Volume 11, Number 1 August 8, 2003

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Review says 1997 research consent form ethically suspect

A U of S committee has determined that a 1997 ethics review application for a whiplash study sponsored by Saskatchewan Government Insurance (SGI) did not make adequate provision to obtain informed consent from participants.

But the University Committee on Ethics in Human Research (UCEHR) stressed that there have been "sweeping and fundamental changes" to the Canadian ethical review process since these protocols were originally reviewed - changes which greatly reduce the chance that similar concerns would arise today.

The review committee's findings were issued in a U of S news release Aug. 1.

The review, initiated by the U of S in response to public concerns, focused on whether the consent procedures described in the protocols met the standards of the time. A 1994 SGI-funded whiplash study protocol was also reviewed, and that protocol was found to contain adequate consent provisions.

The 1994 and 1997 studies were conducted by David Cassidy, director of a U of S research institute. He was later accused by biostatistician Emma Bartfay of counselling her to falsify research data and forcing her to quit. Her subsequent lawsuit against Cassidy, the U of S and SGI was settled out of court a few months ago.

U of S involvement in Cassidy's studies ended more than three years ago when he moved to the University of Alberta

In the UCEHR review, chair Valerie Thompson cautions that on the issue of whether or not informed consent was actually obtained in the 1997 study, the answer "may still be yes." UCEHR did not evaluate whether free and informed consent was in fact obtained, confining its review to documents available to the original ethics committee. But some documents that followed the original review suggest participants were informed that their participation was voluntary.

"We sought this opinion to help us ensure the highest possible standard for ethical review of U of S research applications," said Ken Coates, U of S Provost and Acting Vice-President Academic.

"We are confident that the lessons learned from this review have been addressed and that the public is well protected by our current ethics review processes. Since national ethics review standards were created in 1998, our research ethics committees have developed extensive guidelines for researchers that now include more rigorous requirements for obtaining informed consent from study participants."

On the 1994 study, UCEHR found that prospective participants were invited to participate, given an adequate explanation of the study, offered the option to decline participation and told that their decision to participate would have no bearing on their SGI claim.

The 1997 study was a review of a rehabilitation program funded by SGI for injured people. The protocol was originally reviewed and approved by the U of S Medical Ethics Committee.

UCEHR found that the 1997 protocol should have undergone substantial revision prior to approval. In particular, better provision should have been made to obtain consent from claimants, inform them they could refuse to participate, and inform them that refusal to participate would not jeopardize their SGI benefits.

For more information, contact communications.office@usask.ca

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