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Options for Sharing New Information

1. Verbal Exchange

Information should only be shared in this way if it does not affect risk to subject.
Conducted during a routine study visit or by phone.
Document discussion in the research record.

2. Informational Sheet

Information shared in this way typically does not substantially affect risk to subject.
Does not require a subject signature, but investigator needs to document that information was provided to the subject in a research record.
IRB review/approval is required prior to distributing to subjects.