Federal Research Regulations and Other Resources

Federal Regulations

45 CFR 46: DHHS Protection of Human Subjects

21 CFR 50: FDA Protection of Human Subjects

21 CFR 56: FDA Regulation of Institutional Review Boards

21 CFR 312: FDA Investigational New Drug Application

21 CFR 812: FDA Investigational Device Exemptions

42 CFR 50: US Public Health Service Financial Conflicts of Interest*

45 CFR 94: US Public Health Service Financial Conflicts of Interest*

*St.Vincent Compliance with Federal Financial Conflict of Interest Regulations - In compliance with Federal financial conflict of interest (fCOI) regulations promulgated by the U.S. Public Health Service (PHS) in 42 CFR Part 50, Subpart F and 45 CFR Part 94, St. Vincent has implemented the Policy entitled, "Financial Conflict of Interest for PHS Funded Research".  That policy is available here.

Other Federal Clinical Research Resources

FDA Regulations Relating to Good Clinical Practice and Clinical Trials

Selected FDA GCP/Clinical Trial Guidance Documents

Information Sheet Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors

Federal Research Misconduct Policy

ICH Guidelines for Good Clinical Practice

Links to Federal Research Agencies

US Department of Health and Human Services (DHHS)

National Institutes of Health (NIH)

Food and Drug Administration (FDA)

DHHS Office of Human Research Protection (OHRP)

DHHS Office of Research Integrity (ORI)

Centers for Medicare and Medicaid Services (CMS)

Research Ethics Resources

Belmont Report

Declaration of Helsinki

Ethical and Religious Directives for Catholic Health Care Services

Public Responsibility in Medicine and Research (PRIM&R)

NIH: Bioethics Resources