C-25
Fraser Health Authority Research Ethics Board
BRIEFING NOTE
Date: January 30, 2017
Item
Submission to the Panel on Research Ethics
Re: Changes to the 2nd edition of the Tri-Council Policy Statement:
Ethical Conduct for Research Involving Humans (TCPS 2).
Submitted By
Susan Chunick, Director
Department of Evaluation and Research Services on behalf of the
FHREB
The FHREB thanks the Panel for the opportunity to provide comment on the proposed revisions.
Our concerns are as described below.
1. Recruitment: CHAPTER 3 261 End of Article 3.1 Application 262
Article: Page 7: Line 276: Recruitment may involve several stages of contact and screening
that precede the seeking of consent to participate in research.
Comment: The Fraser Health Authority Research Ethics Board has always subscribed to the
view that ‘screening’ requires consent. With respect to research involving participants, in
particular patients, when data about the patient participant is reviewed and/or collected during
screening, consent of the prospective participant is always required beforehand.
Recommendation: Perhaps a word other than ‘screening’ could be used as it is permissible for
a physician researcher to note that his/her patient might meet criteria for a clinical trial during a
regular office visit. The patient is then asked if they would like to learn more about the study
from the research coordinator. It is only after consent is obtained by the research coordinator
that data used for screening the participant either in or out can then be obtained for that
purpose.
1. Sponsor-Researcher Contracts: CHAPTER 6 660 End of Chapter 661
Articles: 662 Section E. Review of Sponsor-Researcher Contracts
RE: Page 16: 681 “require that any ethical concerns arising in the review be referred to the
REB as an integral part of the research ethics review process;”
RE: Page 16: 701 – 706 “Normally, review of the ethical aspects of researcher-sponsor
contract clauses related to confidentiality, publication and access to data is the responsibility of
the REB. This review may be delegated to an individual or group with the appropriate expertise.
In institutions where contracts are reviewed by an authority other than the REB, the review
C-25
Senior Clinical Leadership Committee Briefing Note
Page 2 of 2
must conform to the mandate and purposes of REB review and involve consultation with the
REB.”
Comment: Article 681 is acceptable if it means that a contracts officer should bring to the
attention of their institutional REB any issues wherein there is some uncertainty about the
ethical requirements of the study, given the terms of the contract.
That being said, the application as described primarily in Article 701-706 is not acceptable for
the following reasons:
1.
The institution is a party/signatory to the contract and as such does not delegate legal
responsibilities to a volunteer REB board that does not have the expertise needed to
conduct full reviews of contracts. Note that the legal representative is not permitted to
give legal advice.
2.
The REB does not have authority over access to data that is held by the institution. The
REB does approve the collection of specific variables/data in order to answer the
research question, but has no authority to address questions of access to data held in
electronic or paper medical health records, or the security provisions required for
transmission of data outside of the institution. This is the remit, usually, of a
Privacy/Data Security department.
3.
While our institutional research policy does not permit secret research, there may be a
valid business reason for the sponsor whose research is proprietary to delay publication.
The institution can however ensure that contracts via contract offices meet minimum
requirements so that there are no restrictive clauses that prevent transmission of new
information to patients.
In conclusion, it is more appropriate for the institution to have the responsibility for contract
review and that minimum requirements be addressed in institutional policy which are then
implemented by trained staff or contracted out to a third party with legal expertise. It is
doubtful that the institution’s insurance would support review of legal contracts by a REB if a
company were to sue for, for example, breach of contract. In addition for practical purposes, it
would become extremely difficult to recruit REB members if their role was to conduct legal
review.