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Current as of January 02, 2025 | Updated by Findlaw Staff
(a) A licensee may conduct research involving human research subjects only if it uses the byproduct materials specified on its license for the uses authorized on its license.
(b) If the research is conducted, funded, supported, or regulated by another Federal agency that has implemented the Federal Policy for the Protection of Human Subjects (Federal Policy), the licensee shall, before conducting research—
(1) Obtain review and approval of the research from an “Institutional Review Board,” as defined and described in the Federal Policy; and
(2) Obtain “informed consent,” as defined and described in the Federal Policy, from the human research subject.
(c) If the research will not be conducted, funded, supported, or regulated by another Federal agency that has implemented the Federal Policy, the licensee shall, before conducting research, apply for and receive a specific amendment to its NRC medical use license. The amendment request must include a written commitment that the licensee will, before conducting research—
(1) Obtain review and approval of the research from an “Institutional Review Board,” as defined and described in the Federal Policy; and
(2) Obtain “informed consent”, as defined and described in the Federal Policy, from the human research subject.
(d) Nothing in this section relieves licensees from complying with the other requirements in this part.
Cite this article: FindLaw.com - Code of Federal Regulations Title 10. Energy § 10.35.6 Provisions for the protection of human research subjects - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-10-energy/cfr-sect-10-35-6/
FindLaw Codes may not reflect the most recent version of the law in your jurisdiction. Please verify the status of the code you are researching with the state legislature before relying on it for your legal needs.
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