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Research Ethics Board: About the REB

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

The Health Canada - PHAC REB reviews all research involving humans that is conducted under the auspices of Health Canada and PHAC to ensure that it meets the highest ethical standards, and that the greatest protection is provided to research participants.

The REB's activities and committee structure are guided by the principles of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans , which sets the standard for research ethics boards in Canada.

On this page

Mandate and scope, committee structure and responsibilities of members, become a member, reb mandate and reporting.

The Health Canada-PHAC REB serves as an independent ethics review board to help ensure that all proposed or ongoing research involving human participants or communities carried out by, funded by, or otherwise under the auspices of Health Canada or PHAC, meets the highest ethical standards. In so doing, it helps ensure that safeguards are implemented to provide the greatest protection to human participants and/or communities. The REB makes recommendations to Health Canada or PHAC as to whether research projects should be approved, rejected, modified, or terminated. The REB reviews applications in accordance with the considerations set forth in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans as the minimum standard, and other applicable policies and norms.

Health Canada's REB became operational on September 1, 2002. On April 1, 2010, the REB became a joint board for both PHAC and Health Canada. The REB reports to the Deputy Minister of Health and the President of PHAC, who jointly appoint REB members, approve REB procedures and authorize research to be initiated or terminated. The Deputy Minister and President have delegated their decisional authority functions to a senior official within Health Canada and PHAC respectively, each of whom is referred to as the Decisional Authority in Research Ethics.

Scope of REB review

The Health Canada-PHAC REB shall review all research involving human subjects in circumstances where the research is:

• Carried out by Health Canada or PHAC employees in the course of their employment;
• Carried out on Health Canada or PHAC premises, or involves technical or consultation support including the use of equipment, laboratories or other facilities belonging to HC or PHAC;
• Undertaken in a collaboration or partnership between Health Canada or PHAC and external researchers; or
• Carried out under contract with Health Canada or PHAC.

The REB may also review research that is funded by Health Canada or PHAC through grants and contributions to external researchers who do not have access to another TCPS-compliant REB.

Research involving humans as "research participants" includes research with:

• Living individuals;
• Human remains, cadavers, embryos or fetuses;
• Human biological materials such as tissues, organs, blood, plasma, serum, DNA, RNA, proteins, cells, hair, nail clippings, feces, urine, saliva and other body fluids; and
• Information from or about humans, such as information obtained through questionnaires, or from records of nonliving humans that are not in the public domain.

For the purposes of this REB, research is defined as an activity designed to test a hypothesis or answer a specific question, permit conclusions to be drawn and develop or contribute to generalizable knowledge through the use of scientific methods, standardized protocols, systematic collection or analysis of data, or other forms of inquiry. Research may rely upon quantitative methods or qualitative approaches. It also includes experimental development of new products or processes.

Examples of activities that do not meet this definition of research and therefore do not require REB review include public opinion research, public consultations, research using publicly available information, and routine public health investigations and surveillance activities. Some boundaries between research and non-research activities may be difficult to define. Whenever there is uncertainty as to whether a proposed activity requires REB review, applicants should consult the REB Secretariat or (for PHAC researchers) the PHAC Office of the Chief Science Officer (OCSO) .

The REB membership is intended to ensure that the REB has the expertise and independence essential for conducting competent research ethics reviews. The REB consists of nine regular and nine alternate members with expertise in the following areas:

• Two members with knowledge/expertise in research ethics;
• One member with knowledge/expertise in law;
• One member from Health Canada with methodological knowledge/expertise in Health Canada research;
• One member from PHAC with methodological knowledge/expertise in PHAC research;
• One member external to Health Canada and PHAC with broad methodological knowledge/expertise in both Health Canada and PHAC research;
• One member with broad expertise in public health;
• One member recruited from the community (general population) served by Health Canada and PHAC; and
• One member from the Indigenous community.

Members are appointed by the Deputy Minister of Health and the President of PHAC. The mandate for each member is for three years and is renewable. All REB member positions are voluntary and no financial remuneration is offered. However, travel, accommodation expenses, parking and other authorized REB meeting expenses are reimbursed through the REB Secretariat.

Responsibilities of REB members

The REB members review the ethical acceptability of research projects, reflecting on, for example, potential risks and benefits; respect for, and protection of, research participants; and relevance and rigour of the research. The following expectations, qualities and skills are required of all members to ensure quorum and optimal group dynamic:

• Be available and willing to commit time for board meetings (including preparation time);
• Participate actively in discussions with other REB members, providing input to research applications/protocols and input in drafting REB documents and procedures;
• Be a team player – present views and opinions clearly and directly, contribute constructively to debate and possess skills that promote working effectively together;
• Listen attentively and respectfully to other members; and
• Consider complex issues thoughtfully and objectively.

REB meeting attendance

The full REB meets monthly (except for August), either by teleconference or face-to-face in Ottawa. Quorum requires that at least five members (regular or alternate) be present, including one member knowledgeable in ethics, one member knowledgeable in law, one member from the community, and two members with expertise in relevant research disciplines, fields and methodologies covered by the REB. All regular and alternate members are invited to the two-day meeting held each June, which includes a focus on REB member training in addition to the regular research ethics review work.

All REB members (regular and alternate) are also expected to participate on a rotating basis in delegated review meetings (typically three or four per year). Delegated review meetings are held weekly by teleconference (biweekly in July and August) and consist of the Chair (or Deputy Chair) and one other REB member.

Chair and Ethics Member

Glenn G. Griener is a philosopher whose primary areas of scholarly activity are applied ethics and the philosophy of science, with a particular focus on the issues arising in health care and the ethics of biomedical research. He has conducted research into the privacy and confidentiality concerns arising from the development of electronic health records. Dr. Griener has been asked to provide advice on these issues by both the Government of Alberta and Alberta Health Services. He has also participated in or led several bodies developing national policy on research ethics.

Dr. Griener has a B.Sc. in physics (Loyola University, New Orleans) and an M.A. and Ph.D. in philosophy from the University of Western Ontario. He retired from the Department of Philosophy at the University of Alberta in 2019. During his long career at the University Dr. Griener enjoyed joint appointments with the Faculty of Medicine and Dentistry, the Faculty of Nursing and the School of Public Health.

Dr. Nancy Walton is the Associate Dean, Student Affairs in the Yeates School of Graduate Studies, and an Associate Professor in the Daphne Cockwell School of Nursing, at Toronto Metropolitan University (TMU). At TMU since 2003, she has previously served as Director of the School of Nursing, as Director of eLearning, and as the Chair of the TMU Research Ethics Board. In 2016-17 she was seconded to the Ontario Ministry of Colleges and Universities as Special Advisor to the Deputy Minister. Dr. Walton also served as the Chair of the Women's College Hospital Research Ethics Board from 2016 to 2021. In 2022, Dr. Walton was appointed to the Interagency Advisory Panel on Research Ethics.

Dr. Walton has a PhD in Nursing with completion of the Collaborative Program in Bioethics from the University of Toronto (2003) and an undergraduate degree in nursing science from TMU (1992). She has published and presented on priority setting and decision-making in cardiac surgery, ethical considerations of internet-based research, research ethics board composition, and ethical and legal considerations in research on children and adolescents, and most recently on ethical issues arising in the Ebola virus disease outbreak as well as the ethical concerns and opportunities of new mobile technologies and artificial intelligence in health care. Her primary areas of research and interest are the experiences of parenting children with disabilities, the ethical considerations in the use of technologies and innovations in healthcare and moral courage.

Dr. Walton is a longstanding member with expertise in ethics on the Research Ethics Board at the Hospital for Sick Children, a founding member of the Research Ethics Board at the Ontario College of Art and Design University and remains an ad hoc member of the TMU REB. She was a previous member of the National Council on Ethics in Human Research (NCEHR) and is a member of both CAREB (Canadian Association of Research Ethics Boards) and PRIMR (Public Responsibility in Medicine and Research). In 2016, she received the CAREB Distinguished Service Award.

She is the Canadian author of the textbook Ethics and Issues in Contemporary Nursing (3 rd edition) and is the co-editor of the textbook Leading and Managing in Nursing (2019).

Dr. Stéphane P. Ahern is an Associate Professor of Medicine at the Université de Montréal in the Faculty of Medicine. He is a specialist in general internal medicine and adult critical care. Since 2007, he has served as Chair or Vice-Chair of the Research Ethics Board (REB) at Maisonneuve-Rosemont Hospital and now at CIUSSS de l'Est-de-l'Ile-de-Montréal - REBs operating in fields at the forefront of stem cell transplantation, psychiatry, advanced ophthalmologic therapy and oncology, among others. He was Chair of the Standing Scientific Committee on Entry on the List of Medications of the Institut national d'excellence en santé et en services sociaux (INESSS) of Quebec for several years, during which time he was interested in responsibly bringing innovation to the fields of oncology and rare diseases.

Dr. Ahern holds a Master's degree in Philosophy from the Université de Sherbrooke and a PhD in Clinical Sciences, also from the Université de Sherbrooke, where the theme of his research was assessing the capacity to consent to treatment.

Julie Toole holds a Bachelor of Arts in International Development from Trent University, a Bachelor of Health Sciences in Midwifery from Ryerson University, and a Master of Health Sciences degree in Medical Sciences, Bioethics from the University of Toronto. She has worked as a Registered Midwife in Toronto, where her practice focused largely on serving uninsured clients and the urban Indigenous community and currently works as a Quality & Risk Management Specialist at the Association of Ontario Midwives. Her particular areas of interest include management of adverse events, outbreaks and pandemics, clinical ethics, privacy, and mental health; clinical areas of interest include equity, informed choice, and prenatal genetic screening. Ms. Toole currently co-leads two ethics task forces, one focused on ethical issues related to the COVID-19 pandemic and the other on the creation of a code of ethics for midwives in Ontario. She supervises both midwifery undergraduate students and graduate students in the fields of bioethics and public health.

Me Jean-Frédéric Ménard is a professor at the Faculty of Law of Université de Sherbrooke since 2017. He teaches the civil law of persons, ethics in the life sciences and the organization of the healthcare system in the Health Law and Policy graduate programme. He is a member of the Quebec Bar since 2007. Upon graduating from McGill, Me Ménard served as a law clerk to the Honourable Justice Louise Charron of the Supreme Court of Canada. Before joining the Université de Sherbrooke Me Ménard worked as an ethicist with the Centre for Applied Ethics of the McGill University Health Centre in Montreal.

Me Ménard holds an undergraduate degree in philosophy from Université Laval (BA, 2001) and law degrees from McGill University (BCL / LLB, 2005), the University of Oxford (Mansfield College, BCL, 2012) and University College London (PhD, 2021). He is a member of GRIIS (Interdisciplinary Research Group in Health Informatics), Centre de recherche sur la régulation et le droit de la gouvernance (CrRDG; Research Centre for Regulation and Governance Rights) and VOICE: Views On Interdisciplinary Childhood Ethics.

Melanie McPhail is currently a Research Associate, Faculty of Health Sciences at Simon Fraser University, focusing on the development of, access to, and funding of expensive treatments for rare diseases. Previously, she has worked as a policy analyst for the Department of Canadian Heritage on the international affairs team and a course instructor at Western University in the Faculty of Health Sciences teaching health policy and advanced health policy.

Ms. McPhail received her Bachelor's degree from Queen's University, where she majored in geography and environmental studies, and her Juris Doctor degree from Western University. After completing her JD, Ms. McPhail completed her Masters of Laws (LLM) from Western University under the supervision of Dr. Jacob Shelley. Her master's research focused on the intersection of public health and the law, analyzing the constitutionality of advertising restrictions on recreational cannabis in Canada. Ms. McPhail is currently a PhD student in the Faculty of Law at the University of British Columbia. Her PhD research focuses on the regulation of innovative health technologies.

Mr. Charles Batrouny is currently a senior associate at the law firm Cozen O’Connor LLP. He represents clients across all Canadian provinces, and has been called to the Bar in Ontario, Alberta, British Columbia, and has a temporary call to the Quebec Bar under Rule 42.1 of the Professional Code. Mr. Batrouny is a Qualified Arbitrator (Q. Arb.) under the ADR Institute of Canada, has completed the Toronto Commercial Arbitration Society’s Gold Standard Course in Commercial Arbitration, regularly volunteers as arbitrator for the world’s largest advocacy competition (the Willem C. Vis International Commercial Arbitration Moot [Hong Kong and Vienna]), is involved in various local arbitration and ADR societies, was a teaching assistant for the ADR and Professionalism class in his law school, graduated with a distinction in ADR, and is further refining his skills as he pursues his Master of Laws (LLM) through the LLM in Dispute Resolution program with Osgoode Hall Law School.

Mr. Batrouny earned his degrees in biomedical sciences (B.Sc. Hons.), common law (J.D. with a focus on dispute resolution), and civil law (LL.L.) from the University of Ottawa. Mr. Batrouny is fluent and practices in French and English, and can converse in Arabic.

Dr. Jane Ingman Baker is a lawyer practicing in British Columbia with a national law firm that has offices in Vancouver and Toronto. She was a law clerk in the British Columbia Supreme Court and is a member of the Law Society of British Columbia. Her law practice focuses on complex litigation matters with a specialty in construction, environmental and insurance coverage matters. She has represented clients in many different parts of Canada.

Dr. Ingman Baker was trained as a biochemist, first as an undergraduate at the University of Sussex, England, and then as a post graduate student at the University of British Columbia. After completing her Ph.D., she completed two Medical Research Council Post Doctoral Fellowships in the departments of Physiology and Microbiology at UBC, before becoming a lawyer.

Dr. Ingman Baker has taught in both the Faculties of Law and Medicine at the University of British Columbia and is a member of the UBC Clinical Research Ethics Board and the Children’s and Women’s Research Ethics Board.

Health Canada Researcher

Dr. Thea Rawn is a senior research scientist and Head of the Chemical Contaminants Section of the Food Research Division, Bureau of Chemical Safety, Health Canada. Her area of specialization is method development and analysis of environmental organic contaminants in food and biological tissues. She is currently an adjunct professor at Trent University.

In addition to her work to determine dietary exposure to the chemicals of interest (e.g., polychlorinated dibenzo-p-dioxins, polychlorinated biphenyls, halogenated flame retardants, perfluoroalkyl substances, historical pesticides), Dr. Rawn has participated in studies to determine chemical concentrations in human tissues. She participated in the early work to measure chemicals in Canadian serum as part of the Canadian Health Measures Survey (CHMS). Dr. Rawn also participated in the pan-Canadian Maternal-Infant Research on Environmental Chemicals (MIREC) study, focusing on human milk analyses. She has collaborated with researchers in other groups within Health Canada in addition to those from academia (e.g., McGill University, Université du Québec à Montréal [UQAM]) to examine the linkage between chemical exposure and biological impacts.

Dr. Rawn is currently the Head of the Canadian Delegation to the Committee on Methods of Analysis and Sampling under the WHO/FAO food standards programme Codex Alimentarius and has contributed to the WHO/FAO Joint Expert Committee on Food Additives and Contaminants (JECFA).

Dr. Rawn has a B.Sc. in Chemistry from the University of Winnipeg, an M.Sc. and Ph.D. from the University of Manitoba in Environmental Organic Chemistry.

Louis Forti obtained his Ph.D. degree in Medical Sciences (Option: Gerontology) and a Master's degree of Biomedical Science in Cell and Gene Therapy from the Free University of Brussels, Belgium. His research activities focused on investigating the effect of physical exercise on inflammation in older persons and various projects on diabetes. He is also academically trained in drug regulatory affairs (post-graduate Diploma in Drug Development and Master of Pharmaceutical Sciences from the University of Montreal).

Dr. Forti has worked as Regulatory Affairs Officer for the Natural and Non-prescription Health Products Directorate at Health Canada where he reviewed non-prescription drugs to ensure they complied with the Plain Language Labelling Regulations. The regulations improve the safe use of drugs by making drug labels and packaging easier to read and understand by Canadians. Dr. Forti currently works as a Scientific Evaluator at Health Canada's Natural and Non-prescription Health Products Directorate. He routinely conducts critical reviews of disinfectant drug submissions for efficacy and safety to support regulatory decision-making. He is author and co-author of several peer reviewed publications and a scientific contributor with the Frailty in Ageing Research group (FRIA) of the Free University of Brussels, Belgium.

Public Health Agency of Canada Researcher

Stephanie Booth is the Public Health Agency of Canada's senior research scientist on prion diseases and has a laboratory at the National Microbiology Laboratory in Winnipeg. She completed her Bachelor's degree in Microbiology at University College London, followed by a Doctorate in Biochemistry and Virology at the University of Oxford. Her primary research interests include developing innovative molecular techniques for surveillance and diagnosis of human prion diseases (Creutzfeldt-Jakob Disease) and understanding the molecular mechanisms by which infectious prions kill brain cells.

Researcher External to Health Canada and the Public Health Agency of Canada

Dr. John Frank has held the following major positions: Professor (now Emeritus) at the University of Toronto, at the Dalla Lana School of Public Health, since 1983; founding Director of Research at the Institute for Work & Health in Toronto from (1991-1997); and inaugural Scientific Director of the Canadian Institutes of Health Research – Institute of Population and Public Health (2000-2008). From 2008 to 2018, he was the founding Director of an Edinburgh-based Unit, funded by the Medical Research Council and the Scottish Chief Scientist Office: The Scottish Collaboration for Public Health Research and Policy. The Collaboration has sought to develop and robustly test novel public health policies and programs to equitably improve health status in Scotland, through the convening and ongoing support of researcher/research-user consortia. Dr. Frank has held a Personal Chair in Public Health Research and Policy in the Usher Institute at the University of Edinburgh, where he was also Director of Knowledge Exchange and Research Impact from 2017 to 2021, at which time he retired, and currently holds the post of Professorial Fellow.

Dr. Frank trained in Medicine and Community Medicine at the University of Toronto, in Family Medicine at McMaster University, and in Epidemiology at the London School of Hygiene and Tropical Medicine.

Dr. Tyler Peikes is a practicing Medical Geneticist and Healthcare Ethics Consultant at the Health Sciences Centre in Winnipeg, Manitoba. He is the director of the Clinical Ethics service for the largest tertiary hospital in the province. He has conducted research in prenatal whole genome sequencing and advanced fetal diagnostic imaging.

Dr. Peikes is a member of the Ethics, Education and Public Policy committee for the Canadian College of Medical Geneticists (CCMG) and a co-author of the Joint Statement on Involvement of Human Participants in Genetic Research, soon to be released. He also serves as the Choosing Wisely Canada (CWC) representative for CCMG and chaired a working group to publish new Medical Genetics recommendations. Dr. Peikes also enjoys teaching Medical Genetics and Ethics as an Assistant Professor at the University of Manitoba and has won several teaching awards. He also serves on several committees as ethics representative, including Differences in sex development committee, Child Health Program Tracheostomy committee, Perinatal Screening Committee and Child Health Quality Improvement team. Dr. Peikes previously served on the University of Manitoba Health REB and co-authored a report on Genetic Testing in Research including new informed consent templates and educational materials.

Dr. Peikes has a B.A. (honours) with distinction in Philosophy (Queen’s University), M.A. Bioethics & Health Policy (Loyola University, Chicago), M.D. (University of Manitoba) and HealthCare Ethics Consultant-Certified (ASBH).

Public Health Community Member

Dr. Michael Wray Clarke is an adjunct professor in the Interfaculty Program in Public Health at Western University where his teaching focusses on global health practice and research. He is a member of the Board of Directors of the Middlesex Hospital Alliance. As well, he is a member of the Editorial Board of Globalization and Health, a BioMed Central journal, and former Chief Executive Officer of the Middlesex-London Health Unit.

Dr. Clarke was the inaugural Director of the Global Health Policy Program Area at the International Development Research Centre in Ottawa where he founded the Advisory Committee on Research Ethics and served as Chair for two years. In this capacity he worked with the Secretariat on Responsible Conduct of Research to develop a CORE module on the ethics of multi-jurisdictional research.

Previously, he was a professor in the Schulich School of Medicine and Dentistry where his research focussed on the molecular genetics of African trypanosomes. He also served as Chair of the University Council on Animal Care for three years and served as Chair for many site visits and assessments at university research facilities on behalf of the Canadian Council on Animal Care.

Dr. Clarke's formative years were in Sierra Leone where he served as a CUSO co-operant as a teacher and researcher. He has a PhD from the Department of Pathology of the University of Guelph.

Dr. Diane Lu is a public health physician and medical advisor in communicable diseases in the Department of National Defence. She also provides clinical care services with Correctional Services Canada. Dr. Lu has adjunct appointments to both the University of Ottawa and Queen's University working with public health and preventive medicine residents. Her current research interests include health surveillance of Canadian Armed Forces members. Dr. Lu holds both an MD and PhD degree from the University of Toronto and was a Postdoctoral Fellow at Harvard University. She also earned a Master's of Public Health from Queen's University and is a Fellow of the Royal College of Physicians of Canada.

Community Member - General Population

Ms. Janaki Jayanthan is a Senior Primary Care Program Developer (Vancouver Island) with the Primary Care Division of the British Columbia Ministry of Health. In her current role she supports the implementation of Urgent and Primary Care Centres and Community Health Centres as part of provincial efforts towards team-based primary and community care. Ms. Jayanthan's passion and appreciation for research ethics began while supporting the work of the Conjoint Faculties and Conjoint Health Research Ethics Boards at the University of Calgary over a four-year period. As a Research Ethics Advisor, she worked alongside researchers, the REB Chairs and members, and her administrator colleagues to navigate complex issues in the protection of participants in research, laying the foundation for a lasting interest in the field.

Ms. Jayanthan has contributed to public health research and community-based projects in Canada and abroad in diverse areas such as the experiences of marginalized groups in self-managing their chronic conditions in Vancouver, patient reported measures of outpatient care quality in Sri Lanka, antibiotic knowledge and use in central Mexico and household water treatment in Eastern Bolivia. Ms. Jayanthan holds a Bachelor of Arts in International Relations from the University of Calgary and a Masters of Public Health (Global Health) from Simon Fraser University.

Madzouka Kokolo is academically trained both in Epidemiology (Master of Science, University of Ottawa) and in Public Ethics (Master of Arts, Saint Paul University). She has been involved in health science projects in academic, governmental and non-profit contexts, locally, nationally, and internationally (e.g., Canadian Society for International Health, United Nations Population Fund). Her M.Sc. thesis quantitatively analyzed intersections between methods and ethics considerations in the design of HIV pre-exposure prophylaxis trials, which involved populations in situations of vulnerability. Her research contributed to increasing awareness and clearing misconceptions on that (then) novel intervention in the community (e.g., collaboration with the Canadian AIDS Society).

Having previous work experience as a Methodologist (Ottawa Hospital Research Institute), Ms. Kokolo has extensive knowledge and experience in clinical research designs, research conduct and methodological assessments, and is a published author. She also worked as an Epidemiologist in Health Canada's Health Products and Food Branch, routinely conducting critical appraisals of scientific evidence to support regulatory decision-making. Ms. Kokolo is currently working as a Senior Policy Analyst in the Office of the Chief Accessibility Officer at Employment and Social Development Canada.

Community Member - Indigenous Population

Jean Levasseur-Moreau is an Innu from the community of Essipit, where he grew up. In 2017, he received his PhD in experimental medicine from Laval University. His academic research focused on the clinical, cognitive and neurobiological effects of transcranial magnetic stimulation in military personnel diagnosed with post-traumatic stress disorder that was resistant to usual treatments. During his studies, he obtained several awards from the Fonds de Recherche en Santé du Québec and the Tshakapesh Institute. He was also involved in the Indigenous Student Association as well as a regional representative for Indspire, an organization that provides scholarships to Indigenous students in need. From 2020 to 2023, he was a member of the Human Research Ethics Committee of the Université du Québec en Abitibi-Témiscamingue.

Dr. Levasseur-Moreau has worked in the field of governance at the First Nations of Quebec and Labrador Health and Social Services Commission, where he had the privilege of visiting almost all First Nations communities in Quebec and witnessing the major issues related to health. He subsequently worked in the Quebec Ministry of Public Security to promote access to justice for Indigenous people and to offer culturally sensitive services. Dr. Levasseur-Moreau is currently the Director General of the Centre multi-services Mamuk, whose mission is to offer quality services to the Indigenous population in urban areas and to promote Indigenous cultures and harmony between peoples.

Kathleen Makela, a member of the Fort Resolution Métis Nation in the Northwest Territories, lives in Edmonton, Alberta. A descent of Old Man Beaulieu on her mother's side, and Finnish on her father's side (he is a first-generation Canadian), she is deeply committed to improving the socio-economic conditions of Indigenous people through access to equitable, culturally relevant and responsive education and legal systems.

Ms. Makela holds a BA interdisciplinary honors degree with distinction from Saint Thomas University and a law degree from the University of New Brunswick. She is currently an Indigenous Support Officer at the University of Alberta Faculty of Law. Over the years, Ms. Makela has had the good fortune to work with many traditional knowledge keepers and she appreciates the importance of spiritual teachings and ceremonies.

The Health Canada and Public Health Agency of Canada Research Ethics Board welcomes membership applications from interested individuals at any time. If there are no openings, applications will be kept on file for future consideration.

Current Opportunities

The Health Canada and Public Health Agency of Canada (PHAC) Research Ethics Board (REB) is expanding its Indigenous research ethics capacity following an agreement to provide research ethics review services to Indigenous Services Canada (ISC). The REB has a long history of Indigenous representation on the board and currently has two Indigenous community members. To support this expansion, the REB is seeking to recruit two additional Indigenous community members.

The members must:

• Be external to Health Canada, PHAC and ISC
• Identify as Indigenous (First Nations, Inuit or Métis) and have demonstrated involvement working directly with Indigenous communities
• Demonstrate a broad understanding of matters that are important to Indigenous communities and the ability to express this perspective in the context of research ethics reviews
• Have an interest in (or experience with) research with human participants, and in particular research with Indigenous people and communities
• Have a general understanding of the key ethical principles related to research with human participants, including those set out in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2) and guidance from Indigenous organizations
• Be able to fulfill the responsibilities of REB members as described above , and willing to participate in other activities such as providing feedback and advice to policymakers on matters involving Indigenous communities.

Bilingualism (English/French) and experience as an REB member are assets.

As part of the agreement with ISC, we aim to increase Indigenous research ethics knowledge across the entire REB membership and position the REB to offer feedback and advice to policymakers from Health Canada, PHAC and ISC on matters that are important to Indigenous communities. The Indigenous community members will be heavily involved in determining the scope and extent of these activities, with the support of the REB Secretariat and the ISC Office of Chief Science Officer.

Closing date for applications: September 13, 2024.

Individuals who would like to apply to become an REB member should send their curriculum vitae along with a covering letter outlining their interest and how they meet the criteria to:

Dr. Gregory Huyer Manager, Health Canada-PHAC REB Secretariat [email protected] Tel : 613-941-5199

We thank all those who apply.

Only applicants chosen for an interview will be contacted.

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Unity Health eREB Launched – Mandatory for New Study Submissions; Migrations Underway for Existing Studies

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 underway.  Once your study has been migrated, all post-approval submissions (amendments, renewals, etc.) must be submitted via the eREB.

Studies that are not yet migrated should continue to submit post-approval submissions (amendments, renewals, etc.) to the REB inbox using the current forms.

*WHAT’S NEW AT THE REB*

• February 2024: Began hosting Virtual Office Hours .

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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Research Ethics Board

Osler's Research Ethics Board (REB) exists to ensure all research meets current scientific, regulatory and ethical standards. All research involving patients, physicians, staff, students (i.e., research within the institution or using institutional resources), volunteers or visitors must obtain ethical approval from the REB before research can begin.

The REB operates in compliance with the following:

• the Tri-Council Policy Statement 2 (TCPS2): Ethical Conduct for Research Involving Humans (2022);
• the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines;
• Part C, Division 5 of the Food and Drug Regulations of Health Canada; and
• the Personal Health Information Protection Act (PHIPA-Ontario 1998, updated through November 2005).

All applications to conduct research at Osler must be submitted to the REB for review and approval. View a list of current REB members .

To be considered at an upcoming REB meeting, you must submit your application package to [email protected] by the deadline noted below.

Please note: Dates are subject to change. As the REB will not be meeting in August, please submit your documents to the July or September board meeting.

To learn more, please review our frequently asked questions about the REB .

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Canada’s new ethical guidelines for research with humans: a critique and comparison with the United States

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Canada’s Tri-Council Policy Statement: Ethical conduct for research involving humans, first published in 1998, has recently been updated. 1 The US Department of Health and Human Services has just issued an Advance Notice of Proposed Rulemaking that would substantially change the 20-year-old Common Rule governing most federally funded research involving human participants. 2 A comparison of the two countries’ systems for protecting human research participants is therefore timely. This analysis situates the Canadian system in an international context, with particular attention to its similarities and differences to the US system and their shared challenges going forward with their changes.

• Systems of oversight for research with humans

Prior review of research proposals by a research ethics committee according to legally binding standards is the primary means used around the world to protect research participants. In Canada and the United States, the institutions that conduct research are responsible for its review. As a result, most academic centres have their own research ethics committee — a research ethics board in Canada or an institutional review board in the US. Similar institutional models are followed by other developed countries, such as Australia and Japan. By contrast, regional models — in which a research ethics committee reviews all the research conducted in a particular geographic area — are common in Europe.

In Canada, any institution that receives funding from one of the three federal granting agencies — the Canadian Institutes of Health Research, the Social Sciences and Humanities Research Council, and the Natural Sciences and Engineering Research Council of Canada —must ensure that all research involving humans conducted at that institution complies with the Tri-Council Policy Statement. Health Canada also requires that sponsors of clinical trials of drugs and devices obtain approval from a research ethics board, and two provinces (Quebec, and Newfoundland and Labrador) require ethics review for some or all of the research that takes place within them. 3 , 4 However, the Tri-Council Policy Statement is the primary source of concrete guidance regarding the ethical oversight of research with humans in Canada. From its inception, the statement has been intended to be a “living, evolving document that reflects developments in research and research ethics.” 5 Hence the current revisions.

In the US, most research involving human participants funded by federal government agencies is subject to the Common Rule — a set of regulations delineating the requirements for review by an institutional review board. 6 Similar rules apply to research regulated by the Food and Drug Administration (FDA). 7 Although US institutions could decline to apply the Common Rule to research that does not receive federal funding, relatively few do so. 8 The reforms proposed in the recent Advance Notice of Proposed Rule-making have two goals. First, to improve the effectiveness of the system of federal oversight, for example, by reducing the amount of time spent reviewing low-risk research and by allowing only one institutional review board of record for multisite studies. 9 Second, to enhance protections for research participants, for example, by imposing uniform standards of security of data and requiring all research at institutions receiving funding from Common Rule agencies to follow the Common Rule (just as the Tri-Council Policy Statement does for Canada).

In both systems, then, ethics review of research is necessary if funding is received from the federal government or regulatory approval of new drugs and devices is sought. Again, this differs from many other countries, where all research with human participants within their borders may be required to undergo review. For example, the European Clinical Trials Directive applies to all clinical trials, irrespective of source of funding or other contact with government bodies. 10

The institutional model of review has the advantages that members of the research ethics committee are more likely to be familiar with the research they review, monitoring of ongoing research is easier and it is possible to impose institutional sanctions for violations by investigators. However, this model has several drawbacks. First, conflicts of interest are more likely because the institution hosting the research ethics committee has an interest in the research proceeding, and members of the research ethics committee may be colleagues of the researchers. 11 Second, an increasing amount of research now takes place at multiple sites. 12 In Canada and the US, because institutions are held liable for regulatory breaches, this usually entails a research ethics committee at each site reviewing the research proposal. Multiple reviews take up time and resources, and researchers complain of inconsistent judgments from research ethics committees that mandate minor changes without improving protections for research participants. 13 , 14

Use of government funding or contact with regulatory agencies as the way to ensure ethics review carries the risk of ethically problematic research falling through the cracks. For example, pharmaceutical companies may conduct research that is not part of marketing applications, and experimentation with surgical techniques may not use novel drugs or devices. Stories of people being enrolled in risky research without protections has led to calls in the US for a nationwide law requiring ethics review. 15 , 16

This method of ensuring ethics review can also lead to research falling under multiple sets of regulations. For example, the US federal government funds a substantial amount of research involving human participants abroad, including in Canada (e.g., in 2010 the National Institutes of Health gave nearly US$64 million in direct grants to Canadian institutions). 17 Because of the funding source, the researchers must follow the Common Rule; but at Canadian institutions they must simultaneously follow the Tri-Council Policy Statement. The same concern arises when researchers from Canadian institutions conduct research abroad.

Where possible, the Tri-Council Policy Statement and the Common Rule do attempt to address these problems. The Tri-Council Policy Statement has considered conflicts of interest, including conflicts of interest for members of research ethics boards, since 1998. 18 The updated statement extends its analysis of conflicts of interest and the measures that should be taken to address them, for instance, by addressing conflicts of interest for institutions and institutional officials. With regard to multiple reviews, both Canadian and US rules permit institutions to rely on outside research ethics committees, although relatively few institutions currently use this option. 19 However, experiments with centralizing review — such as the US National Cancer Institute’s Central Institutional Review Board and the Ontario Cancer Research Ethics Board — have had broadly positive results. 20 , 21 An analysis of centralized and noncentralized review in five English-speaking countries suggested that centralizing at least the administrative aspects of ethics review is helpful in reducing delays and excessive work from multisite trials. 22 Moreover, one key change in the US Advance Notice of Proposed Rulemaking would require there to be just one institutional review board of record for all domestic sites involved in a multisite study. Multijurisdictional research has its own chapter in the updated Tri-Council Policy Statement, which includes extensive discussion of a range of different models for review by research ethics boards of multisite research.

The problem of having both sets of regulations apply to research in Canada funded by the US government could also be solved under the current regulations. For research at institutions in foreign countries that follow different procedures for protecting human participants, the Common Rule states the following:

if a department or agency head determines that the procedures prescribed by the institution afford protections that are at least equivalent to those provided in this policy [the Common Rule], the department or agency head may approve the substitution of the foreign procedures in lieu of the procedural requirements provided in this policy. 23

However, despite the development of a method for determining whether a set of procedures offers “equivalent protections,” this option has never been taken. 24

The problems just noted stem from structural features of the systems of review. In some instances, documents like the Tri-Council Policy Statement can be helpful. For example, a future revision could follow the Advance Notice of Proposed Rulemaking and require that only one research ethics board conduct most of the review for multisite studies. In other instances, however, legislative action would be needed to change the systems in ways that would address the problems. For example, as it stands, the Tri-Council Policy Statement does all that it can to ensure that potentially risky research undergoes review — the Tri-Council agencies do not have the power to require review at institutions where they do not fund research. That would require provincial or national legislation.

• The process of ethical review

Like the ethics review systems in other countries, the Canadian and US systems have provoked criticism from researchers for inappropriately applying biomedical models to research from other disciplines and for requiring low-risk research to undergo excessive scrutiny.

The Common Rule was written in response to abuses by biomedical researchers and designed to regulate biomedical research. Nonetheless, it applies to any research that involves obtaining data through “intervention or interaction” with living persons, and review by institutional review boards of humanities and social science research is now common. The Tri-Council Policy Statement was explicitly intended to cover nonbiomedical research. However, in both countries, some social science researchers complain that a biomedical model is inappropriately imposed on their discipline with a potentially chilling effect on important research. 25 , 26 The updated Tri-Council Policy Statement places greater emphasis than its predecessor on distinguishing the standards that should apply to different types of research; for example, it now has separate chapters discussing qualitative research and clinical trials. It is also the result of an extensive process of consultation, including with academics in the social and behavioural sciences, and, as a Tri-Council statement, has been endorsed by the Social Sciences and Humanities Research Council.

Both jurisdictions exempt some research with humans from review, and countenance an expedited or delegated form of review for some research involving “minimal risk” whereby the review is conducted by just one or two members of a research ethics committee. Nevertheless, full review by a research ethics committee is common even for research that falls into one of these categories. 27 , 28 One of the changes proposed by the US Advance Notice of Proposed Rulemaking would attempt to address this problem by excusing a wider category of studies from review, including all studies whose risks are mostly informational, provided that they adhere to strict standards for data security and confidentiality. Crucially, researchers engaged in excused research would be permitted to begin research immediately after registering their study with the institutional review board, so as to avoid the current situation where many institutions require some prior review of purportedly exempt studies to ensure that they are exempt.

The updated Tri-Council Policy Statement continues to place more emphasis on flexibility than the Common Rule (although the Advance Notice of Proposed Rulemaking offers some ways to make the scrutiny of research proposals more proportionate to levels of risk than at present). The updated statement consistently emphasizes the importance of a “proportionate approach to research ethics review” 29 according to which the most risky research receives the “most intensive scrutiny, time and resources.” 30 Moreover, individual institutions are granted considerable leeway in deciding how to institute this proportionate approach, who may carry out delegated reviews and so forth. This flexibility is a model for others to follow, and Canadian institutions should make the most of it — the resources for ethics review are always limited, so they should be used to focus on the research most likely to raise ethical concerns. 31

• The Tri-Council Policy Statement

Its significantly greater length allows the Tri-Council Policy Statement to address many more ethical issues than the Common Rule. Although guidance on specific questions is periodically issued by the FDA or the Office for Human Research Protections, the US does not have regulatory requirements covering so many key issues. 32 The updated Tri-Council Policy Statement mostly consists of changes or additions, which have nearly doubled its size. 33 These include further guidance on research involving Aboriginal people, incidental findings relevant to participants’ health, conflicts of interest and research during emergencies. The additions reflect ethical issues that have become much more prominent over the last decade. The updated statement also casts its net more widely to cover more than just the protection of research participants. For instance, like the 2008 Declaration of Helsinki, it now requires the registration of clinical trials before recruitment begins. 34

The core principles of the Tri-Council Policy Statement have been radically revised. According to the first version of the statement, respect for human dignity was the foundational principle of research ethics. Somewhat confusingly, it was also one of eight guiding ethical principles. The updated version consolidates these principles to three — respect for persons, concern for welfare, and justice. These correspond to the principles underlying the US regulations as stated in the Belmont Report. 35 The updated Tri-Council Policy Statement purports to retain “respect for human dignity” as its “underlying value.” However, the concept does not do any real work independent of the core principles.

The new approach is an improvement: the three principles better reflect the content of ordinary moral thought. Ethical dilemmas that people face in all areas of life — not just in research — involve the consideration of how to respect people’s rights, balance benefits and harms, and treat people fairly. Moreover, none of these three principles can be assimilated to any of the others; for example, it is important to respect someone’s autonomous decisions, even if they are likely to negatively affect his or her welfare. Hence, these three principles are both central and basic to moral thought.

• Substantive disagreements

The original Tri-Council Policy Statement and the US regulations differed on several issues, most notably on the use of placebo controls and research with children. These disagreements remain. The US FDA permits placebo controls even when there exists an effective treatment for the condition being studied in a wide range of cases in which use of placebo is deemed scientifically necessary. 36 The updated Tri-Council Policy Statement is much more restrictive. The only instance it suggests in which it would be permissible to randomly assign participants to placebo when a proven treatment for those participants exists is when “patients have provided an informed refusal of established effective therapy” before recruitment. 37 This is strict in comparison to even the Declaration of Helsinki, which now allows the use of placebos when an effective treatment exists if there are “compelling and scientifically sound methodological reasons” for using placebo, and participants will not be at risk of serious harm. 38

The updated Tri-Council Policy Statement permits research with children only when it poses minimal net risk to participants. This is consistent with international guidelines such as the Declaration of Helsinki. 39 In the US, children may be enrolled in research that involves a “minor increase over minimal risk” with no prospect of direct benefit if the research is expected to produce important knowledge about the participants’ disorder or condition. 40 There is even provision for the approval of riskier research in exceptional circumstances. 41

With these rules strictly applied, one would expect these differences to lead to different research being conducted in the two countries and to impede some collaborative research. If they have not, it might illuminate the practice of review by research ethics committees to investigate why.

• Looking forward

The updated Tri-Council Policy Statement improves on the guidance of its predecessor and expands on ethical issues that were less prominent in 1998. It should also prove a useful resource in the US, where institutional review boards sometimes lack clear guidance on the novel ethical issues they face. However, the biggest problems for both systems concern the implementation of the rules, not their content. Many of these problems — such as conflicts of interest in research ethics committees, underreview and overreview — are related to the institution-based model of ethical review in both countries. For the most part, guidance and regulatory resources, like the Tri-Council Policy Statement, address these problems, but their suggested solutions require work by institutions and government agencies to implement them effectively. Either greater efforts to implement them are needed, or stricter rules — like those now proposed for multisite review in the US —must be imposed.

The updated Tri-Council Policy Statement has nearly doubled in length and improves on its 1998 predecessor.

The recent US Advance Notice of Proposed Rulemaking suggests substantial changes to the Common Rule.

Canada and the United States have similar systems of ethical review with similar problems.

The problems that have not been addressed thus far mostly concern the application and scope of rules, not their content.

• Acknowledgements

The author thanks Kirstin Borgerson and Jim Lavery for helpful comments on an earlier draft of this manuscript.

Competing interests: None declared.

This article has been peer reviewed.

Disclaimer: The opinions expressed are those of the author and do not reflect the position or policy of the National Institutes of Health, the Public Health Service or the Department of Health and Human Services.

• ↵ Tri-council policy statement: ethical conduct for research involving humans . Ottawa (ON) : Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada ; 2010 .
• ↵ Food and Drug Administration and the Office of the Secretary . Human subjects research protections: enhancing protections for research subjects and reducing burden, delay, and ambiguity for investigators . Washington (DC) : US Department of Health and Human Services ; 2011 .
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• ↵ Health Research Ethics Authority Regulations under the Health Research Ethics Authority Act, NL R 57/11.
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• ↵ Protections of human subjects, 45 CFR part 46, subpart A (1991). Revised Jan. 15, 2009; effective July 14, 2009.
• ↵ Food and Drugs, 21 CFR parts 50 and 56 (2010). Chapter I: Food and Drug Administration, Department of Health and Human Services. Subchapter A: General. Revised as of Apr. 1, 2011.
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• ↵ EC, Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, [2001] OJ, L 121/34.
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• ↵ Tri-Council policy statement: ethical conduct for research involving humans . Ottawa (ON) : Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada ; 1998 (with 2000, 2002 and 2005 amendments).
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• ↵ Tri-Council policy statement: ethical conduct for research involving humans [article 6.12] . Ottawa (ON) : Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada ; 2010 .
• ↵ Tri-Council policy statement: ethical conduct for research involving humans [article 2.9] . Ottawa (ON) : Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada ; 2010 .
• ↵ Office for Human Research Protections . Policy and guidance . Washington (DC) : US Department of Health and Human Services . Available: www.hhs.gov/ohrp/policy/index.html ( accessed 2011 Dec. 6 ).
• ↵ Tri-Council policy statement: ethical conduct for research involving humans. [table of concordance] . Ottawa (ON) : Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada ; 2010 .
• ↵ World Medical Association . Declaration of Helsinki . Ferney-Voltaire (France) : The Association ; 2008 .
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• ↵ World Medical Association . Declaration of Helsinki [principle 32] . Ferney-Voltaire (France) : The Association ; 2008 .
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• ↵ Protections of human subjects, 45 CFR §46.406. Revised Jan. 15, 2009; effective July 14, 2009.
• ↵ Protections of human subjects, 45 CFR §46.407. Revised Jan. 15, 2009; effective July 14, 2009.

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