Ways to improve informed consent are testable, study says

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Ways to improve informed consent are testable, study says

Findings could prevent costly but worthless attempts to improve

mainstay of clinical trials

http://www.eurekalert.org/pub_releases/2008-01/jhmi-wti011108.php

New ways to make sure people are adequately informed about the risks

and benefits of taking part in a clinical trial can be field-tested

for effectiveness as vigorously as new medical treatments

themselves, a study led by a s Hopkins bioethicist suggests.

Informed consent, a mainstay of ethical clinical trials, is the

process by which potential research subjects are asked to decide

whether to participate in research. The bedrock components of the

process include gaining an understanding of the study's goals and

benefits, as well as the risks and roles of the subjects themselves.

" Many clinical researchers believe that the informed consent process

and documents need to be better and that people often consent

without understanding that the research is not intended to benefit

them personally, " says Sugarman, professor of bioethics and

medicine at the Berman Institute of Bioethics at The s Hopkins

University.

" Although numerous improvements have been suggested, no sound

objective method existed to test them, leaving the process open to

costly or time-consuming interventions that could ultimately have no

effect, " he adds.

Writing in the December 2007 Clinical Trials, Sugarman and his

colleagues, Philip W. Lavori of Stanford University School of

Medicine and J. Wilt of the Minneapolis VA Center for

Chronic Disease Outcomes Research, describe a questionnaire tool

they developed and tested at 30 study sites in five ongoing clinical

trials for medical treatments that include from administering

selenium and vitamin E to prevent cancer and giving female veterans

therapy for post-traumatic stress disorder.

Though the tool ultimately proved ineffective in improving informed

consent in this experiment with its use, Sugarman says the

evaluation method they developed is helpful in ruling out what

doesn't work.

Sugarman and his colleagues started with the idea that if those

seeking informed consent from potential subjects were armed with

reminders of the steps needed to adequately educate them,

participants would be more likely to receive and understand the

information they need to make good decisions.

Consequently, the investigators put together a short, self-

monitoring questionnaire for researchers to fill out after each time

they obtained informed consent. This questionnaire is a checklist of

18 questions that review critical parts of the informed consent

process designed to help ensure that potential participants

understand what is being asked of them.

In an experiment to test the questionnaire, clinical trial

administrators used it at half of the study sites so that they could

compare its impact.

Volunteers at a phone bank spoke with study subjects who minutes

before had agreed to join a clinical trial at all the study sites,

asking a series of questions to assess how much the subjects

understood about the trial, their role in the research and what the

trial's benefits would be. The callers didn't know which subjects

had joined the trials at sites that used the questionnaire and which

did not.

When the researchers compared results from the calls to participants

at all of the sites, they found similar results, suggesting that the

questionnaire did nothing to improve informed consent. A significant

number of patients did not fully understand the purpose of the

research, that the research may not benefit them or that agreeing to

participate was completely voluntary.

" Implementing changes to the informed consent process is like taking

new medicine - you wouldn't want to take a drug if it was too

expensive or burdensome unless it's really helpful, " Sugarman

says. " This study shows that we can do rigorous clinical testing of

informed consent, just like we can do rigorous testing of drugs in

clinical trials. "