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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) 

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.