The following links
provide access to bioethics related organizations, reports, regulations,
and educational resources produced by federal government agencies other
than the NIH. Federal
Register, Publications, and Regulations - sources for bioethics
related documents
The National Records and Archives Administration - website provides access to:
Federal Regulations, Policies, and Assurances for the Protection of Human Subjects - provided by the Office for Human Research Protections (OHRP) healthfinder - a comprehensive DHHS funded database of health related resources that includes several bioethics links. Health Law Hippo - a collection of policy and regulatory materials related to health care and bioethics. (Note: this not a federal web site.) Web site is provided by Findlaw. DHHS Office of the Inspector General Reports - Office of Evaluation and Inspection (OEI) - see "Institutional Review Boards: A Time for Reform" The Advisory Committee on Human Radiation Experiments - The Final Report FedWorld.gov - provides a search engine for government reports that can be obtained on the Web or purchased. Computer Retrieval of Information on Scientific Projects (CRISP) - this is a database of available and historical award information funded by NIH, SAMHSA, HRSA, FDA, CDC, AHCPR, and OASH. Use search phrase "ethics". From Test Tube To Patient: New Drug Development in the United States - an informative primer from the Food and Drug Administration that explains the role of clinical trials in the drug development process.
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 works to undertake fundamental inquiry into the human and moral significance of developments in biomedical and behavioral science and technology; to explore specific ethical and policy questions related to these developments; to provide a forum for a national discussion of bioethical issues; to facilitate a greater understanding of bioethical issues; and to explore possibilities for useful international collaboration on bioethical issues. 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. FDA Guidance for Industry - Financial Disclosure by Clinical Investigators [Guidance] . The National Bioethics Advisory Commission (NBAC) - The Commission's charter expired in October, 2001, but 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 Decisionmaking Capacity, and Cloning Human Beings. Department of Health and Human Services (DHHS) - the United States government's principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. Click here for DHHS agencies. Office for Human Research Protections - formerly the Office for Protections from Research Risks (OPRR). The Office provides guidance and oversight for human subjects research conducted with Public Health Service (PHS) funds. This site contains the IRB Guidebook, federal regulations, guidance and educational materials, as well as sample informed consent and assurance documents. The National Science Foundation (NSF)'s Societal Dimensions of Engineering, Science, and Technology (SDEST) consolidates two former NSF programs: Ethics and Values Studies, and Research on Science and Technology. Information is included here on special NSF funding opportunities in environmental ethics, and value dimensions associated with the conduct and impacts of science, engineering, and technology The National Science Foundation's Interpreting the Common Rule for the Protection of Human Subjects in Behavioral and Social Science Research -- a set of frequently asked questions and vignettes. The Office of Research Integrity (ORI) - of the Department of Health and Human Services. Site includes publications, regulations and guidelines, information on whistleblower issues, and case studies and data. Centers for Disease Control (CDC) Office of Genomics and Disease Prevention - provides public health professionals with current information on the impact of human genetic research and gene discoveries on disease prevention and health promotion. Secretary's Advisory Committee on Genetic Testing (SACGT) - site includes background and meeting information, and a list of reports. The Department of Energy (DOE) Protecting Human Subjects page has links to human subjects policies and regulations, educational information and resources, genome research resources, a national conference calendar, 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 soon, a site for Scientific Integrity DOE Office of Human Radiation Experiments - established in March 1994, leads the Department of Energy's efforts to tell the agency's Cold War story of radiation research using human subjects. The website provides historical information, multimedia clips, a searchable database, and related links.
The Advisory Committee
on Human Radiation Experiments - dissolved in October, 1995, the
website is now maintained by the National Security Archive. Site includes
information on the committee meetings and the final report.
Office for Human Research Protections - formerly the Office for Protections from Research Risks (OPRR). The Office provides guidance and oversight for human subjects research conducted with Public Health Service (PHS) funds. This site contains the IRB Guidebook, federal regulations, guidance and educational materials, as well as sample informed consent and assurance documents. The Office of Research Integrity of the Department of Health and Human Services promotes integrity in biomedical and behavioral research supported by the Public Health Service (PHS) at about 4,000 institutions worldwide. ORI monitors institutional investigations of research misconduct and facilitates the responsible conduct of research through educational, preventive, and regulatory activities. DHHS
Final Policy on Instruction in the Responsible Conduct of Research - Suspended. 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. From Test Tube To Patient: New Drug Development in the United States - an informative primer from the Food and Drug Administration that explains the role of clinical trials in the drug development process. Information for Clinical Investigators - provided by the Center for Drug Evaluation and Research of the FDA. 45-CFR-46 - Protection of Human Subjects (The Common Rule) - (Code of Federal Regulations effective August 19, 1991) Interpretive Guide to the Common Rule (45-CFR-46) - published by USAID - guide developed by a working group of Federal Agency individuals involved in human research subjects protections. The Department of Energy (DOE) Protecting Human Subjects page has links to human subjects policies and regulations, educational information and resources, genome research resources, a national conference calendar, 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 soon, a site for Scientific Integrity The Department of Education Protection of Human Subjects Page - contains both department and federal regulations.
CDC Human Subjects Research
Page - provides human subjects regulating documents, ethical guidelines
for the protection of human subjects, and IRB checklists and forms. Human Genome Project (HGP) Information by the DOE - features links on the HGP, including 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
Centers for Disease
Control (CDC) Office of Genomics and Disease Prevention - provides
public health professionals with current information on the impact of
human genetic research and gene discoveries on disease prevention and
health promotion. Last updated: 12/06/02 10:33 AM |