a research ethics board

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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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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Unity Health eREB Launched – Mandatory for New Study Submissions; Migrations 95% Complete

The Unity Health eREB is now mandatory for new study submissions . For information on creating an account and logging in, please see the eREB page .

The migration process for existing studies is almost complete.  Once your study has been migrated, all post-approval submissions (amendments, renewals, etc.) must be submitted via the eREB.

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REMINDER: The Research Ethics Office is not accepting hard copy submissions. Submissions for pre-eREB studies that have not yet been migrated should sent to the REB Inbox ( [email protected] ). Send only one form (with related attachments) per email. All communications to the REB Inbox should be sent by the PI or by a research team member with the PI cc’d.

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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

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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 .

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• Published: 18 August 2017

Improving the process of research ethics review

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

Research Integrity and Peer Review volume  2 , Article number:  14 ( 2017 ) Cite this article

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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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National Institutes of Health (NIH). Final NIH policy on the use of a single institutional review board for multi-site research. 2017. NOT-OD-16-094. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html . Accessed 21 Jun 2017.

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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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Authors’ contributions

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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• National Center for Biotechnology Information - PubMed Central - Institutional Review Boards

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 result of the Tuskegee Syphilis Study , in which human subjects received substandard medical care without their consent . The IRB system subsequently was established with the passage of the National Research Act of 1974. The Office of Human Research Protections, within the U.S. Department of Health and Human Services , is responsible for the registration of IRBs and their oversight.

Initially focused on biomedical research, IRBs later were also developed for research in the social sciences and liberal arts (e.g., for research involving living history interviews). Institutions seeking federal funding must have an IRB, and the IRB must review and approve federally funded research studies. Most institutions require IRB approval for all research that involves human subjects, not only that funded by the federal government.

The IRB process begins before participants are recruited for a study. The study protocol must satisfy the three basic principles of the Belmont Report (a summary of ethical principles and guidelines for the conduct of research involving human subjects): 1) respect for persons, 2) beneficence (avoiding harm to subjects and maximizing the benefits compared with the risks of participation), and 3) justice . Once the study is approved, the IRB is charged with overseeing the research from an ethics perspective. This oversight usually is exercised through two mechanisms. First, participants are provided with a means of contacting the IRB directly if they have concerns, and, second, the IRB conducts periodic reviews of the study to monitor the research progress and address any ethical issues. The review process usually occurs annually. Although rarely used, the IRB can carry out additional reviews and actively conduct surprise inspections of research records.

IRBs for institutions receiving U.S. federal funds are required to have at least five members, though most institutions have more. The IRB must include members who represent diverse bodies of knowledge relevant to the conduct of ethical research. For example, at least one member must be from the scientific community and knowledgeable about scientific research, and there must be at least one member from outside the scientific community; this person should advocate for the nonscientific issues relevant to ethical conduct of research, such as legal issues and standards for professional conduct. In addition, at least one person must be from outside the institution; this person (who may also serve as the nonscientific member) usually is a community member and represents the community standard for assessing the ethics of a study.

When the research proposed is outside the expertise of the IRB members, the IRB can invite experts in the research area to provide additional information in the review; however, these consultants are not allowed to vote. Most IRBs use a consensus approach (i.e., votes must be unanimous) to reach a decision, although some IRBs allow a majority vote. When a majority vote is used, the community member typically still has substantial power because most IRBs will not override the perspective of the community member. The administration of an institution (e.g., president of a university or director of a hospital ) must allow the IRB to function independently, without undue influence related to funding pressures or other administration priorities.

Institutional Review Boards and Ethics Committees

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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.

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IRB and Review Process for Multisite Trials

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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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Research Ethics Board: Policies, guidelines and resources

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The Health Canada-PHAC REB reviews applications in accordance with the considerations set out in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2) as the minimum standard. TCPS 2 is the foundation for the REB's operational and guidance documents (which include the Operational Policy Framework, evaluation criteria and requirements for informed consent). The REB also takes into account to relevant federal laws and regulations, such as the Privacy Act and clinical trial regulations, where applicable.

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REB evaluation criteria

Clinical trial regulations, reb operational policy framework, tcps 2 and related ethics resources.

The  Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2)  is a joint policy of Canada's three federal research agencies – the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSERC), and the Social Sciences and Humanities Research Council of Canada (SSHRC). Recognizing that TCPS is the prevailing Canadian standard for ethical research, Health Canada and PHAC have adopted TCPS to guide the ethical aspects of the design, review and conduct of research involving humans. Related links:

• TCPS 2 interpretations
• TCPS 2 tutorial: Course on Research Ethics (CORE)
• Panel on Research Ethics

The  Declaration of Helsinki  is an official policy document of the World Medical Association, the global representative body for physicians, developed as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects.

The  Belmont Report  was the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 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.

Research involving humans can be ethically justified only when:

• The research is scientifically sound;
• The potential benefit significantly outweighs the potential for harm;
• There is an adequate process for informed consent, and assent where applicable; and
• There is justice or fairness in selection of participants.

Thus, when assessing whether a proposal meets the ethical requirements for research involving humans, the REB focuses on the following five elements:

• Methodology
• Selection and recruitment
• Informed consent process
• Potential harms and benefits
• Privacy and confidentiality

Applicants should ensure that their research protocols provide sufficient detail so that the REB can appropriately assess the proposal against these criteria. The research protocol instructions on the REB website provide additional information relevant to each of these elements. Applicants are advised to follow these instructions closely when drafting their protocols.

Health Canada regulates the sale and importation of certain drugs, medical devices and natural health products that will be used in human clinical trials. This includes health products not authorized/licenced in Canada, as well as Canadian market authorized drugs and licensed medical devices and natural health products that are being investigated for potential use outside their approved indication. Health Canada requires that the drug sponsor (individual, corporate body, institution or organization) and medical device manufacturer/importer undertaking the clinical study obtain institutional Research Ethics Board approval prior to opening the clinical trial in Canada, in accordance with Division 5 of the Food and Drug Regulations , Part 4 of the Natural Health Product Regulations or Part 3 of the Medical Devices Regulations .

The Health Canada-PHAC REB only reviews clinical trials being undertaken and conducted by investigators from Health Canada or PHAC. The REB does not provide advice to external researchers.

For further information regarding the regulatory requirements, investigators may contact:

• For pharmaceutical drugs : Office of Clinical Trials, Therapeutic Products Directorate. Email: [email protected]
• For biologics and radiopharmaceuticals : Office of Regulatory Affairs, Biologic and Radiopharmaceutical Drugs Directorate. Email: [email protected]
• For medical devices : Bureau of Investigational Testing Authorization, Special Access Program and Post-Market Surveillance, Medical Devices Directorate. Email: [email protected]
• For natural health products : Natural and Non-prescription Health Products Directorate. Email: [email protected]

For more information, please see:

• Clinical trials and drug safety
• Guidance Document For Clinical Trial Sponsors: Clinical Trial Applications
• Clinical Trials For Natural Health Products
• Applications for Medical Device Investigational Testing Authorizations Guidance Document
• Guidance document for Preparation of an Application for Investigational Testing - In Vitro Diagnostic Devices
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• ICH Guidance E6(R2): Good Clinical Practice

In most cases, Health Canada is not involved in conducting clinical trial research, but only in the regulation of the sale (distribution) and importation of non-approved drugs for use in human clinical trials. This applies to drugs not marketed in Canada and for approved drugs used outside of the parameters of the Notice of Compliance. As part of that regulatory function, the Therapeutic Products Directorate (TPD) and the Biologics and Genetic Therapies Directorate (BGTD), require that the sponsor (individual, corporate body, institution or organization) undertaking the research, obtain the approval of an appropriate Research Ethics Board before the clinical trial begins, in accordance with the Division 5 of the Food and Drugs Act and Regulations.

However, there may be circumstances where Health Canada will be involved in conducting clinical trials. In such situations, an application to Health Canada's Research Ethics Board (REB) for an ethical review of the proposed research by the REB will be required in order to proceed.

Guidance for sponsors of clinical trials including the process of filing a clinical trial application and the responsibilities of the sponsor can be found in the document " Guidance for Clinical Trial Sponsors ".

ICH Harmonised Tripartite Guideline

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration. The " Guidelines for Good Clinical Practice " is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects, and is adopted by Health Canada which applies to drug and device studies undertaken by industry or with industry support.

The REB Operational Policy Framework provides information about the REB's authorities, mandate and scope, committee structure and review process.

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About the IRB

The Institutional Review Board (IRB) is a federally mandated committee whose purpose is to ensure that 1) the rights, well-being, and safety of human subjects in research are protected; and 2) that Iowa State University research is compliant with applicable federal and state regulations as well as Iowa State policies and guidelines.  Toward that end, the IRB has the authority to:

• approve, require modifications to secure approval, or disapprove human subjects research.
• oversee the conduct of the study and monitor ongoing progress.
• suspend or terminate approval of research that is not conducted in accordance with the IRB’s requirements or that has been associated with harm to participants.

Authority for IRB oversight of all federally-regulated human subjects research is provided in the regulations of the U.S. Department of Health and Human Services (DHHS) at 45 CFR 46, similar regulations issued by other federal agencies, and the Food and Drug Administration (FDA) at 21 CFR 50 and 56. In addition, Iowa State University Policy mandates that all human subjects research conducted by agents or employees of Iowa State or under Iowa State’s auspices must receive IRB approval or certification of exemption prior to initiation.

Committee Membership

IRB members are appointed by Iowa State’s Vice President for Research who serves as the Institutional Official (IO). The IRB is comprised of persons knowledgeable in the areas of research conducted at Iowa State; it must include scientists, non-scientists, and at least one person who is not affiliated with Iowa State.

Current Membership Rosters

IRB #1 – August 2024

IRB #2 – August 2024

IRB Registration and FWA

Federal regulations require that institutions receiving federal funding for research have a Federalwide Assurance (FWA) with the U.S. Department of Health and Human Services (DHHS), and have their IRBs registered with the federal Office for Human Research Protections.  The FWA is a formal commitment by Iowa State University that its human subjects research will abide by ethical principles and federal regulations.

Iowa State’s FWA:   FWA00002678 expires February 16, 2026

Iowa State IRB Registration Numbers:

• ISU’s IRB #1: IRB00000473
• ISU’s IRB #2: IRB00005531 (IRB #2 Reviews research involving prisoners as subjects)
• IORG0000280 expires December 21, 2026

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The Research Ethics Boards are looking for the following volunteers:

• Indigenous Research Expert - August 2023
• Community Members - July 2021

Research Ethics Board - Natural, Physical and Engineering Sciences (REB-NPES)

• Mandate - review of applications involving topics in health, natural sciences, and engineering from CBS, CEPS, and OVC
• REB-NPES Membership

Research Ethics Board - General (REB-G)

• Mandate - review of applications primarily involving topics in the social sciences and humanities, from CSAHS, OAC, COA and Lang
• REB-G Membership

Submission Deadlines

• REB-NPES Meeting Dates and Deadlines for full board review
• REB-G Meeting Dates and Deadlines for full board review
• Minimal risk studies can be submitted anytime. Please submit your application as soon as you can;
• Studies requiring full board review (higher than minimal risk) MUST be submitted at least  two weeks  prior to the meeting date. Submitting by this deadline does not guarantee that your project will be reviewed on that specific meeting date.

NOTE: If your submission requires pre-review clarification it will be reviewed at the next full board meeting once pre-review clarification is complete. Give yourself time.

See the Approval Process  for definitions of full board and pre-review for clarification.

Terms and Conditions

Terms and Conditions - a document which formally outlines the structure, composition, and function of the Research Ethics Boards.

Board of Record

Vineland research and innovation centre.

The University of Guelph Research Ethics Board - General is the Board of Record for all University of Guelph researchers who are also cross-appointed to the  Vineland Research and Innovation Centre . Any research undertaken by these individuals (and involving human participants) would need ethics review from the University of Guelph Research Ethics Board - General .

Vineland Research and Innovation Centre employees who do not hold cross-appointments with the University of Guelph would not be able to access this service.

Annual Report

An  Annual Report , produced by the Ethics Office on behalf of the Chairs of the REB-General and REB-Natural, Physical and Engineering Sciences, summarizes the work of the REB members and the Ethics Office during the fiscal year, and the goals for the coming year. Information about current membership, number and distribution of submissions, as well as metrics on the functioning of the two boards are included, along with updates on process or procedure and educational outreach to the community.

• Printer-friendly version
• Overview of Research Ethics
• Indigenous Research Ethics
• Templates & Resources
• REB Working Group Report

The Office of Research oversees a $186 million research enterprise across seven colleges, our regional campus at Ridgetown, 15 research centres, and the University of Guelph/Ontario Ministry of Agriculture, Food and Rural Affairs Agreement. We are committed to supporting the research programs of University of Guelph faculty across all disciplines.

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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.

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]

J. Anneke Rummens, PhD Interim Chair, Health Sciences Research Ethics Board 416-979-5000 ext. 543595 [email protected]

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

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

Federica Berdini (she/they), PhD Research Ethics Administrator 416-979-5000 ext. 552963  [email protected]

Melissa Sidhu 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.

Interim Chair, Health Sciences Research Ethics Board

Ex-Officio Members (non-voting)

Faculty and Staff Representatives

Community Members

Ad Hoc / Advisors

Human Research Ethics Office

Human ethics review at usask, how to submit, behavioural, provincial reciprocity and multi-jurisdictional research, frequently asked questions, current approval times.

Files Approved from July 1, 2024 through August 23, 2024 (i.e., most recent 8 weeks)

Updated August 26, 2024

Research involving t he following requires ethics review and approval by a Research Ethics Board (REB) before the research commences:

• living human participants;
• human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive materials and stem cells. This applies to materials derived from living and deceased individuals;
• secondary use of data, health information, or biological materials.
• USask Human Research Ethics Policy
• Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (2022)
• Applying for ethics approval
• Applying for exemption
• Requesting Acknowledgement of a project that has been approved by another institution

Need Help with your application?

The Research Ethics Office offers scheduled consultation sessions where researchers can seek help with a human ethics application. The goal of these sessions is to provide one-on-one assistance to answer specific questions that people have about their drafted application .   Sessions are available weekly on Wednesday mornings from 10am to noon . To book a half-hour session please send an email to [email protected] , indicating your preferred time slot and whether your application is Biomedical or Behavioural. The deadline for booking on any given Wednesday is Tuesday at noon.

• Book one-on-one assistance!
• Call: 306-966-2975
• Call toll free: 1-888-966-2975
• Search Knowledge Base (login required)
• Contact us! (login required)

Deadlines, timelines, board membership, and meetings

• Above minimal risk submissions are reviewed at full board meetings.
• Minimal risk submissions are reviewed in the order received. 

Education and training

• The University of Saskatchewan REBs require that all students engaged in research complete t he TCPS 2 Tutorial Course on Research Ethics (CORE) . Please submit the certificate of completion for all students.
• The University of Saskatchewan REBs require that all students involved in chart review or data abstraction activities also complete the McMaster Chart Review Tutorial . Please submit the certificate of completion for all students.
• Research Ethics Presentation
• University of Saskatchewan faculty and their research staff
• Staff and students of the University of Saskatchewan
• Saskatoon Health Region and affiliate staff and practitioners
• U.S. federal-wide Assurance Training Modules
• National Institutes of Health Research (NIH) Researcher Training
• The Fundamentals of OCAP®  (updated fall 2023)

Policies, guidelines, and standard operating procedures

• University of Saskatchewan Policies and Procedures for Ethics in Human Research
• Procedures for Stewardship of Research Records at the University of Saskatchewan
• Human Ethics Review Fee Policy
• Guidelines for Registering in a Clinical Trials Registry
• Research Participants Funding Requisition Guidelines and Procedures

Standard Operating Procedures

• Research Ethics Board Standard Operating Procedures (18 February 2022)
• SOP Table of Contents

100 General Administration (101-108)

• SOP 101 Authority and Purpose
• SOP 102 Research Requiring REB Review
• SOP 103 Training and Education
• SOP 104 Management of REB Office Personnel
• SOP 105A Conflicts of Interest REB Members and REB Office Personnel
• SOP 105B Conflicts of Interest Researcher
• SOP 105C Conflicts of Interest Organization
• SOP 106 USask Addendum
• SOP 107 Use and Disclosure of Personal Information
• SOP 108 Standard Operating Procedures Maintenance

200 REB Organization (201-204)

• SOP 201 Composition of the REB
• SOP 202 Management of REB Membership
• SOP 203 Duties of REB members
• SOP 204 REB Office Personnel Serving as REB Members

300 Functions and Operations (301-303)

• SOP 301 REB Submission Requirements and Administrative Review
• SOP 302 USask Addendum
• SOP 303 Document Management

400 Reviews of Research (401-407)

• SOP 401 Delegated Review
• SOP 402 REB Review Decisions
• SOP 403 Initial Review Criteria for REB Approval
• SOP 404 USask Addendum
• SOP 405 USask Addendum
• SOP 406 Research Completion
• SOP 407 Suspension or Termination of REB Approval

500 Reviews Requiring Special Consideration (501-503)

• SOP 501 REB Review During Publicly Declared Emergencies

600 REB Communication and Notification (601-602)

• SOP 601 Communication Researcher
• SOP 602 Communication Research Participants

700 Informed Consent (701)

• SOP 701 Informed Consent Form Requirements and Documentation

800 Responsibilities of Investigators (801)

• SOP 801 Researcher Qualifications and Responsibilities

900 Quality Management (901-903)

• SOP 901 Quality Assurance Inspections
• SOP 902 External Inspections or Audits
• SOP 903 Noncompliance

—————————–

• Glossary of Terms
• Table of Concordance
• Download and complete the appropriate form (see links below) and submit, with all supporting documents, to [email protected] .
• CC the principal investigator on the submission email.
• Submit any revised documents (i.e., amendment or response to a notice of ethical review) with tracked changes.
• If you have been assigned an Ethics ID# include the # on the submission email and associated forms.
• Scanned forms cannot be accepted.
• The University of Saskatchewan REBs require that all students complete the  TCPS2 Tutorial (CORE)  and that all students involved in chart review or data abstraction complete the  Hamilton Integrated Research Ethics Board (HiREB) Chart Review Tutorial . Please submit the certificate(s) of completion for all students and medical residents.

  Questions? Contact us at 306-966-2975 or  [email protected]

Forms — Behavioural

Behavioural Application Form:

• Behavioural Application Form
• Understand the lifecycle of your application: Behavioural REB Delegated Review Workflow

Course-Based Research Application Form:

The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (2022) places under REB purview pedagogical activities involving human participants that are conducted by students as part of a course: "[The REB's scope] includes course-based research activities, the primary purpose of which is pedagogical, because of the possible risks to those recruited to participate in such activities, and the fact that, from their perspective, such activities may appear indistinguishable from those that meet this Policy's definition of research.”

The Application for Review of Course-Based Research can be used for courses where students are engaging in research activities solely for pedagogical purposes. This application can NOT be used for thesis or dissertation projects, including at the undergraduate level.

The Application for Review of Course-Based Research allows the Behavioural Research Ethics Board and Biomedical Research Ethics Board to provide REB approval to the course instructor for the general form and content of course-based research activities. The REB then delegates responsibility to the instructor for ensuring that students’ specific processes and project materials adhere to the REB approved application and the TCPS2. 

Please note that the course-based approval is for one year, and can be renewed twice. After three years, a new course-based application form must be submitted for review.

• Course-based Research Application Form

Behavioural Consent Form Templates/Guides:

• Consent Form Template & Guidelines - Individual Participation
• Consent Form Template & Guidelines - Online Survey
• Consent Form Template & Guidelines - Group Activity
• Recruitment Poster Template
• Consent Form Template & Guidelines for Individual Interviews by Videoconference
• Consent Form Template & Guidelines for Group Interviews by Videoconference
• Transcript Release Form Template

Behavioural Amendment Form:

Behavioural Amendment Form

Behavioural Renewal and Closure Forms:

• Behavioural Closure Form
• Behavioural Renewal Form

Behavioural Protocol Deviation Form:

• Behavioural Protocol Deviation Form

Research During the COVID19 Pandemic:

Human Ethics applications that include in person activities may require extra considerations to safeguard participants from COVID-19 transmission. This also applies to amendments where the protocol is changing from virtual to in-person research activities.

Please include in your application/amendment form a description of protocols that will be in place to manage the risk of viral transmission. If no such protocols are required or necessary, please indicate that in your application/amendment instead, along with a brief explanation of why the project doesn’t require them. Please consider the following:

• Protocols must meet the minimum requirements for the location of the research activities.
• Where participants will be particularly vulnerable (e.g., due to advanced age or co-morbidities), it may be prudent to have protocols that exceed the requirements at the location.
• It may help to consult the guidance document and template below when drafting your plan.
• Please ensure that your consent material includes a brief description of any protocols you are following, such as masking, screening questions, and a description of how (and for how long) you will store participants’ contact information if you are keeping it for contact tracing.
• Safe Research Plan Template
• Safe Research Guidelines

Forms — Biomedical

Biomedical Application Forms/Guides:

• Above Minimal-Risk Application Checklist
• Biomedical Application - Secondary Use of Health Data
• Biomedical Application - Secondary Use of Biological Materials
• Biomedical Application – Prospective Research
• Biomedical Application – Creation of Biobank and/or Data Registry

Biomedical Consent Form Templates/Guides:

• NEW - Above Minimal Risk Consent Form Template
• NEW - Minimal Risk Consent Form Template
• Tissue Banking and Genetic Consent Form
• Tips for Filling Out Secondary Use of Health Data Forms
• Telephone Consent Script Template
• Assent Overview
• Assent SOP Sample

Biomedical Renewal and Closure Forms:

• Biomedical Renewal Form – Prospective
• Biomedical Renewal Form - Secondary Use of Health Data and Biological Materials
• Biomedical Renewal Form- Biobank and Data Registry
• Biomedical Closure Form

Biomedical Post-Approval Reporting:

Biomedical Protocol Deviation Form

Biomedical Local Unanticipated Problem Form

Biomedical Non-Local Unanticipated Problem Form

Biomedical Additional Reportable Events/Documents Form

Biomedical Amendment Form

Research During the COVID19 Pandemic

Human Ethics applications that include in person data collection may require extra considerations to safeguard the wellbeing of the participants during the pandemic.

• Biomedical Guidance on Consent During COVID-19

The Research Ethics Boards (REB) in the province of Saskatchewan have moved to a policy of full reciprocity. Approval by an REB at University of Saskatchewan, University of Regina, or Saskatchewan Health Authority will be accepted by the REBs at the other two institutions without the need for additional REB review, provided the protocol is identical in its content and activities. Please note that there are criteria for determining which REB is the one that you must seek approval from (it is not necessarily your home institution), so before you begin preparing your REB application, please check in with the staff at your local REB office for guidance.  

For all other Canadian institutions, the USask REBs may provide a Letter of Acknowledgement of the primary institution’s approval, rather than perform a second review.  More information is available on knowledge base .

Plese consult the TCPS2 (2022) - Chapter 8  regarding Multi-Jurisdictional research.

Saskatchewan Health Authority — Operational Approval

Saskatchewan Health Authority (SHA) Operational Approval to Conduct Research:  Review and approval of research projects that impact or affects any SHA resources/facility(s). This includes all research projects conducted by SHA employees.

The requirements for obtaining SHA Operational Approval (OA) for research are twofold:

• Assurance of research ethics approval from the appropriate Research Ethics Board (REB) must be provided before OA can be granted. Research ethics approval must be obtained from one of the following Saskatchewan Research Ethics Boards: SHA (located in Regina), University of Regina or University of Saskatchewan. Do not submit your SHA Operational Approval application until AFTER the REB application has been submitted for review to the appropriate REB.
• The Principal Investigator (PI) must complete and submit the SHA Application for Operational Approval to Conduct a Research Study. The purpose of the application is to ensure that research using SHA or affiliated resources or patients occurs with the approval of the appropriate authorities, as well as to ensure that all research occurring within the SHA meets the requirements of the applicable policies, legislation, and guidelines for conducting responsible research. It is essential to determine whether the SHA has the appropriate resources in place to support the research question or hypothesis, that the areas being affected have an opportunity to review the project details and assess their impact, and to ensure that all necessary ethical and operational processes have been completed prior to the commencement of the project.

Research Approval Coordinator Contact Information:

Regina/South: [email protected] , telephone: 306-766-0893

Saskatoon/North: [email protected] , telephone: 306-655-1442

Who Can I Contact For Human Ethics Information?

Questions? Please contact:

• Susan Jelinski (Director) at [email protected]
• Tenille Shivak (Research Ethics Administrator) at 306-966-2975 or  [email protected]
• Caitlin Prebble (Research Ethics Specialist) at  [email protected]
• Adrian Taylor (Research Ethics Coordinator) at  [email protected]
• Melanie Bayly (Research Ethics Coordinator) at  [email protected]
• Shalini Reymond (Research Ethics Coordinator) at [email protected]
• Hamisi Mwaguni (Research Ethics Coordinator) at [email protected]

In order to contact the Biomedical or Behavioural Research Ethics Board Chair, please email  [email protected]  and it will be directed to the appropriate person immediately. 

How Do I Get Human Ethics Approval?

Step-by-step  .

Step 1: Determine If Your Project Requires Ethics Review

  Step 2: Determine Which Research Ethics Board Your Project Should Be Reviewed By

  Step 3: Assess The Risk Level Of Your Project (Minimal Risk Or Above Minimal Risk)

  Step 4: Submit An Ethics Application To The Ethics Office

  Step 5: Make The Requested Revisions As Suggested By The Research Ethics Board (If Necessary)

During the Ethics Review Process the REB will often respond to you with suggested revisions or modifications to the research protocol, consent form, recruitment protocol, etc. These revisions will need to be made and submitted for review prior to ethics approval being granted. Revisions must be submitted electronically.

  Step 6: Receive The Certificate Of Approval And Begin The Project

Approval is issued for the protocol and corresponding documents that are described in the application. Changes to any aspect of this protocol (i.e. a change in research method, recruitment of participants, participant population, consenting process, consent form, etc.) require approval from the appropriate REB. An amendment form  (Bio)   (Beh)   must be submitted to  [email protected] .

How do I get assistance with my Ethics Application?

Beginning in August 2024,   the Research Ethics Office will offer scheduled consultation sessions where researchers can seek help with their in-progress human ethics applications. The goal of these sessions is to provide one-on-one assistance to answer specific questions that people have about their application.   Consultation sessions will be available weekly on Wednesday mornings from 10am to noon. To book a half-hour session please send an email to   [email protected] , indicating your preferred time slot and whether your application is Biomedical or Behavioural. The deadline for booking on any given Wednesday is Tuesday at noon.

  Book one-on-one assistance!

Does my project require human ethics review and approval?

University of Saskatchewan Research Ethics Boards (REBs) operate in accordance with the  Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans - TCPS 2 (2022)  and the  University of Saskatchewan Policies and Procedures for Ethics in Human Research  (June 2013) .

The following list represents a broad overview of the range of research projects or situations that would require review and approval by the REB:

• Projects where participants are from inside or outside the university.
• Research that is funded or unfunded.  Funding may be internal or external.
• Research that is conducted by students or faculty.
• Research projects that are conducted inside or outside the institution.
• Information that is collected directly from participants or from existing records not in the public domain.
• Projects that are conducted in person or remotely (e.g., mail, electronic mail, fax, online video conferencing, or telephone).
• Research designs that are observational, experimental, correctional, or descriptive.
• Review is still required even if a similar project has been approved elsewhere.
• Pilot studies or fully developed projects undergo the same review process.
• The primary goal of the research is for teaching or training purposes, or the acquisition of knowledge

Which Research Ethics Board Should I Submit My Project To?

The University has established two Research Ethics Boards (REBs), which have defined Terms and Conditions of Appointment for Members and Chairs. The appropriate REB must approve any project involving the use of human participants.

The  Biomedical Research Ethics Board  (Bio-REB) is responsible for the review of all protocols involving human participants which include:

• medically invasive physical procedures, invasive interventions and invasive measures (includes administration and testing of drugs); physical interventions that have the potential for adverse effects such as drug, exercise and dietary interventions; surgical procedures such as biopsies, the collection of blood or other specimens;
• use of permanent charts or records in accordance with provincial legislation.

The  Behavioural Research Ethics Board  (Beh-REB) is responsible for the review of all protocols involving human participants which include:

• non-invasive interventions and measures including interviews, surveys, questionnaires, psychological, social or behavioural interventions, non-invasive physiological measures (e.g. heart rate, blood pressure);
• observation or descriptive research, including drug, dietary, and exercise protocols that are observational in nature with no intervention;
• audio and/or video recording or other monitoring.

The Research Ethics Office may determine that an ethics application is more appropriately reviewed by one REB than the other and reserves the right to move the ethics application to the REB with the most appropriate expertise to conduct the review. In those cases the researcher will be consulted and informed of the transfer. No new submission will be required, but additional information may be requested.

With the increasing numbers of multidisciplinary research projects and the use of mixed methods, research ethics submissions that combine elements of both biomedical and behavioural research are becoming more common. An ethics application using mixed methods will be reviewed by the REB with the best expertise in the methods that may impose the greater risk to a research participant from either a biomedical or behavioral standpoint. Where appropriate, the Biomedical and Behavioural REB may collaborate in the ethics review of the submission.

Can Ethics Approval Be Granted Retroactively?

All research that involves human participants requires review and approval by a Research Ethics Board (REB) in accordance with the  Tri-Council Policy Statement   before  the research is started.

REB review and approval of the ethical acceptability of research is required prior to the start of recruitment of participants, access to data, or collection of human biological materials.

Questions?  Contact the Research Ethics Office at 306-966-2975 or  [email protected] .

Can I Make Changes To My Project After Ethics Approval Has Been Granted?

An  Amendment Form  must be completed for all revisions to your approved study including changes to research personnel (PI, sub-I, student), sponsor and/or funder, location, questionnaires, consent forms, recruitment material.

• Include any revised documents with changes tracked or highlighted, indicating the version number or date.
• Changes must be submitted for approval   before   implementation.

How Do I Assess The Risk Level Of My Project?

Your project is minimal risk if the risk of harm anticipated in the proposed research is not greater, considering probability and magnitude, than that which is ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Risks of daily life mean those risks encountered in the daily lives of the participants of the research, considering their actual life situations, as opposed to the daily life of "all persons" or of "healthy volunteers" as the case may be.

If your study is minimal risk, it will be reviewed via delegated review by the Chair or Vice-Chair of the Research Ethics Board (REB).

If your study is above minimal risk, it will be reviewed by the REB at a full board meeting, and will need to be submitted by the appropriate deadlines:

Biomedical Research Ethics Submission Deadlines

Behavioural Research Ethics Submission Deadlines

How Do I Close My Ethics Once I Have Completed My Research Study?

The REB requires that a closure form is submitted when the research study is completed.

A study is completed when there is no further contact between the researcher and participants.  This point might come, for example, at the end of data collection when the researcher has no intent of further contact with participants or after data analysis because some follow-up contact with participants may be needed or possible. In some cases, researchers undertake to report back to individuals, or to the community or group from whom they collected data. In these cases, contact with participants would only end once they have reported their findings in accordance with this undertaking. This would occur after data analysis, interpretation of the findings, and/or drafting of the research report.

• The PI’s affirmation that participant data collection is completed;
• Total number of research participants enrolled at the local site;
• The number of Serious and Unexpected Adverse Events;
• The date of the study monitor’s final visit;
• The final disposition/storage of all research related study documents;
• The final disposition of any electronic data, and;
• Any other information required by the study sponsor.
• Total number of research participants enrolled at the U of S local site;
• The final disposition/storage of all research-related study documents.
• The final disposition of any electronic data, and
• Any other information relevant to the REB.
• The PI must notify the REB that the acquisition of data is complete.
• Studies that are funded or supported by the US federal government may not be closed until analysis of all individually identifiable information is completed

How Do I Submit A Human Ethics Post-Approval Reporting Form?

Step-by-step.

• Download the appropriate form to your desktop.
• Type in your responses, and save a copy and any associated documents.
• Questions marked with an  *  are mandatory.
• Signatures are not required on any forms.
• Submit the completed form and all associated documents electronically to  [email protected] .  DO NOT SCAN DOCUMENTS.
• If submitting a form on behalf of the Principal Investigator (PI), you must copy the PI on the email submission.

Biomedical post-approval reporting Forms:

I Have Ethics Approval From Another University. Do I Need Approval From the University of Saskatchewan's Research Ethics Board?

Within Saskatchewan

The Research Ethics Boards (REBs) in the province of Saskatchewan have a policy of full reciprocity.  This means that if your application has been approved by one of the following SK REBs; the University of Saskatchewan, the University of Regina, or the Saskatchewan Health Authority, approval will be accepted by the other institution(s) without the need for additional REB review, provided the protocol is identical in its content and activities.

Please note:  There are criteria for determining which REB is the one that you must seek approval from (it is not necessarily your home institution). Before you begin preparing your REB application, please check in with the staff at your local Research Ethics Office for guidance.

Other Canadian Institutions

For all other Canadian institutions, the USask REBs may provide a Letter of Acknowledgement of the primary institution’s approval, rather than perform a second review. The acknowledgement serves to confirm that the project meets the REB’s requirements for the ethical conduct of research and can proceed at the University of Saskatchewan. A certificate of Approval is not issued, and the ethical oversight remains at the primary institution. This process is considered when a project meets the following criteria:

• The project is minimal risk, as defined by the   TCPS 2 (2022) .
• The project has been approved by a TCPS2 compliant REB.
• The project does not require release of personal health information from any trustee, designated archive, or health information custodian and the collection of information is prospective and supported through consent.

The USask Behavioural and Biomedical REBs have additional criteria that must be met when determining whether an external application can be acknowledged.  To request a review of an external application, please send an email the research ethics office ( [email protected] ) , copying the lead Principal Investigator and attaching the following documents (as applicable):

• Evidence of external REB approval (e.g., a Certificate of Approval)
• The approved REB application
• The approved consent form(s)
• The approved data collection tools (e.g., surveys, questionnaires etc.).
• The approved recruitment material(s) that will be used to advertise the study at USask.

When the request is received, the Research Ethics Office will arrange for the documents to be reviewed by a Chair or Vice-Chair of the appropriate REB to ensure that the external approval meets the USask REB’s requirements. This review typically takes 2 to 3 weeks. If the reviewer is satisfied, a Letter of Acknowledgement will be issued. Where the reviewer has questions, especially as it relates to provincial HIPA legislation, the REB may request revisions, or that an application be submitted for approval as opposed to acknowledgement.

Is My Project Eligible For Exemption From Ethics Review?

In order for the REB to determine whether your project is exempt, please send the following information to   [email protected] :

• Describe the project, and its primary purpose.
• Include the project title and the name of a faculty member or supervisor that would serve as the Principal Investigator responsible for the conduct of the project, as well as any student researchers.
• Describe the criteria for including participants.
• Provide any participant materials (e.g., survey/interview questions, questionnaires) and describe how the data will be collected.
• Justify why you think the project should be exempt. Please see: Criteria for exemption as per  TCPS 2 (2022) – Chapter 2

Research Exempt from Research Ethics Board (REB) Review:

• publicly available through a mechanism set out by legislation or regulation and that is protected by law; or
• in the public domain and the individuals to whom the information refers have no reasonable expectation of privacy
• it does not involve any intervention staged by the researcher, or direct interaction with the individuals or groups;
• individuals or groups targeted for observation have no reasonable expectation of privacy; and
• any dissemination of research results does not allow identification of specific individuals.
• REB review is not required for research that relies exclusively on secondary use of anonymous information, or anonymous human biological materials, so long as the process of data linkage or recording or dissemination of results does not generate identifiable information.

Activities Not Requiring Research Ethics Board Review:

• Quality assurance and quality improvement studies, program evaluation activities, performance reviews, or testing within normal educational requirements when used exclusively for assessment, management or improvement purposes, do not constitute research as defined by the  Tri-Council Policy Statement  and do not fall within the scope of REB review.
• Creative practice activities, in and of themselves, do not require REB review. However, research that employs creative practice to obtain responses from participants that will be analyzed to answer a research question  is  subject to REB review.

Case Reports:

Typically, writing a report of a unique or interesting clinical case (N=1) does not constitute research as defined by the  Tri-Council Policy Statement   and does not fall within the scope of REB review. The primary intent of a case study is the treatment and well-being of a particular individual, at the discretion of the treating physician, and is not the answer to a research question.

If you are planning to do a case study, the REB strongly encourages you to send an email to   [email protected]   with the following information:

• A short summary of what you plan to do. E.g., what the rare condition is etc.
• Confirmation that consent will be sought from the individual
• The name/department/contact information of the principal investigator
• The name(s) of any student researcher(s) involved

What If I Need More Time To Complete My Research But My Ethics Approval Is Expiring Soon?

Human Research Ethics Approval is granted for   one year , provided there is no change to the approved protocol or consent process. The initial Certificate of Approval includes the approval period the Research Ethics Board (REB) has assigned to your study. If your research is continuing past the expiry date, c ompleted renewal applications should be submitted to the REB a minimum of 10 but not more than 30 business days prior to the study expiry date (unless special permission has been granted). Renewals that require full board review should be submitted prior to or on the submission deadline date (no later than 11 but not more than 30 business days) for the scheduled REB full board meeting, prior to the study expiry date in order to be added to the meeting agenda. We encourage study teams to submit early in order to ensure their study is re-approved on time.

The REB requires that a renewal form be submitted once per year until all of the data has been collected, all contact with research participants has concluded and the closure of the research has been acknowledged by the REB.

• Biomedical Renewal Form - Prospective
• Biomedical Renewal Form - Biobank or Data Registry

If   the research received initial approval via delegated review it may undergo delegated review at the time of renewal. Research that was previously reviewed by the full board may also be reviewed at the time of renewal using delegated review procedures if certain conditions are met.

If a renewal meets the criteria for full board review, the REB will discuss the research at a Full Board meeting and will make a decision regarding the continued approval of the research, as well as any other additional determinations regarding the conduct of the research, as applicable.

If a renewal or closure form is not submitted to the ethics office by the expiry date, a warning notice will be issued to you. After the expiry date, the research is out of compliance, and you must cease all research activities. If the REB approval lapses and you want to continue with the research, you must submit a renewal form within one month of the current expiry date.

When are the Biomedical Research Ethics Submission Deadlines?

Biomedical Research Ethics Submissions Deadlines

Please Note:  The deadlines are only applicable to  above minimal risk studies requiring full-board review . Minimal risk studies are processed in the order received. If you require clarification as to whether your study is above minimal risk, please see FAQ above: How Do I Assess The Risk Level Of My Project?

When are the Behavioural Research Ethics Submission Deadlines?

Please Note:   The deadlines are only applicable to   above minimal risk studies requiring full-board review . Minimal risk studies are processed in the order received. If you require clarification as to whether your study is above minimal risk, please see  FAQ above: How Do I Assess The Risk Level Of My Project?

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• Ethical Considerations in Research | Types & Examples

Ethical Considerations in Research | Types & Examples

Published on October 18, 2021 by Pritha Bhandari . Revised on May 9, 2024.

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.

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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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The Research Ethics Board 'REB' reviews the ethical acceptability of all research involving humans conducted within the jurisdiction or under the auspices of SFU, that is, by their faculty, staff or students, regardless of where the research is conducted.  Human research must be reviewed and approved by the REB before commencing the project.  The REB is independent in decision making relating to the ethical review of research but is created by the institution, draws its authority and resources from the institution, and is accountable for the integrity of its process to the institution.  The REB is supported by the Research Ethics administration team.

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The REB complies with the US Department of Health and Human Services (DHHS) Code of Federal Regulations ( 45 CFR 46.103 ). These regulations state that every institution engaged in human subject research supported or conducted by the DHHS must have assurance of compliance approved by the US Office for Human Research Protections (OHRP/FDA).

Federalwide Assurance (FWA) and Institutional Review Board (IRB) assurances with OHRP/FDA have been obtained for both SFU and the SFU Research Ethics Board (REBs in Canada are referred to as IRBs in the US):

Institutional Organization: SFU (IORG0001878)

• Type of Assurance: Federalwide Assurance for "Simon Fraser University"
• Assurance Number: FWA00002324
• Expiry Date: 4/5/2028
• Type of Assurance: Federalwide Assurance for "Simon Fraser U IRB #1 - SFU Rsch Ethics Board"
• Assurance Number: IRB00002371
• Expiry Date: 7/8/2027

For details or confirmation of SFU approved OHRP/FDA assurances, go to the  Office for Human Research Protections database  and search by entering the IORG, FWA or IRB numbers.

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Ethics Committees: Structure, Roles, and Issues

Pankti mehta.

1 Department of Clinical Immunology and Rheumatology, King George’s Medical University, Lucknow, India.

Olena Zimba

2 Department of Clinical Rheumatology and Immunology, University Hospital in Krakow, Krakow, Poland.

3 National Institute of Geriatrics, Rheumatology and Rehabilitation, Warsaw, Poland.

4 Department of Internal Medicine N2, Danylo Halytsky Lviv National Medical University, Lviv, Ukraine.

Armen Yuri Gasparyan

5 Departments of Rheumatology and Research and Development, Dudley Group NHS Foundation Trust (Teaching Trust of the University of Birmingham, UK), Russells Hall Hospital, Dudley, UK.

Birzhan Seiil

6 Department of Biology and Biochemistry, South Kazakhstan Medical Academy, Shymkent, Kazakhstan.

Marlen Yessirkepov

An Ethics Committee (EC) is an independent body composed of members with expertise in both scientific and nonscientific arenas which functions to ensure the protection of human rights and the well-being of research subjects based on six basic principles of autonomy, justice, beneficence, nonmaleficence, confidentiality, and honesty. MEDLINE, Scopus, and Directory of Open Access Journals were searched for studies relevant to this topic. This review is focused on the types of research articles that need EC approval, the submission process, and exemptions. It further highlights the constitution of ECs, their duties, the review process, and the assessment of the risk-benefit of the proposed research including privacy issues. It’s pertinent for academicians and researchers to abide by the rules and regulations put forth by ECs for upholding of human rights and protecting research subjects primarily, as well as avoiding other issues like retraction of publications. Despite various issues of cost, backlogs, lack of expertise, lesser representation of laypersons, need for multiple approvals for multisite projects, conflicts of interest, and monitoring of ongoing research for the continued safety of participants, the ECs form the central force in regulating research and participant safety. Data safety and monitoring boards complement the ECs for carrying out continuous monitoring for better protection of research subjects. The establishment of ECs has ensured safe study designs, the safety of human subjects along with the protection of researchers from before the initiation until the completion of a study.

Graphical Abstract

INTRODUCTION

The journey of the role of ethics in biomedical research began with “The Doctor’s Trial” post-World War II in which 23 doctors and administrators were tried for war crimes, crimes against humanity, and conducting research without informed consent. This judgment, known as the “Nuremberg Code” was one of the first international ethical standards which gave a ten-point rule with respect to the protection of human research participants. The core principle was the requirement of voluntary consent of human subjects and respecting human autonomy. 1 , 2

However, some researchers continued to ignore the code and violations like the Willow Brook Hepatitis Study (1956), Jewish Chronic Disease Study (1963), and 22 others were highlighted by Beecher in 1966. 3 , 4 This led to the composition of the Declaration of Helsinki by the World Medical Association in Finland in 1964 with revisions at regular intervals. 5 This affirmed the principles highlighted in the Nuremberg Code stating that research should be conducted upholding the interests and rights of the human subjects. It proposed for the first time, the submission of a research protocol to an ethics committee (EC) before the initiation of the study ( Fig. 1 ). 6

EC refers to “Committees established by professional societies, health facilities, or other institutions to consider decisions that have bioethical implications. The role of these committees may include consultation, education, mediation, and/or review of policies and practices.” Committees that consider the ethical dimensions of patient care are Clinical ECs whereas committees established to protect the welfare of research subjects are Research ECs. 7 In this review, we will be using the terms ECs and Research ECs interchangeably.

It was in the 1960s that most nations developed guidelines regarding the formation of ECs with the main task of protection of human subjects. 8 EC is an independent body composed of members with expertise in both scientific and nonscientific arenas which functions to ensure the protection of human rights and the well-being of research subjects. ECs can be of two types—Institutional Review Boards (IRBs) or Institutional ECs (IECs) (referred to IRB or IEC by different countries) that are formally constituted by an institution to review research projects for that institute. An independent EC is an autonomous EC that is not part of any institute and performs the same functions independently. It is helpful for institutes that don’t have an IRB.

Despite these regulations, the unethical standards of the Tuskegee Syphilis study emerged in 1972 in which treatment was denied to the participants in order to study the natural course of the disease. This was followed by the conversion of the National Research Act in the USA into law (1974) and the setting up of the national commission of ‘International Ethical Guidelines for Biomedical Research Involving Human Subjects’ that submitted the Belmont report in 1979. The Belmont report described the role of assessment of risk-benefit of research involving human subjects, appropriate guidelines for selection of human subjects, and definition of informed consent. It was based on the three pillars of ethics- respect, beneficence, and justice. 9 , 10 It stressed the need for the approval of studies by an EC in accordance with the 1975 revision of the World Medical Association in Tokyo. Subsequently, countries like China, India, and South Korea adopted and legalized the need for submission of protocols to ECs from the 1980s onwards. 11 , 12 , 13 , 14

ECs function on six basic principles 15 :

• 1. Autonomy: respect the patient’s right to act on his/her own value and choice.
• 2. Justice: fair treatment of the research subjects.
• 3. Beneficence: work for the benefit of the patient.
• 4. Nonmaleficence: primum non-nocere or first do no harm to the patient.
• 5. Confidentiality: privacy protection.
• 6. Honesty: truthfulness in terms of the study.

Ethics approval is required for most research studies to uphold the above-mentioned principles, and protect the participants as well as the researcher. 16

In this narrative review, we aim to study the structure and function of ECs or IRBs with a focus on the composition, role, violations, and development perspectives of ECs.

Searches through MEDLINE (PubMed) and Scopus were performed in line with previously published recommendations. 17

Articles published till March 15, 2023 were reviewed using the following keywords: ("Ethics Committees, Clinical/classification"[Mesh] OR "Ethics Committees, Clinical/economics"[Mesh] OR "Ethics Committees, Clinical/ethics"[Mesh] OR "Ethics Committees, Clinical/history"[Mesh] OR "Ethics Committees, Clinical/legislation and jurisprudence"[Mesh] OR "Ethics Committees, Clinical/organization AND administration"[Mesh] OR "Ethics Committees, Clinical/standards"[Mesh] OR "Ethics Committees, Clinical/statistics and numerical data"[Mesh] OR "Ethics Committees, Clinical/trends"[Mesh]). Additional searches about subtopics were also carried out (“Data Safety Monitoring Boards” OR “Independent Data Review Committees”, “Institutional Review Boards” OR “Ethics Committees” and “Problems” OR “Issues”).

Articles in languages other than English, and reviews, conference proceedings, and editorials were excluded. Relevant articles searchable at the Directory of Open Access Journals and references of included articles were also processed for eligibility and inclusion for this narrative review. 18 , 19 , 20 , 21

RESEARCH, SUBMISSION PROCESS, AND EXEMPTIONS

IRB approval is required for most research to protect human rights and assess the scientific soundness of the research. For this, we first need to understand what research is. Research is defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” ( Table 1 ). 8

IRB = Institutional Review Board.

An EC approval is required for studies with more than minimal risk to the subjects where the intention is to publish findings or contribute to the scientific knowledge, studies involving the compilation or analysis of data containing patient identifying information, studies with any risk of physical or mental discomfort to participants or their families, and studies on vulnerable groups. 22 Minimal risk refers to the probability of discomfort posed by the research is not greater than that ordinarily encountered in routine daily life activities of an average healthy individual. 5 , 8 , 22

Thus, even surveys and archived data that contain patient identifying information (name, age, address) and sensitive information (illicit drug use, comorbidities, communicable diseases, e.g., HIV AIDS) need ethical approval to uphold the privacy and anonymity of the participants as well as protection the possibility of psychological discomfort to them. 10 , 23 , 24 , 25

Some studies may be exempted from ethical approval including most educational research, case reports on one to three patients (without any hypothesis testing), those that pose no risk to the participants, involve information freely available in the open domain for the community, analysis of open-source datasets or anonymized datasets obtained from other researchers with due informed consent taken at the time of primary data collection, research evaluating the public health programs or government public schemes. 26 , 27 However, a formal exemption is to be decided by the IRB and not the investigator. 8 , 28

For projects requiring an EC approval, the type of reviews includes expedited and a full board review. Expedited review is for research involving no more than minimal risk to the subjects, minor revisions of an already approved study, and is usually conducted by an experienced person or the chair of the IRB. A full board review on the other hand is for research with greater than minimal risk to the subjects or those involving vulnerable populations. This is reviewed extensively by a full IRB meeting.

The documents usually required for a full ethics review include the name of the applicant with designation, approval of the head of the department, research/trial protocol, ethical issues if any, and plans to address them, written informed consent form (and assent forms) in the language the participant understands, data collection tools, patient information sheet, regulatory clearances (e.g., Drug Controller General of India in India for drug trials), finance and funding details, Insurance, statement of conflicts of interest, information about payment or compensation to the subjects, scientific or departmental review board permission, Curriculum Vitae of the investigators, declaration of interests and any other relevant information. 29 , 30 Waivers of consent may be provided for no more than minimal risk to the subjects when the waiver will not endanger the rights and welfare of the subjects like retrospective studies, secondary analysis of data wherein consent had been taken previously, use of open access databases with anonymized data, and emergency research as seen fit by the EC. 31 , 32 In emergencies like the coronavirus disease 2019 pandemic, waivers may be provided if the patient is incapacitated or in life-threatening situations where there is no time for informed consent. Pandemics like these may even call for common documents for risk disclosure and audio/video/electronic consent. 33 , 34

EC PERSONNEL, THEIR EXPERIENCE, AND DUTIES

ECs have the primary responsibility of reviewing research and its alignment with the Good Clinical Practice (GCP) guidelines. 35 The research design must be scientifically sound and conducted in an ethical way to include human subjects with voluntary informed consent.

The composition of ECs varies depending on the country, center, volume, and nature of the research reviewed. However, there are some basic recommendations laid down by national authorities and GCP. 30

• a) Most countries in Europe, the USA, and South Korea have a requirement of at least five members whereas recommendations in China and India need a minimum of seven members and a maximum of 12–15 members. 14 , 36 , 37 , 38 , 39
• b) At least one member who is autonomous, independent of the institution or trial site. It is mandatory that the chairperson of the EC is not part of the institution where the research is to be conducted.

Others include a member secretary from within the institution and members from the scientific field. The composition should have an adequate gender and age representation with a blend of basic scientists, clinician scientists, one legal expert, one social scientist, one philosopher, and one layperson. Review of research involving vulnerable populations like children, pregnant women, handicapped, prisoners, etc., must involve one member with expertise in dealing with that population. 40 , 41 It is also desirable to have a member or expert advisor for special areas of research who has proficiency in that field.

Responsibilities

The chairperson has the primary responsibility of independent and smooth functioning of the EC, ensuring the participation of all members, seeking Conflict of Interests from all members, and handling complaints against the researchers and EC members. 39 It’s the responsibility of the member secretary to schedule EC meetings, handle documentation, organize an effective review of proposals, define and maintain adherence to standard operating procedures (SOPs), train EC members, and assess the need for expedited reviews/exemption from review. 39 The members of the scientific community have the primary responsibility of reviewing the research protocols and their scientific soundness. The non-scientist member is crucial to safeguard the human subjects and practical issues of the research. 40 , 41 However, studies have shown lesser participation by laypersons as compared to scientific members. A study conducted across 10 academic centers across the USA with 20 IRB meetings recorded noted that 29 community members were present in 17 of those meetings. They were primary reviewers in only two of the 93 submitted protocols due to refusal on grounds of lack of knowledge regarding medical research. Even as secondary and tertiary reviewers, they were less active and were more likely to focus on issues related to confidentiality. However, they played a greater role when they were not designated reviewers. 42

The EC or IRBs function to review and approve research protocols, monitor ongoing research involving human subjects with the aims of continual protection of human volunteers, advancement of research, and protecting the institute from litigation. Its main role is the protection of the human rights, autonomy, confidentiality, and welfare of the research subjects especially vulnerable populations. The GCP recommends the following for duties of the IRB ( Table 2 , Fig. 3 ) 35 :

e.g., An immunosuppressive drug “X” being evaluated for patients with Lupus Nephritis.

IRB = Institutional Review Board, SOC = standard of care, GCP = Good Clinical Practice, MMF = mycophenolate mofetil, CYC = cyclophosphamide, ICU = intensive care unit, SOP = standard operating procedure, RCT = randomized controlled trial.

• • The IRB should obtain and review all the necessary documents for the research/trial within a reasonable time and document its views following standardized operating procedures with clear identification of the dates for approval, modifications, disapproval, or termination of an ongoing trial that was initially approved in writing.
• • Qualification of the investigators should be considered for the proposed research.
• • Reviewing of ongoing research as appropriate to the risks involved (at least once a year).
• • Protocols indicating exemption of prior consent of the subject or their legally acceptable representative (e.g., emergency situations) should be assessed in detail for all the regulatory needs.
• • Review the sum and method of compensatory payment to subjects if required.
• • Functions should be performed as per written SOPs which should comply with the GCP guideline.

Most IRBs conduct meetings regularly (one–two per month depending on the number of protocols) and SOPs are followed as per the national governing authority.

An EC review is a continuous process and is needed before the initiation of research, before the extension of the approval period, prior to modifications to an already approved study, for monitoring of any adverse events, and until all the data collection and analysis is complete. 8 An oversight to the monitoring of trials (usually single center, early phase, less risky) is provided by the IRBs through annual reviews, adverse event monitoring, and reporting of undue events by the principal investigator (PI). However, complex clinical trials and/or multicenter, randomized controlled trials, interventional studies with pre-existing concerns about safety, or study participants who might need additional protection through an additional committee referred to as the Data Safety Monitoring Board (DSMB). 43 , 44

RISKS, BENEFITS, CONFIDENTIALITY, AND PRIVACY ISSUES IN RESEARCH PROTOCOLS

The role of the EC is not only to provide direct protection to human subjects from physical or mental harm but also to weigh the risks and benefits involved in the research. It must be assessed if the study is designed to add to the current scientific knowledge base and help society. 8

The research protocol is the document that includes the research question, aims and objectives, a critical literature review, methodology, and statistical plan. It is pertinent that the IRB reviews the protocol with respect to the clarity and focus of the research question; and whether the study design is suitable to answer the same. This is decided by the chair or a special departmental committee ( Table 2 , Fig. 3 ).

Privacy and confidentiality are a part and parcel of every physician-patient relationship. Needless to say, this must be maintained in a researcher-human subject relationship as well. It helps build trust, curbs participant anxiety, maintains their dignity, and above all their autonomy. 10 The International Committee of Medical Journal Editors recommends that authors must ensure that nonessential information like names, initials hospital record numbers, etc., are omitted during data collection, storage, and publication whenever possible. 45 However, there’s an extent to which this confidentiality can be maintained. Information required for scientific purposes (e.g., clinical photographs) or those with mandated legal reporting may breach participant privacy. This needs to be explained to the participant and recorded in written informed consent ( Table 2 ).

The role of the IRB with respect to privacy and confidentiality is to:

• • Review the consent document and assess the sensitivity of the information, the duration for which it will be held, the usefulness of the information, and the ability to protect it.
• • For multicenter projects, review the measures taken by the research team to maintain the privacy of the research subjects including the number of personnel with access to the information, data storage, and transfer.
• • An ongoing review of the research must include monitoring of confidentiality issues to check for maintenance of the same and the need for a revised privacy protection plan.
• • Educate researchers and IRB members regarding the data privacy and protection process. 46

Review of informed consent by IRBs is especially important in low-middle-income countries. There are various issues related to the lack of understanding of the information provided, maintaining privacy due to interference by family members, and the inability to assess risk and benefit by the research participant. IRBs have an additional responsibility to ensure that studies have minimal/no risk to the participant, the consent forms are clear and simple to understand and ensure the proper process of obtaining informed consent is being followed without undue pressure or coercion to participate in the study. 47

VIOLATIONS OF ETHICS APPROVAL RULES AND REGULATIONS

Violations of IRB approval rules like lack of approval, lack of approval of modifications to the protocol, and lack of informed consent can result in dire aftermaths for the authors. It can result in the withdrawal of the article if it’s still in press, retraction if it’s already published, and even removal if it has legal consequences. The number of papers retracted as searched on the retraction database 48 is steadily increasing by the decade from 474 in the 1990s to 6120 in the 2010s. The most common reason for retraction is plagiarism whereas violation of IRB rules accounts for 4–5% of all retractions. 49 , 50 When consultations for ethical inquiries to the Korean Association of Medical Journal Editor were analyzed, the most common reason was duplicate publications (12 of 80) with issues with IRB approval (5 of 80) and informed consent (6 of 80). 51 Some of the examples of types of studies and their reasons for retractions have been summarized in Table 3 .

Violations can be assessed before the studies are published for those with IRB approval. It is the responsibility of the IRBs to monitor whether ongoing studies are abiding by the ethical regulations and whether the approved protocol is being followed. A study conducted in India by an IRB at a tertiary care hospital in Mumbai monitored 12 clinical trials from 2011–2017. The most common violations were related to informed consent, followed by a lack of understanding of protocol and protocol deviations. This was corrected by re-taking of the informed consent and retraining in GCP by the IRB. 52 A similar study in Uganda done from 2007–2010 with monitoring of 40 research projects also found a similar frequency and reasons for violations. 53

Journal editors routinely check if a statement mentioning whether ethics approval was sought has been mentioned in the manuscript. Depending on the journal and type of article, further details of the EC approval can be sought by the journal editorial board. 54

ISSUES AND ONGOING DEVELOPMENTS

ECs were developed to provide ethical oversight to clinical research. But here are various issues associated with the functioning of IRBs.

• • Composition: Most studies indicate a skewed gender representation in the structure IRBs. Further, the participation of laypersons on the board is minimal. 14 , 42 , 55 , 56 , 57
• • Overburdened IRBs, delays, and operational costs: The IRB reviews have been associated with delays from over 4 to 7 months on average from surveys conducted across the USA. 58 , 59 A delay in biomedical research can translate into more than monetary loss as biomedical research saves lives and a delay in the approvals can result in greater loss of life. 60 An older survey conducted across 63 institutions (with 20 being low volume, 24 intermediate volume, and 19 being high volume centers) in the USA in 2005 reported the median amount spent by academic medical centers on IRB was $750,000/year with an average of $559 per review. The main costs are divided across staff salary, board salary, space, outsourcing of the reviews, travel, supplies, and equipment. 61 Over the years, there is a definite increase in the number of ongoing research projects thus increasing these costs further. Furthermore, documentation of Food and Drug Administration (FDA) warning letters to IRBs was predominantly related to paperwork stressing on documentation of reviews and meetings rather than ethical issues. 62 Increasing paperwork further results in delays and added costs. These deficiencies are more marked in developing nations like India and China dealing with issues like lack of regulation, informal ethics reviews, lack of supervision, and insufficient ethics review capacity. 63 , 64
• • Multi-site projects: With multicenter projects on the rise, a single protocol is often reviewed by multiple IRBs. In a review of 17 articles reported from UK, USA and Europe, which underwent multiple IRB reviews of the same protocol there were discrepancies in the judgment. Five of 26 reported rejection at some and acceptance by some IRBs. However, there were great differences in the protocol revisions, consent, patient information sheets, risk-benefit assessment, and compensation arrangements. 65 Keeping these issues in mind, the Common Rule in the USA was revised in 2017 with IRB approval required only from one center for multisite projects. 66 This may be extrapolated to other nations or consideration of an expedited review at other sites when fully reviewed at one IRB can be considered.
• • Independent EC and IEC: Independent ECs have inherent tissues of limitation of knowledge about the local community and use of these may promote IRB shopping. Whereas, local IRBs can have conflicts of interest as colleagues of investigators may be on the review board. Thus, a central IRB can alleviate some of these concerns by avoiding repetitive reviews, minimizing conflicts, and establishing a centralized adverse event reporting system. 67 , 68 , 69 A central IRB can be formed by experts on a particular subject or by a group of institutes like the National Cancer Institute’s Central IRB and the Biomedical Research Alliance of New York respectively. 70 , 71
• • Scientific expertise of the IRB reviewers: The IRB reviewers may lack the scientific expertise to review sophisticated research projects that may affect the quality of the research. 11 , 14 , 57 , 72 Regular training in research ethics and GCP along with adequate consultations with external experts is needed. This can be done at a national, regional, and international level. First, by identifying core issues and then solutions for them by focused training. 73 Training of EC members is conducted across Central Asia and Eastern Europe under the framework of Forum for Ethics Committees in the Confederation of Independent States and Strategic Initiative for Developing Capacity in Ethical Review program that train members regarding GCP, bioethics, the establishment of an EC, review processes and SOPs, choosing independent consultants, and confidentiality agreements. 74
• • Review of studies involving complementary and integrative medicine (CIM) is a challenge due to the lack of quality evidence to support the basis for their use. Moreover, most international regulatory bodies and research regulations do not address CIM, thus leaving the review process and decision-making to the IRBs. However, it is to be emphasized here studies irrespective of the type (modern or CIM) must be reviewed using the same principles of respect, beneficence, and justice. Well-designed studies on CIM are essential to ascertain the health and safety of patients. 75

DSMB is defined by the FDA, USA as “a group of individuals with pertinent scientific expertise that review research data of an ongoing trial on a regular basis, advises the sponsor/or researcher regarding the continuing safety of research subjects and those yet to be recruited into the research trial, and advises as to the continuing validity and scientific merit of the trial.” 76 It’s an autonomous entity independent of the researchers, sponsors, and the IRB so as to control data sharing and protect the authenticity of the clinical trial from unfavorable impact. 35 It was first developed in the USA in the 1960s as the NIH began sponsoring multicenter trials, the first trial was the Coronary Drug Project which used a DSMB for monitoring. 77 Over time, it became a common practice for the sponsors to have experienced scientific personnel serving on these committees. Although the FDA does not mandate DSMB for all trials, DSMBs are generally recommended for large, multi-site studies evaluating treatments that intend to reduce mortality and morbidity.

DSMBs are usually constituted for:

• • The study outcome is such that a highly encouraging or detrimental result is a possibility in an interim analysis that may require an early termination of the study on ethical grounds.
• • When the safety concerns are high, e.g., invasive therapy is administered.
• • Previous data suggesting serious toxicity with the study treatment.
• • Studies involving vulnerable populations.
• • Studies including subjects at an increased risk of death or serious outcomes.
• • Large, multisite, long-duration studies.

In India, it is recommended by the Indian GCP guidelines that the sponsor may establish a DSMB to assess the progress of the trial, and in 2006 Indian Council of Medical Research (ICMR) mandated a DSMB to review data emerging from research on interventions in the emergency setting. 39 These were updated in 2012 by the ICMR to include all stem cell research involving human subjects. The SOPs for the constitution and responsibilities of the DSMB are laid down by the World Health Organization and are similar across USA, Europe, and South Korea. 78 , 79

DSMBs are constituted by scientific members and are appointed by the funding agency, before the recruitment of the first subject in the trial. It can consist of as few as three members and is typically constituted of clinicians and at least one biostatistician. Others that may be included are medical ethicists, other scientists, etc. The most important requisite is that the members should be independent of the sponsors, investigators IRBs, regulatory authorities, and site or study staff. They should have no conflicts of interest with the sponsors, researchers, or study staff.

The functions of the DSMB are:

• • To uphold participant safety.
• • Ensure credibility and integrity of the trial for future subjects.
• • Ensure the timely conclusion of the study so that the results can be disseminated.
• • Identify protocol violations if any.
• • Identify unexpectedly high dropouts and evaluate for the same.
• • Ensure the validity of the results.

The above functions are carried out by an initial organizational meeting to understand the protocol and safety monitoring plan followed by an early safety review meeting to review early safety information. Continuing periodic reviews to assess safety, efficacy, and the progress of the trial are then carried out with reporting of serious adverse events. 44 A final meeting is to be held at the termination of a study. DSMBs function independently of the IRBS but the PIs must submit DSMB reports or minutes to the IRB.

Dramatic instances in which trials have been stopped prematurely on the recommendation of the DSMB include the withdrawal of rofecoxib and celecoxib in two trials on the prevention of colonic polyps due to increased cardiovascular events. 80 , 81

We have come a long way from the horrific ethical compromises in clinical studies in history to establishing adequate safety for the human subjects participating in clinical research today. The establishment of the IRB or EC has ensured safe study designs and the safety of human subjects right from before the study initiation until its completion. This is further supplanted by additional boards like DSMBs. However, we still need studies assessing the outcomes of the ECs on a global basis and addressing various issues that are still pertinent to the working of the ECs. 82

Disclosures: The authors have no potential conflicts of interest to disclose.

Author Contributions:

• Conceptualization: Mehta P, Zimba O, Gasparyan AY, Seiil B, Yessirkepov M.
• Data curation: Mehta P.
• Writing - original draft: Mehta P.
• Writing - review & editing: Mehta P, Zimba O, Gasparyan AY, Seiil B, Yessirkepov M.

The University of Chicago The Law School

Kirkland & ellis corporate lab clinic—significant achievements for 2023-24.

Founded in 2009, the Kirkland & Ellis Corporate Lab (the “Lab”) provides students with “real-world” experience and context to prepare them to become well-rounded attorneys with sound knowledge and judgment.

Lab students undertake a wide variety of assignments from the legal and business teams of significant publicly traded and privately held corporations, many of which are household names. Through this work and through classroom instruction, students in the Lab acquire the necessary legal and interpersonal skills and knowledge to excel in their future legal practice.

During the 2023-2024 academic year, Lab students successfully completed in excess of 100 projects for more than thirty largely publicly traded companies across a wide range of legal disciplines—e.g., contract drafting and corporate transactions, labor and employment, intellectual property and copyright, artificial intelligence, litigation risk assessment, and legal research. Specific examples include the following:

Contract Drafting and Corporate Transactions

• Drafting of template agreements on behalf of a global consulting firm;
• Revision of standard license agreements to address AI concerns for multinational software development company;
• Preparation of a cease-and-desist letter for a sports agency;
• Preparation of risk factor section of 10-K for a global specialty retailer’s 10-K;
• Detailed analysis of master terms and conditions for a national retailer, and resulting revision of same;
• Preparation of data and retention policy for an investment advisory firm;
• Preparation of code of conduct and code of ethics for financial services firm re compliance with recent Canadian labor legislation;
• Presentation to leadership team of global consulting firm re the European Union’s Whistleblower Directive;
• Board presentation to a multinational computer and information technology company addressing the European Union’s Digital Operational Resilience Act;
• Presentation to the Board of a national logistics company addressing director duties; and
• Presentation to an international specialty retailer addressing the legal consequences of implementing session replay technology and detailing modifications to privacy policy and popup banners to ensure compliance.

Labor and Employment

• Preparation of employment agreements and stock option and stock grant terms for multiple Booth New Venture clients;
• Revision of employee manual for global telecom company; and
• Presentation to the legal department of a national logistics company detailing OSHA violations and factors informing calculation of fines.

Intellectual Property and Copyright

• Memorandum assessing the current and potential future states of IP protection afforded to AI-generated work product;
• Guidance memoranda to several startup companies on the difference between copyrights, trademarks and trade secrets, and which categories of protectability their IP portfolios fall under; and
• FAQ and quick reference guide on the NCAA’s name, image and likeness rules for a sports agency to distribute to its clients.

Litigation Risk Assessment

• Review of commercial contracts and related communications for multiple publicly traded companies to address likely litigation success.

Artificial Intelligence

• Preparation of draft generative AI legal terms for subsidiary of a global consulting firm; and
• Presentation to the legal department of a global telecom company re ethical issues in popular, open-source datasets used for training AI models.

Legal Research

• Research memorandum for a multinational computer and information technology company exploring copyright of algorithm terms;
• Research memorandum for knowledge management team of global law firm re “assignment by operation of law” provision in reverse triangular mergers across multiple states;
• Research memorandum for a global consulting firm addressing the enforceability of contingent fee agreements under laws of various states;
• Research memorandum for a multinational food company re compliance with food and drug laws in the United States and the European Union;
• Memorandum to a multinational IT services provider discussing key contract terms related to generative AI;
• Memorandum to a multinational financial services provider researching data and document retention, which resulted in a drafted outline of corporate policy;
• Research memorandum to global telecom company re SEC swap rules Memorandum to a global leader in business and financial information comparing SEC swap rules;
• Research memorandum for a national sporting goods retailer regarding compliance with ESG regulations;
• Research memorandum for a global footwear and apparel retailer re compliance with the Central America-Dominican Republic Free Trade Agreement;
• Research memorandum for medical device company re compliance with advertising regulations in the United States, United Kingdom, and Spain;
• Memoranda to multiple clients discussing data privacy laws in the European Union, Asia-Pacific, and Latin America;
• Memorandum to a multinational technology corporation addressing current and proposed legislation in the United States and multiple foreign jurisdictions re launch and disposal of satellites;
• Research memorandum for multinational healthcare and consumer goods manufacturer assessing the risk of omni-channel distribution of professional products that reach consumers;
• Research memorandum for a global professional services company exploring the implications of the Regional Internet Registries’ promulgated guidelines on IP addresses; and
• Research memorandum for an energy infrastructure startup exploring the regulatory landscape of Texas’s energy regulation.

Included in the Lab’s client roster are the following:

• Academy Sports + Outdoors
• A.T. Kearney
• Base Power Company
• Jones Lang LaSalle
• Kirkland & Ellis
• Koch Industries
• Kraft Heinz
• The Motley Fool
• NSi Insurance Group
• Owens Corning
• Schneider National
• Ulta Beauty
• Unison Risk Advisors
• Vayner Sports
• Victoria’s Secret
• WEC Energy Group

The Lab also worked with more than twenty entrepreneurs on an individual basis and through an ongoing collaboration with the Booth School’s New Venture Challenge and Social New Venture Challenge. Specific assignments included the following:

• Instruction to Booth students on options for entity formation, stock grants and options, and required organizational documents; and
• Preparation of employment agreements, non-disclosure agreements, founders’ agreements, and other documents for launching a startup business.

Beyond the essential clinic training, the Lab hosts an ongoing speaker series throughout the year that brings to campus experienced practitioners, business leaders, and other esteemed guests to discuss topical business and legal issues, substantive areas of law, and other topics of interest to the speakers and students. Recent speakers have included senior executives from Amazon, Coinbase, Google, IBM, the Illinois Gaming Board, Meijer Microsoft, Victoria’s Secret, WTW and partners from Kirkland & Ellis, Cleary Gottlieb, Dechert, Morgan Lewis, and Sidley.

Other enrichment activities include our cross-border negotiation training exercises with the law schools of Tel Aviv University and Reichman University.