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Regulations
Resources about the regulations that govern human subject protection in medical research:
- Protection of Human Subjects: Code of Federal Regulations
(US Department of Health & Human Services 45CFR56) - Good Clinical Practice & Clinical Trials
(US Food & Drug Administration) - Office of Pediatric Therapeutics
(US Food & Drug Administration) - HIPAA: The Privacy Rule
(U.S. Department of Health & Human Services 45CFR160 and 164)
Ethics
Resources that help you learn about ethical issues surrounding human subject protection in medical research:
Essential Documents
Agencies
- US Food & Drug Administration
- Secretary's Advisory Committee on Human Research Protection
- Office of Research Integrity
- National Institutes of Health (NIH) Bioethics Resources
Organizations
- American Association for the Advancement of Science (AAAS)
- American Nurses Association (ANA) The Center for Ethics and Human Rights
- American Psychological Association (APA) Ethics Office
- Public Responsibility in Medicine and Research (PRIMR)
- Kennedy Institute of Ethics (Georgetown University)
- Online Ethics Center for Engineering and Science at Case Western Reserve University
- World Health Organization: Ethical Standards and Procedures for Research on Human Beings
- World Medical Association: Ethics
Publications
- Ethical Issues in Research Involving Human Participants National Institutes of Health
- On Being a Scientist:Responsible Conduct in Research National Academy Press
Contact Us
Nemours Office of Human Subjects Protection
Robert Colnes
Director
robert.colnes@nemours.org
Suzanne Murphy
Associate Director
suzanne.murphy@nemours.org
Monica Pyewell
Administrative Assistant
monica.pyewell@nemours.org
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