The Revised Common Rule requires informed consent documents to begin with a concise summary of information that a “reasonable” person would want to know when deciding to participate or not participant in a research study. At the 2018 Advancing Ethical Research conference, panelists from the Office of Human Research Protections (OHRP), National Institutes of Health (NIH), and two research institutions discussed considerations for implementing the key information requirement.
This post originally appeared on Ampersand, the blog of Public Responsibility in Medicine & Research (PRIM&R), as a contribution to the Blog Squad for the 2018 Advancing Ethical Research Conference in San Diego, California.
“One person’s flexibility is another person’s ambiguity.”
I kept going back to this comment, articulated by Carrie Wolinetz (NIH), as I helped ORRP prepare for the revised Common Rule implementation in January 2019. Although Dr. Wolinetz was referring to the NIH’s Genomic Data Sharing Policy, the phrase is a perfect expression of my thoughts on the “concise and focused presentation of the key information” that now must appear at the beginning of consent forms.
This topic was addressed at the 2018 Advancing Ethical Research Conference plenary session “To Participate or Not to Participate, that Is the Question.” Moderated by Ivor Pritchard (OHRP), panelists Celia Fisher (Fordham University), Jonathan Green (NIH), and Ada Sue Selwitz (University of Kentucky) took on the challenge of interpreting the Revised Common Rule’s “reasonable person” standard and developing effective, study-specific key information. A few main points stuck with me.
“Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.”
45 CFR 46.116(a)(5)(i)
First, it’s helpful to frame the key information in terms of pros and cons—as the regulations put it, reasons why a person might or might not want to participate in a particular study. In addition, the panelists suggested that investigators think about aspects of a study that participants are likely to misunderstand and use these as the basis for developing key information. In most cases, investigators will be best able to determine what their target population would want to know and should craft the concise summary accordingly. That said, investigators and IRBs alike should take into account both the nature/type of research and the target population(s) when developing and evaluating key information.
Second, each institution must determine the degree to which key information will be prescribed by institutional policy, guidance documents, and/or consent templates. Specific guides, such as concise summary checklists, may reduce the time and effort required of study teams, IRB staff, and IRB reviewers to implement the new regulations; however, a mandated list of key information topics is unlikely to—and really shouldn’t—be appropriate for every study type or research population. Further, this approach doesn’t seem to honor the spirit of the concise summary requirement, which aims to enhance the consent process as a whole.
On the other hand, merely restating the regulations without providing guidance is likely to lead to frustration. I appreciated the University of Kentucky’s experience in its first attempt to implement the concise summary requirement: they received technical language pulled directly from clinical protocols, redundant summary information, lengthy lists of risk information, and so on. Leaving the concise summary completely open to investigators’ interpretation will require more thoughtful engagement on the part of study teams (which is not necessarily a bad thing), as well as significantly more staff and IRB review time.
A happy medium would be for institutional Human Research Protection Programs (HRPPs) to provide structure and guidance without prescribing the content or format of key information. I loved Kentucky’s approach of providing example key information pages for different types of studies, such as healthy volunteer Social, Behavioral, and Education Research (SBER) studies; placebo-controlled clinical trials; and biobanks. These samples were created for simulated studies, but HRPPs could consider identifying outstanding real-life examples of concise summaries as they are submitted; with investigators’ permission, they could be provided for download or otherwise made available to the local research community.
What I love about this approach is that the examples not only serve as models that researchers can use for their own consent documents, but also highlight the flexibility of the regulations and the variety of approaches available. So often, researchers (and IRBs) want to know the “right” way to comply with regulations; Kentucky’s models help remind the research community that the focus should be on what’s right for a particular study, rather than applying a one-size-fits all solution.