The more we learn about the Revised Common Rule’s (RCR) requirement that “informed consent begin with a concise and focused presentation of the key information … most likely to assist” in the decision whether or not to join a study, the more we realize that there’s still a lot more to learn, much of which we’ll be able to figure out only after the RCR’s Jan. 19, 2019, implementation date. But, we’ve received some suggestions that will help us meet this new requirement right out of the gate that we wanted to share.
While the Office for Human Research Protections (OHRP) has yet to issue any formal guidance about what these “key elements” are to address, the Secretary’s Advisory Committee on Human Research Protections (SACHRP; pronounce it “sack-harp”) has weighed in. Read SACHRP’s entire comment here.
It’s noteworthy that neither the regulation nor SACHRP specifically mandate what should be included as “key information.” Both groups recognize the need for flexibility, given the wide variety of research types and subject populations subject to the RCR. SACHRP does provide a list of questions to guide investigators determinations of what to include. These questions are:
- What are the main reasons a subject will want to join this study?
- What are the main reasons a subject will not want to join this study?
- What is the research questions the study is trying to answer? Why is it relevant to the subject?
- What aspects of research participation or this particular study are likely to be unfamiliar to a prospective subject, diverge from a subject’s expectations, or require special attention?
- What information about the subject is being collected as part of this research?
- What are the types of activities that subjects will do in the research?
- What impact will participating in this research have on the subject outside of the research? For example, will it reduce options for standard treatments?
- How will the subjects experience in this study differ from treatment outside of the study?
- In what ways in this research novel?
It’s also important to note SACHRP specifically states this is not an exhaustive list, and this list should not be used as a checklist. We feel the same way about the “key information” template we’ve made available on the IRB’s website. The template is a guide, and nothing about is set in stone. Investigators are encouraged to adapt it as needed to best suit their studies and target populations.
IRB Blog Central thanks Christopher Trudeau, JD, Associate Professor at the UAMS Center for Health Literacy, for his assistance in distilling the SACHRP guidance.