Relavent 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 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

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)