montreal

Canada's three major research fund-granting councils have published what they claim is the first broad-ranging ethics policy statement produced for research involving humans in all academic disciplines.

The statement is aimed at ensuring that research subjects will be treated with respect and privacy; that researchers and their institutions will know their work meets ethical standards; and that Canadian society will benefit from research conducted in a socially and scientifically responsible manner.

It results from several years of discussion, consultation and consensus-building among Canadian academic researchers in the humanities, social and natural sciences, medicine and engineering.

The Medical Research Council, the Natural Sciences and Engineering Research Council and the Social Sciences and Humanities Research Council have had separate ethics policies for 20 years, but this is their first joint document. All researchers and institutions receiving their grants will have to adhere to it.

Some 350 research ethics boards in universities, hospitals and research institutes across the country review proposals for research involving humans, with authority to approve or reject proposals. The new code will update their guidelines.

A news release said the policy statement “seeks to balance the need to advance knowledge and understanding with the need to respect the existing legal, social and moral principles and responsibilities to those who participate in research as research subjects”.

The document deals with consent, privacy and confidentiality; conflicts of interest; exclusion of certain groups; research involving aboriginal peoples; the conduct of clinical trials; human genetic research; and research using human gametes, embryos and fetuses.

The document cites changes in the context of research as reasons for a new approach. These included new research tools, a shift from individuals working alone to teams in centres around the world, and questions of ownership and commercialization.

Recent events have thrust such issues into the public eye. In June, for example, the pharmaceutical company Bristol-Myers Squibb attempted to stop publication of an independent report on cholesterol-lowering drugs by the Canadian Co-ordinating Office for Health Technology Assessment (CCOHTA).

CCOHTA challenged this in court, calling it an issue of freedom of speech. The company said the report was flawed and that it was not trying to stifle free speech, but to ensure that the medical profession had correct information. CCOHTA won the case.