Federal Regulations:
Department of Health & Human Services
45 CFR 46: Protection of Human Subjects
FDA
21 CFR 50 Protection of Human Subjects
21 CFR 54 Financial Disclosure by Investigators
21 CFR 56 Institutional Review Boards
21 CFR 312 Investigational New Drug Application
21 CFR 812 Investigational Device Exemption
Federal Regulatory Agencies:
OHRP
FDA
NIH
Federal Guidance:
OHRP Guidance (listed by topic)
FDA Good Clinical Practice in FDA Regulated Clinical Trials
NIH Guidance for Vulnerable Populations:
NIH POLICY AND GUIDELINES ON THE INCLUSION OF WOMEN AND MINORITIES AS SUBJECTS IN CLINICAL RESEARCH
Inclusion of Women and Minorities As Participants In Research Involving Human Subjects -
Policy Implementation Page
Inclusion of Children -
Policy Implementation Page
Research Involving Individuals with Questionable Capacity to Consent: Points to Consider
Ethical Principles & Codes:
Belmont Report
Nuremberg Code
Declaration of Helsinki
International Conference on Harmonisation
HIPPA:
Professional Organizations & National Workshops:
Public Responsibility in Research & Medicine
Applied Research Ethics National Assoc.
OHRP Workshops
AAMC
Other Links of Interest:
Secretary's Advisory Committee
President's Council on Bioethics
Bioethics.net
AAMC Research Compliance Resources
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