Ethical Codes and Good Clinical Practice


Belmont Report
Released in 1978, this report expands on the Nuremberg Code. It is a statement of basic ethical principles and guidelines designed to help resolve the ethical problems in the conduct of research with human subjects.

http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm


Declaration of Helsinki
This declaration, adopted by the World Medical Assembly in 1964, is a list of recommendations for the conduct of Biomedical research, emphasizing consideration for the welfare of subjects and patients.

http://www.fda.gov/oc/health/helsinki89.html


FDA's Good Clinical Practice Guidance
Good Clinical Practice (GCP) is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. The Good Clinical Practice Program is the focal point within FDA for Good Clinical Practice issues arising in human research trials regulated by FDA.

http://www.fda.gov/cder/guidance/959fnl.pdf


Title 45 CFR 46: Protection of Human Subjects

http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm


Title 21 CFR 50: Protection of Human Subjects

http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr50_01.html


Title 21 CFR : Institutional Review Boards

http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr56_01.html


Comparison of FDA and HHS Human Subject Protection Regulations

http://www.fda.gov/oc/gcp/comparison.html