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Online Resources

DHHS Code of Federal Regulations — 45 CFR 46 – Protection of Human Subjects. Subpart A (also known as “The Common Rule”) is also accepted by 16 other federal agencies. The protections for special populations in Subparts B-D are unique to DHHS.

The Belmont Report — “Ethical Principles and Guidelines for the Protection of Human Subjects of Research”

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.”

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