Agencies
Center for Drug Evaluation and Research (CDER) Clinical Investigator Information
U. S. Food and Drug Administration (FDA)
International Conference on Harmonisation
Office for Human Research Protections (OHRP)
World Medical Association
The World Medical Association (WMA) is the organization that issued the Declaration of Helsinki and is responsible for its updates.
Bioethics Resources on the Web
This site is maintained by the National Institute of Health and provides links to a wide variety of bioethics resources on the web.
Human Subjects Research and IRBs
Other Information
Department of Health and Human Services (HHS) Protection of Human Subjects Regulations 45 CFR 46
Electronic Records 21 CFR 11
These are the FDA regulations on the use of electronic records and electronic signatures in the FDA approval process
NIH Required Education in the Protection of Human Research Participants
Source of Potential Investigators