Informed consent

In a clinical study, informed consent is consent given by a participant, or in the case of an individual that can only give assent, by a parent or legal guardian, for the participation in a clinical study only after having achieved an understanding of both the relevant medical facts and the relevant risks involved. Informed consent is usually documented by means of a written, signed, and dated informed consent form, which has been approved by an Institutional Review Board (IRB).

An informed consent for a registry is consent given by a participant or their legal guardian to participate in the registry after understanding the purpose of the registry, how the participant’s information with be used and shared, safeguards to personal identifying and sensitive information, plans to maintain the registry, etc. IRB approval may be required depending on the data being collected and the goal(s) of the registry.

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National Institute on Aging (NIA) Glossary of Clinical Research Terms
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NCATS Toolkit for Patient-Focused Therapy Development: Consent Requirements
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