Relevant Links & Resources

Regulations:

• Common Rule (45 CFR 46)
• eCFR: 21 CFR Part 50-Protection of Human Subjects
• eCFR: 21 CFR Part 56-Institutional Review Boards

National Institutes of Health:

• NIH Home Page

NIH Basics of Clinical Trials Office of Recombinant DNA Activities (ORDA) Office of Grants and Contracts National Human Genome Research Institute

• Ethical, Legal and Social Implications (ELSI)

UNMC Links:

• General Counsel's Memo on Mandatory Reporting of Child Abuse and Related Statute of Limitations
• Institutional Biosafety Committee (IBC)
• Animal Care and Use Program (IACUC)
• Sponsored Programs Administration (SPA)

Food and Drug Administration:

• FDA Web Site
• FDA - Center for Drug Evaluation and Research (CDER)
• FDA - Center for Devices and Radiological Health

International Standards:

• International Compilation of Human Research Standards

Other Federal Agencies:

• National Archive and Records Administration
  • Federal Register Online
• Office for Civil Rights
  • Medical Privacy - National Standards to Protect the Privacy of Personal Health Information
• Department of Health and Human Services
  • Child Abuse Reporting Memo
  • HHS - About Research Participation

Organizations and Other Items of Interest:

• Public Responsibility in Medicine & Research (PRIM&R)
• National Bioethics Advisory Commission (NBAC)
• American Society for Bioethics and Humanities

IRB History and Principles:

• “What Makes Clinical Research Ethical?” Emanuel, et al; JAMA 283(20):2701, 2000
• THE BELMONT REPORT: Ethical Principles and Guidelines for the Protection of Human Subjects of Research(UNMC)
• The Belmont Report(HHS)