Question:

Is it mandatory to update the consent form during a yearly Investigator Brochure update (when the safety updates were already shared with sites via Dear Investigator letters), or can the updates wait until the next protocol amendment that requires a consent form update?
– Study Lead at a Large Biopharma

Response:

The answer to this question largely depends on what new information is contained within the Investigator’s Brochure update.  When the new information is significant, such as new risk or safety information, then the start of the answer to this question is in 21 CFR 50.25(b)(5), which states that “significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided to the subject.”

The question is when, and how. These aspects were addressed by the Secretary’s Advisory Committee on Human Research Protections (SACHRP) in their recently published recommendation titled “New Information Provided to Previously Enrolled Research Subjects.” In this recommendation, SACHRP notes that consent is an ongoing process and that “in some research studies, circumstances arise in which new information becomes available that needs to be shared with subjects as part of this ongoing consent process.”

As noted in the SACHRP recommendation, there is no regulatory requirement that states that the new information must be added to the consent form, and subjects thereafter re-consent to participation in the research. However, when the information is significant, it must be communicated to subjects, which can be done in several different ways. It may be by providing the information verbally to subjects and documenting the discussion in the research record, or the use of a consent form addendum. However, modification to the existing consent form and re-consent of subjects is often a best practice.

A few key points to consider when determining when and how to provide significant new information to research subjects:

  • Subjects should be provided significant new information as soon as possible
  • The significant new information will also need to be provided to new subjects that enroll in the research if the study is still open to enrollment
  • It is appropriate to document, by a research record note or consent form (including addendum), that the subjects received the information and thereafter still agree to participation in the research

Given these points, when there is significant new information that has been provided to investigator’s via a Dear Investigator Letter, the most prudent time to provide information to subjects is upon provision of the Dear Investigator Letter, rather than waiting until the time of updating the Investigator’s Brochure.  If the Consent Form has not yet been updated by the time the Investigator’s Brochure has been updated, it would be appropriate to update the Consent Form at that time, rather than waiting until there is a protocol amendment necessitating further consent form updates.

 [LA2]https://www.hhs.gov/ohrp/sachrp-committee/recommendations/april-7-2020-attachment-a/index.html