Examining and understanding the need for Canadian Research Ethics Board (REB) Member Standardized Education: governance views from the field.

• Author: Sampson, Heather

Introduction

The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS), was rolled out in 1998. This unique Canadian research guidance document is updated regularly and posts the following instructions: "Notice: Effective 2003, the electronic version of the TCPS constitutes the official version of the policy document." (1) This dynamic document was joined, in 2004, by the Panel for Research Ethics (PRE) Tutorial that includes the following statement: "The Tutorial for the TCPS helps to educate the research community about the TCPS. It also facilitates the use, interpretation and implementation of the TCPS." (2) In our view, the Tutorial relates more to principles than the practice covered in the first five chapters of the TCPS. As of October 31st 2008, 35,399 individuals had completed the tutorial since its introduction. (3) These two living documents frame and inform the Research Ethics Board (REB) decisionmaking process. However, given that there is no formal governance or monitoring of Canadian REBs, one can hypothesize that variable standards of what constitutes human research ethics review may exist. (4) Since there is no accreditation or formal national oversight system, it is not surprising that there is also no standardized or national REB member orientation or continuingeducation program.

This paper offers some background and examples of challenges to Canadian REB members' baseline knowledge and education in an attempt to shed light on various learning needs. Recommendations made in another national socialized health care system that may contribute to governance in Canadian research ethics are then examined.

Ethics Review

REB membership responsibility is evolving, and clinical research is a dynamic process that is becoming more elaborate. The protocol approval process and monitoring responsibilities take on greater complexity as, for example, we are faced with the advent of vaccine and stem cell research, gene transfer protocols, and social science research that investigates such matters as the need for and barriers to teen sex education. These protocols are examples of the complex human research projects that are presented to REB members who may not have the necessary innate or experiential knowledge to review appropriately and/or may have inherent conflicts of interest. Although we may have learned some prudent behaviour from Jesse Gelsinger, who tragically died as a direct result of participating in a gene transfer study, nothing yet has transformed the guidelines to regulations. While Canadian research organizations have formal conflicts of interest guidelines and the TCPS provides guidance on conflicts of interest among REB members, Canadian REB members do not have clear instructions for dealing with perceived or real conflicts of interest in clinical research. (5)

For REB members charged with decision-making aimed ultimately at safeguarding participants in clinical research, there are three main documents that drive the Canadian perspective of REB review in addition to the Declaration of Helsinki and International Committee on Harmonization (ICH) guidelines: the TCPS; the Therapeutic Products Directorate Guidelines (which utilize the ICH Guidelines, per Health Canada); and the Division 5 Regulations of the Food and Drugs Act. The only ones having any force of law are the Canadian Food and Drugs Act Regulations. (6) Within these guidelines, including Division 5, there are few guiding principles as to the criteria that REBs should follow in evaluating research protocols, other than broad ethical guidelines, and they are really aimed at the institution conducting the research versus the REB review process. This is somewhat confounding when sorting through REB responsibilities.

The TCPS and ICH guideline policies have commonalties (7) as well as areas of disparity, such as the appropriate use of placebos in the conduct of placebo-controlled trials. (8) The ICH guideline is more specific than the TCPS with respect to the responsibilities and procedures to be undertaken by the REB; however, these are not ethical guidelines. A list of documents to be obtained for review, the requirement that the qualifications of the investigator be reviewed, the frequency of ongoing review, the needs of non-therapeutic participants, and elements to be included in the informed consent form are all specifically addressed in the ICH guidelines. Despite the clearer set of rules, the impact of the ICH guidelines in Canada is somewhat tempered; provincial or regional policies and laws may supersede them. In addition, the guidelines only apply to data generation that will ultimately be submitted for regulatory approval, leaving a wide area of clinical research exposed.

The tension between the TCPS and Health Canada ICH guideline regulations formed the backdrop of a debate in the CMAJ in 2002 sparked by a commentary entitled "Placebo Trials and Tribulations." (9) Some of those concerns set the stage for the joint sponsored Health Canada/CIHR Placebo Initiative report submitted to CIHR and Health Canada in July...