Viewpoint

Group applauds ethics committee's finding on study

By Lorie Terry

I am writing regarding an article entitled "Review says 1997 research consent form ethically suspect" in the August 8th issue of On Campus News.

First the accident victims of Saskatchewan and I would like to thank the UCEHR (University Committee on Ethics in Human Research) for their honest opinions regarding the "free and informed consent" issues involved in "The Outcomes Assessment of Treatment and Rehabilitation After Traffic Injuries in Saskatchewan" (The Outcomes Study) by Cassidy et.al. This panel did the best it could with the limited information that was provided to them due to vital missing documents.

The statement that "some documents that followed the original review suggest participants were informed that their participation was voluntary" is misleading. The UCEHR was missing crucial documents from "The Outcomes Study" protocol (pages 6-16 of the telephone scripts and the actual letter that was sent to claimants) that would have allowed UCEHR to determine whether or not "free and informed consent" was actually obtained. Therefore the board had to narrow the scope of their review to whether or not the material they had available to them constituted "free and informed consent". They found that the protocol was not adequate and that there were elements of coercion.

The Coalition Against No-Fault received copies of the entire Outcomes Protocol, including the missing documents in a brown paper envelope. The letter sent out to claimants was obtained by the accident claimants themselves, voicing disgust over what they were expected to do to receive SGI benefits. On August 8, 2003 we forwarded these documents to Mr. Ken Coates, U of S Provost and Acting Vice-President Academic. We consulted the opinion of other Ethics specialists and they have concluded that none of these documents constituted "free informed consent". It is interesting to note a statement in section C: Consent to participate:

"This study has been approved by the University of Saskatchewan Advisory Committee on Ethics in Human Experimentation. No consent is being requested from claimants. Because of its role in providing treatment and rehabilitation for claimants suffering traffic injuries and making personal injury claims, SGI has the legal right under the Act to collect information and to share that information with appropriate sources to ensure quality of care. The Freedom of Information agreement outlines the specifics of information sharing. Claimants sign the last page of the Application for Benefits, which states that they may be contacted by researchers at the University of Saskatchewan".

I am happy that the University of Saskatchewan is assuring us that this type of unethical research will never be conducted on humans again, but I feel it should never have happened in the first place. The Declaration of Helsinki mapped out the rules regarding research on humans shortly after World War II, and it is my understanding that these are the rules of conduct that researchers have used as guide for well over 40 years. I also find it ironic that the 1994 PICSTIS study, (which contains a whole new set of problems) did obtain informed consent, but in 1997 these rules of conduct were not followed.

Over 750 baseline variables of accident victim's data were obtained by SGI and The Institute for Health and Outcomes Research (IHOR) because the claimants felt that if they did not cooperate they would not receive benefits, and in fact The Application For Benefits form you had to sign in order to receive benefits was deemed by the UECHR to be coercive in nature, the following are excerpts:

"I understand that holding back information about income, interfering with or delaying my recovery, or not cooperating with rehabilitation or with reasonable requests for medical examination may cause my benefits to be cut back or cancelled altogether."

After this application sets up the claimant to be concerned about losing benefits, it offers this clause in the way of "free and informed consent":

"I understand and agree that SGI may share the information regarding my claim for benefits with health care professionals, vocational rehabilitation professionals, Saskatchewan Social Services and the Institute for Health and Outcomes Research at the University of Saskatchewan. I further understand and agree to better facilitate the administration of my claim, medical or vocational information may be exchanged directly between health care professionals or vocational rehabilitation professionals, and I hereby authorize such direct exchange or provision of information.

The one thing that bothers me the most about this whole issue is that the U of S was not solely responsible for our loss of rights and the private information gained in this manner. It's a slippery slope to a loss of rights, perpetrated by our own government against its own citizens to create public policy regarding no-fault insurance. We hope it never happens again.

Lorie Terry is with The Coalition Against No-Fault (www.againstnofault.ca), in Regina.