Federal research code nears approval

BRUCE ROLSTON | A controversial new set of national guidelines for research involving humans has been significantly amended to reflect researchers' concerns, according to one of its drafters.

The guidelines, the latest draft of which has not been made public, go before the three federal research granting councils for approval this spring. They will establish Canada-wide procedures for reviewing the ethics of all research involving humans, from invasive medical procedures to interviews for a historical biography.

University researchers strongly criticized a draft set of guidelines made public by the councils last year, which many saw as setting up an authoritarian and costly review procedure for every questionnaire, research interview and case study.

In addition to being costly and time-consuming, the new guidelines would impinge upon academic freedom by allowing university research ethics boards to examine the underlying science of proposals, and due to a requirement for researchers to obtain the collective approval of identifiable groups, effectively prevent research into groups such as business leaders or street gangs whose leaders would prefer not to be studied.

That's all changed, said Nina Stipich, senior policy analyst for the Social Sciences and Humanities Research Council, who is heading SSHRC's involvement in the tri-council initiative. While the councils are declining to release the amended draft until after it has been fully approved, researchers should rest assured that the concerns they raised last year have been responded to, she said. "Basically the proscriptive tone (of the earlier draft) has been eliminated."

Among the measures that will be dropped is the requirement that every university's research ethics board include a lawyer in addition to research and ethics experts. The provision, which had been strongly opposed as sharply driving up the costs of research approval, has been amended so that a board only needs one member who is "knowledgeable in the area of law," she said.

The language of the previous document, which seemed to suggest that all research proposals need full ethics board review, has also been changed, Stipich said.

"Clearly we were not explicit enough. Now it is very clear. The board will be looking at the high-risk stuff -- the process for the rest would really be up to the institution, whether by a subcommittee or a departmental review. Ninety-five per cent should not have to go to full board review."

Another controversial section, on collective consent, has also been amended. "We have backed off completely, gone back to the status quo," Stipich said. "Collective consent will only be required for research into aboriginal peoples and vulnerable minorities."

Nor will ethics boards be entitled to consider whether a proposal's underlying science is valid, only whether its ethics are sound, she said.

One of those who had strongly opposed the new guidelines is University of Toronto psychology professor Ken Dion. He's sceptical whether the research councils' latest draft will be much better than what came before, saying the whole notion of unifying ethics procedures across all kinds of science is fundamentally flawed.

"Setting a national standard was a good thing to try for. The problem was trying to apply a biomedical ethics framework to everything. Everybody understands the need for thorough review when you're dealing with a physically invasive procedure but when you're dealing with filling out a questionnaire, it's a different ballgame. The social sciences have their own ethics codes: why do we have to reinvent the wheel?"

Dion questions the whole need for the process, which has cost the Medical Research Council, the sponsoring council, over $500,000 over the last two years. "They are wrapping themselves in the flag of virtue. Who's going to be against ethics? Look, none of us are doing unethical research. We're already doing ethical research, thank you.

"Now, research will be scrutinized a lot more, certainly. But will it be better research? I doubt it."

This article is reprinted with the kind permission of the University of Toronto Bulletin.