Ways to improve informed consent are testable, study says

Jan 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: Continued reliance on Windows XP in physician practices may threaten data security

add to favorites email to friend print save as pdf

Related Stories

Transgene insects: Scientists call for more open data

Feb 01, 2012

While genetically modified plants have already been introduced into the wild on a large scale in some parts of the world, the release of genetically modified animals is still at a relatively early stage. A ...

Recommended for you

Obese British man in court fight for surgery

Jul 11, 2011

A British man weighing 22 stone (139 kilograms, 306 pounds) launched a court appeal Monday against a decision to refuse him state-funded obesity surgery because he is not fat enough.

2008 crisis spurred rise in suicides in Europe

Jul 08, 2011

The financial crisis that began to hit Europe in mid-2008 reversed a steady, years-long fall in suicides among people of working age, according to a letter published on Friday by The Lancet.

New food labels dished up to keep Europe healthy

Jul 06, 2011

A groundbreaking deal on compulsory new food labels Wednesday is set to give Europeans clear information on the nutritional and energy content of products, as well as country of origin.

Overweight men have poorer sperm count

Jul 04, 2011

Overweight or obese men, like their female counterparts, have a lower chance of becoming a parent, according to a comparison of sperm quality presented at a European fertility meeting Monday.

User comments : 0

More news stories

New clinical trial launched for advance lung cancer

Cancer Research UK is partnering with pharmaceutical companies AstraZeneca and Pfizer to create a pioneering clinical trial for patients with advanced lung cancer – marking a new era of research into personalised medicines ...

'Chief Yahoo' David Filo returns to board

Yahoo announced the nomination of three new board members, including company co-founder David Filo, who earned the nickname and formal job title of "Chief Yahoo."

More vets turn to prosthetics to help legless pets

A 9-month-old boxer pup named Duncan barreled down a beach in Oregon, running full tilt on soft sand into YouTube history and showing more than 4 million viewers that he can revel in a good romp despite lacking ...