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A. The HSC may waive the requirement to obtain a signed consent form for some or all of the subjects if the investigator presents evidence and the HSC agrees either
1. that (a) the only record linking the subject and the research would be the consent document, (b) the principal risk would be potential harm resulting from breach of confidentiality, and (c) each subject will be asked whether the subject wants documentation linking the subject with the research and the subject's wishes will govern.
or
2. that (a) the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
B. In cases where the documentation is waived, the HSC may require the investigator to provide the subjects with a written statement regarding the research.
C. Investigators seeking waiver of documentation requirements should include in the Application for Approval of Activity Involving Human Subjects (UCSB/ORDA Form 112f, Attachment A) the basis for such a request.
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