We are submitting an amendment and revised informed consent document to our currently approved study. Do all subjects need to be reconsented with the revised consent form?
The federal regulations do not specifically address “reconsent”. Both the Common Rule and the FDA regulations require that researchers provide subjects with significant new findings developed during the course of the research when those findings may relate to subject’s willingness to continue participation in the research.
When it is anticipated that significant new findings that would be pertinent to the subject’s continued participation are likely to occur during the subject’s participation in the study, the IRB should determine that a system, or a reasonable plan, exists to make such notification to subjects.FDA–A Guide to Informed Consent
Many researchers, IRBs, and sponsors struggle with just how that notification should take place. In March 2020, the Secretary’s Advisory Committee on Human Research Protections (SACHRP) published a set of recommendations on this topic. The SACHRP recommended that IRBs should encourage use of the least burdensome approach for the subject. “…the provision of new information should not automatically result in a process whereby subjects are expected to review and initial every page of the revised consent form every time there is a minor change.”
Examples provided by SACHRP of instances where changes to the study may affect a research participant’s willingness to continue and therefore should be disclosed to participants include:
- New research-related risks or increased frequency or magnitude of risks or a decrease in expected benefits
- Change to the research that add burden / discomfort to the subject
- Availability of new alternative therapies
SACHRP also devised a list of scenarios and suggested options for communicating new findings depending urgency of the communication and on the status of the subject. That table can be found at: https://www.hhs.gov/ohrp/sachrp-committee/recommendations/april-7-2020-attachment-a2-reconsent-appendix-2/index.html
Building on the SACHRP’s recommendations, Currien MacDonald and Bert Wilkins, WCG IRB Chairs, proposed the following hierarchy for communicating new information to subjects:
When the information is not likely to change participant’s decision to remain in the study. A verbal discussion may also be a first communication when providing new information that is urgent in nature and an addendum or revised consent document is being drafted.
|Examples include informing participants that certain procedures are no longer necessary without changes to the visit schedule (e.g., “|
When the information is simple but important for the participants to have in writing for future reference.
|Examples include informing participants that they can use a commercial lab to have blood samples drawn or informing the participants of a change of investigator.|
When information may impact the participant’s decision to remain in the study but not to the level of needing discussion of the entire study. The benefit of using a consent form addendum is that it can provide a focused discussion of the new information than a full reconsent process.
The decision to continue in the study is documented by signing the addendum.
|Examples include new safety information or the addition of a new study procedure.|
(With a revised consent form) when there is complex information to be conveyed and participants will have not started the study or will still be having regularly scheduled procedures or study visits. Participant signature indicates their willingness to continue in the study.
|Examples include participants are moving into a new cohort or phase of the study, when an adaptive study design may be changing, or when there are multiple changes being made to the study and it would be impractical to provide the new information in any other way.|