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Attachment A1 - Reconsent 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)

Related Letters

Content created by Office for Human Research Protections (OHRP)
Content last reviewed on May 4, 2020