Additional Online Human Subjects Resources

Office for Human Research Protections (OHRP) -- formerly OPRR -- The DHHS office for information and regulations

Protecting Human Subjects -- DOE site

10 CFR 745 - Protection of Human Subjects -- DOE regulations

FDA Guidance for Institutional Review Boards and Clinical Investigators

21 CFR 50 - Protection of Human Subjects, 21CFR56 - IRBs -- FDA regulations

21 CFR 812 - Investigational Device Exemptions

FDA Information Sheet - Medical Devices -- September 1998

FDA Information Sheet - Emergency Use of an Investigational Drug or Biologic -- 1998 Update

ICH Guidelines for Good Clinical Practice

Department of Education - Protection of Human Subjects in Research -- Resources for research under the auspices of the Department of Education

The Declaration of Helsinki -- The World Medical Association code for research involving human participants - last updated in October 2000

The Nuremberg Code -- The first world-wide research code -- developed to introduce in the trial of Nazi doctors

NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research -- Updated August 1, 2000

NIH Policy Guidelines on the Inclusion of Children in Research -- July 1, 1998

OHRP Common Findings and Guidance

PRIM&R - Public Responsibility in Medicine and Research

ARENA - Applied Research Ethics National Association

Operational Guidelines for Ethics Committees that Review Biomedical Research -- The World Health Organization

Which state laws do you need to know about before conducting research at your site? -- Schulman Associates Institutional Review Board Inc.

Association of Internet Researchers

Bioethics Resources on the Web -- NIH collection of resources

Bioethics Net -- "where the world finds bioethics" -- maintained by the University of Pennsylvania Center for Bioethics

National Bioethics Advisory Commission (NBAC) -- See especially their current draft report "Ethical and Policy in Research Involving Human Participants."

Contact Information

Brenda Lawson
Compliance Officer and IRB Administrator
UT Knoxville Office of Research
1534 White Ave.
Knoxville, TN 37996-1529
Phone: (865) 974-7697
Email: blawson@utk.edu