Navigation Links
Clinical trials: Comprehension unaffected by simplified consent forms or payment
Date:8/10/2010

(Garrison, NY) Although informed consent is an ethical cornerstone in research with humans, some studies suggests that volunteers often do not understand key aspects of the research in which they participate. Recent efforts have been made to improve informed consent by simplifying the consent forms.

A new study refutes two common assumptions about consent forms: that the length and complexity of forms affect comprehension and that people who are paid to enroll in research may be "blinded by money" and thus ignore key details of the study.

In a randomized controlled trial of a standard versus concise consent form for a low-risk phase I bioequivalence study of a marketed drug, the authors found that overall comprehension was comparable and high with both forms. Furthermore, the shorter form appeared to have no adverse effect on the quality of informed consent. Another intriguing finding was that comprehension was slightly higher among the paid volunteers than those who were unpaid. And, the study revealed that the overall comprehension scores of socioeconomically disadvantaged participants was good, negating the common claim that this population of research participants requires special protections.

The report of the study appeared in IRB: Ethics & Human Research, published by The Hastings Center. The authors include two Hastings Center Fellows and bioethics leaders in the federal government: Ezekiel Emanuel, head of the Department of Bioethics at the National Institutes of Health Clinical Center and special advisor for health policy to the director of the White House Office of Management and Budget; and Christine Grady, acting chief of the Department of Bioethics at the NIH Clinical Center and a member of the Presidential Commission for the Study of Bioethical Issues. Other authors are Leanne Stunkel and Ninet Sinaii, of the NIH Department of Bioethics; and Meredith Benson, Louise McLellan, and Garbriella Bedarida, of Pfizer.

Although informed consent is an ethical cornerstone in research with humans, some studies suggest that volunteers often don't understand key aspects of the research. Recent efforts have been made to improve informed consent by simplifying the consent forms. A new study refutes two common assumptions about consent forms: that the length and complexity of forms affect comprehension and that people who are paid to enroll in research may be "blinded by money" and thus ignore key details of the study.


'/>"/>

Contact: Susan Gilbert
gilberts@thehastingscenter.org
845-424-4040 x244
The Hastings Center
Source:Eurekalert

Related medicine news :

1. Clinical trials abroad: Making non-English language consent forms readable
2. Childrens Hospital of Philadelphia creates free clinical info app for iPhone and iPod Touch
3. Human clinical trial of NIH-developed dengue vaccine begins
4. Clinical trials can be improved by managing the learning curve
5. Sickle cell treatment developed at LA BioMed enters Phase 3 clinical trial
6. UC San Diego receives major clinical and translational science award
7. Hopkins faculty lead development of report to FDA on ethical, scientific issues related to post-market clinical trials
8. Pediatric clinical studies appear prone to bias, Hopkins review shows
9. CI-Now™ Brings Clinical Integration to Health Care Providers
10. Damon Runyon Cancer Research Foundation awards $3.1M to 8 top young clinical investigators
11. University at Buffalo launches clinical trial of new multiple sclerosis treatment
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... ... June 26, 2016 , ... Many women are ... with endometriosis. These women need a treatment plan to not only alleviate symptoms ... can help for preservation of fertility and ultimately achieving a pregnancy. The specialists ...
(Date:6/25/2016)... ... , ... "With 30 hand-drawn hand gesture animations, FCPX users can easily customize ... Pixel Film Studios. , ProHand Cartoon’s package transforms over 1,300 hand-drawn pictures into ... Simply select a ProHand generator and drag it above media or text in the ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... On Friday, ... presented a Bronze Wellness at Work award to iHire in recognition of their exemplary ... part of the 7th annual Maryland Workplace Health & Wellness Symposium at the BWI ...
(Date:6/24/2016)... ... June 24, 2016 , ... June 19, 2016 is ... associated with chronic pain and the benefits of holistic treatments, Serenity Recovery Center ... suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) is a disorder of ...
(Date:6/24/2016)... ... June 24, 2016 , ... Dr. Amanda Cheng, ... treatment. Dr. Cheng has extensive experience with all areas of orthodontics, including robotic ... osteogenic orthodontics. , Micro-osteoperforation is a revolutionary adjunct to orthodontic treatment. It ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... -- According to a new market research ... Safety Pen Needles), Needle Length (4mm, 5mm, 6mm, 8mm, ... Purchase (Retail, Non-Retail) - Trends & Global Forecasts to ... for the forecast period of 2016 to 2021. This ... 2021 from USD 1.65 Billion in 2016, growing at ...
(Date:6/24/2016)... , Belgium , June 24, ... VNRX), today announced the appointment of Dr. ... Directors as a Non-Executive Director, effective June 23, ... Audit, Compensation and Nominations and Governance Committees.  As ... Futcher will provide independent expertise and strategic counsel ...
(Date:6/23/2016)... -- MedSource announced today that it has selected Datatrial,s ... choice.  This latest decision demonstrates MedSource,s commitment to ... by offering a state-of-the-art electronic data capture (EDC) ... the EDC platform of choice in exchange for ... long been a preferred EDC platform by our ...
Breaking Medicine Technology: