Canadian Medical Association Journal 1996; 155: 363
As author Nicole Baer points out (see pages 442 to 444) the new code emphasizes the rights of the research subject. A subject-centred perspective will affect procedures for obtaining informed consent, points to the need to offer counselling to research subjects when screening tests are done and, for some types of research, promotes the right of research subjects to review data for accuracy before they are published. Research procedures being culturally appropriate is also emphasized.
The code calls for an important new mandate for research ethics review boards: to continue ethical review and follow-up on research after the initial protocol has been approved. It states unequivocally that women of childbearing age, elderly people, children and people from minority groups should not be systematically excluded from trials when the results of the research may affect them.
Some areas remain unresolved, such as how to maintain patient confidentiality when pedigrees of genetic disorders are published. Other areas remain contentious, such as determining who should seek consent from research subjects. Nonetheless, the code's importance is indisputable: it is posed to become the Canadian gold standard for defining what is ethical research. A copy of the draft document can be obtained from the MRC (fax 613 954-6653).