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Duties of the Committee

    1. Ensures the safe use of all radioactive materials and sources of radiation throughout NIH and those NIH-occupied buildings included within the NIH Radiation Safety Program, for the Director, NIH.

    2. Delegates to the NIH Radiation Safety Officer the authority to implement the Radiation Safety Program and enforce applicable Federal regulations and NIH radiation safety policies and procedures to ensure the radiation safety of persons and protection of the environment.

    3. Provides technical advice, assistance, and management-level support to the Radiation Safety Officer in implementing the Radiation Safety Program and the NIH program for maintaining radiation exposures to employees, patients, and research subjects as low as reasonably achievable (ALARA).

    4. Reviews the Radiation Safety Program at least annually to determine that all activities involving radioactive materials and sources of radiation are being conducted safely and in accordance with applicable Federal regulations and NIH radiation safety policies.

    5. Reviews the qualifications of licensed physicians and grants approval for the use of radioactive materials in human subjects. If a Committee member is an investigator who may participate in the research being proposed in an application to the Committee, he or she shall abstain from voting on the approval or disapproval of the application.

    6. Performs functions of the Radioactive Drug Research Committee in accordance with applicable regulations of the Food and Drug Administration, PHS, DHHS.

    7. Approval of the RSC is required before the initiation of approved clinical research studies involving exposure of human subjects to ionizing radiation for research purposes from which the subject does not benefit, i.e., when normal volunteers or patient volunteers are involved and the use of radiation or radioactive materials is not a standard medical procedure which is required for the clinical management of the patient. Research uses subject to this review shall include all studies involving normal volunteers and experimental procedures for diagnosis or treatment, including uses for which an Investigational New Drug (IND) application is required by the FDA and radioactive research drugs regulated under FDA regulations contained in 10 CFR 361, §361.1.

    8. The Chairperson of the Radiation Safety Committee acts for the Director, NIH, in all matters relating to Federal or State radioactive material or radiation source licensing.

    9. Establishes and revises radiation safety policies, consulting with the Office of the Director through the Management Representative on issues that require involvement of upper level management, e.g., in cases when there is significant potential for impact on the NIH mission.

    10. Establishes working groups and appoints ad hoc members to the Committee, as the Committee deems necessary.



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