A Survey on Including Risks in the New “Key Information” Section of an Informed Consent Form

A Survey on Including Risks in the New “Key Information” Section of an Informed Consent Form
Katelyn Le, Stacy Kopka, Doreen Chaitt, Jerome Pierson, Martha Nason, Tracey Miller
Clinical Research (Alex), December 2018; 32(10) pp 18–29
Informed consent forms (ICFs) are growing longer and more complex.{14} The forces behind this trend may be well-intentioned, such as the desire to disclose more accurate and complete information{1}; however, it raises questions about whether important information is buried in lengthy documents, as well as whether ICFs can be structured to better emphasize the information that is most relevant to a study participant.

Recent updates to what is generally known as the Common Rule for protection of human subjects in research are in part meant to respond to this trend. Among these updates is the introduction of a new section called “Key Information”—every ICF now must open with the most important information that potential subjects would want to know when deciding to join a study. But what exactly should this new section contain?

This question is crucial to us, a group of writers and reviewers who work with investigators to develop ICFs (the program was described in a 2013 issue of the ACRP Monitor{5}). For groups like ours, it is important to explore how best to implement the new regulations in a way that promotes consistency across different ICFs.

As an initial step, we wanted to understand how to objectively decide which risks to provide as Key Information. A survey was conducted to investigate how institutional review board (IRB) members, medical monitors, and principal investigators (PIs) view which risks should be considered Key Information. The hypothesis was that cohorts would have differing viewpoints on selecting these risks.

While the findings of this exploratory study demonstrate variability in viewpoints, they also suggest a number of points of consensus to consider when writing Key Information.

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