New Exemption Categories 7 and 8 – Storage or Maintenance of Identifiable Information or Identifiable Biospecimens / Secondary Research Requiring Broad Consent
| Final Rule13 (new exemption categories at 45 CFR §46.104) | |
| (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 45 CFR §46.111(a)(8). | |
| (8) Secondary research for which broad consent is required: research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met: (i) broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with 45 CFR §46.116(a)(1) through (4), (a)(6), and (d); and (ii) documentation of informed consent or waiver of documentation of consent was obtained in accordance with 45 CFR §46.117; (iii) an IRB conducts a limited IRB review and makes the determination required by 45 CFR §46.111(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. |
IRB, institutional review board.