Re-Consenting Human Subjects in Research

Guidelines

If any significant changes are made in a research protocol, or new findings are developed during the course of the research, and such changes/new findings may relate to the subject's willingness to continue participation or may affect the long term health of the subject, the IRB may determine that the investigator must provide already-enrolled participants in the research with this information. The investigator should use one of the following methods to accomplish this: