Links & Resources

UM Resources

Human Research Protections Office (HRPO)
General Clinical Research Center (GCRC)
Office of Research and Development (ORD)
Office for Research and Graduate Studies (ORAGS)
Environmental Health and Safety (EHS)

Federal Agencies

FDA (Food and Drug Administration)
NIH (National Institutes for Health)
DHHS (Department of Health and Human Services)
OHRP (Office of Human Research Protection)
VA (Veteran’s Administration)
CMS (Center for Medicare and Medicaid)
OIG (Office of the Inspector General)
ORI (Office of Research Integrity)
ORO (Office of Research Oversight- Veteran’s Health Administration)

Good Clinical Practice

ICH (International Conference on Harmonization) - ICH Harmonised Tripartite Guideline (Click on "Guidelines" which is located under "Publications" on the left menu.)
ICH Guidance for Industry - E6 Good Clinical Practice: Consolidated Guidance
Good Clinical Practice in FDA-Regulated Clinical Trials

Federal Regulations

Code of Federal Regulations: 45 CFR Part 46
Belmont Report
VA - Current ORD Policy Documents
VA Regulations - Human Subjects Protections

FDA Regulations:  21 CFR: 

Part 11 - Electronic Records; Electronic Signatures
Part 50 - Protection of Human Subjects
Part 54 - Financial Disclosure by Clinical Investigators
Part 56 - Institutional Review Boards
Part 312 - Investigational New Drug Application (IND)
Part 314 - Applications for FDA Approval to Market a New Drug (NDA)
Part 600 - Biological Products
Part 812 - Investigational Device Exemptions

Research Organizations

AAHRPP (Association for the Accreditation of Human Research Protections Programs)
AAMC Medical Research
PRIM&R (Public Responsibility in Medicine & Research)
The Hastings Center
ACRP (Association of Clinical Research Professionals)
SOCRA (The Society of Clinical Research Associates)
Research Practitioner

Other Resources

NIH Bioethics Resources
Clinical Trials.gov
Centerwatch
Certificates of Confidentiality
FDA Information Sheets

News & Announcements