FDA and the Office for Human Research Protections (OHRP) issued a 16-page draft guidance, entitled “Key Information and Facilitating Understanding in Informed Consent,” to provide recommendations for developing a key information section for clinical trials including strategies to make consent information more understandable for prospective research participants, the background section of the proposed rule explains. 

To provide context and analysis to this draft guidance, PRIM&R reached out to obtain a variety of prospectives from the field to help members of the PRIM&R community understand the ramifications of this guidance.  

This draft guidance, according to the Federal Register, “provides recommendations related to two provisions of the revised Federal Policy for the Protection of Human Subjects (the revised Common Rule) by the U.S. Department of Health and Human Services (HHS) and identical provisions in FDA’s proposed rule “Protection of Human Subjects and Institutional Review Boards.”  

Robert Nobles, DrPH, MPH serves as the Vice President for Research Administration at Emory University. In an email to PRIM&R, he explained his view: “The new draft guidance aims to simplify and capture the attention of prospective participants of FDA regulated research studies,” Dr. Nobles said. “I do believe that the core objective will be achieved, which is that key information of the trial will be presented and received in a palatable and understandable way.” 

Together, the PRIM&R community can offer important perspectives and be a valued voice in shaping federal policy. Share your thoughts with the FDA and OHRP about this draft guidance. The deadline for submitting a comment is April 30. 

“FDA’s proposed rule, if finalized, would harmonize certain sections of FDA’s regulations on human subject protections and institutional review boards (IRBs), to the extent practicable and consistent with other statutory provisions, with the revised Common Rule, in accordance with the 21st Century Cures Act (Cures Act),” the notice states. “The guidance addresses the provisions of the revised Common Rule that require informed consent to begin with key information about the research and to present information in a way that facilitates understanding and identical provisions in FDA’s proposed rule.” 

Albert J. Allen, MD, PhD, a member of PRIM&R’s Public Policy Committee, who has previously served on SACHRP to consider this issue, shared his thoughts with PRIM&R about this proposed guidance. “The guidance makes the very important point that the key information section should be relatively short – three pages or less – and is not unlike the verbal consenting process that occurs in clinical practice (short, hits the high points and key info, etc.)   

That is something that I think has been lost on some in industry, notably some lawyers in industry who often interpret ethics regulations for companies,” Dr. Allen said.  “So, I think the key information draft guidance provides some very important direction.”  

Dr. Nobles said, “The guidance is reflective of the fact that key information has historically been integrated into lengthy consent documents that often create periods of information overload for prospective participants or their legal guardians. The ‘bubble’ format is creative, in a time where many individuals in our communities have short attention spans and rely on social media and other headlines as a mechanism to capture information on critical topics.”  

“This guidance parallels the consumption practices of our prospective research participants. Overall, I think this is a positive step forward, but it doesn’t come with unintended consequences,” Dr. Nobles said 

“One of those unintended consequences is that prospective participants may believe that all they need to know is captured in the ‘Key Information’ section, which to some would be the executive summary of the entire consent document,” Dr. Nobles said. “Another risk is that IRBs will have another section that would need to be reviewed, revised, and often times negotiated with sponsors, as the sponsors may have strong opinions on what is ‘key’ and how the information is presented to the participants. The formatting is another challenge, as creating bubbles assumes that technology platforms are consistent across our communities.” 

Dr. Nobles said a final unintended consequence of the guidance is with respect to the following instructional statement: “We encourage interested parties to develop innovative ways and utilize available technologies to provide key information that will help prospective subjects better understand the reasons why one might or might not want to participate in the research.” Specifically, the guidance stated, “The key information section could also be presented using alternative media, such as illustrations, video, and electronic tablets, to meet the goals of improving clarity and increasing prospective subjects’ understanding of consent information.”   

“Introducing and encouraging innovation, creates additional considerations, competition, marketing, and ultimately ethical and compliance assessments that will need to be discussed locally within the IRBs to create alignment on cultural appropriateness and reflective enough of the study to be considered our best attempt at representing the study, in a condensed fashion,” Dr. Nobles said. 

Martha F. Jones, Vice President, Human Research Affairs at Mass General Brigham told PRIM&R, “I applaud FDA for its efforts to harmonize differences between their regulations and those of the Common Rule. The Key Information requirement for consent information is a prime example of where there is opportunity for both the FDA and the Common Rule to enact identical language in their respective regulations and the FDA has taken the opportunity to do so under their proposed regulations for Key Information.”  

“However, I am concerned about the amount of detailed information that is suggested to be included in the key information section and whether this really will serve the purpose of enhancing the understanding of participants,” Ms. Jones said. “For example, the amount of detail regarding the ‘reasonably foreseeable risks and discomforts’ could be interpreted to encompass the entirety of a consent section regarding the risks of the study.” 

Ms. Jones elaborated, “Noting that this should be included on the first page of the key information section is likely going to be challenging if one also considers that putting this type of information into a compact paragraph format is not ideal, but the use of even bulleted lists, or other formats such as bubbles, pictures, diagrams or images could greatly increase the number of pages needed to accommodate this information. The example of the bulleted information in the guidance appendix is helpful, but seems somewhat inconsistent with the extent of the information proposed in the guidance itself.”  

Jones shared that she participated in focus groups with research participants regarding what they would like to see in the Key Information section when the Common Rule was enacted. 

“The proposed amount of risk information was not at the top of the list for these individuals,” Ms. Jones said. “Rather at the top of their lists were: they wanted to know the time commitment; where they had to go to participate; what they needed to do; and what was the reimbursement or compensation for participation or if they were injured in some way.” 

“These participants wanted something like a table of contents at the beginning of their consents to allow them to jump quickly to the parts of the consent that most interested them and their particular situation,” she said. 

“Given that each person’s perspective and unique situation may make different information more ‘key’ to them than someone else, it is very difficult to develop a common approach to key information,” she said.  

A table of contents is included in the FDA guidance as a tool for navigating the consent information, she noted. “This along with the guidance to consider using a tiered approach to consent organization could be very useful in creating a more comprehensible set of information and, in fact, has been implemented with success as some research institutions,” Ms. Jones said. 

“The FDA guidance will be useful in reconsidering how the Key Information section of the consent should be presented,” Ms. Jones said. “However, more research with actual research participants on what is most important in the Key Information section and the best presentation methods would give us a better understanding of what is actually useful for different types of research regulated by the FDA.” 

 

Share your thoughts with the FDA and OHRP about this draft guidance. The deadline for submitting a comment is April 30.