This monthly features presents questions from clinical trial professionals with answers from WCG’s expert staff. This month features insights from quality assurance advisor Yvonne Higgins.

Question: We are submitting an amendment and revised informed consent document to our currently approved study. Do all participants need to be reconsented with the revised consent form?

Answer: Federal regulations do not specifically address “reconsent.” Both the Common Rule and FDA regulations require that researchers provide participants with significant new findings developed during the course of the research when those findings may relate to willingness to continue participation in the research.

The FDA’s informed consent information sheet says that “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.”

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. SACHRP recommended IRBs encourage use of the least burdensome approach for the participant: “…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 in which changes to the study might 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 adds burden/discomfort to the participant; and
• Availability of new alternative therapies.

SACHRP also devised a table of scenarios and suggested options for communicating new findings depending on the urgency of the communication and status of the participant.

The following hierarchy, proposed by WCG IRB chairs Currien MacDonald and Bert Wilkins, should be considered.

Verbal discussion should be considered when the information is not likely to change a 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.

When the information is simple but important for the participants to have in writing for future reference, consider informing them by letter. 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.

Consider an addendum when information may impact the participant’s decision to remain in the study but not to the level of needing to discuss the entire study. The benefit of using a consent form addendum rather than a full reconsent process is that it can provide a focused discussion of the new information. The decision to continue is documented by signing the addendum. Examples include new safety information or the addition of a new study procedure.

Reconsenting with a revised consent form should be considered when there is complex information to be conveyed and patients have not started the study or are continuing regularly scheduled procedures or study visits. Examples include participants moving into a new cohort or phase of the study, a changing adaptive study design or multiple changes being made to the study that make it impractical to provide the new information in any other way.

Read the FDA’s draft informed consent information sheet here: https://bit.ly/3AoxeSl.

Read the SACHRP table here: https://bit.ly/3Pm4WMi.