Ways to improve informed consent are testable, study says

January 11, 2008

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 Johns 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 Jeremy Sugarman, professor of bioethics and medicine at the Berman Institute of Bioethics at The Johns 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 Timothy 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.”

Source: Johns Hopkins Medical Institutions

Explore further: Confronting issues of race in the medical community

Related Stories

Confronting issues of race in the medical community

September 23, 2015

Growing up in a segregated health care community in Baltimore during the 1920s, Henrietta Lacks experienced the disparities that were fundamentally a part of her environment. At the time, most hospitals would not admit black ...

Patient consent forms should educate not intimidate

December 17, 2008

It's time patient consent forms came back full circle to a tool for patient education, rather than the waiver of liability they have become. The original purpose of the consent forms was for a surgeon or doctor to inform ...

Recommended for you

How the finch changes its tune

August 3, 2015

Like top musicians, songbirds train from a young age to weed out errors and trim variability from their songs, ultimately becoming consistent and reliable performers. But as with human musicians, even the best are not machines. ...

Machine Translates Thoughts into Speech in Real Time

December 21, 2009

(PhysOrg.com) -- By implanting an electrode into the brain of a person with locked-in syndrome, scientists have demonstrated how to wirelessly transmit neural signals to a speech synthesizer. The "thought-to-speech" process ...


Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.