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Other Sites of Interest

*DOE*	DOE Protecting Human Subjects Home Page Human Subjects Protection Resource Book Human Genome Project (HGP) Human Subjects Policy Statement Human Subjects Research Database (HSRD) 10 CFR Part 745 - Protection of Human Subjects (.pdf) Order 443.1 - Protection of Human Subjects (.pdf) Policy 443.1 - Protection of Human Subjects (.pdf) Order 481.1C - Work for Others (Non-Department of Energy Funded Work) Order 484.1 � Reimbursable work for the Department of Homeland Security DOE Openness: Human Radiation Experiments DOE Former Worker Medical Surveillance Program
*DHHS/NIH*	NIH/BMI Federal Wide Assurance NIH Office of Human Subjects Research (OHSR) DHHS Office for Human Research Protections (OHRP) Compilation of International Policies Secretary's Advisory Committee on Human Research Protections (SACHRP) 45 CFR Part 46 - Protection of Human Subjects Subpart A - Federal Policy for the Protection of Human Subjects (Basic DHHS Policy for Protection of Human Research Subjects) Subpart B - Addition and Related Activities Involving Fetuses, Pregnant Women, and Human In Vitro Fertilization Subpart C - Additional DHHS Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects Subpart D - Additional DHHS Protections for Children Involved as Subjects in Research Applicability of 45 CFR part 46 to Clinical Investigations Conducted Under FDA's Interim Final Rule at 21 CFR 50.23(e) NIH National Human Genome Research Database NIH Bioethics Resources on the Web NIH Implementation of Office for Human Research Protections (OHRP) Guidance on Research Involving Coded Private Information or Biological Specimens NIH How to Write a Human Subjects Grant Application Pending Legislation Health Insurance Portability and Accountability Act 801996 (HIPAA) for Research ClinicalTrials.gov
*FDA*	Medical Devices; Exception From General Requirements for Informed Consent. 21 CFR 50.23(e) FR Doc E6-8790 CFR Title 21, Part 361.1 - Radioactive Drugs for Certain Research Uses CFR Title 21, Part 50 - Food and Drug Administration (FDA) Human Subjects Regulations Information for Health Professionals Center for Biologics Evaluation and Research (CBER) Licensed Establishments and Products FDA Warning Letters Sent for Violation of FDA Rules
*CDC*	Confidentiality Manual (.pdf) Privacy and Confidentiality Protection in CDC-funded Activities, including Certificates of Confidentiality
*Battelle*	Battelle Federal Wide Assurance Software Systems Engineering Process (SSEP) Guide - Human-Computer Interaction (restricted access) PNNL Institutional Biological Safety Committee (restricted access)
*DoD*	DoD Directive 3216.2 (.pdf) - "Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research" DoD Instruction 1100.13 (.pdf) - "Surveys of DoD Personnel"
*Other*	The President�s Council on Bioethics Public Responsibility in Medicine and Research (PRIM&R) Advisory Committee on Human Radiation Experiments (ACHRE) (at the National Security Archive) Code of Federal Regulations (CFR) International Oral History Association SBMS References