U of S Committee Questions Consent Provisions in 1997 Whiplash Study

Posted August 01, 2003


FOR IMMEDIATE RELEASE - August 1, 2003 2003-08-01-OTHER

U of S Committee Questions Consent Provisions in 1997 Whiplash Study

A University of Saskatchewan 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 chances that similar concerns would arise
today.

The review, initiated by U of S in response to public concerns, focused on
whether the consent procedures described in the protocols (applications from
researchers for ethics review of their research plans) 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. U of S
involvement in the studies ended more than three years ago.

But UCEHR 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 indeed 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 that they were free to
refuse to participate or withdraw at any time, and inform them that their
decision to participate or withdraw would not jeopardize their SGI benefits.


UCEHR found no evidence that the medical ethics committee erred "either in
judgment or in process" and concludes the committee exercised "due
diligence."

For instance, the committee asked the researchers to clarify that
participation in the study would be voluntary. "The researchers did so,
indicating that there would be no punitive measures for any claimant who did
not wish to participate in the study," UCEHR states.

As well, the 1997 protocol implied that a primary goal of the study was to
evaluate the effectiveness of a treatment program for SGI, noting SGI had
the legal right to collect information and share it with appropriate sources
to ensure quality of care. Program evaluations by non-university agencies
often proceed without a formal consent process.

But UCEHR concluded the stated goals of the study went beyond a program
evaluation by including "an element of research" and therefore adequate
consent provisions should have been required.

The 16-page UCEHR report calls for clear consent guidelines for reviewing
applications that involve a program evaluation. Coates said U of S will
develop its own guidelines and press for similar national guidelines during
the review of national standards that is underway.

Coates thanked the UCEHR members for their thorough review. UCEHR's mandate
is to propose and adopt policies and procedures for research ethics boards
in compliance with national standards. It is not a reviewing body for
specific research projects.

Findings from the 1994 study were published in the prestigious,
peer-reviewed New England Journal of Medicine in April, 2000. The U of S
Institute for Health and Outcomes Research which conducted the studies
disbanded after the lead researcher left the U of S.

Visit http://www.usask.ca/research/ethics.shtml for information about U of S
research ethics guidelines and
http://www.nserc.ca/programs/ethics/english/policy.htm for information on
the Tri-Council Policy Statement on Ethical Conduct for Research Involving
Humans.

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For more information or a copy of the report, contact:

Kathryn Warden
U of S Research Communications
(306) 966-2506
kathryn.warden@usask.ca
www.usask.ca/research