Clinical Scholars Program at The Rockefeller University Hospital/CTSA

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Protection of Human Subjects

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