From code to policy statement: creating Canadian policy for ethical research involving humans.

Introduction

While the history of U.S. and international research ethics is well documented, little has been written on the formation of Canadian policy and practice. (2) Most commentary on Canadian policy has centred on content, particularly on gaps and shortcomings. (3) This is an unfortunate situation with both practical and intellectual implications. If Canadians are to understand and assess our policies and practices in this area, it is vital to have a sound historical understanding of our situation. Otherwise policy-making is likely to be erratic and ineffective. Intellectually the history of research ethics has become a subject in its own right. Beyond Canada the lack of a good Canadian history adds to the misperception that all national policies are clones of Belmont. It is vital, then, to have a sound intellectual history of key periods in Canadian research ethics policy.

My intention is to provide a sketch of the formation of the 1998 Tri-Council Policy Statement: Ethical Conduct of Research Involving Humans (TCPS). (4) My primary focus will be on process and contextual elements with less emphasis on content issues. This is in part due to space limitations--each of the multiple content issues deserve detailed treatment in their own right. However, I also believe that what is most lacking at this stage is a discussion of process and context.

I have several reasons for focussing on TCPS. The TCPS is now Canada's policy for research ethics in most of the public research sector even though other policies (particularly ICH-GCP) are also relevant. (5) Moreover, issues arising during the TCPS process continue to this day. This history may also have particular relevance as a new formulation of the TCPS is being advanced for fall 2008, (6) and the Sponsors' Table continues its deliberations on research governance. (7)

The formation of any policy for advancing ethical practice is a complex matter requiring a context sensitive balancing of matters of principle with practical considerations. The challenge is to balance these in a realistic and ethical way. Locating our situation historically helps answer the question of whether a good balance has been struck. In this paper I will first address two questions: what were the circumstances that led to the creation of the TCPS and how was the TCPS created? In the final section I will draw some lessons from this history.

This paper draws on my experience as a member and deputy chair of the Tri-Council Working Group on Ethics (TCWG)--the group that drafted the document (the "Code") that led to the TCPS. I draw also on the subsequent work that my colleagues and I did for the Law Commission of Canada (LCC) and on a CIHR-sponsored study on Canadian governance of ethical health research involving humans and a comparison of US and Canadian governance. (8)

As part of the latter, Dr. Fern Brunger (MUN) interviewed key participants (n=9) in the formation of TCPS. I have also drawn on documentation from the TCWG period and afterwards.