APPENDIX 1
New Information Provided to Previously Enrolled Subjects
Examples* of Instances where changes to the study may affect a research participant’s
willingness to continue and therefore should be disclosed to participants are, but not limited to, the following:
• Identification of new research-related risks
• Increase in the frequency or magnitude of previously described risks (e.g., serious cardiac event, severe allergic reaction)
• Unanticipated problem that exposes subjects to new risks, such as a data breach.
• Decrease in expected benefits to participation (e.g., limited efficacy of experimental therapy)
• Change to the research that results in increased burden / discomfort
• Availability of new alternative therapies (e.g., FDA approval of a new drug or device for the condition under study)
• Impact of participation on alternative therapies (e.g., investigational agent reduces effectiveness of alternatives or precludes future treatment with standard of care therapy)
