Navigation Links
Informed-consent forms should be shortened, simplified, Johns Hopkins bioethicists confirm
Date:7/15/2011

An in-depth review of consent forms provided to volunteers for HIV/AIDS research in the United States and abroad about study procedures, risks and benefits has found that the forms were extremely long and used wording that may have been complex enough to hinder full understanding, according to bioethicists at The Johns Hopkins University.

A systematic analysis of 124 informed-consent documents for U.S. government-sponsored, multinational HIV/AIDS research conducted in 2006 revealed that the forms spanned more than 20 pages, says the study's lead investigator, Nancy Kass, Sc.D., deputy director for public health at the Johns Hopkins Berman Institute of Bioethics.

"While we were familiar with many fairly long consent forms for several different types of studies," Kass says, "we were honestly surprised to see that the median length was 22 pages, and the median length for adult forms was a full 27 pages."

Their study, described in the August issue of the Journal of General Internal Medicine, and funded by the National Institute of Allergy and Infectious Diseases, also found that commonly misunderstood research conceptsnamely, randomization and placebosseemed to be explained with far less attention. For instance, whereas confidentiality sections had a median length of about two pages, randomization was treated to just 53 words.

Randomization is one of science's most trusted tools for minimizing biases in studies. But when studies spend so much time explaining why they are testing a new medicine or approach, and so little on randomization itself, participants may be left not realizing that half of them will get a different medicine, or perhaps no medicine at all, Kass points out.

Kass says this "unfortunate" trend may be because research regulations don't require that forms explain such concepts. Indeed, her study shows that researchers spend considerable time on the key concepts regulations require them to cover, such as purpose, procedures and risks.

Kass also found that the majority of the forms weren't as readable as they should be. Generally, institutional review boards recommend that consent documents be written at or below the eighth-grade level. But the majority of the forms that Kass reviewed required readers with at least a ninth-grader's comprehension. Such findings, while still not meeting commonly agreed-upon standards, demonstrate lower readability than consent form studies from decades past.

By making informed-consent documents so long and complex, Kass concludes, researchers neglect their ethical duty to describe their research in ways that help participants truly understand. In this study, all of the consent forms were based on templates provided by the funder, and researchers themselves may have had little authority to change or shorten them.

"In this study, the forms that researchers were given by their funders as modelswhat we call 'template' formswere themselves very, very long," Kass explains. "I imagine many researchers wish they could use methods that were not only shorter, but maybe that used strategies other than written communication altogether."

The authors cite data on literacy rates in the United States and abroadin light of the rise in research in developing countries, where half or more of the populations are illiterate. For instance, literacy rates in India, Bangladesh and Senegal are 63, 55 and 42 percent, respectively. Almost half of Americans read at or below the eighth-grade level, the authors state.

As long as these template forms, which come from research funders, remain lengthy, the investigators and review boards in the field will assume they must use those forms, Kass says. So, the overall goal of the study is to supply hard facts that policy specialists can use as they consider developing recommendations for shortening and simplifying consent forms, or for, otherwise, helping participants in complex clinical research understand what they are joining.


'/>"/>

Contact: Michael Pena
mpena@jhu.edu
410-614-5381
Johns Hopkins Medical Institutions
Source:Eurekalert

Related medicine news :

1. Experts seek reforms to prevent errors from medical resident fatigue, lack of supervision
2. Physician-rating websites are biased, says paper at INFORMS Healthcare conference
3. Hartford Program issues geriatric social work awards, forms VA partnership
4. The brain performs visual search near optimally
5. INFORMS health care conference highlights increased role of math modeling in health systems
6. Artery Plaque Forms in Short Time Span, Scientists Say
7. Report indicates that new welfare reforms hark back to Victorians
8. US health care reforms should use model developed by Queens University professor
9. Protein study helps shape understanding of body forms
10. New forms of dietary fiber to boost health
11. New standards of care and novel treatment options for several forms of lymphoma unveiled
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... ... June 27, 2016 , ... ... industry today announced its strategic partnership with Connance, a healthcare industry leader ... two companies’ proven, proprietary technology combine to provide health systems, hospitals and ...
(Date:6/26/2016)... Michigan (PRWEB) , ... June 26, 2016 , ... On ... as sponsor of the 2016 Cereal Festival and World’s Longest Breakfast Table in Battle ... honor of the city’s history as home to some of the world’s leading providers ...
(Date:6/26/2016)... Michigan (PRWEB) , ... June 26, 2016 , ... ... to fertility once they have been diagnosed with endometriosis. These women need a ... they also require a comprehensive approach that can help for preservation of fertility ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX users ... - CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms over 1,300 ... Pro X . Simply select a ProHand generator and drag it above media or ...
(Date:6/25/2016)... ... ... On Friday, June 10, Van Mitchell, Secretary of the Maryland Department of Health and ... their exemplary accomplishments in worksite health promotion. , The Wellness at Work Awards took ... the BWI Marriott in Linthicum Heights. iHire was one of 42 businesses to receive ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... --  Pulmatrix, Inc ., (NASDAQ: PULM ), ... today that it was added to the Russell Microcap ... set of U.S. and global equity indexes on June ... for Pulmatrix," said Chief Executive Officer Robert Clarke ... in developing drugs for crucial unmet medical needs, and ...
(Date:6/23/2016)... Research and Markets has announced the addition of ... report to their offering. ... kidney failure, it replaces the function of kidneys by removing ... thus the treatment helps to keep the patient body,s electrolytes ... Increasing number of ESRD patients & substantial healthcare expenditure ...
(Date:6/23/2016)... , June 23, 2016 Roche (SIX: RO, ... clearance for its Elecsys BRAHMS PCT (procalcitonin) assay as ... or septic shock. With this clearance, Roche is the ... fully integrated solution for sepsis risk assessment and management. ... bacterial infection and PCT levels in blood can aid ...
Breaking Medicine Technology: