Regulations and Guidance
Office for Human Research Protections (OHRP), U.S. Department of Health and Human Services: OHRP Home Page
45 CFR 46
Federal Policy for the Protection of Human Subjects (Basic DHHS Policy for Protection of Human Research Subjects)
This is a link to step-by-step instructions for how to file an FWA in the USA.
The Office for Human Research Protections (OHRP) provides graphic aids as a guide for institutional review boards (IRBs), investigators and others who determine whether an activity is research involving human subjects and thus requires review by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46.
U.S. Food and Drug Administration (FDA)
GCP – Good Clinical Practices
ICH Good Clinical Practices (GCP) – This is a link to the FDA division responsible for overseeing Good Clinical Practice (GCP). GCP is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials.
International Conference on Harmonisation (ICH)
This website offers access to all guidance documents produced by ICH.
Council for International Organizations of Medical Sciences
The Council for International Organizations of Medical Sciences (CIOMS) is an international, non-government, nonprofit organization established jointly by WHO and UNESCO in 1949.
World Medical Association
The World Medical Association (WMA) is an international organization representing physicians. The organization was created to ensure the independence of physicians and to work for the highest possible standards of ethical behavior and care by physicians at all times.