medical Cannabis)
  • Limited contextual sensitivities (e.g., home phone number or exercise and eating habits)
  • Non-sensitive (e.g., business contact information)
  • Who is responsible for the initial collection of the samples/data/information, and in the case of secondary use of samples/data/information, how will the researchers obtain access?
  • Is the information directly identifying (e.g., name, personal health number, other identifying numbers)?
  • Is the information indirectly identifying; that is, information that could be used alone or in combination with other information to identify an individual (e.g., date of birth, place of residence or unique personal characteristic)?
  • Is the information coded, and if so, how was the code established and who has access to the key?
  • Will the information be anonymized (i.e., the information is irrevocably stripped of direct identifiers and a code is not kept to allow future re-linkage), and if so, how?
  • Is the information anonymous (i.e., never had identifiers associated with it and cannot be linked to any other information to re-identify individuals)?

Access to and storage of the samples/data/information

  • Who will be the primary collector or custodian of the samples/data/information, and who will have access?
  • How will the samples/data/information be securely stored and maintained (e.g., in a locked room or file cabinet with restricted access, as encrypted and password-protected computer files)?
  • Will any samples/data/information be stored outside of Canada, and if so, what controls and safeguards will be put in place to protect participants' confidentiality and minimize privacy risks?
  • If data or datasets will be combined or linked for the purposes of analysis and/or publication, who will be responsible for linking the data, how will the linkage be done and is there a risk of re-identification of participants?

Sharing and disclosure of samples/data/information

  • Will any samples/data/information be shared with individuals or organizations outside of Health Canada or PHAC, and if so, with whom and by what transmission method (e.g., courier service, encrypted server)?
  • If the research will be done in collaboration with individuals or organizations from outside Canada, what are the organizations that are involved, and does that jurisdiction have a strong privacy regime?
  • Has consent been obtained from the participants to disclose their information?
  • If the research generates important incidental findings about the health and safety of participants or third parties, how will this information be communicated to the participants and/or the authorities as appropriate, and how will confidentiality be maintained?
  • Will the results of the research be published or disseminated, and if so, how will the privacy of the participants be respected (e.g., by excluding names, nicknames, physical descriptions, clues to their location or place of study)?

Retention and disposition of the samples/data/information

  • For how long will the samples/data/information be stored?
  • How will the samples/data/information be destroyed?

For research protocols that involve personal information Footnote 2 under the control of Health Canada/PHAC researchers, applicants should also describe:

  • The authorized Health Canada/PHAC program or project under which the personal information is collected (e.g., paragraph 4 of the Department of Health Act , or paragraph 3 of the Public Health Agency of Canada Act ), and the reason that the proposed research requires the information
  • Whether and how participants will be notified of the purpose for which their personal information is being collected
  • How the personal information will be used, and whether the information will be used for a purpose other than that for which it was collected

Please Note: PMD may request for their analysis additional details on how personal information is collected, used, shared and disposed of. However, every effort will be made to leverage all information provided in the research protocol to minimize duplication and additional work for the researcher.

Conflicts of interest have ethical implications in that they could, or could be perceived to, introduce biases into the research as it is performed, including the recruitment of participants. The REB therefore needs to be made aware of any real, apparent or potential conflicts of interest that may affect how the research is done, and the steps that will be taken to minimize their impact. For additional information, consult TCPS 2, Chapter 7 .

Applicants should also describe any important limitations to their study, such as those that may result from the study design, sample size or population, analysis plan, or scope of the proposed research, and the strategies that will be taken to mitigate those limitations. For significant limitations, indicate whether and how the research project will still be able to generate meaningful results and accomplish the desired objectives.

Researchers have an obligation to share the results of their research. When the research involves human participants, it is especially important that the participants themselves, and their communities, receive and can benefit from the results of the research. Thus, applicants must explain their knowledge translation plan and how they intend to disseminate the results of their research, including whether the results of the study will be made available to the study participants. For certain types of research, the activities may consist solely of publishing a manuscript in a peer-reviewed (and ideally open access) journal or publishing a report online. However, for other types of research, particularly those involving strong community engagement, a more extensive knowledge translation plan will be expected that describes:

  • Who the target audience will be
  • How the information will be disseminated (i.e., the products, tools and processes that will be used)
  • How and when the results are expected to be used by the target audience

Applicants are reminded that a study budget sheet must be included with the application, either as a separate attachment or as a section within the research protocol. The study budget should provide a clear picture of how the funds will be expended, broken down by project year and activity (e.g., personnel and salary costs, equipment, consumables, service contracts, travel, knowledge translation activities).

The following considerations may not apply to all research protocols and only need to be addressed where relevant. Applicants are welcome to include a separate section if necessary to address these issues; however, in most cases it is expected that these considerations can (and should) be addressed throughout the protocol, and especially in the Methods section.

  • Multicentre or multijurisdictional research For research projects involving multiple centres and/or jurisdictions, describe the activities that will be conducted at the various sites. Applicants must also explain the plan for obtaining approval from other REBs and authorities where needed if not already secured or in progress.
  • Sex and gender The Government of Canada is committed to using Gender-Based Analysis Plus (GBA+) to develop effective policies and programs. GBA+ is an analytical tool used to assess the potential impacts of policies, programs, services and other initiatives on diverse groups of people, taking into account sex, gender and other intersecting identity factors (such as age, culture, language, education, sexual orientation, ability and faith). From an ethical perspective, GBA+ aligns with the core principle of justice - the obligation to treat people fairly and equitably. Applicants are therefore expected to consider sex and gender in their research design, methodology and analysis.
  • Official languages Health Canada and PHAC have obligations and responsibilities under the Official Languages Act and to Official Language Minority Communities (OLMCs). These include ensuring respect for English and French; ensuring equality of status and equal rights and privileges as to the use of both languages in federal institutions; supporting the development of English and French linguistic minority communities; and advancing the equal status and use of English and French. Applicants should ensure that appropriate consideration is given to the use of French and English, and to the engagement of individuals from both linguistic communities (including linguistic minority communities).
  • Indigenous research Research involving Indigenous peoples must take into account their unique status and must respect community customs and codes of research practice. Applicants should adhere to the principles outlined in TCPS 2, Chapter 9 and ensure that their research protocol aligns with these principles.
  • Community engagement Research involving humans often extends beyond individuals to include the broader community, for example through community-based participatory research. Community engagement is also a key requirement in Indigenous research. Where appropriate, applicants should describe how the community will be engaged in the research and include letters of support from community leaders.
  • Legislation and regulations Legislation and regulations at federal, provincial or local levels can influence the performance of the proposed research. Applicants should note any legislation or regulation that could affect the proposed research and describe the steps that will be taken to ensure the research is in compliance.

List all references cited in the research protocol.

Applicants must include two independent scientific peer reviews with their application. Applicants are encouraged to use the following template when soliciting reviews of their research protocol:

  • Scientific Peer Review of Research Involving Humans (PDF format, 414 KB, 10 pages)

Upon receipt of an application, the REB Secretariat will review the application for completeness, identify outstanding items that are required for REB review and follow up with the applicant to request the required information. Once the application is deemed complete, it will be referred for REB review.

At the REB review meeting, applicants are invited to make a brief presentation on their research (either in person or remotely) and respond to questions from the REB members. The REB's recommendations are sent to the applicant within 7 to 10 business days following the meeting. The research under review will receive one of the following decisions from the REB:

  • The application meets ethics requirements for research involving humans.
  • The REB requires modification of the application or clarification before the members can finalize their assessment.
  • The application does not meet ethics requirements for research involving humans and it is unlikely that revision will lead to a positive determination.

If clarifications or revisions to the protocol are required, the letter of approval and Certificate of Ethics Review will not be issued until the REB has reviewed and approved the applicant's response. It is the responsibility of the researcher to respond promptly to the REB's concerns.

Applications for initial review of research involving humans are normally reviewed at the monthly meetings of the full REB as per the schedule below. Applications for each meeting are accepted on a first come, first served basis and must be received by the application deadline for that meeting. The Secretariat reserves the right to limit the number of applications reviewed by the REB at each meeting. Applicants are encouraged to inform the REB Secretariat in advance of the deadline of their intention to submit an application.

All documents should be sent by email to the REB Secretariat: [email protected] .

For more information, including definitions of the types of information, see TCPS 2, Chapter 5, Part A https://ethics.gc.ca/eng/tcps2-eptc2_2022_chapter5-chapitre5.html#a

Return to footnote 1 referrer

Personal information is information about an identifiable individual that is recorded in any form. It can include name; contact information; health, financial and biometric information; personal opinions; and identifying numbers.

Return to footnote 2 referrer

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Ethical Issues in Research: Perceptions of Researchers, Research Ethics Board Members and Research Ethics Experts

Marie-josée drolet.

1 Department of Occupational Therapy (OT), Université du Québec à Trois-Rivières (UQTR), Trois-Rivières (Québec), Canada

Eugénie Rose-Derouin

2 Bachelor OT program, Université du Québec à Trois-Rivières (UQTR), Trois-Rivières (Québec), Canada

Julie-Claude Leblanc

Mélanie ruest, bryn williams-jones.

3 Department of Social and Preventive Medicine, School of Public Health, Université de Montréal, Montréal (Québec), Canada

In the context of academic research, a diversity of ethical issues, conditioned by the different roles of members within these institutions, arise. Previous studies on this topic addressed mainly the perceptions of researchers. However, to our knowledge, no studies have explored the transversal ethical issues from a wider spectrum, including other members of academic institutions as the research ethics board (REB) members, and the research ethics experts. The present study used a descriptive phenomenological approach to document the ethical issues experienced by a heterogeneous group of Canadian researchers, REB members, and research ethics experts. Data collection involved socio-demographic questionnaires and individual semi-structured interviews. Following the triangulation of different perspectives (researchers, REB members and ethics experts), emerging ethical issues were synthesized in ten units of meaning: (1) research integrity, (2) conflicts of interest, (3) respect for research participants, (4) lack of supervision and power imbalances, (5) individualism and performance, (6) inadequate ethical guidance, (7) social injustices, (8) distributive injustices, (9) epistemic injustices, and (10) ethical distress. This study highlighted several problematic elements that can support the identification of future solutions to resolve transversal ethical issues in research that affect the heterogeneous members of the academic community.

Introduction

Research includes a set of activities in which researchers use various structured methods to contribute to the development of knowledge, whether this knowledge is theoretical, fundamental, or applied (Drolet & Ruest, accepted ). University research is carried out in a highly competitive environment that is characterized by ever-increasing demands (i.e., on time, productivity), insufficient access to research funds, and within a market economy that values productivity and speed often to the detriment of quality or rigour – this research context creates a perfect recipe for breaches in research ethics, like research misbehaviour or misconduct (i.e., conduct that is ethically questionable or unacceptable because it contravenes the accepted norms of responsible conduct of research or compromises the respect of core ethical values that are widely held by the research community) (Drolet & Girard, 2020 ; Sieber, 2004 ). Problematic ethics and integrity issues – e.g., conflicts of interest, falsification of data, non-respect of participants’ rights, and plagiarism, to name but a few – have the potential to both undermine the credibility of research and lead to negative consequences for many stakeholders, including researchers, research assistants and personnel, research participants, academic institutions, and society as a whole (Drolet & Girard, 2020 ). It is thus evident that the academic community should be able to identify these different ethical issues in order to evaluate the nature of the risks that they pose (and for whom), and then work towards their prevention or management (i.e., education, enhanced policies and procedures, risk mitigation strategies).

In this article, we define an “ethical issue” as any situation that may compromise, in whole or in part, the respect of at least one moral value (Swisher et al., 2005 ) that is considered socially legitimate and should thus be respected. In general, ethical issues occur at three key moments or stages of the research process: (1) research design (i.e., conception, project planning), (2) research conduct (i.e., data collection, data analysis) and (3) knowledge translation or communication (e.g., publications of results, conferences, press releases) (Drolet & Ruest, accepted ). According to Sieber ( 2004 ), ethical issues in research can be classified into five categories, related to: (a) communication with participants and the community, (b) acquisition and use of research data, (c) external influence on research, (d) risks and benefits of the research, and (e) selection and use of research theories and methods. Many of these issues are related to breaches of research ethics norms, misbehaviour or research misconduct. Bruhn et al., ( 2002 ) developed a typology of misbehaviour and misconduct in academia that can be used to judge the seriousness of different cases. This typology takes into consideration two axes of reflection: (a) the origin of the situation (i.e., is it the researcher’s own fault or due to the organizational context?), and (b) the scope and severity (i.e., is this the first instance or a recurrent behaviour? What is the nature of the situation? What are the consequences, for whom, for how many people, and for which organizations?).

A previous detailed review of the international literature on ethical issues in research revealed several interesting findings (Beauchemin et al., 2021 ). Indeed, the current literature is dominated by descriptive ethics, i.e., the sharing by researchers from various disciplines of the ethical issues they have personally experienced. While such anecdotal documentation is relevant, it is insufficient because it does not provide a global view of the situation. Among the reviewed literature, empirical studies were in the minority (Table  1 ) – only about one fifth of the sample (n = 19) presented empirical research findings on ethical issues in research. The first of these studies was conducted almost 50 years ago (Hunt et al., 1984 ), with the remainder conducted in the 1990s. Eight studies were conducted in the United States (n = 8), five in Canada (n = 5), three in England (n = 3), two in Sweden (n = 2) and one in Ghana (n = 1).

Summary of Empirical Studies on Ethical Issues in Research by the year of publication

Further, the majority of studies in our sample (n = 12) collected the perceptions of a homogeneous group of participants, usually researchers (n = 14) and sometimes health professionals (n = 6). A minority of studies (n = 7) triangulated the perceptions of diverse research stakeholders (i.e., researchers and research participants, or students). To our knowledge, only one study has examined perceptions of ethical issues in research by research ethics board members (REB; Institutional Review Boards [IRB] in the USA), and none to date have documented the perceptions of research ethics experts. Finally, nine studies (n = 9) adopted a qualitative design, seven studies (n = 7) a quantitative design, and three (n = 3) a mixed-methods design.

More studies using empirical research methods are needed to better identify broader trends, to enrich discussions on the values that should govern responsible conduct of research in the academic community, and to evaluate the means by which these values can be supported in practice (Bahn, 2012 ; Beauchemin et al., 2021 ; Bruhn et al., 2002 ; Henderson et al., 2013 ; Resnik & Elliot, 2016; Sieber 2004 ). To this end, we conducted an empirical qualitative study to document the perceptions and experiences of a heterogeneous group of Canadian researchers, REB members, and research ethics experts, to answer the following broad question: What are the ethical issues in research?

Research Methods

Research design.

A qualitative research approach involving individual semi-structured interviews was used to systematically document ethical issues (De Poy & Gitlin, 2010 ; Hammell et al., 2000 ). Specifically, a descriptive phenomenological approach inspired by the philosophy of Husserl was used (Husserl, 1970 , 1999 ), as it is recommended for documenting the perceptions of ethical issues raised by various practices (Hunt & Carnavale, 2011 ).

Ethical considerations

The principal investigator obtained ethics approval for this project from the Research Ethics Board of the Université du Québec à Trois-Rivières (UQTR). All members of the research team signed a confidentiality agreement, and research participants signed the consent form after reading an information letter explaining the nature of the research project.

Sampling and recruitment

As indicated above, three types of participants were sought: (1) researchers from different academic disciplines conducting research (i.e., theoretical, fundamental or empirical) in Canadian universities; (2) REB members working in Canadian organizations responsible for the ethical review, oversight or regulation of research; and (3) research ethics experts, i.e., academics or ethicists who teach research ethics, conduct research in research ethics, or are scholars who have acquired a specialization in research ethics. To be included in the study, participants had to work in Canada, speak and understand English or French, and be willing to participate in the study. Following Thomas and Polio’s (2002) recommendation to recruit between six and twelve participants (for a homogeneous sample) to ensure data saturation, for our heterogeneous sample, we aimed to recruit approximately twelve participants in order to obtain data saturation. Having used this method several times in related projects in professional ethics, data saturation is usually achieved with 10 to 15 participants (Drolet & Goulet, 2018 ; Drolet & Girard, 2020 ; Drolet et al., 2020 ). From experience, larger samples only serve to increase the degree of data saturation, especially in heterogeneous samples (Drolet et al., 2017 , 2019 ; Drolet & Maclure, 2016 ).

Purposive sampling facilitated the identification of participants relevant to documenting the phenomenon in question (Fortin, 2010 ). To ensure a rich and most complete representation of perceptions, we sought participants with varied and complementary characteristics with regards to the social roles they occupy in research practice (Drolet & Girard, 2020 ). A triangulation of sources was used for the recruitment (Bogdan & Biklen, 2006 ). The websites of Canadian universities and Canadian health institution REBs, as well as those of major Canadian granting agencies (i.e., the Canadian Institutes of Health Research, the Natural Sciences and Engineering Research Council of Canada, and the Social Sciences and Humanities Research Council of Canada, Fonds de recherche du Quebec), were searched to identify individuals who might be interested in participating in the study. Further, people known by the research team for their knowledge and sensitivity to ethical issues in research were asked to participate. Research participants were also asked to suggest other individuals who met the study criteria.

Data Collection

Two tools were used for data collecton: (a) a socio-demographic questionnaire, and (b) a semi-structured individual interview guide. English and French versions of these two documents were used and made available, depending on participant preferences. In addition, although the interview guide contained the same questions, they were adapted to participants’ specific roles (i.e., researcher, REB member, research ethics expert). When contacted by email by the research assistant, participants were asked to confirm under which role they wished to participate (because some participants might have multiple, overlapping responsibilities) and they were sent the appropriate interview guide.

The interview guides each had two parts: an introduction and a section on ethical issues. The introduction consisted of general questions to put the participant at ease (i.e., “Tell me what a typical day at work is like for you”). The section on ethical issues was designed to capture the participant’s perceptions through questions such as: “Tell me three stories you have experienced at work that involve an ethical issue?” and “Do you feel that your organization is doing enough to address, manage, and resolve ethical issues in your work?”. Although some interviews were conducted in person, the majority were conducted by videoconference to promote accessibility and because of the COVID-19 pandemic. Interviews were digitally recorded so that the verbatim could be transcribed in full, and varied between 40 and 120 min in duration, with an average of 90 min. Research assistants conducted the interviews and transcribed the verbatim.

Data Analysis

The socio-demographic questionnaires were subjected to simple descriptive statistical analyses (i.e., means and totals), and the semi-structured interviews were subjected to qualitative analysis. The steps proposed by Giorgi ( 1997 ) for a Husserlian phenomenological reduction of the data were used. After collecting, recording, and transcribing the interviews, all verbatim were analyzed by at least two analysts: a research assistant (2nd author of this article) and the principal investigator (1st author) or a postdoctoral fellow (3rd author). The repeated reading of the verbatim allowed the first analyst to write a synopsis, i.e., an initial extraction of units of meaning. The second analyst then read the synopses, which were commented and improved if necessary. Agreement between analysts allowed the final drafting of the interview synopses, which were then analyzed by three analysts to generate and organize the units of meaning that emerged from the qualitative data.

Participants

Sixteen individuals (n = 16) participated in the study, of whom nine (9) identified as female and seven (7) as male (Table  2 ). Participants ranged in age from 22 to 72 years, with a mean age of 47.5 years. Participants had between one (1) and 26 years of experience in the research setting, with an average of 14.3 years of experience. Participants held a variety of roles, including: REB members (n = 11), researchers (n = 10), research ethics experts (n = 4), and research assistant (n = 1). As mentioned previously, seven (7) participants held more than one role, i.e., REB member, research ethics expert, and researcher. The majority (87.5%) of participants were working in Quebec, with the remaining working in other Canadian provinces. Although all participants considered themselves to be francophone, one quarter (n = 4) identified themselves as belonging to a cultural minority group.

Description of Participants

With respect to their academic background, most participants (n = 9) had a PhD, three (3) had a post-doctorate, two (2) had a master’s degree, and two (2) had a bachelor’s degree. Participants came from a variety of disciplines: nine (9) had a specialty in the humanities or social sciences, four (4) in the health sciences and three (3) in the natural sciences. In terms of their knowledge of ethics, five (5) participants reported having taken one university course entirely dedicated to ethics, four (4) reported having taken several university courses entirely dedicated to ethics, three (3) had a university degree dedicated to ethics, while two (2) only had a few hours or days of training in ethics and two (2) reported having no knowledge of ethics.

Ethical issues

As Fig.  1 illustrates, ten units of meaning emerge from the data analysis, namely: (1) research integrity, (2) conflicts of interest, (3) respect for research participants, (4) lack of supervision and power imbalances, (5) individualism and performance, (6) inadequate ethical guidance, (7) social injustices, (8) distributive injustices, (9) epistemic injustices, and (10) ethical distress. To illustrate the results, excerpts from verbatim interviews are presented in the following sub-sections. Most of the excerpts have been translated into English as the majority of interviews were conducted with French-speaking participants.

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Ethical issues in research according to the participants

Research Integrity

The research environment is highly competitive and performance-based. Several participants, in particular researchers and research ethics experts, felt that this environment can lead both researchers and research teams to engage in unethical behaviour that reflects a lack of research integrity. For example, as some participants indicated, competition for grants and scientific publications is sometimes so intense that researchers falsify research results or plagiarize from colleagues to achieve their goals.

Some people will lie or exaggerate their research findings in order to get funding. Then, you see it afterwards, you realize: “ah well, it didn’t work, but they exaggerated what they found and what they did” (participant 14). Another problem in research is the identification of authors when there is a publication. Very often, there are authors who don’t even know what the publication is about and that their name is on it. (…) The time that it surprised me the most was just a few months ago when I saw someone I knew who applied for a teaching position. He got it I was super happy for him. Then I looked at his publications and … there was one that caught my attention much more than the others, because I was in it and I didn’t know what that publication was. I was the second author of a publication that I had never read (participant 14). I saw a colleague who had plagiarized another colleague. [When the colleague] found out about it, he complained. So, plagiarism is a serious [ethical breach]. I would also say that there is a certain amount of competition in the university faculties, especially for grants (…). There are people who want to win at all costs or get as much as possible. They are not necessarily going to consider their colleagues. They don’t have much of a collegial spirit (participant 10).

These examples of research misbehaviour or misconduct are sometimes due to or associated with situations of conflicts of interest, which may be poorly managed by certain researchers or research teams, as noted by many participants.

Conflict of interest

The actors and institutions involved in research have diverse interests, like all humans and institutions. As noted in Chap. 7 of the Canadian Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2, 2018),

“researchers and research students hold trust relationships, either directly or indirectly, with participants, research sponsors, institutions, their professional bodies and society. These trust relationships can be put at risk by conflicts of interest that may compromise independence, objectivity or ethical duties of loyalty. Although the potential for such conflicts has always existed, pressures on researchers (i.e., to delay or withhold dissemination of research outcomes or to use inappropriate recruitment strategies) heighten concerns that conflicts of interest may affect ethical behaviour” (p. 92).

The sources of these conflicts are varied and can include interpersonal conflicts, financial partnerships, third-party pressures, academic or economic interests, a researcher holding multiple roles within an institution, or any other incentive that may compromise a researcher’s independence, integrity, and neutrality (TCPS2, 2018). While it is not possible to eliminate all conflicts of interest, it is important to manage them properly and to avoid temptations to behave unethically.

Ethical temptations correspond to situations in which people are tempted to prioritize their own interests to the detriment of the ethical goods that should, in their own context, govern their actions (Swisher et al., 2005 ). In the case of researchers, this refers to situations that undermine independence, integrity, neutrality, or even the set of principles that govern research ethics (TCPS2, 2018) or the responsible conduct of research. According to study participants, these types of ethical issues frequently occur in research. Many participants, especially researchers and REB members, reported that conflicts of interest can arise when members of an organization make decisions to obtain large financial rewards or to increase their academic profile, often at the expense of the interests of members of their research team, research participants, or even the populations affected by their research.

A company that puts money into making its drug work wants its drug to work. So, homeopathy is a good example, because there are not really any consequences of homeopathy, there are not very many side effects, because there are no effects at all. So, it’s not dangerous, but it’s not a good treatment either. But some people will want to make it work. And that’s a big issue when you’re sitting at a table and there are eight researchers, and there are two or three who are like that, and then there are four others who are neutral, and I say to myself, this is not science. I think that this is a very big ethical issue (participant 14). There are also times in some research where there will be more links with pharmaceutical companies. Obviously, there are then large amounts of money that will be very interesting for the health-care institutions because they still receive money for clinical trials. They’re still getting some compensation because its time consuming for the people involved and all that. The pharmaceutical companies have money, so they will compensate, and that is sometimes interesting for the institutions, and since we are a bit caught up in this, in the sense that we have no choice but to accept it. (…) It may not be the best research in the world, there may be a lot of side effects due to the drugs, but it’s good to accept it, we’re going to be part of the clinical trial (participant 3). It is integrity, what we believe should be done or said. Often by the pressure of the environment, integrity is in tension with the pressures of the environment, so it takes resistance, it takes courage in research. (…) There were all the debates there about the problems of research that was funded and then the companies kept control over what was written. That was really troubling for a lot of researchers (participant 5).

Further, these situations sometimes have negative consequences for research participants as reported by some participants.

Respect for research participants

Many research projects, whether they are psychosocial or biomedical in nature, involve human participants. Relationships between the members of research teams and their research participants raise ethical issues that can be complex. Research projects must always be designed to respect the rights and interests of research participants, and not just those of researchers. However, participants in our study – i.e., REB members, researchers, and research ethics experts – noted that some research teams seem to put their own interests ahead of those of research participants. They also emphasized the importance of ensuring the respect, well-being, and safety of research participants. The ethical issues related to this unit of meaning are: respect for free, informed and ongoing consent of research participants; respect for and the well-being of participants; data protection and confidentiality; over-solicitation of participants; ownership of the data collected on participants; the sometimes high cost of scientific innovations and their accessibility; balance between the social benefits of research and the risks to participants (particularly in terms of safety); balance between collective well-being (development of knowledge) and the individual rights of participants; exploitation of participants; paternalism when working with populations in vulnerable situations; and the social acceptability of certain types of research. The following excerpts present some of these issues.

Where it disturbs me ethically is in the medical field – because it’s more in the medical field that we’re going to see this – when consent forms are presented to patients to solicit them as participants, and then [these forms] have an average of 40 pages. That annoys me. When they say that it has to be easy to understand and all that, adapted to the language, and then the hyper-technical language plus there are 40 pages to read, I don’t understand how you’re going to get informed consent after reading 40 pages. (…) For me, it doesn’t work. I read them to evaluate them and I have a certain level of education and experience in ethics, and there are times when I don’t understand anything (participant 2). There is a lot of pressure from researchers who want to recruit research participants (…). The idea that when you enter a health care institution, you become a potential research participant, when you say “yes to a research, you check yes to all research”, then everyone can ask you. I think that researchers really have this fantasy of saying to themselves: “as soon as people walk through the door of our institution, they become potential participants with whom we can communicate and get them involved in all projects”. There’s a kind of idea that, yes, it can be done, but it has to be somewhat supervised to avoid over-solicitation (…). Researchers are very interested in facilitating recruitment and making it more fluid, but perhaps to the detriment of confidentiality, privacy, and respect; sometimes that’s what it is, to think about what type of data you’re going to have in your bank of potential participants? Is it just name and phone number or are you getting into more sensitive information? (participant 9).

In addition, one participant reported that their university does not provide the resources required to respect the confidentiality of research participants.

The issue is as follows: researchers, of course, commit to protecting data with passwords and all that, but we realize that in practice, it is more difficult. It is not always as protected as one might think, because professor-researchers will run out of space. Will the universities make rooms available to researchers, places where they can store these things, especially when they have paper documentation, and is there indeed a guarantee of confidentiality? Some researchers have told me: “Listen; there are even filing cabinets in the corridors”. So, that certainly poses a concrete challenge. How do we go about challenging the administrative authorities? Tell them it’s all very well to have an ethics committee, but you have to help us, you also have to make sure that the necessary infrastructures are in place so that what we are proposing is really put into practice (participant 4).

If the relationships with research participants are likely to raise ethical issues, so too are the relationships with students, notably research assistants. On this topic, several participants discussed the lack of supervision or recognition offered to research assistants by researchers as well as the power imbalances between members of the research team.

Lack of Supervision and Power Imbalances

Many research teams are composed not only of researchers, but also of students who work as research assistants. The relationship between research assistants and other members of research teams can sometimes be problematic and raise ethical issues, particularly because of the inevitable power asymmetries. In the context of this study, several participants – including a research assistant, REB members, and researchers – discussed the lack of supervision or recognition of the work carried out by students, psychological pressure, and the more or less well-founded promises that are sometimes made to students. Participants also mentioned the exploitation of students by certain research teams, which manifest when students are inadequately paid, i.e., not reflective of the number of hours actually worked, not a fair wage, or even a wage at all.

[As a research assistant], it was more of a feeling of distress that I felt then because I didn’t know what to do. (…) I was supposed to get coaching or be supported, but I didn’t get anything in the end. It was like, “fix it by yourself”. (…) All research assistants were supposed to be supervised, but in practice they were not (participant 1). Very often, we have a master’s or doctoral student that we put on a subject and we consider that the project will be well done, while the student is learning. So, it happens that the student will do a lot of work and then we realize that the work is poorly done, and it is not necessarily the student’s fault. He wasn’t necessarily well supervised. There are directors who have 25 students, and they just don’t supervise them (participant 14). I think it’s really the power relationship. I thought to myself, how I saw my doctorate, the beginning of my research career, I really wanted to be in that laboratory, but they are the ones who are going to accept me or not, so what do I do to be accepted? I finally accept their conditions [which was to work for free]. If these are the conditions that are required to enter this lab, I want to go there. So, what do I do, well I accepted. It doesn’t make sense, but I tell myself that I’m still privileged, because I don’t have so many financial worries, one more reason to work for free, even though it doesn’t make sense (participant 1). In research, we have research assistants. (…). The fact of using people… so that’s it, you have to take into account where they are, respect them, but at the same time they have to show that they are there for the research. In English, we say “carry” or take care of people. With research assistants, this is often a problem that I have observed: for grant machines, the person is the last to be found there. Researchers, who will take, use student data, without giving them the recognition for it (participant 5). The problem at our university is that they reserve funding for Canadian students. The doctoral clientele in my field is mostly foreign students. So, our students are poorly funded. I saw one student end up in the shelter, in a situation of poverty. It ended very badly for him because he lacked financial resources. Once you get into that dynamic, it’s very hard to get out. I was made aware of it because the director at the time had taken him under her wing and wanted to try to find a way to get him out of it. So, most of my students didn’t get funded (participant 16). There I wrote “manipulation”, but it’s kind of all promises all the time. I, for example, was promised a lot of advancement, like when I got into the lab as a graduate student, it was said that I had an interest in [this particular area of research]. I think there are a lot of graduate students who must have gone through that, but it is like, “Well, your CV has to be really good, if you want to do a lot of things and big things. If you do this, if you do this research contract, the next year you could be the coordinator of this part of the lab and supervise this person, get more contracts, be paid more. Let’s say: you’ll be invited to go to this conference, this big event”. They were always dangling something, but you have to do that first to get there. But now, when you’ve done that, you have to do this business. It’s like a bit of manipulation, I think. That was very hard to know who is telling the truth and who is not (participant 1).

These ethical issues have significant negative consequences for students. Indeed, they sometimes find themselves at the mercy of researchers, for whom they work, struggling to be recognized and included as authors of an article, for example, or to receive the salary that they are due. For their part, researchers also sometimes find themselves trapped in research structures that can negatively affect their well-being. As many participants reported, researchers work in organizations that set very high productivity standards and in highly competitive contexts, all within a general culture characterized by individualism.

Individualism and performance

Participants, especially researchers, discussed the culture of individualism and performance that characterizes the academic environment. In glorifying excellence, some universities value performance and productivity, often at the expense of psychological well-being and work-life balance (i.e., work overload and burnout). Participants noted that there are ethical silences in their organizations on this issue, and that the culture of individualism and performance is not challenged for fear of retribution or simply to survive, i.e., to perform as expected. Participants felt that this culture can have a significant negative impact on the quality of the research conducted, as research teams try to maximize the quantity of their work (instead of quality) in a highly competitive context, which is then exacerbated by a lack of resources and support, and where everything must be done too quickly.

The work-life balance with the professional ethics related to work in a context where you have too much and you have to do a lot, it is difficult to balance all that and there is a lot of pressure to perform. If you don’t produce enough, that’s it; after that, you can’t get any more funds, so that puts pressure on you to do more and more and more (participant 3). There is a culture, I don’t know where it comes from, and that is extremely bureaucratic. If you dare to raise something, you’re going to have many, many problems. They’re going to make you understand it. So, I don’t talk. It is better: your life will be easier. I think there are times when you have to talk (…) because there are going to be irreparable consequences. (…) I’m not talking about a climate of terror, because that’s exaggerated, it’s not true, people are not afraid. But people close their office door and say nothing because it’s going to make their work impossible and they’re not going to lose their job, they’re not going to lose money, but researchers need time to be focused, so they close their office door and say nothing (participant 16).

Researchers must produce more and more, and they feel little support in terms of how to do such production, ethically, and how much exactly they are expected to produce. As this participant reports, the expectation is an unspoken rule: more is always better.

It’s sometimes the lack of a clear line on what the expectations are as a researcher, like, “ah, we don’t have any specific expectations, but produce, produce, produce, produce.” So, in that context, it’s hard to be able to put the line precisely: “have I done enough for my work?” (participant 3).

Inadequate ethical Guidance

While the productivity expectation is not clear, some participants – including researchers, research ethics experts, and REB members – also felt that the ethical expectations of some REBs were unclear. The issue of the inadequate ethical guidance of research includes the administrative mechanisms to ensure that research projects respect the principles of research ethics. According to those participants, the forms required for both researchers and REB members are increasingly long and numerous, and one participant noted that the standards to be met are sometimes outdated and disconnected from the reality of the field. Multicentre ethics review (by several REBs) was also critiqued by a participant as an inefficient method that encumbers the processes for reviewing research projects. Bureaucratization imposes an ever-increasing number of forms and ethics guidelines that actually hinder researchers’ ethical reflection on the issues at stake, leading the ethics review process to be perceived as purely bureaucratic in nature.

The ethical dimension and the ethical review of projects have become increasingly bureaucratized. (…) When I first started working (…) it was less bureaucratic, less strict then. I would say [there are now] tons of forms to fill out. Of course, we can’t do without it, it’s one of the ways of marking out ethics and ensuring that there are ethical considerations in research, but I wonder if it hasn’t become too bureaucratized, so that it’s become a kind of technical reflex to fill out these forms, and I don’t know if people really do ethical reflection as such anymore (participant 10). The fundamental structural issue, I would say, is the mismatch between the normative requirements and the real risks posed by the research, i.e., we have many, many requirements to meet; we have very long forms to fill out but the research projects we evaluate often pose few risks (participant 8). People [in vulnerable situations] were previously unable to participate because of overly strict research ethics rules that were to protect them, but in the end [these rules] did not protect them. There was a perverse effect, because in the end there was very little research done with these people and that’s why we have very few results, very little evidence [to support practices with these populations] so it didn’t improve the quality of services. (…) We all understand that we have to be careful with that, but when the research is not too risky, we say to ourselves that it would be good because for once a researcher who is interested in that population, because it is not a very popular population, it would be interesting to have results, but often we are blocked by the norms, and then we can’t accept [the project] (participant 2).

Moreover, as one participant noted, accessing ethics training can be a challenge.

There is no course on research ethics. […] Then, I find that it’s boring because you go through university and you come to do your research and you know how to do quantitative and qualitative research, but all the research ethics, where do you get this? I don’t really know (participant 13).

Yet, such training could provide relevant tools to resolve, to some extent, the ethical issues that commonly arise in research. That said, and as noted by many participants, many ethical issues in research are related to social injustices over which research actors have little influence.

Social Injustices

For many participants, notably researchers, the issues that concern social injustices are those related to power asymmetries, stigma, or issues of equity, diversity, and inclusion, i.e., social injustices related to people’s identities (Blais & Drolet, 2022 ). Participants reported experiencing or witnessing discrimination from peers, administration, or lab managers. Such oppression is sometimes cross-sectional and related to a person’s age, cultural background, gender or social status.

I have my African colleague who was quite successful when he arrived but had a backlash from colleagues in the department. I think it’s unconscious, nobody is overtly racist. But I have a young person right now who is the same, who has the same success, who got exactly the same early career award and I don’t see the same backlash. He’s just as happy with what he’s doing. It’s normal, they’re young and they have a lot of success starting out. So, I think there is discrimination. Is it because he is African? Is it because he is black? I think it’s on a subconscious level (participant 16).

Social injustices were experienced or reported by many participants, and included issues related to difficulties in obtaining grants or disseminating research results in one’s native language (i.e., even when there is official bilingualism) or being considered credible and fundable in research when one researcher is a woman.

If you do international research, there are things you can’t talk about (…). It is really a barrier to research to not be able to (…) address this question [i.e. the question of inequalities between men and women]. Women’s inequality is going to be addressed [but not within the country where the research takes place as if this inequality exists elsewhere but not here]. There are a lot of women working on inequality issues, doing work and it’s funny because I was talking to a young woman who works at Cairo University and she said to me: “Listen, I saw what you had written, you’re right. I’m willing to work on this but guarantee me a position at your university with a ticket to go”. So yes, there are still many barriers [for women in research] (participant 16).

Because of the varied contextual characteristics that intervene in their occurrence, these social injustices are also related to distributive injustices, as discussed by many participants.

Distributive Injustices

Although there are several views of distributive justice, a classical definition such as that of Aristotle ( 2012 ), describes distributive justice as consisting in distributing honours, wealth, and other social resources or benefits among the members of a community in proportion to their alleged merit. Justice, then, is about determining an equitable distribution of common goods. Contemporary theories of distributive justice are numerous and varied. Indeed, many authors (e.g., Fraser 2011 ; Mills, 2017 ; Sen, 2011 ; Young, 2011 ) have, since Rawls ( 1971 ), proposed different visions of how social burdens and benefits should be shared within a community to ensure equal respect, fairness, and distribution. In our study, what emerges from participants’ narratives is a definite concern for this type of justice. Women researchers, francophone researchers, early career researchers or researchers belonging to racialized groups all discussed inequities in the distribution of research grants and awards, and the extra work they need to do to somehow prove their worth. These inequities are related to how granting agencies determine which projects will be funded.

These situations make me work 2–3 times harder to prove myself and to show people in power that I have a place as a woman in research (participant 12). Number one: it’s conservative thinking. The older ones control what comes in. So, the younger people have to adapt or they don’t get funded (participant 14).

Whether it is discrimination against stigmatized or marginalized populations or interest in certain hot topics, granting agencies judge research projects according to criteria that are sometimes questionable, according to those participants. Faced with difficulties in obtaining funding for their projects, several strategies – some of which are unethical – are used by researchers in order to cope with these situations.

Sometimes there are subjects that everyone goes to, such as nanotechnology (…), artificial intelligence or (…) the therapeutic use of cannabis, which are very fashionable, and this is sometimes to the detriment of other research that is just as relevant, but which is (…), less sexy, less in the spirit of the time. (…) Sometimes this can lead to inequities in the funding of certain research sectors (participant 9). When we use our funds, we get them given to us, we pretty much say what we think we’re going to do with them, but things change… So, when these things change, sometimes it’s an ethical decision, but by force of circumstances I’m obliged to change the project a little bit (…). Is it ethical to make these changes or should I just let the money go because I couldn’t use it the way I said I would? (participant 3).

Moreover, these distributional injustices are not only linked to social injustices, but also epistemic injustices. Indeed, the way in which research honours and grants are distributed within the academic community depends on the epistemic authority of the researchers, which seems to vary notably according to their language of use, their age or their gender, but also to the research design used (inductive versus deductive), their decision to use (or not use) animals in research, or to conduct activist research.

Epistemic injustices

The philosopher Fricker ( 2007 ) conceptualized the notions of epistemic justice and injustice. Epistemic injustice refers to a form of social inequality that manifests itself in the access, recognition, and production of knowledge as well as the various forms of ignorance that arise (Godrie & Dos Santos, 2017 ). Addressing epistemic injustice necessitates acknowledging the iniquitous wrongs suffered by certain groups of socially stigmatized individuals who have been excluded from knowledge, thus limiting their abilities to interpret, understand, or be heard and account for their experiences. In this study, epistemic injustices were experienced or reported by some participants, notably those related to difficulties in obtaining grants or disseminating research results in one’s native language (i.e., even when there is official bilingualism) or being considered credible and fundable in research when a researcher is a woman or an early career researcher.

I have never sent a grant application to the federal government in English. I have always done it in French, even though I know that when you receive the review, you can see that reviewers didn’t understand anything because they are English-speaking. I didn’t want to get in the boat. It’s not my job to translate, because let’s be honest, I’m not as good in English as I am in French. So, I do them in my first language, which is the language I’m most used to. Then, technically at the administrative level, they are supposed to be able to do it, but they are not good in French. (…) Then, it’s a very big Canadian ethical issue, because basically there are technically two official languages, but Canada is not a bilingual country, it’s a country with two languages, either one or the other. (…) So I was not funded (participant 14).

Researchers who use inductive (or qualitative) methods observed that their projects are sometimes less well reviewed or understood, while research that adopts a hypothetical-deductive (or quantitative) or mixed methods design is better perceived, considered more credible and therefore more easily funded. Of course, regardless of whether a research project adopts an inductive, deductive or mixed-methods scientific design, or whether it deals with qualitative or quantitative data, it must respect a set of scientific criteria. A research project should achieve its objectives by using proven methods that, in the case of inductive research, are credible, reliable, and transferable or, in the case of deductive research, generalizable, objective, representative, and valid (Drolet & Ruest, accepted ). Participants discussing these issues noted that researchers who adopt a qualitative design or those who question the relevance of animal experimentation or are not militant have sometimes been unfairly devalued in their epistemic authority.

There is a mini war between quantitative versus qualitative methods, which I think is silly because science is a method. If you apply the method well, it doesn’t matter what the field is, it’s done well and it’s perfect ” (participant 14). There is also the issue of the place of animals in our lives, because for me, ethics is human ethics, but also animal ethics. Then, there is a great evolution in society on the role of the animal… with the new law that came out in Quebec on the fact that animals are sensitive beings. Then, with the rise of the vegan movement, [we must ask ourselves]: “Do animals still have a place in research?” That’s a big question and it also means that there are practices that need to evolve, but sometimes there’s a disconnection between what’s expected by research ethics boards versus what’s expected in the field (participant 15). In research today, we have more and more research that is militant from an ideological point of view. And so, we have researchers, because they defend values that seem important to them, we’ll talk for example about the fight for equality and social justice. They have pressure to defend a form of moral truth and have the impression that everyone thinks like them or should do so, because they are defending a moral truth. This is something that we see more and more, namely the lack of distance between ideology and science (participant 8).

The combination or intersectionality of these inequities, which seems to be characterized by a lack of ethical support and guidance, is experienced in the highly competitive and individualistic context of research; it provides therefore the perfect recipe for researchers to experience ethical distress.

Ethical distress

The concept of “ethical distress” refers to situations in which people know what they should do to act ethically, but encounter barriers, generally of an organizational or systemic nature, limiting their power to act according to their moral or ethical values (Drolet & Ruest, 2021 ; Jameton, 1984 ; Swisher et al., 2005 ). People then run the risk of finding themselves in a situation where they do not act as their ethical conscience dictates, which in the long term has the potential for exhaustion and distress. The examples reported by participants in this study point to the fact that researchers in particular may be experiencing significant ethical distress. This distress takes place in a context of extreme competition, constant injunctions to perform, and where administrative demands are increasingly numerous and complex to complete, while paradoxically, they lack the time to accomplish all their tasks and responsibilities. Added to these demands are a lack of resources (human, ethical, and financial), a lack of support and recognition, and interpersonal conflicts.

We are in an environment, an elite one, you are part of it, you know what it is: “publish or perish” is the motto. Grants, there is a high level of performance required, to do a lot, to publish, to supervise students, to supervise them well, so yes, it is clear that we are in an environment that is conducive to distress. (…). Overwork, definitely, can lead to distress and eventually to exhaustion. When you know that you should take the time to read the projects before sharing them, but you don’t have the time to do that because you have eight that came in the same day, and then you have others waiting… Then someone rings a bell and says: “ah but there, the protocol is a bit incomplete”. Oh yes, look at that, you’re right. You make up for it, but at the same time it’s a bit because we’re in a hurry, we don’t necessarily have the resources or are able to take the time to do things well from the start, we have to make up for it later. So yes, it can cause distress (participant 9). My organization wanted me to apply in English, and I said no, and everyone in the administration wanted me to apply in English, and I always said no. Some people said: “Listen, I give you the choice”, then some people said: “Listen, I agree with you, but if you’re not [submitting] in English, you won’t be funded”. Then the fact that I am young too, because very often they will look at the CV, they will not look at the project: “ah, his CV is not impressive, we will not finance him”. This is complete nonsense. The person is capable of doing the project, the project is fabulous: we fund the project. So, that happened, organizational barriers: that happened a lot. I was not eligible for Quebec research funds (…). I had big organizational barriers unfortunately (participant 14). At the time of my promotion, some colleagues were not happy with the type of research I was conducting. I learned – you learn this over time when you become friends with people after you enter the university – that someone was against me. He had another candidate in mind, and he was angry about the selection. I was under pressure for the first three years until my contract was renewed. I almost quit at one point, but another colleague told me, “No, stay, nothing will happen”. Nothing happened, but these issues kept me awake at night (participant 16).

This difficult context for many researchers affects not only the conduct of their own research, but also their participation in research. We faced this problem in our study, despite the use of multiple recruitment methods, including more than 200 emails – of which 191 were individual solicitations – sent to potential participants by the two research assistants. REB members and organizations overseeing or supporting research (n = 17) were also approached to see if some of their employees would consider participating. While it was relatively easy to recruit REB members and research ethics experts, our team received a high number of non-responses to emails (n = 175) and some refusals (n = 5), especially by researchers. The reasons given by those who replied were threefold: (a) fear of being easily identified should they take part in the research, (b) being overloaded and lacking time, and (c) the intrusive aspect of certain questions (i.e., “Have you experienced a burnout episode? If so, have you been followed up medically or psychologically?”). In light of these difficulties and concerns, some questions in the socio-demographic questionnaire were removed or modified. Talking about burnout in research remains a taboo for many researchers, which paradoxically can only contribute to the unresolved problem of unhealthy research environments.

Returning to the research question and objective

The question that prompted this research was: What are the ethical issues in research? The purpose of the study was to describe these issues from the perspective of researchers (from different disciplines), research ethics board (REB) members, and research ethics experts. The previous section provided a detailed portrait of the ethical issues experienced by different research stakeholders: these issues are numerous, diverse and were recounted by a range of stakeholders.

The results of the study are generally consistent with the literature. For example, as in our study, the literature discusses the lack of research integrity on the part of some researchers (Al-Hidabi et al., 2018 ; Swazey et al., 1993 ), the numerous conflicts of interest experienced in research (Williams-Jones et al., 2013 ), the issues of recruiting and obtaining the free and informed consent of research participants (Provencher et al., 2014 ; Keogh & Daly, 2009 ), the sometimes difficult relations between researchers and REBs (Drolet & Girard, 2020 ), the epistemological issues experienced in research (Drolet & Ruest, accepted; Sieber 2004 ), as well as the harmful academic context in which researchers evolve, insofar as this is linked to a culture of performance, an overload of work in a context of accountability (Berg & Seeber, 2016 ; FQPPU; 2019 ) that is conducive to ethical distress and even burnout.

If the results of the study are generally in line with those of previous publications on the subject, our findings also bring new elements to the discussion while complementing those already documented. In particular, our results highlight the role of systemic injustices – be they social, distributive or epistemic – within the environments in which research is carried out, at least in Canada. To summarize, the results of our study point to the fact that the relationships between researchers and research participants are likely still to raise worrying ethical issues, despite widely accepted research ethics norms and institutionalized review processes. Further, the context in which research is carried out is not only conducive to breaches of ethical norms and instances of misbehaviour or misconduct, but also likely to be significantly detrimental to the health and well-being of researchers, as well as research assistants. Another element that our research also highlighted is the instrumentalization and even exploitation of students and research assistants, which is another important and worrying social injustice given the inevitable power imbalances between students and researchers.

Moreover, in a context in which ethical issues are often discussed from a micro perspective, our study helps shed light on both the micro- and macro-level ethical dimensions of research (Bronfenbrenner, 1979 ; Glaser 1994 ). However, given that ethical issues in research are not only diverse, but also and above all complex, a broader perspective that encompasses the interplay between the micro and macro dimensions can enable a better understanding of these issues and thereby support the identification of the multiple factors that may be at their origin. Triangulating the perspectives of researchers with those of REB members and research ethics experts enabled us to bring these elements to light, and thus to step back from and critique the way that research is currently conducted. To this end, attention to socio-political elements such as the performance culture in academia or how research funds are distributed, and according to what explicit and implicit criteria, can contribute to identifying the sources of the ethical issues described above.

Contemporary culture characterized by the social acceleration

The German sociologist and philosopher Rosa (2010) argues that late modernity – that is, the period between the 1980s and today – is characterized by a phenomenon of social acceleration that causes various forms of alienation in our relationship to time, space, actions, things, others and ourselves. Rosa distinguishes three types of acceleration: technical acceleration , the acceleration of social changes and the acceleration of the rhythm of life . According to Rosa, social acceleration is the main problem of late modernity, in that the invisible social norm of doing more and faster to supposedly save time operates unchallenged at all levels of individual and collective life, as well as organizational and social life. Although we all, researchers and non-researchers alike, perceive this unspoken pressure to be ever more productive, the process of social acceleration as a new invisible social norm is our blind spot, a kind of tyrant over which we have little control. This conceptualization of the contemporary culture can help us to understand the context in which research is conducted (like other professional practices). To this end, Berg & Seeber ( 2016 ) invite faculty researchers to slow down in order to better reflect and, in the process, take care of their health and their relationships with their colleagues and students. Many women professors encourage their fellow researchers, especially young women researchers, to learn to “say No” in order to protect their mental and physical health and to remain in their academic careers (Allaire & Descheneux, 2022 ). These authors also remind us of the relevance of Kahneman’s ( 2012 ) work which demonstrates that it takes time to think analytically, thoroughly, and logically. Conversely, thinking quickly exposes humans to cognitive and implicit biases that then lead to errors in thinking (e.g., in the analysis of one’s own research data or in the evaluation of grant applications or student curriculum vitae). The phenomenon of social acceleration, which pushes the researcher to think faster and faster, is likely to lead to unethical bad science that can potentially harm humankind. In sum, Rosa’s invitation to contemporary critical theorists to seriously consider the problem of social acceleration is particularly insightful to better understand the ethical issues of research. It provides a lens through which to view the toxic context in which research is conducted today, and one that was shared by the participants in our study.

Clark & Sousa ( 2022 ) note, it is important that other criteria than the volume of researchers’ contributions be valued in research, notably quality. Ultimately, it is the value of the knowledge produced and its influence on the concrete lives of humans and other living beings that matters, not the quantity of publications. An interesting articulation of this view in research governance is seen in a change in practice by Australia’s national health research funder: they now restrict researchers to listing on their curriculum vitae only the top ten publications from the past ten years (rather than all of their publications), in order to evaluate the quality of contributions rather than their quantity. To create environments conducive to the development of quality research, it is important to challenge the phenomenon of social acceleration, which insidiously imposes a quantitative normativity that is both alienating and detrimental to the quality and ethical conduct of research. Based on our experience, we observe that the social norm of acceleration actively disfavours the conduct of empirical research on ethics in research. The fact is that researchers are so busy that it is almost impossible for them to find time to participate in such studies. Further, operating in highly competitive environments, while trying to respect the values and ethical principles of research, creates ethical paradoxes for members of the research community. According to Malherbe ( 1999 ), an ethical paradox is a situation where an individual is confronted by contradictory injunctions (i.e., do more, faster, and better). And eventually, ethical paradoxes lead individuals to situations of distress and burnout, or even to ethical failures (i.e., misbehaviour or misconduct) in the face of the impossibility of responding to contradictory injunctions.

Strengths and Limitations of the study

The triangulation of perceptions and experiences of different actors involved in research is a strength of our study. While there are many studies on the experiences of researchers, rarely are members of REBs and experts in research ethics given the space to discuss their views of what are ethical issues. Giving each of these stakeholders a voice and comparing their different points of view helped shed a different and complementary light on the ethical issues that occur in research. That said, it would have been helpful to also give more space to issues experienced by students or research assistants, as the relationships between researchers and research assistants are at times very worrying, as noted by a participant, and much work still needs to be done to eliminate the exploitative situations that seem to prevail in certain research settings. In addition, no Indigenous or gender diverse researchers participated in the study. Given the ethical issues and systemic injustices that many people from these groups face in Canada (Drolet & Goulet, 2018 ; Nicole & Drolet, in press ), research that gives voice to these researchers would be relevant and contribute to knowledge development, and hopefully also to change in research culture.

Further, although most of the ethical issues discussed in this article may be transferable to the realities experienced by researchers in other countries, the epistemic injustice reported by Francophone researchers who persist in doing research in French in Canada – which is an officially bilingual country but in practice is predominantly English – is likely specific to the Canadian reality. In addition, and as mentioned above, recruitment proved exceedingly difficult, particularly amongst researchers. Despite this difficulty, we obtained data saturation for all but two themes – i.e., exploitation of students and ethical issues of research that uses animals. It follows that further empirical research is needed to improve our understanding of these specific issues, as they may diverge to some extent from those documented here and will likely vary across countries and academic research contexts.

Conclusions

This study, which gave voice to researchers, REB members, and ethics experts, reveals that the ethical issues in research are related to several problematic elements as power imbalances and authority relations. Researchers and research assistants are subject to external pressures that give rise to integrity issues, among others ethical issues. Moreover, the current context of social acceleration influences the definition of the performance indicators valued in academic institutions and has led their members to face several ethical issues, including social, distributive, and epistemic injustices, at different steps of the research process. In this study, ten categories of ethical issues were identified, described and illustrated: (1) research integrity, (2) conflicts of interest, (3) respect for research participants, (4) lack of supervision and power imbalances, (5) individualism and performance, (6) inadequate ethical guidance, (7) social injustices, (8) distributive injustices, (9) epistemic injustices, and (10) ethical distress. The triangulation of the perspectives of different members (i.e., researchers from different disciplines, REB members, research ethics experts, and one research assistant) involved in the research process made it possible to lift the veil on some of these ethical issues. Further, it enabled the identification of additional ethical issues, especially systemic injustices experienced in research. To our knowledge, this is the first time that these injustices (social, distributive, and epistemic injustices) have been clearly identified.

Finally, this study brought to the fore several problematic elements that are important to address if the research community is to develop and implement the solutions needed to resolve the diverse and transversal ethical issues that arise in research institutions. A good starting point is the rejection of the corollary norms of “publish or perish” and “do more, faster, and better” and their replacement with “publish quality instead of quantity”, which necessarily entails “do less, slower, and better”. It is also important to pay more attention to the systemic injustices within which researchers work, because these have the potential to significantly harm the academic careers of many researchers, including women researchers, early career researchers, and those belonging to racialized groups as well as the health, well-being, and respect of students and research participants.

Acknowledgements

The team warmly thanks the participants who took part in the research and who made this study possible. Marie-Josée Drolet thanks the five research assistants who participated in the data collection and analysis: Julie-Claude Leblanc, Élie Beauchemin, Pénéloppe Bernier, Louis-Pierre Côté, and Eugénie Rose-Derouin, all students at the Université du Québec à Trois-Rivières (UQTR), two of whom were active in the writing of this article. MJ Drolet and Bryn Williams-Jones also acknowledge the financial contribution of the Social Sciences and Humanities Research Council of Canada (SSHRC), which supported this research through a grant. We would also like to thank the reviewers of this article who helped us improve it, especially by clarifying and refining our ideas.

Competing Interests and Funding

As noted in the Acknowledgements, this research was supported financially by the Social Sciences and Humanities Research Council of Canada (SSHRC).

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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    Research Ethics Boards (REBs) are independent committees established by the University and in partnership with its affiliated hospitals and research institutes.

  5. Institutional review board (IRB)

    institutional review board (IRB), in the United States, ethics committee that reviews proposed and ongoing research involving human subjects. The institutional review board (IRB) exists to protect the rights and safety of human subjects who participate in research studies. The need for an IRB became apparent in the 1960s and 1970s, largely as a ...

  6. Ethical Considerations in Research

    Revised on June 22, 2023. Ethical considerations in research are a set of principles that guide your research designs and practices. Scientists and researchers must always adhere to a certain code of conduct when collecting data from people.

  7. Institutional Review Boards and Ethics Committees

    This chapter provides an overview of the history of ethical violations in clinical research and emergence of IRBs and ethics committees, a summary of IRB functions and operations, an outline of the requirements for informed consent, and an overview of recent changes to the system of IRB review and oversight.

  8. Improving the process of research ethics review

    Research Ethics Boards, or Institutional Review Boards, protect the safety and welfare of human research participants. These bodies are responsible for providing an independent evaluation of proposed research studies, ultimately ensuring that the research does not proceed unless standards and regulations are met. Main body

  9. Ethics in educational research: Review boards, ethical issues and

    Volume 19, Issue 1 https://doi.org/10.1177/1474904118796315 PDF / ePub More Abstract Educational research, and research in the Social Sciences more generally, has experienced a growth in the introduction of ethical review boards since the 1990s.

  10. Institutional review board (IRB) and ethical issues in clinical research

    Biomedical research has made remarkable advances over the past century; as a result, ethics in clinical research is of more concern than ever before. There was little public dispute over the ethics of biomedical research until the 1960s, when scandals appeared to erupt worldwide and were opened to the public (Fig. 1). There have been many ...

  11. Improving the process of research ethics review

    Research Ethics Boards (REBs) also known as Institutional Review Boards (IRBs) and Research Ethics Committees (RECs) are charged with ensuring that research is planned and conducted in accordance with such laws and regulatory standards.

  12. Research Ethics Board : PSI

    Research Ethics Board Our Research Ethics Program is responsible for the ethical and regulatory compliance of research that involves human subjects. We are committed to protecting the rights and welfare of subjects enrolled in its research activities. As a result, in 2009 the PSI Board of Directors established a Research Ethics Board (REB) to review all human […]

  13. Ethics committee

    In the United States, an ethics committee is usually known as an institutional review board (IRB) or research ethics board (REB) and is dedicated to overseeing the rights and well-being of research subjects participating in scientific studies in the US. Similarly in Canada, the committee is called a Research Ethics Board (REB).

  14. Research Ethics

    The Belmont Report contains three basic ethical principles: (1) respect for persons, (2) beneficence, and (3) justice. Additionally, the Belmont Report details research-based protective applications for informed consent, risk/benefit assessment, and participant selection. [3] Go to: Issues of Concern

  15. Research Ethics Board: About the REB

    The Health Canada-PHAC REB serves as an independent ethics review board to help ensure that all proposed or ongoing research involving human participants or communities carried out by, funded by, or otherwise under the auspices of Health Canada or PHAC, meets the highest ethical standards.

  16. Research Ethics Boards

    Research Ethics Boards On this page: University of Toronto (U of T) Research Ethics Boards (REBs) REB Contacts & Affiliations Submission Deadlines & Important Dates VPRI Role VPRI Contact Who is this for? What do I need before I can begin? University of Toronto (U of T) Research Ethics Boards (REBs)

  17. Research Ethics Boards

    Overview REB 1 and REB 2 review the full range of social sciences, behavioral, education, arts, business, humanities, and engineering research conducted by University staff and students. The Health Research Ethics Board (HREB) was established in 1997 by Capital Health (now AHS), Caritas Health (now Covenant Health) and the University of Alberta.

  18. A brief introduction to institutional review boards in the United

    GLOBALIZATION OF CLINICAL RESEARCH AND ETHICAL CONCERNS. Economic globalization is an important development in the last twenty years. The globalization of clinical research is also an increasing phenomenon in the last decade, with many industry and government sponsors in developed countries choosing to conduct clinical trials in developing countries. 1 The percentage of active U.S. Food and ...

  19. Research Ethics Board: Policies, guidelines and resources

    It identifies three basic principles underlying the ethics of human research: respect for persons, beneficence and justice. The Canadian Association of Research Ethics Boards (CAREB) is a grassroots national membership organization intended to represent the interests of all Canadian REBs and to reflect REB perspectives and concerns.

  20. Research Ethics

    Research Ethics University research is governed by policies and practices that ensure the protection of research participants, researchers (faculty, students and staff members), the university and the public. These policies and practices cover research involving humans, the use of animals, controlled goods and hazardous materials, among others.

  21. Research Ethics Board: Apply for ethics review

    Research Ethics Board: Apply for ethics review. Applicants must apply for ethics review before the start of the study. Note that the REB cannot retroactively review research involving humans. A letter of approval from the Decisional Authority of Health Canada or PHAC and a Certificate of Ethics Review must be obtained from the REB before the ...

  22. Ethical Issues in Research: Perceptions of Researchers, Research Ethics

    According to Sieber ( 2004 ), ethical issues in research can be classified into five categories, related to: (a) communication with participants and the community, (b) acquisition and use of research data, (c) external influence on research, (d) risks and benefits of the research, and (e) selection and use of research theories and methods.

  23. Research Ethics Board

    The Research Ethics Board reviews all proposed research from scientific and ethical perspectives before the research is started, and promotes the research ethics education of the research community. Unity Health eREB Launched - Mandatory for New Study Submissions; Migrations Underway for Existing Studies ...

  24. Annual Research Ethics Day Conference

    Join interdisciplinary experts for a unique Research Ethics Day Conference focused on the topic of building partnerships with investigators, communities, clinical research professionals, and companies to promote the ethical conduct and translation of research. National leaders will discuss successes and challenges in a wide range of research programs.