Navigation Links
Ways to improve informed consent are testable, study says
Date:1/11/2008

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 studys 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 doesnt 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 trials benefits would be. The callers didnt 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 wouldnt want to take a drug if it was too expensive or burdensome unless its 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.


'/>"/>

Contact: Christen Brownlee
cbrownlee@jhmi.edu
410-955-7832
Johns Hopkins Medical Institutions
Source:Eurekalert

Related medicine news :

1. Doctor pay-for-performance improves patient care
2. Better access to cool caps improves outcomes, lowers cost of treating asphyxia in newborns
3. UAB research could improve the prognosis and treatment of lung cancer
4. Exercise program improves symptoms in arthritis patients
5. Ambien CR(R) (zolpidem tartrate extended-release) tablets CIV Improved Chronic Insomnia in Patients with Co-Morbid Generalized Anxiety Disorder
6. Tonsillectomy significantly improves quality of life in adult and pediatric patients
7. Risk of HIV, West Nile Virus, E Coli Transmission May be Reduced Through Improved Blood Screening Methods
8. New ingredients in drug-like anti-aging products improve skin
9. Human factors researchers test voting systems for seniors that can improve voting accuracy and speed
10. Sutter Solano Medical Center Wins National Improvement Award
11. Bevacizumab found to improve survival for patients with advanced breast cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/22/2017)... ... September 22, 2017 , ... SABRE ... Scholarship Sweepstakes.,  , Molli C., a graduate student from Sonora, California, who will ... Administration at St. Thomas University in Miami, Florida, was selected from a pool ...
(Date:9/22/2017)... HOUSTON, Texas (PRWEB) , ... September 22, 2017 ... ... leading network of independent freestanding emergency rooms is celebrating the one year anniversary ... anniversary of our facility opening,” said Dr. Otinwa, Facility Medical Director of First ...
(Date:9/22/2017)... ... September 22, 2017 , ... ... products at customers’ doorstep. According to Smart Mart, customers can now order vegetable, ... offer wearable, and customers can find clothing at discounted prices. Apart from this, ...
(Date:9/21/2017)... ... September 21, 2017 , ... Process Capability ... p.m. – 3:00 p.m. ET, http://www.fdanews.com/processcapabilityindices      , Quality ... run afoul of The Quality System Regulation (§820.250), and Devicemakers find themselves staring ...
(Date:9/21/2017)... (PRWEB) , ... September 21, 2017 , ... ... in their communities, nine governmental public health departments have been awarded five-year accreditation ... decisions mean that the benefits of being served by a PHAB-accredited health ...
Breaking Medicine News(10 mins):
(Date:9/13/2017)... Sept. 13, 2017   OrthoAtlanta has been named ... Football Host Committee (AFHC) for the 2018 College Football Playoff ... 2018, at Mercedes-Benz Stadium in Atlanta, Georgia ... AFHC "I,m In" campaign, participating in many activities leading up ... ...
(Date:9/12/2017)... , Sept. 12, 2017  ValGenesis Inc., ... Solutions (VLMS), is pleased to announce the appointment ... member of its Board of Directors and Chairman ... VLMS enables life science companies to manage their ... use of paper in this process. Furthermore, ValGenesis ...
(Date:9/9/2017)...  Eli Lilly and Company (NYSE: LLY ... for lasmiditan, an investigational, oral, first-in-class molecule for the ... compared to placebo in the Phase 3 SPARTAN study. ... Congress of the International Headache Society (IHC) in ... today demonstrate lasmiditan,s potential to reduce pain and provide ...
Breaking Medicine Technology: