Other Federal Resources
The following links provide access to bioethics regulations, agency resource sites and reports produced by federal government agencies other than the NIH.
Register, Regulations, and Publications
US Government Printing Office GPO Access – This site provides access to resources from the National Archives and Records Administration (NARA) and links to:
The Federal Register(1994-forward).
The Code of Federal Regulations (1996-forward) .
Public and Private Laws (1995-forward).
Code of Federal Regulations-45CFR46 - Protection of Human Subjects, Regulations provided by the federal Office for Human Research Protections (OHRP) have been adopted in common by several Federal agencies.
healthfinder - A comprehensive DHHS funded database of health related resources that includes several bioethics links.
DHHS Office of the Inspector General Reports – The Office of Evaluation and Inspection (OEI) has published a number of reports. Search for Clinical Research Ethics, for Institutional Review Boards, Clinical Research or other topics
FedWorld.gov – Provides a search engine for government reports that can be obtained on the Web or purchased. Search for Bioethics or specific topics.
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Committees, and Offices
The President's Council on Bioethics - Advises the President on bioethical issues that may emerge as a consequence of advances in biomedical science and technology. It undertakes inquiries into the human and moral significance of developments in biomedical and behavioral science and technology; explores specific ethical and policy questions related to these developments; provides a forum for a national discussion of bioethical issues; facilitates a greater understanding of bioethical issues; and explores possibilities for useful international collaboration on bioethical issues
Department of Health and Human Services (DHHS) – DHHS is the US government's principal agency for protecting the health of Americans and providing essential human services. Many of the key federal agencies, offices and committees that work in bioethics are part of DHHS. Please note that NIH, also part of DHHS, is described in the preceding section.
Food and Drug Administration - The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, food supply, cosmetics, and products that emit radiation. The FDA also is responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safe, and affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
Information Sheets for the Guidance of IRBs and Clinical Investigators - Provided by the Food and Drug Administration (FDA). Topics include, among others: answers to FAQs, informed consent guidance, list of various regulations and their differences, and information on continuing review. Also see the FDA Center for Biologics Evaluation and Research for information, guidelines, speeches, and publications about storing tissue samples.
FDA Guidance - Financial Disclosure by Clinical Investigators (1999) – Guidance for industry on disclosure of financial interests.
From Test Tube To Patient: Improving Health through Human Drugs (2006) - A primer from the Food and Drug Administration that explains the role of clinical trials in the drug development process.
Information for Clinical Investigators (2004) - Provided by the Center for Drug Evaluation and Research (CDER) - The FDA's CDER provides guidance for conducting clinical trials with investigational drugs and information for compliance with the regulations of the FDA.
Center for Disease Control and Prevention (CDC) - CDC works with partners to monitor health, detect and investigate health problems, conduct research, develop and advocate public health policies, implement prevention strategies, promote healthy behaviors, and to foster safe and healthful environments,CDC Office of the Associate Director for Science - This site includes CDC policies for protection of human subjects, IRB procedures and other policies.
CDC – This site includes web versions of publications from conferences and workshops that address ethical issues.
Centers for Disease Control (CDC) Office of Genomics and Disease Prevention – This site provides current information on the impact of human genetic research and gene discoveries on disease prevention and health promotion.
Indian Health Service (IHS) – The IHS seeks to foster the physical, mental, social, and spiritual health of American Indians and Alaska Natives. The IHS supports medical and behavioral/social research. In addition to adhering to the Regulations in 45CFR46, there are additional requirements for the IHS Research Program
Office for Human Research Protections – This DHHS Office provides leadership on human research subject protections and implements a program of compliance oversight for regulations for the protection of human subjects. This site contains federal regulations, and policy guidance. It is also the office for IRB registration and for obtaining an approved federal wide assurance. The site includes educational material and notices and reports of educational conferences, including the 2005 report and the 2006 report on alternative IRB models. It includes references to international policies and other documents.
The Office of Research Integrity (ORI) – This DHHS site includes publications, regulations and guidelines, information on whistleblower issues, educational material, case studies and data, and information on research programs in responsible conduct of research and scientific integrity.
The Secretary's Advisory Committee on Human Research Protections (SACHRP) – The Committee provides expert advice and recommendations to the Secretary, DHHS on issues and topics pertaining to or associated with the protection of human research subjects. The site posts reports in its documents section.
The National Bioethics Advisory Commission (NBAC) - The Commission's charter expired in 2001 and it has been discontinued. This web site has archived information on its meetings, subcommittees, and reports, including: Ethical Issues in Human Stem Cell Research, Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, Research Involving Persons with Mental Disorders That May Affect Decision-making Capacity, and Cloning Human Beings.
Secretary's Advisory Committee on Genetics, Health and Society (SACGHS) – This committee provides policy advice to the DHHS on the broad array of complex medical, ethical, legal, and social issues raised by the development and use of genetic technologies. This site houses the archives of the Secretary's Advisory Committee on Genetic Testing (SACGT), a committee that has been discontinued. The Committee is managed by the Office of Biotechnology Activities, NIH.
Secretary’s Advisory Committee on Xenotransplantation (SACX) The SACX was discontinued in June 2005. Because xenotransplantation remains an important public health issue, the DHHS continues to monitor xenotransplantation issues. PHS PHS Guideline on Infectious Disease Issues in Xenotransplantation are posted. The site is maintained by the Office of Biotechnology Activities at NIH.
Computer Retrieval of Information on Scientific Projects (CRISP) – This resource is a database of current and historical information on awards funded by NIH, SAMHSA, HRSA, FDA, CDC, AHRQ, and OASH (DHHHS agencies). Use the search phrase "ethics” to identify research and conference awards on that address ethics.
Department of Education (ED) – The ED site includes information about protection of human subjects in ED supported and conducted research and links to Regulations Governing the Protection of Human Subjects in Research.
Department of Energy (DOE) – The DOE seeks to protect the health and safety of workers and of the environment. The DOE partnered in the Human Genome Project and has an active program to protect human subjects of research. Search the DOE page for ‘ethics’ to access codes of ethics and reports, Search for human research ethics to access DOE information on human subjects protections.
DOE Office of Human Radiation Experiments – The Office was established in1994 to provide information about the agency's radiation research using human subjects during the Cold War. The website provides historical information, multimedia clips, a searchable database, and related links.
The Advisory Committee on Human Radiation Experiments – This group was dissolved in1995 The website is now maintained by the National Security Archive. Site includes information on the committee meetings and the final report. The Advisory Committee on Human Radiation Experiments - The Final Report.
The Department of Energy (DOE) Protecting Human Subjects page – The page has links to human subjects policies and regulations, educational information and resources, genome research resources, computer-based training for human subjects researchers, as well as links to the DOE Human Subjects Working Group, Research Projects Data Base, Worker Health Related Studies, the Human Radiation Experiments, and Scientific Integrity. The DOE newsletter on human research protections is published periodically.
Human Genome Project (HGP) Information by the DOE – This site features links on progress and goals of the HGP and information for educators and students. For the ethical, legal and social issues raised by the project see the DOE's ELSI page.
Department of Defense (DoD) - This link provides information for researchers and IRBs for research conducted or supported by the DoD. It includes references to Regulations and supplementary policy and guidance documents.
The links below for the different services specify the human protections and other policies and directives governing research with humans by military organizations. For additional information on human subjects protection programs of the U.S. military services see:
U.S. Army Clinical Investigation Regulatory Office (CIRO) This site links to other Army policy documents.
Bureau of Medicine and Surgery (BUMED)
Office of Naval Research (ONR)
US Air Force Protection of Human Subjects in Biomedical and Behavioral Research
DoD Directive 3216.2, “Protection of Human Subjects and Adherence to Ethical Standards in DoD–Supported Research”
Title 32, Code of Federal Regulations, Part 219, “Protection of Human Subjects,” also known as the “Common Rule,”
Section 980 of title 10, United States Code
DoD Directive 6200.2, “Use of Investigational New Drugs for Force Health Protection,”
DoD Directive 6000.8, “Funding and Administration of Clinical Investigation Program,"
Environmental Pro tection Agency (EPA) – The EPA regulations for protection of human subjects of research recently have been modified. Expanded Protections for Human Subjects in Research Studies provides further guidance to the EPA document What Do We Mean by Human Studies.
National Aeronautics and Space Administration (NASA) - NPD 7100.8, Protection of Human Research Subjects is the NASA policy for protecting human welfare in research.
The National Science Foundation (NSF) - Interpreting the Common Rule for the Protection of Human Subjects in Behavioral and Social Science Research is a set of frequently asked questions and vignettes for different types of research.
Department of Veterans Affairs (VA) – The VA has several programs to protect the welfare of research subjects. Program for Research Integrity Development and Education (PRIDE). PRIDE is responsible for all policy development and guidance, and all training and education in human research protection throughout the VA.
Department of Agriculture (USDA) – The Agricultural Research Service has adopted policies and regulations to protect human welfare in research and that outline requirements for membership on IRBs and research review committees. They are specified in Protection of Human Subjects
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