Useful Links

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)

FWA Instructions
This is a link to step-by-step instructions for how to file an FWA in the USA and the actual form.

Decision Charts
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 that require 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)

FDA Home page | FDA Industry Portal | Center for Drug Evaluation in Research (CDER) | Center for Devices and Radiological Health Devices (CDRH) | Pediatric Medical Devices

International Organizations

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, non-profit 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.