The Revised Common Rule and New “Concise Summary” Requirements

Applied Clinical Trials

Linda Reuter, CIP, Director of BRANY IRB, discusses the Revised Common Rule that now requires informed consent to begin with a concise and focused presentation of key information that will help the patient better understand the reasons why they might or might not want to participate in the research.

For years the research community has struggled with ways to improve the consent process for research. Questions have been raised about whether or not the current regulatory requirements are effective in meeting the needs of individuals who are asked to participate in research, or whether the process has evolved to meet the needs of sponsors and institutions instead. In the midst of the ongoing debate, new regulations were promulgated that impose additional requirements on the form itself, while questions about how to improve the process remain.

The Revised Common Rule now requires informed consent to begin with a concise and focused presentation of the “Key Information” that is most likely to assist a prospective subject or their legally authorized representative in understanding the reasons why they might or might not want to participate in the research. According to the regulations, this part of the consent form is to be organized in a way that facilitates comprehension. This new requirement was included in the revised rule to address a growing concern that consent forms had evolved into legal documents much too dense with information, where the most important information for subjects to consider was buried within a lengthy and complex document. The newly required “concise summary” section of the form was intended to parse out the information that seemed most important for a potential subject to consider, one that would answer the most common questions an individual would have when being asked to participate in research. The rest of the consent form would then include everything else, including all of the remaining required elements of consent, HIPAA information, and other required language.

In order to prepare for this new requirement, and with the long-awaited guidance from regulators still pending, BRANY developed a Key Information Template. The template was developed using information supplied by regulators in the Preamble to the 2018 Rule (which provided background information and comments received prior to implementation of the Rule), insight gleaned from BRANY IRB member focus groups, and opinions from other IRBs on how they were handling the new requirement. What we noticed is that there is great variation in how institutions implemented the new requirement for a concise summary and templates ranged from a short paragraph to multi-page documents.

Feedback from IRB Members in these early days of implementing the Key Information section in the informed consent form has been positive. Some of the ongoing concerns about lengthy and complex consent documents has eased somewhat because IRB reviewers are more confident that the information they believe is most important for subjects to consider is featured at the beginning of the consent document. The template has been effective in framing that information, and IRB members generally feel better about the fact that at least the first few pages contain many of the key details. However, what we have also learned is that there are differing opinions among IRB members and sponsors on what information should be included. Different people very often want to know different things depending on the lens through which they view the prospect of research. In an industry where consent forms are increasing in length to the point where the average consent form is greater than 25 pages, the challenge in deciding what portions should be presented first is a challenge.

A form, no matter how concisely and accurately it conveys the details of a research study, could never achieve a true informed consent process by itself. Components that are essential to the informed consent process include the person presenting the research opportunity to potential subjects, and how thoroughly they have been trained in matters related to effective communication with subjects, the role of the consent document in the initial consent discussion and the ongoing process that consent is supposed to be. At the end of the day it is the process that matters.

Linda Reuter, CIP,Director, BRANY IRB