Archived in January 2013 Schedule 2: Ethics Review of Research Involving Humans
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The Agencies developed, approved and implemented a joint policy statement to promote the ethical conduct of research involving human subjects – the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS), the official version of which can be found at http://pre.ethics.gc.ca.
The Agencies will only fund researchers, Institutions or partnering organizations that adhere to the ethical principles and articles of the TCPS. In addition, CIHR and NSERC will only fund human pluripotent stem cells research that adheres to CIHR’s recently updated guidelines ( www.cihr-irsc.gc.ca/e/15255.html).
In addition to the TCPS, the ethics review of research involving humans may, where appropriate, be subject to other legislation and policies.
The Agencies encourage investigators to become involved in the work of their Institutional Research Ethics Board(s), and encourage Institutions to recognize this work as a valuable service to the research community.
2.1 Responsibilities of the Institution
The Institution agrees to:
- develop an institutional human research ethics policy/policies and procedures or institutional guidelines and procedures to review the ethics of research involving humans that, as a minimum, meets the requirements set out in the TCPS;
- adhere to current guidelines on human pluripotent stem cell research;
- apply the Institutional policy or guidelines to all research involving humans that is conducted under the auspices or jurisdiction of the Institution;
- promote education for, and provide training opportunities to, members of the Institution's community in the area of ethics of research involving humans;
- ensure that Researchers, Administrators and Research Ethics Boards (REBs) are aware of all applicable policies, regulations and guidelines. In some cases, it may be necessary for Institutions or REBs to have recourse to specific expertise to identify legal and other issues in the ethics review process;
- release research funds to researchers only after an Institutional REB has approved the research. This review can be a formal review of the detailed protocol and the related continuing review process, or the review can be a two-stage process if the activities involving humans will only take place in a future fiscal year and the methodology still needs to be determined. In the latter case, funds may be released, on a pro-rated basis, following the "in principle" approval of the research protocol for activities up to the start of the work involving humans. In any case, the research must maintain REB approval for the duration of the project;
- inform the Agency of a delay, and explain the reason for the delay, if REB approval is not obtained within six months of the award date, in which case the Agency may consider that the condition of award has not been fulfilled and reallocate the funds;
- provide its REBs with training opportunities and appropriate financial and administrative independence to fulfil their duties; and
- investigate allegations of individual non-compliance in accordance with the institutions’ policies and procedures; and by taking appropriate follow-up measures, including reporting to the Agency, as required.
2.2 Responsibilities of the Federal Granting Agencies
Each Agency agrees to:
- review the relevant policies of Institutions that wish to be declared eligible to receive Agency funding to ensure that these policies meet TCPS requirements;
- review and update the TCPS on a regular basis in consultation with the broader community, and inform researchers and Institutions of any changes made to the TCPS;
- provide guidance to Institutions and REB members on the interpretation of the TCPS;
- act as a resource for Institutions and REBs in their promotion and application of ethical standards in research involving humans; and
- refer to Institutions, for their action, and with supporting documentation, any allegations of non-compliance against Researchers.
The Agencies reserve the right to request that Institutions report periodically on the status of their ethics review process.
3. Good Practices
In the process of commenting on individual institutional ethics policies, the Federal Granting Agencies have identified examples of "good practices." These are posted on our Web site.
4. Resolution of Issues of Non-Compliance
In the event that circumstances arise in which an Institution appears to be, or is found to be, in non-compliance with Agency policy under this Schedule, the Agency will follow the procedures described in Schedule 8, starting with an entry level 2 or 3, depending on the circumstances.
5. Transfer of Funds
When a Primary Institution transfers grant or award funds to a Secondary Institution for the purpose of research involving humans, Schedule 9 applies.