The 2018 Common Rule’s requirement that informed consent begin with a concise and focused summary of “key information” to facilitate a prospective participant’s understanding of the reasons why one might or might not choose to participate in research is intended to improve the informed consent process. Whether it will succeed in doing so depends in large part on how the requirement is met. A team comprising Holly Taylor of the NIH Clinical Center’s Department of Bioethics; Susan Kornetsky of Boston Children’s Hospital; and Megan Kasimatis Singleton of the Johns Hopkins University School of Medicine, and myself recently completed a project examining how, in the absence of federal guidance, institutions are interpreting and applying the key information requirement and, specifically, whether and to what extent they are developing policies, guidance, templates, or other tools to help researchers and IRBs apply this provision of the Common Rule.
We undertook this project as part of the Consortium to Advance Effective Research Oversight (AEREO)—a group of leaders in human research oversight, research ethics, and empirical methods dedicated to evaluating and improving the effectiveness of IRBs and HRPPs through empirical research. To conduct our analysis, we requested that the 26 AEREO members who lead or are actively involved with the HRPP at their institution provide any templates, guidance, and examples they have created related to the key information requirement. Twenty-four individuals responded with materials. We collected 21 templates, 9 guidance documents, and 8 sets of examples. Two members of our project team reviewed each set of documents, highlighting areas of similarly and variability, and a summary of our findings was completed.
One key overall finding was that most AEREO institutions are providing templates to their researchers, but that the templates vary significantly in content and format. We also found that there is wide variation in how directive the materials provided are regarding what information to include in a “key information” section of consent, with the documents covering the whole spectrum from being very directive about specific language to use to encouraging creativity about what to include based on the specifics of the study and the study population.
PRIM&R is pleased to share with the human research protections community the materials collected during this project as a public resource. We have created a webpage that provides a summary of our project and its findings (as both a narrative report and PowerPoint deck) as well as redacted versions of each of the specific documents collected from AEREO institutions. We hope it will be interesting and useful to the community to see examples of what some of your sister institutions are doing to meet they key information requirement. On behalf of the project team, I want to thank the AEREO members who participated and agreed to allow us to share their documents with the community.
Finally, as you peruse these documents, I encourage you to share any of your experiences with the approaches identified here, and to share your own documents, which we would be happy to post to the site as well.