19 September 2002

Dr. Clive Seligman         safs@niagara.com
President
Society for Academic Freedom & Scholarship
1673 Richmond Street, Number 344
London, Ontario
N6G 2N3

Re: PRE’s 1st Position Paper on National Governance Issues in Human Research Ethics

Dear Dr. Seligman:

Thank you for your letter of 29 July 2002 on behalf of the Society for Academic Freedom and Scholarship.

We are pleased that you are addressing some of the national governance issues raised by the Interagency Advisory Panel on Research Ethics (PRE) position paper, Process and Principles for Developing a Canadian Governance System for the Ethical Conduct of Research involving Humans (Apr. 2002).1 We wrote the position paper precisely to advance debate on the basic principles and processes that should guide the development of a national governance system.

While we thus welcome your comments, it would seem that most of them should be directed to the authors of the accreditation document that you discuss in your letter. Indeed, your letter devotes most of its content to the accreditation model outlined in a March 2002 report entitled, Final Report of the Task Force to Study Models of Accreditation2 by the National Council on Ethics in Human Research (NCEHR). You offer a number of observations on accrediting research ethics committees, to which the authors (NCEHR) may wish to respond.

Please understand, therefore, that PRE has not authored, endorsed or participated in the preparation of NCEHRs accreditation document. The letter inaccurately associates PRE with the NCEHR accreditation document. However, PRE and NCEHR are distinct, separate entities, as are our documents. NCEHR is a non-governmental organization involved in research ethics. PRE is a recently created interdisciplinary governmental advisory committee mandated by the three federal granting Agencies -- CIHR, NSERC, SSHRC -- to advise on the updating and revision of the Tri-Council Policy Statement Ethical Conduct for Research
Involving Human Subjects (TCPS) of 1998. As the PRE position paper states, the granting Agencies have further mandated PRE to participate in national discussion on the development of an oversight system for the ethics of research involving humans. The PRE position paper is one of its first contributions to that discussion.

I should also emphasize that PRE has not formalized a position on the accreditation of REBs.  Accreditation models warrant the kind of debate and reflection that you and NCEHR have begun to devote to it. PRE’s position paper does not, however, address the merits of accreditation. Rather, it notes the accreditation proposal in passing, and calls more broadly for good process and basic principles like ‘public participation’ and ‘inclusive and critical dialogue’ for building a coherent governance system.

If you have not already done so, we encourage you to share your views with Health Canada. As you may know, it has recently been active in consulting on national oversight for the governance of research involving humans. Following regional consultations earlier this year, Health Canada indicated that it would likely create an Advisory Committee on a National System of Governance for Research Involving Humans. PRE’s position paper had called for the creation of a properly-constituted national task force on such governance issues. We are pleased that some steps have since been taken in this regard.

Finally, so as to further an open and informed dialogue, we shall forward our response to your letter to those institutions that we know to have received your correspondence. To complement this, we would make a simple request: that you also take appropriate steps to inform the many recipients of your letter of our response. We have no objection to your posting our letter next to yours on your website. Such measures will help to ensure that the research ethics committee has a more accurate and clear sense of the positions, roles, and responsibilities of the diverse players at work on national research ethics governance issues.

As we welcome your comments into this evolving national discussion, we also hope this clarifies the purpose and content of PRE’s position paper.

____________________________________
1 www.nserc.ca/programs/ethics/english/pre_e.htm
2 www.ncehr-cnerh.org/english/mstr_frm.html
 

Sincerely,

Howard Brunt, Chair
Interagency Advisory Panel on Research Ethics (PRE)
secretariat@pre.ethics.gc.ca

CC:  T. Flaherty, Ethics Office, Health Policy and Communications, Health Canada
        K. Davey, National Council on Ethics in Human Research (NCEHR)
        Presidents, CIHR, NSERC, SSHRC
 
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