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Compliance In Focus
Posted by Stephani Hulec on Fri, Mar 14, 2014

Pros and Cons: Shortened Informed Consent Form

I came across an article describing the benefits to having a shortened informed consent form. Pros and Cons - Shortened Informed Consent Form As a monitor who has had experience with reviewing informed consents, as well as a former research coordinator who has obtained consent from study participants, I have mixed feelings on the topic.

The article stresses that an overly-lengthy informed consent document might prevent an investigator from properly obtaining informed consent, if a potential participant does not fully understand the form.  Others agree with this theory, such as the bioethicists at Johns Hopkins University in this study, and others in this peer-reviewed journal article.  I agree that in some instances, the wordiness of the informed consent document may hinder the subject’s ability to comprehend the research study, or may prevent the subject from being able to ask well-informed questions. 

As an alternative, as the first article suggests, a shortened informed consent that includes the essential elements of informed consent could be used.  In such cases, detailed information could be outlined in a separate study handbook and more focus would be placed on the consent form discussion.  While this may be an appropriate alternative to incorporating the comprehensive language into the actual informed consent document, having an additional form or handbook may come with its own set of problems.  Specifically, how could a researcher be sure that the subject read and understood all of the additional information in the handbook?  Or, how would the site best document that the consent discussion was adequate?

I encourage you to read these articles and share your opinions with us.  What do you think are the pros and cons to investigative sites adopting the approach of a three-page informed consent document?

Photo Credit: The Open University

Product Accountability in Clinical Trials

Topics: Informed Consent, FDA, Clinical Research


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