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

concepts — namely, randomization and placebos — seemed 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

models — what we call ‘template’ forms — were 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 abroad —

in 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.

 

In addition to Kass, the study was conducted by Holly Taylor, Ph.D.,

M.P.H., also a core faculty member at the Berman Institute, as well as

Lelia Chaisson, B.A., and Jennifer Lohse, B.A., both former research staff

at the institute.

 

The study, “Length and Complexity of U.S. and International HIV Consent

Forms from Federal HIV Network Trials,” can be found at

http://www.springerlink.com/content/n2671q0593647610/.

 

Media Contact: Michael Pena
410-614-5381; mpena@jhu.edu

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