Research Ethics Board
The Ottawa Hospital Rehabilitation Centre Research Ethics Board (TOHRC REB) is in the process of merging with the Ottawa Hospital Research Ethics Board (OHREB). The merger will streamline the review process while ensuring that the Rehabilitation Centre’s high standard for research is maintained. It will also allow researchers to track the status of their applications in real-time, using the Ottawa Health Research Institute’s Integrated Research Information System (IRIS). The merger will involve replacing TOHRC REB with a Research Advisory Committee, which will review applications and recommend either expedited review or review by the full board of the OHREB. Prior to the Advisory Committee review, projects will still be submitted for scientific peer review and administrative review by the departments that may be impacted by the research. The Advisory Committee will formally replace TOHRC REB on April 1, 2009. |
Review Procedure
For details on how to obtain REB approval, and other review question, please contact Christina DeCurtis .
Forms and Guidelines for Researchers
The following documents are in MS Word format. If you require paper copies, please contact Christina DeCurtis at (613) 737-7350 ext. 75321, or email cdecurtis@ottawahospital.on.ca.
- COREB Common Application Form
- COREB Application Guidelines
- IRRD Impact Sheet
- Guideline for obtaining informed consent
- Informed consent form (sample)
Selected links to web resources
Research Ethics Boards at Canadian hospitals and universities
- Ottawa Health Research Institute (OHRI), The Ottawa Hospital:
- Ottawa Hospital Research Ethics Board (OHREB)
- Ethics Review of Research Involving Human Subjects
- University of Ottawa: Research Ethics Boards
- McGill University: Biomedical Ethics Unit
- University of Toronto: Joint Centre for Bioethics
- Queen's University, Office of Research Services:
- General Research Ethics Board (GREB), for research falling outside biomedical disciplines.
- Health Sciences Research Ethics Board (REB): Human Ethics Procedural Guidelines
- University of Western Ontario, Office of Research Ethics. This has links to the Health Sciences Research Ethics Board (HSREB) and the Non-Medical Research Ethics Board (NMREB)
- Simon Fraser University: Office of Research Ethics
- The Hospital for Sick Children, Toronto: Research Ethics Board
- McMaster University, Office of Research Services, Information for Members of the Ethics Review Board (MREB) and Student Committees (SRECs): Introduction, On-line Tutorial, Sample Cases, and Handbook.
- University of Calgary: Research Ethics
- University of Alberta: Health Research Ethics Board, University of Alberta Standards for the Protection of Human Research Participants
- University of British Columbia, Office of Research, Ethical Reviews: The two links below are elegant. On each page, a single table provides links to all of the documents relevant to researchers, including all of the application/report forms and their guidelines, along with their descriptions and revision dates. A sidebar menu provides links to other information such as deadlines, fees and contacts.
- Clinical Research Ethics Board (CREB): on-line forms. This board reviews research involving clinical interventions such as the testing of drugs, medical devices, rehabilitation exercise programs, and/or the analysis of clinical data obtained from medical records or studies of a clinical nature involving linkage of data from existing databases. For most of the documents on this page the on-line forms are available in a choice of two formats, MS Word or Adobe PDF.
- Behavioural Research Ethics Board (BREB): on-line forms. Behavioural projects may involve asking subjects to participate in studies that use, for example, questionnaires, interviews, focus groups, observation, data linkage, secondary use of data, deception, testing, video and audio taping.
- University of New Brunswick, Office of Research Services: University Policy on Research Involving Humans
Ethics links at other Canadian sites:
- Canadian Institutes of Health Research (CIHR): Ethics, and CIHR Privacy Best Practice Guidelines. Note also their Useful Links
- Natural Sciences and Engineering Research Council (NSERC): Res ponsible Conduct in Research and Scholarship
- Social Sciences and Humanities Research Council (SSHRC): Integrity in Research and Scholarship
- National Research Council (NRC): http://www.nrc-cnrc.gc.ca/randd/ethics/human_e.html
- Interagency Advisory Panel on Research Ethics (PRE): Selected Human Research Ethics
Norms, Organizations & Resources
- PRE is a body of external experts established in November 2001 by Canada's three Federal Granting Agencies – CIHR (formerly MRC, the Medical Research Council of Canada), NSERC and SSHRC – to support the development and evolution of their joint research ethics policy, the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS).
- This link provides an extensive list of web links to organizations and guidelines related to the ethics of research involving human subjects. The list includes not only federal, provincial, and territorial links within Canada but also links to other nations and international organizations.
- National Council on Ethics in Human Research (NCEHR): Established by the Royal College of Physicians and Surgeons of Canada in 1995 at the request of MRC and with funding from MRC and Health Canada, "to serve as a forum for discussion and collaboration of institutional research ethics"; detailed Terms of Reference are given on their web page.
- The Personal Information Protection and Electronic Documents Act (PIPEDA): federal legislation to protect an individual’s privacy in the electronic age.
- PHIPA, the Personal Health Information Protection Act or Ontario Bill 31, came into effect on November 1st 2004. It is “An Act to enact and amend various Acts with respect to the protection of health information”. Section 44 of the Act deals specifically with the disclosure of personal health information for medical research. In the particular area of personal health information, PHIPA will probably override the federal privacy legislation, PIPEDA.
- The Ethics Web, EthicsWeb.ca: This is an excellent portal to dozens of internet resources on research ethics, most with a Canadian slant. The Ethics Web is run by philosopher-ethicist Chris MacDonald.
- Canadian Medical Association Journal (CMAJ) bioethics series "Bioethics for Clinicians": Chapters in this series include: Consent, Disclosure, Capacity, Voluntariness, Substitute decision-making, Advance care planning, Truth telling, Confidentiality, Involving children in medical decisions, Research ethics, Euthanasia and assisted suicide, Ethical dilemmas that arise in the care of pregnant women (rethinking "maternal-fetal conflicts"), Resource allocation, Ethics and genetics in medicine, Quality end-of-life care, Dealing with demands for inappropriate treatment, Conflict of interest in research, education and patient care. Articles are available for downloading in PDF and full-text versions.
- Other CMAJ collections include Competing interests, conflicts of interest, Confidentiality, End-of-life decisions, Informed consent, and Other ethics. Again, these articles are available for downloading.
- The W. Maurice Young Centre for Applied Ethics, University of British Columbia: Links to applied ethics resources on the web, the Association for Moral Education, the Association for Practical and Professional Ethics, the Bioethics and Society Research Register, the Canadian Applied Ethics Research Nets, the Center for Clinical Bioethics, the Ethics Officer Association, the Genetics and Ethics web page, the Practical Ethics Center of the University of Montana, and a UBC resource "Starting points in applied ethics".
- Canadian Psychological Association: CPA Code of Ethics and Code Comparison (the CPA Code of Ethics compared with the APA and ASPPB codes).
- Commission de l'éthique de la Science et de la technologie (CEST), established by the Gouvernement du Québec to foster reflection and organize debate on the ethical issues inherent in science and technology.
American sites:
- Office for Human Research Protections (OHRP), U.S. Dept. of Health and Human Services (DHHS): IRB Guidebook
- DHSS Code of Federal Regulations, Title 45, Part 46 (Protection of Human Subjects), Subpart A: Federal Policy for the Protection of Human Subjects: Otherwise known as "The Common Rule", this document provides comprehensive definitions, guidelines on the membership and operations of an Institutional Review Board (IRB), special policies for vulnerable populations, guidelines for conducting expedited reviews etc.
- The BelmontReport, U.S. Department of Health, Education, and Welfare, 1979: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
- The President's Council on Bioethics: Ethics bookshelf. Miscellaneous readings in bioethics, including history, philosophy, literature and religious meditation.
- U.S. Food and Drug Administration (FDA): Guidance for Institutional Review Boards and Clinical Investigators. Detailed, comprehensive guidelines on all aspects of clinical investigations.
- U.S. National Institutes of Health (NIH) information on clinical trials: ClinicalTrials.gov. This is an excellent review of clinical trials, touching on some ethical issues. For an up-to-date list of ongoing trials, click on “Listings” in the top menu.
- FDA guidelines on conflict of interest: Guidance: financial disclosure by clinical investigators
- NIH guidelines on conflict of interest: Financial conflicts of interest and research objectivity: issues for investigators and institutional review boards
- American Psychological Association(APA): Ethics Code (downloadable in HTML, PDF and MS Word formats)
Online training courses:
- Introductory tutorial for the Tri-Council Policy Statement: Ethical conduct for research involving humans – a 2-hour tutorial developed by the Interagency Advisory Panel on Research Ethics (PRE).
- Tutorial in Research Ethics – a tutorial from the Ministry of Health and Social Services (Ministère de la Santé et des Services sociaux, or MSSS); it focuses on those issues and texts that are of particular concern in the Québec context. For the French version, click on “Français” in the upper right corner.
- Research Ethics Tutorial at McMaster University. See also Sample Cases – case studies cross-linked to the relevant sections of the Tri-Council Policy Statement.
- Human Participant Protections Education for Research Teams – a 2-hour tutorial from the U.S. National Cancer Institute
- IRB Computer-Based Training – a computer-based training course for NIH IRB members, about their roles and responsibilities.
- Ethical Issues in International Health Research From Harvard University , this course includes sections on principles of research ethics, informed consent, responsibility to the study community, mechanisms of approval, and the role of funders. It also includes useful case studies and links to relevant reading lists and websites.
Other international sites:
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, mercifully abbreviated "ICH". Industry-sponsored clinical trials are required to follow the guidelines given in these documents:
- The Common Technical Document for the Registration of Pharmaceuticals for Human Use. Efficacy - M4E. Clinical Overview and Clinical Summary of Module 2. Module 5: Clinical Study Reports.
- ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice (E6)
- World Medical Association (WMA) - Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects
- The Council for International Organizations of Medical Sciences (CIOMS) - an international non-governmental organization affiliated with the World Health Organization (WHO):
- International Ethical Guidelines for Biomedical Research Involving Human Subjects. These Guidelines include ethical justification and scientific validity of research; ethical review; informed consent; vulnerability of individuals, groups, communities and populations; women as research subjects; equity regarding burdens and benefits; choice of control in clinical trials; confidentiality; compensation for injury; strengthening of national or local capacity for ethical review; and obligations of sponsors to provide health-care services.
- Medical Research Council (MRC, U.K.) Guidelines for Good Clinical Practice in Clinical Trials. A common set of guidelines for clinical trials that are funded by public and charity sectors in the U.K.; equivalent of the ICH guidelines that apply to industry-funded clinical trials. See also: MRC Ethics Series [downloadable PDF documents]
- The Danish Council of Ethics provides advice to the Danish Parliament and raises public debate about ethical problems in the field of biomedicine. The International Bioethics Committee (IBC) is a body of 36 independent experts appointed by the Director-General of UNESCO. The committee follows progress in the life sciences and its applications in order to ensure respect for human dignity and freedom. It was created in 1993. The IBC provides the only global forum for in-depth bioethical reflection by exposing the issues at stake. It does not pass judgment on one position or another. Instead, it is up to each country, particularly lawmakers, to reflect societal choices within the framework of national legislation and to decide between the different positions.
- Bioethics Today is a web-based bioethics resource for the United Kingdom, developed by Sheffield, Lancaster and Oxford Universities. The site provides resources on many ethical issues including those related to humans (bioethics, consent, medical ethics, patients' rights, public health); animals (animal experimentation, transgenic animals, xenotransplantation); biotechnology (bioterrorism, tissue engineering); cloning; environment; genetics; GM issues (GM food, biodiversity); human disorders (Alzheimer's, CJD); medical developments (clinical trials, developing world); medical procedures (abortion, euthanasia); reproduction (embryology, designer babies, IVF); stem cells.