Good novel or research policy?  You decide

This year public consultations were conducted by the Interagency Advisory Panel on Research Ethics on the Draft 2 edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (Policy). The consultations were held in major centers across Canada to afford the opportunity for all stakeholders to review changes to the original Policy document and to discuss content additions.

The Policy aims to assist those involved in research “ … to identify ethical issues in the design, conduct, and oversight of research and to point the way to arriving at reasoned and ethical responses to these issues.” Stakeholders involved in research, other than researchers and participants, are sponsors, members of research ethics boards (REB) and the general public.

The corner stone of the Policy and the foundation on which the three core principles are derived is respect for human dignity. The core principles guided the development of the original document and the Draft 2 revision. They are:

• Concern for Welfare
• Respect for autonomy
• Respect for the equal moral status of all humans

The Policy is a “must “ read for all people involved in research, and particularly for individuals who are or might become human subjects. It is easy to read and understand and is as absorbing as any novel I have read over the past six months. A friend and colleague from the Consumer Advisory Board of the Arthritis Research Centre of Canada and I attended the public consultations held in Vancouver. In order to fully participate, we reviewed the document before attending. We expected it to be a dry read punctuated with clinical jargon and legalese but were pleasantly surprised. The Policy content is comprehensive and our issues relating to the risks of research, real or imagined, were addressed. We also saw in the section on governance and composition of REBs the opportunity to be involved as members of these Board. We were impressed.

The Policy covers a variety of types of research and is divided into 12 chapters that focus on different aspects of ethical conduct such as:

• Free and informed consent
• Privacy and confidentiality
• Conflict of interest
• Research involving Aboriginal Peoples
• Human genetic research

Each chapter contains Articles that provide guidance specific to the chapter topic including forms of research that do not require REB review. For example, publicly available information and some observational research are exempt from REB review. To assist the stakeholder in interpreting the scope of the Article, an Application section follows each Article.

For arthritis consumers involved in research, the Policy is essential reading.

Joint Health Monthly, January 2009, focused on the value and types of research and the numerous ways of being involved, including as a participant in clinical trials. CAPA members are often involved as research participants but also as co-investigators and collaborators working with researchers to develop the research question and facilitate the work throughout the project. We have been involved as consultants providing consumer advice to the project and recruiting research subjects. And we are and will continue to be involved in disseminating results. The new portal on CAPA’s website is being designed to enable us to publicize research results, a service we hope will facilitate positive arthritis practices and self-management at the consumer level and also influence policy change through the consumer.

Whatever the level of your involvement in research, the value of the Draft 2 edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans cannot be overstated. I recommend downloading a copy and sitting back with a cup of coffee prepared to be amazed.