Featured Research

from universities, journals, and other organizations

Ways To Improve Informed Consent Are Testable, Study Says

Date:
January 15, 2008
Source:
Johns Hopkins Medical Institutions
Summary:
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 bioethicist suggests.

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.

Related Articles


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."

This study was funded by the Cooperative Studies program of the Department of Veterans Affairs' Office of Research and Development, Clinical Science Research and Development Service.


Story Source:

The above story is based on materials provided by Johns Hopkins Medical Institutions. Note: Materials may be edited for content and length.


Cite This Page:

Johns Hopkins Medical Institutions. "Ways To Improve Informed Consent Are Testable, Study Says." ScienceDaily. ScienceDaily, 15 January 2008. <www.sciencedaily.com/releases/2008/01/080111123308.htm>.
Johns Hopkins Medical Institutions. (2008, January 15). Ways To Improve Informed Consent Are Testable, Study Says. ScienceDaily. Retrieved April 1, 2015 from www.sciencedaily.com/releases/2008/01/080111123308.htm
Johns Hopkins Medical Institutions. "Ways To Improve Informed Consent Are Testable, Study Says." ScienceDaily. www.sciencedaily.com/releases/2008/01/080111123308.htm (accessed April 1, 2015).

Share This


More From ScienceDaily



More Health & Medicine News

Wednesday, April 1, 2015

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Liberia Sees Resurgence of Drug Trafficking as Ebola Wanes

Liberia Sees Resurgence of Drug Trafficking as Ebola Wanes

AFP (Apr. 1, 2015) The governments of Liberia and Sierra Leone have been busy fighting the menace created by the deadly Ebola virus, but illicit drug lords have taken advantage of the situation to advance the drug trade. Duration: 01:12 Video provided by AFP
Powered by NewsLook.com
Stigma Stalks India's Leprosy Sufferers as Disease Returns

Stigma Stalks India's Leprosy Sufferers as Disease Returns

AFP (Apr. 1, 2015) The Indian government declared victory over leprosy in 2005, but the disease is making a comeback in some parts of the country, with more than a hundred thousand lepers still living in colonies, shunned from society. Duration: 02:41 Video provided by AFP
Powered by NewsLook.com
7-Year-Old Girl Gets 3-D Printed 'robohand'

7-Year-Old Girl Gets 3-D Printed 'robohand'

AP (Mar. 31, 2015) Although she never had much interest in prosthetic limbs before, Faith Lennox couldn&apos;t wait to slip on her new robohand. The 7-year-old, who lost part of her left arm when she was a baby, grabbed it as soon as it came off a 3-D printer. (March 31) Video provided by AP
Powered by NewsLook.com
Solitair Device Aims to Takes Guesswork out of Sun Safety

Solitair Device Aims to Takes Guesswork out of Sun Safety

Reuters - Innovations Video Online (Mar. 31, 2015) The Solitair device aims to take the confusion out of how much sunlight we should expose our skin to. Small enough to be worn as a tie or hair clip, it monitors the user&apos;s sun exposure by taking into account their skin pigment, location and schedule. Matthew Stock reports. Video provided by Reuters
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins