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Research consent forms -- pull up a chair and make yourself comfortable

June 1, 2010 |  1:12 pm

Participation in clinical trials is critical to progress in medicine. But researchers have a difficult task in how to present research opportunities to people using consent forms. A study published Tuesday shows that the forms are more accurate than ever before but are becoming unreasonably long.

Researchers at the University of Pennsylvania Law School and Columbia University examined 215 research protocols and their accompanying consent forms from the years of 1977 to 2002. Consent forms are mandated by law and by institutional review boards to ensure that the rights and safety of research participants are protected. Through the years, more effort has been made to ensure that people have all the information they need regarding the potential risks and benefits of participating in research. Indeed, the study found that the problem of discrepancies between the information in the study protocol and the information presented to consumers in the consent form has improved dramatically. Discrepancies were found 57.7% of the time in 1977 studies compared to 0% in 2002 studies.

However, that effort has resulted in much longer forms: from an average of fewer than two pages in 1977 to more than five pages today. Other studies have suggested that consent forms that are even four pages long are unlikely to be read because of the length and time involved.

"Our findings highlight the inherent paradox in attempting to use consent forms to convey ever-more-complicated information to potential research subjects," the authors wrote. Researchers may need to work on keeping consent forms at a reasonable length and offer people other ways of learning about the study, such as through supplementary booklets or computer programs.

The study was published in the journal IRB: Ethics & Human Research.

-- Shari Roan


 

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