Do sponsors have to change their informed consent documents?

Question:

I work for a small biotech company. We’ve been hearing some of our investigators talk about a new regulatory requirement for informed consent documents that includes a summary section in the front of the consent. Our regulatory team cannot find this in any new regulation or guidance from FDA. Can you help?

Answer:

There are two main federal entities of the US Department of Health and Human Services that have regulations that govern informed consent as part of the protection of human research participants; the Food and Drug Administration (FDA), which has oversight of studies being performed with the purpose of seeking marketing approval for a drug, biologic or medical device, and the Office of Human Research Protection (OHRP), which has oversight of research that is funded by the US Department of Health and Human Services (including the National Institutes of Health and the National Cancer Institute).

The research you do is most likely overseen by FDA. While FDA has not changed its regulations about informed consent, OHRP recently did, with some new requirements that went into effect in January 2019. These requirements include a “key information” section that summarizes the information most important for a potential participant to know about the study.

Technically, these requirements do not apply to FDA-regulated research- at least not until the FDA harmonizes with the OHRP requirements, which they have said they intend to do. However, at many research sites which use a local IRB, the institution may have decided to apply the same new requirements for consent forms for all research, regardless of whether the research is under OHRP or FDA. So, you may be asked to update your consent forms to comply with this new requirement, at least at some sites.

We have written Recommendations for Study Sponsors on Anticipated Required Changes for Informed Consent Documents, which goes into more detail about the consent changes, to help answer questions on this topic.