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.
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.
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.
