| http://www.w3.org/ns/prov#value | - The significant risk (SR)/non-significant risk (NSR) determination is made initially by the sponsor (or sponsor-investigator) but must be confirmed by an IRB. If the sponsor believes the study is NSR, the sponsor provides the reviewing IRB with an explanation of its determination and any other information that may assist the IRB in evaluating the risk of the study.
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