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  • IRB: ETHICS & HUMAN RESEARCH

Reducing Consent Form Length: Stakeholder Support, Evidence-Based Strategies, and Regulatory Requirements

As reported elsewhere, we recently conducted a study—the Effective Delivery of Informed Consent (EDICT) study—designed to advance the use of shorter informed consent forms (ICFs) in clinical research. Previous research has demonstrated that potential participants’ understanding of research is not compromised when shorter instead of longer ICFs are used. Yet, lengthy ICFs are commonly used. In our research, six groups of research stakeholders, all engaged in biomedical HIV prevention research, participated in a consensus-building process focused on shortening ICFs. The process resulted in three empirically supported strategies for shortening ICFs. Since these strategies could likely be applicable beyond biomedical HIV prevention research, we solicited the views of such stakeholders during presentations of the preliminary EDICT study data at two research ethics conferences: The Schulman Associates IRB’s 17th Annual Human Subjects Protection Regional Conference (October 2015) and The Advancing Ethical Research Conference sponsored by Public Responsibility in Research and Medicine (PRIM&R) (November 2015). This paper discusses the results of our polls at these conferences and relates our findings to the final rule issued in January 2017 for the Federal Policy for the Protection of Human Subjects, or the “Common Rule.”

 Keywords: Common Rule, Federal Policy for the Protection of Human Subjects, informed consent form, informed consent process

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LET US SHARE OUR EXPERIENCES WITH YOU!

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