Source: https://www.govregs.com/regulations/title29_part21_section21.104
Timestamp: 2019-04-21 15:06:44+00:00

Document:
29 CFR 21.104 - Exempt research. § 21.104 - Exempt research.
§ 21.104 - Exempt research.
(iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by § 21.111(a)(7).
(C) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by § 21.111(a)(7).
(7) Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by § 21.111(a)(8).
(iii) An IRB conducts a limited IRB review and makes the determination required by § 21.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and (iv) The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.

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