Re-Consenting Subjects Guidance

Version Date: October 10, 2005

Guidance regarding provision of significant new findings and consent form revisions to research subjects

The Health Sciences Institutional Review Boards (HS-IRBs) require disclosure to subjects of significant new findings that develop during the course of a research study, which may relate to the subject's willingness to continue participation in the research study [45 CFR 46.115(a)(7), 45 CFR 46.116(b)(5); 21 CFR 50.25(b)(5), 21 CFR 56.115(a)(7)].  Significant new findings often result in changes to the consent form or protocol after subjects have signed a consent document.  The purpose of this document is to provide guidance to researchers regarding the types of information the IRB considers to constitute significant new findings, what changes to the protocol or consent form should and should not be conveyed to subjects, and the means through which the IRB expects significant new findings or changes to be conveyed to subjects.

What constitutes significant new findings requiring report to subjects
Significant new findings generally include, but are not limited to:

How to report significant new findings or changes to subjects
The presentation of significant new findings to subjects can be accomplished through various means, including the following.
IRB review of significant new findings or changes
In general, the HS-IRBs must review the new information to be provided to subjects prior to its dissemination unless the information must be provided to subjects to eliminate an apparent immediate hazard to subjects or others.  In the case where the new findings must be reported to subjects before IRB approval can be obtained because of a potential immediate hazard, the researcher must report the dissemination of this information to the applicable IRB within 14 business days.

Significant new findings that the researchers propose to disseminate can be submitted for IRB review using a Change of Protocol.  In the case of oral dissemination of new findings, please provide the IRB a copy of the script that will be followed when contacting the subject or describe the information that will be conveyed to subjects.  If subjects will be provided with written materials, these documents should be submitted with the Change of Protocol.

When re-consenting subjects should not be pursued
The HS-IRBs are aware that study sponsors often request or require researchers to present revised consent documents to subjects to sign ("re-consent") when they have been revised, regardless of the significance of the new information or change.  In many cases asking subjects to sign a revised consent form is inappropriate and may result in needless burden on the subject, presentation of irrelevant information to the subjects and potential dilution of the impact of significant new findings.  Consequently, the HS-IRBs generally disallow re-consenting subjects when the revisions to consent documents would not or could not affect the subject's willingness to continue participation in the research study.  Examples of situations the IRBs generally would not approve re-consenting subjects include:
Addendum for Reconsenting Subjects