ACHRE Report
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DOE Openness: Human Radiation Experiments: Roadmap to the Project ACHRE Report |
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ACHRE Report Part III Chapter 14 The Federal Policy for Human Subject Protections (The Common Rule) Research Involving Ionizing Radiation Scope of Programs of Research Involving Human Subjects Administravtive Structures and Procedures for Research Oversight Federal Responses to Violations of Human Subjects Protections |
Chapter 14: Research Involving Ionizing RadiationBeyond the strictures of the Common Rule, research involving either external radiation or radioactive drugs usually undergoes additional reviews for safety and risk (including a review of radiation dose) prior to IRB review at the local research institution. Most medical institutions have a radiation safety committee (RSC) responsible for evaluating the risks of medical activities involving radiation, whether for diagnostic, treatment, or research purposes, and limiting the exposure of both employees and subjects to radiation. In addition, research and medical institutions that perform basic research involving human subjects and radioactive drugs must have such studies reviewed and approved by a radioactive drug research committee (RDRC)--a local institutional committee approved by the Food and Drug Administration (FDA) to ensure that safeguards, including limitations on radiation dose, in the use of such drugs are met.[12] Notwithstanding the prior review and approval of either or both of these radiation committees, the IRB must also assess the risks and potential benefits of the proposed research before approving it.[13]
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