Interpretations of the TCPS

Subject	Proposed Establishment of Extra-Jurisdictional REB Subcommittee
Keywords	institutional agreements, REB jurisdiction, REB authority, REB liability, ethics review, regional cooperation, REB subcommittee
TCPS Articles	1.2, 1.3, 1.4, 1.11, 1.14
Date	March 2005

Proposed Establishment of Extra-Jurisdictional REB Subcommittee .pdf

1. This is in response to your query whether an institutional Research Ethics Board (REB) with defined jurisdiction may form a subcommittee to deal with protocols from another institution. Your question raises issues of institutional responsibilities, potential liability, and considerations for making official agreements between institutions for ethical review of research involving humans based on the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS). Your question has been referred to members of the Interagency Advisory Panel on Research Ethics (PRE) for advice.¹

2. As elaborated below, the TCPS has provisions for institutions to authorize their REB, or make special arrangements to create a subcommittee of an REB, to review applications from other institutions for ethical review. This is provided that the two institutions have in place an agreement with certain components to formalize the associated responsibilities. Such an agreement raises potential liability issues that both institutions need to address. While institutional cooperation and alliances merit support, there is a need to pay attention to issues resulting from the creation of multiple REBs within the same institution.

Flexibility of the TCPS – Inter-Institutional Agreements for REB Review

3. Based on TCPS article 1.2, an institution, through its normal process of governance, is mandated to define the jurisdiction of its REB, to define its relationship to other relevant bodies or authorities, and to delegate to its REB the authority to conduct ethical review of research involving humans using the TCPS as a minimum standard. The TCPS provides flexibility to institutions to develop the necessary structure for the review process based on their size, as well as the nature of research conducted within their jurisdiction. It gives large institutions the option of creating multiple REBs; small institutions have options regarding the sharing of the research ethics review process, including the sharing of REBs (TCPS article 1.4[c]) and the sharing of appeal boards (TCPS article 1.11[b]). In 2000, amendments to the TCPS introduced new provisions: ²

Small institutions may wish to explore regional cooperation or alliances, including the sharing of appeal boards. If two institutions decide to use each other’s REB as an appeal board, a formal letter of agreement is required. (TCPS article 1.11[b]). Each institution is accountable for the research carried out in its own jurisdiction or under its auspices. An institution can authorize its REB(s) to accept the review of other REBs constituted under the Tri-Council Policy Statement if it so wishes. This might involve specific agreements between institutions for sharing the work (TCPS section 1.B1, page 1.3).

4. We understand “regional cooperation” generally to mean cooperation between different regions within the same province. An institution may thus authorize its REB to review applications submitted by other institutions if both institutions have an official agreement that includes at least the following components:

• All institutions involved must adopt and adhere to the TCPS, and the cross-institutional agreement must be formalized and documented.
• The decision to allow an REB to recognize decisions made by another institution’s REB must be made at the highest institutional level, by the body that originally defined the jurisdiction of the REB and its relationship to other relevant bodies or authorities (in accordance with TCPS article 1.2).
• Approvals based on cross-institutional agreements should be brought to the attention of the full REB, in the same way as are decisions that are reached by expedited review.
• The principle of accountability requires that, regardless of the review mechanism, the REB continues to be responsible for the ethics of all research involving human subjects that is carried out within its institution or under its auspices (in accordance with TCPS article 1.14).

Potential Liability Issues

5. With this responsibility comes accountability and potential liability. The TCPS specifies that “each institution is accountable for the research carried out in its own jurisdiction or under its auspices” (TCPS section 1.B1 [page 1.3]). It is advisable for both institutions to consult their institutional legal counsel to address potential liability issues resulting from the extension, or delegation, of reviews of institutional REB to other jurisdictions—a step that we understand you plan to pursue. In consulting with your legal counsel, we suggest that you take the above-listed elements into consideration.

Benefits and Considerations in Creating an REB Subcommittee

6. Institutional alliances for the review of research involving humans, such as in creating a subcommittee of an REB at a well-established institution to accommodate reviews of another with a mix of expertise from both institutions, contributes to transfer of knowledge and develops expertise at both institutions. This is a clear demonstration of institutional cooperation that merits support.

7. At the same time, your institution may want to consider issues raised in the TCPS about multiplicity of REBs within the same institution. While TCPS article 1.4 allows for the creation of more than one REB within the same institution as long as the jurisdiction, authority, responsibility and reporting mechanisms are clear and approved of, the policy statement is also clear that the creation of multiple REBs with small workloads within the same institution should be avoided. While we cannot assess how the additional applications from the other jurisdiction may affect your REB workload, your institution may wish to consider if these applications warrant the creation of a subcommittee of your REB. If your main REB can handle the review of additional applications, and the issue is one of ensuring that specific expertise is available, your institution may wish to consider using options outlined in the commentary to TCPS article 1.3:

REBs should husband their resources and expertise prudently. For example, in the event that the REB is reviewing a project that requires particular community or research subject representation or a project that requires specific expertise not available from its regular members, the REB Chair should nominate appropriate ad hoc members for the duration of the review. Should this occur regularly, the membership of the REB should be modified.

8. If both institutions—yours and the requesting institution—decide that it is necessary to create an additional REB (albeit a subcommittee), they should ensure that the jurisdiction of the REB is clearly defined by the normal processes of governance within the institutions. Furthermore, based on TCPS article 1.4(b), “a mechanism should be established to coordinate the practices of all REBs within the institution.”

We hope that you find this information helpful to your human research ethics deliberations on the TCPS.

Sincerely,

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

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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.
2. See /eng/policy-politique/tcps-eptc/update2-miseajour2/