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Governance

1. Which institutional body should establish the REB(s)? (August 2011)

TCPS 2 requires that the highest governing body of the institution establish the REB (or REBs), define an appropriate reporting relationship with the REB (or REBs), and ensure that REBs have the necessary financial and administrative resources to fulfil their duties. TCPS 2 does not specify which body within an institution meets this description, as the governance structures of institutions vary. However, in the application to Article 6.2, TCPS 2 provides a range of possibilities as to who could fill this role, with a focus on the one that holds the highest administrative rather than academic responsibility. Institutions determine what is the highest governing authority based on their individual governance structures and taking into consideration whether other responsibilities of those bodies may conflict with the responsibility for establishing an REB.

2. What is the rationale for not permitting external legal counsel from serving on an REB of an institution for which the counsel provides service? (March 2012)

The rationale for excluding external legal counsel from serving on a research ethics board (REB) of the institution, regardless of the type of legal advice he/she provides to the institution, is the same rationale for excluding in-house legal counsel from serving on the REB. There is a danger that the lawyer’s role as a legal adviser and as an REB member will become confused. The external legal counsel, even if retained by the institution only on a case-by-case basis is not immune from the pressures of being identified too closely with the institution’s interests – whether its financial interest in having research go forward or its interest in protecting itself from potential liability. This presents a potential source of conflicts of interest that may undermine the independence and credibility of the REB.

For a research ethics board (REB) to function optimally, it is important that its members, including the member knowledgeable in law, understand the role of the REB as described in Article 6.3, as well as the specific role of the member knowledgeable in law “to alert REBs to legal issues and their implications (e.g. privacy issues), not to provide formal legal opinions or serve as legal counsel for the REB.” (Application of Article 6.4)

3. Can an external legal counsel, who is not currently providing legal services for the institution, serve on that institution’s REB? (March 2012)

While not ideal, it is possible for an external legal counsel to serve as the member knowledgeable in law on the research ethics board (REB) when he/she is no longer providing legal services for the institution. (See application of Article 6.4 for a description of the role of the member knowledgeable in law). In making a decision to appoint a former external legal counsel to the REB, the institution should take into account the following considerations:

  • The amount of time lapsed since the external legal counsel last provided legal services for the institution. 
  • Whether other alternatives are available to the REB for obtaining the same knowledge/expertise.
  • Whether the legal firm to which the external legal counsel is affiliated has an active business relation with the institution (that is, whether other lawyers from that counsel’s firm are providing legal services to the institution).
  • Whether the external legal counsel has an interest in getting future business from that institution.

It is prudent to keep a written record of steps taken to reach the decision to appoint this member.

4. Where an individual working under the auspices of an institution is involved in research solely as a service provider to researchers in other institutions, should the REB of that institution review the research? (March 2012)

The individual in question would not be required to submit the research for research ethics board (REB) review within his/her institution so long as

  • the individual is not a member of the research team,  
  • he/she does not benefit from authorship on publications, and
  • his/her contribution is limited in nature to a service that does not in and of itself constitute research involving humans as defined in TCPS 2 (see application of Article 2.1).

If the service provider meets the above criteria, or falls within an exception set out in his/her institution’s policy, it would be sufficient for the individual to get confirmation from the principal investigator (PI) that this research has been reviewed by the PI's institutional REB so long as it is compliant with TCPS 2.  Alternatively, the individual can make the provision of his/her services conditional on receiving evidence of an REB review and approval in accordance with TCPS 2.

5. If a researcher obtains REB approval at his/her own institution to gather data from participants who are members of other institutions, is it necessary to obtain REB approval at each of the other institutions that employ the participating members? (July 2012)

The issue to consider is whether the research is being conducted under the jurisdiction or auspices of the other institutions as well, necessitating REB review at the other institutions.  The determining factors include (1) the extent and nature of the other institutions’ involvement, and (2) whether it is necessary for the researcher to collaborate with the other institutions in order to carry out the research.

If the researcher is using the resources of other institutions to recruit members of the institution – and those resources are not publicly available – then the research would be under the auspices of these other institutions. It would require ethics review by REBs of the other institutions in addition to the researcher’s REB (see Article 8.3).  The level of REB review may be adjusted in accordance with a proportionate approach to research ethics review (see Article 6.12).

Conversely, if the contact information of members of those institutions is available through other means, for example names of department heads are publicly available on websites or through some disciplinary association, then REB review at the researcher’s institution would suffice.

Note that research that involves members of the institution for the purposes of critical inquiry does not require the permission of the institution (Article 3.6).

6. Should institutions make REB minutes publicly available? (July 2012)

There is no general requirement in TCPS 2 regarding public accessibility of REB minutes. What TCPS 2 advises in the application of Article 6.17 is that files, minutes and other relevant documentation must be accessible to the authorized representatives of the institution, researchers, sponsors and funders under certain circumstances "when necessary to assist internal and external audits, or research monitoring, and to facilitate reconsideration or appeals." (Application of Article 6.17

While not specific to public sharing of minutes, it should be noted that guidance in TCPS 2 encourages institutions' transparency to demonstrate their accountability while maintaining researchers' confidentiality (see Application of Article 6.1).

 

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