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
------------------ archive: http://www.gene.ch/genet.html ------------------
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
"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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