To assist investigators in meeting their responsibilities for the ethical conduct of research, for the protection of human research participants and for ensuring data integrity, investigators and study team members are required to complete appropriate training. Regulators, study sponsors, institutions and REBs often have their own specific training requirements, which depending on the type of research, may include training in Good Clinical Practices (GCPs), in privacy legislation, in other applicable guidelines and regulations in Canada and in the U.S. and in the responsible conduct of research. Some examples and links are provided below.
- The 2nd edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2) is a Canadian guideline for the ethical conduct of research involving humans and/or human biological materials. The online tutorial TCPS 2: CORE (Course on Research Ethics) is an introduction to the TCPS2. www.pre.ethics.gc.ca/eng/education/tutorial-didacticiel/;
- The Interagency Advisory Panel on Research Ethics (PRE or the Panel) manages the ethics policy of Canada’s research agencies. The policy is called the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, or TCPS 2. PRE has developed educational resources to assist people who are participating in research or are considering joining a research study. A brochure “Taking Part in Research” provides basic information about participation in research. “Frequently Asked Questions (FAQs) for Participants” provides more specific information on topics such as privacy, risks and benefits, and consent. These materials provide information about how the ethics guidance in the TCPS2 provides protection for research participants.
- The Canadian Network of Networks (N2) is a not-for-profit organization that is working together with the research community to promote excellence in clinical trials in Canada. N2 has partnered with the CITI program at the University of Miami to provide its members with a access to variety of research related training modules to meet the educational needs of the Canadian researchers. N2 has over 100 member organizations representing thousands of clinical research professionals. Check with your organization to find out if you already are a member. N2 Online Education Program Table of Contents;
- N2 also provides member study sites with a national set of SOPs including SOPs for investigator initiated studies. N2 SOPs Table of Contents;
- The Canadian Association of Research Ethics Board (CAREB/ACCER) partnered with N2 to create a national set of SOPs for REBs that reviews health sciences research. The CAREB/N2 National REB SOPs are available publicly. Adoption of the REB SOPs will facilitate standardization across REBs in Canada. N2 CAREB REB SOPs Table of Contents.