As part of the Consortium to Advance Effective Research Ethics Oversight (AEREO), PRIM&R's Executive Director, Elisa A. Hurley, 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 recently completed a project on the application of the 2019 Common Rule's key information requirement. The Rule requires 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. The project examined 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
Templates, guidance documents, and examples were provided by AEREO members and were analyzed by the project team, who then wrote a summary of their findings. 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. 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 a summary of the findings and redacted materials collected during this project; 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*. Download the findings and materials in zip files** below:
Download summary slides and narrative report from the AEREO project team
*These examples are not a set of instructions, but a set of sample approaches.
**The zip files may take a few minutes to download.
Thank you to the AEREO members who participated and agreed to allow us to share their documents with the community!