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8-Humans: Study finds many gene research consent forms misleading

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TITLE:  Many Gene Research Consent Forms Misleading: Study
SOURCE: Reuters Health, by Vicki Brower
DATE:   Nov 1, 2002

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Many Gene Research Consent Forms Misleading: Study

BALTIMORE (Reuters Health) - Informed consent forms now in use may confuse 
people participating in gene transfer research experiments about what they 
can expect from the experimental procedure, according to preliminary 
results of a new study.

Dr. Nancy M.P. King told attendees at the American Society of Bioethics and 
the Medical Humanities' annual meeting here that investigators and 
institutional review boards (IRBs) still have a way to go to make the forms 
less vague and confusing, and eradicate the misconception that such 
experiments have therapeutic value. King, a professor of social medicine at 
the University of North Carolina at Chapel Hill, is a former member of the 
Recombinant DNA Advisory Committee.

King and colleagues found that important information about risks, a 
blurring of the distinction between research and treatment, and the use of 
inconsistent or contradictory terminology are some of the main problems in 
consent forms currently in use. The researchers examined consent forms for 
322 gene transfer trials conducted between 1990 and 2000.

Ironically, "gene transfer trials' consent forms may actually be among the 
best because they are subject to higher levels of scrutiny than other 
clinical trials," King said.

The study, begun soon after the gene therapy death of Jesse Gelsinger in 
September 1999, recommends a number of simple changes to the consent form 
"to tighten up terminology to more accurately reflect that all gene 
transfer trials are still experimental and not proven treatments," King 
told Reuters Health.

While there has been research into what people think about the potential 
benefits of participating in experimental trials, little attention has been 
paid to what the consent forms they sign say about the benefits of research 
for them.

"Unless we are certain of the information that consent forms actually 
contain, we cannot conclude that they don't influence people's beliefs 
about research, or their decisions about participating in research," King 
said. She noted that the study's goal was to move beyond critiques of the 
informed consent process and improve it so that expectations of both 
patients and investigators are more realistic.

"Gene transfer research consent forms need to find good terms and 
descriptions to explain unfamiliar concepts," King said. Language should be 
chosen carefully to avoid promoting the notion that experimental research 
will be therapeutic, and that the subject is a patient in the trial. 
Language should be adapted to each trial, but in general, should convey 
explicitly that "this medical research project is not expected to benefit 
you," King said. Words such as "treat" and "treatment" should also be 
avoided, she added.

Over half of the trials the group examined were early-stage, or Phase I, 
trials, designed to determine an intervention's safety, not its 
effectiveness, and most involved cancer research. Only 1% of trials 
examined stated that "you will not benefit."


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