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IRB-HSR > IRB-HSR Resources > Regulations

 

 

 

 

 

 

Regulations

Guidance

National Commission for the Protection of Human Subjects of Biomedical and Behavioral
Research, The Belmont Report (April 18, 1979) 

World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects (amended October 2000) 

DHHS Office for Protection from Research Risks ("OPRR") OHRP IRB Guidebook (1993)

DHHS Office of Human Research Protection ("OHRP"), Compliance Activities: Common Findings and Guidance

OHRP Determination Letters


FDA (Food and Drug Administration)
IRB Information Sheets-policy statement and guidance documents

FDA International Conference on Harmonization, Guidance on General Considerations for Clinical Trials, 62 Federal Register 66113 (December 17, 1997).


International Conference on Harmonisation (ICH)
, Good Clinical Practice Guidelines 

The Nuremburg Code  http://www.hhs.gov/ohrp/references/nurcode.html
Department of Defense Directive Number 3216.02


Other Resources:

Association of American Universities Task Force on Research Accountability. Report on
University Protections of Human Beings Who Are the Subjects of Research. Washington,
DC:AAU, 2000.

Association of American Universities Task Force on Research Accountability. Report on
Individual and Institutional Financial Conflict of Interest. Washington, DC:AAU, 2001.

Association of American Medical Colleges Task Force on Financial Conflicts of Interest in Clinical Research. Protecting Subjects, Preserving Trust, Promoting Progress – Policy and Guidelines for the Oversight of Individual Financial Interests in Human Subjects Research. Washington, DC:AAMC, 2001.

DHHS Office of Inspector General, Protecting Human Research Subjects: Status of
Recommendations, OEI-01-97-00197. Washington, DC:DHHS, 2000.

DHHS Office of Inspector General, Institutional Review Boards: A Time for Reform. OEI-01-9700193. Washington, DC:DHHS, 1998. 

DHHS Office of Inspector General, Institutional Review Boards: The Emergence of Independent Boards. OEI-01-97-00192. Washington, DC:DHHS, 1998.

DHHS Office of Inspector General, Institutional Review Boards: Promising Approaches. OEI-0197-00191. Washington, DC:DHHS, 1998.

DHHS Office of Inspector General, Institutional Review Boards: Their Role in Reviewing
Approved Research. OEI-01-97-00190. Washington, DC:DHHS, 1998.

DHHS Office of Inspector General, Low-Volume Institutional Review Boards. OEI-01-97-00194. Washington, DC:DHHS, 1998.

DHHS Office of Inspector General. FDA Oversight of Clinical Investigators. OEI-05-99-00350. Washington, DC:DHHS, 2000.

DHHS Office of Inspector General. Recruiting Human Subjects. Pressures in Industry-Sponsored Clinical Research. OEI-01-97-00195. Washington, DC:DHHS, 2000.

DHHS Office of Inspector General. Recruiting Human Subjects. Sample Guidelines for Practice. OEI-01-97-00196. Washington, DC:DHHS, 2000.

General Accounting Office, Scientific Research: Continued Vigilance Critical to Protecting Human Subjects, GAO/HEHS-96-72. Washington, DC:GAO (1996)

Institute of Medicine, Preserving Public Trust: Accreditation and Human Research Participant Programs, Washington, DC: National Academy Press, 2001.
National Bioethics Advisory Commission, Ethical and Policy Issues in Research Involving Human Participants, 2001.