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 signitures in the FDA approval process.
Applications for FDA Approval to Market a New Drug. 21 CRF 314
These are the FDA regulations on the application for FDA approval to market a new drug.
Biological Products. 21 CRF 600
These are the FDA regulations concerning biological products.
Investigational Device Exemptions. 21 CRF 812
These are the FDA regulations concerning the conduct of research and application for an Investigational Device Exemption (IDE) from the FDA, establishing many duties and responsibilities for investigators, sponsors and IRBs.
Guide to Informed Consent (FDA Information Sheets)
Continuing Review (FDA Information Sheets)
NIH Required Education in the Protection of Human Research Participants
Source of Potential Investigators