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Past Interpretations of the TCPS

Subject REB Legal Disclaimers and Inter-University Research Ethics Responsibilities
Keywords disclaimer, liability, REB responsibilities, legal, ethics approval/review
TCPS Articles 1.3, 1.13, 1.14, 2.4
Date May 2003

PDF REB Legal Disclaimers and Inter-University Research Ethics Responsibilities_May 2003.pdf

1. Thank you for your inquiries concerning legal disclaimers in ethics approval letters.

2. You ask whether a legal disclaimer should appear in every letter of ethics approval from a Research Ethics Board (REB) if it appears in some letters of approval, and you ask if there is a standard practice for this across Canada. In a follow-up e-mail, you inquire about the REB approval of, and its responsibility regarding, research conducted in an unaffiliated organization with the REB's home institution. Your inquiry has been referred to the Interagency Advisory Panel on Research Ethics (PRE) for advice1.

Inter-University Responsibilities

3. Under the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) of 1998 (with 2000, 2002 amendments), it is clear that a university is responsible for the research that is being undertaken at that institution through its affiliated researchers, regardless of their location.

An institution is responsible for the ethical conduct of research undertaken by its faculty, staff or students regardless of the location where the research is conducted. (TCPS article 1.14)

Legal Disclaimers

4. You indicate that in reviewing proposed research, your university REB includes so-called legal disclaimers in some, but not all, of its letters of approval to researchers. The disclaimer is apparently intended to make explicit the limited scope of REB review to issues of research ethics, and to indicate that the REB is not rendering legal opinions on research that might involve "legal complications." The REB practice of including such disclaimers in some letters, and not others has been questioned.

5. Your question is not addressed by Section 1 of the TCPS, which deals with general ethical requirements of REB review. It is a question with potentially important legal implications. It is beyond PRE's mandate to provide legal advice; our role is to provide guidance by responding to interpretations on the TCPS.

6. In this respect, the requirements and recommendations on REB membership in article 1.3 of the TCPS are relevant. The inclusion in REB membership of a person knowledgeable in law is intended to help the REB identify legal issues and requirements in research ethics review. In some instances, the legal issues identified by the REB will necessitate further scrutiny and even formal legal advice by the legal counsel to the institution. "Legal liability" is a separate issue for institutions to handle through separate mechanisms. Researchers—like other employees—need to understand their potential for liability and for exposing the institution to liability in such areas as discrimination, workplace accidents and harm to research participants. But this analysis or information should come through channels other than the REB.

7. While we have not conducted research on the question, we are not aware of any standard across the country concerning the use of disclaimers in approval letters. We strongly recommend that you discuss these issues with your institution's legal advisor. In this discussion, we foresee at least four options regarding disclaimers on REB approval letters.

8. One is to carry no disclaimers. A second is to include a disclaimer on all letters, regardless of whether the issue is moot or relevant to some research. A third option might be to institute a generic notice in your institutional ethics policy and procedures—that REB letters of approvals are for ethical review, and do not constitute a legal endorsement of the research—and post it on your Web site.

9. Please note that such disclaimers should not be intended to diminish the continuing duties of REBs to maintain an ongoing review of research (TCPS, article 1.13). Nor should they be intended to, or effectively work to, undermine the rights of participants in research. As article 2.4 of the TCPS indicates, the "consent of the participants shall not be conditional upon, or include any statement to the effect that, by consenting, subjects waive any legal rights." A fourth option could be to start your approval letters with a positive statement of what the role of the REB is and what their decision is; that is, the REB has reviewed the proposal in relation to good ethical practice, etc. We tend to favour this last option. It is our opinion that legal disclaimers do not belong in REB decision letters.

We hope you will find this information helpful to your human research ethics deliberations.

Sincerely,

Secretariat on Research Ethics
on behalf of
The Interagency Advisory Panel on Research Ethics
pre.ethics.gc.ca


  1. PRE provides advice on such interpretation questions to assist the research ethics community in applying the TCPS to the ethical issues it faces. While responses to TCPS interpretation questions may address ethical dimensions of legal issues in research ethics, PRE does not provide legal advice. Nor does it act as an appeal body on REB or institutional decisions.