Resource Links

Links to Various Regulations, Policies and Reports

Ethical Principals and Codes:

• Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects
• Belmont Report Historical Archive
• World Medical Association Declaration of Helsinki
• Nuremburg Code

Food and Drug Administration:

• FDA Home Page
• FDA Information Sheets - IRB Operations and Clinical Investigation Requirements
• Institutional Review Boards (21 CFR 56 - FDA)
• Investigational Device Exemptions(21 CFR 812)
• FDA Forms

Office for Human Research Protections (OHRP):

• OHRP 
• The Terms and Conditions of Federal Wide Assurances 
• Protecting Human Research Subjects: IRB Guidebook 
• Protection of Human Subjects (45 CFR 46) 
• Obtaining and Documenting Informed Consent of Subjects Who Do Not Speak English 
• OHRP Guidance on Approving Research Involving Prisoners 
• Consent Form Checklist 
• Human Subject Regulations Decision Charts

National Institutes of Health NIH):

• The National Institutes of Health home page
• Office of Extramural Research Grants Website Map
• NIH Bioethics Resources
• NIH Guidance on Reporting Clinical Trial Adverse Events to the IRB
• Freedom of Information Act (FOIA) - Explanation of Federal Policy on Public Access to Research Data
• NIH Guidelines for Research Involving Recombinant DNA Molecules
• "Further Guidance on a Data Safety and Monitoring For Phase I and Phase II Trials"
• NIH Revised Policy for IRB Review of Human Subjects Protocols in Grant Applications
• NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research Amended, October, 2001

PeaceHealth Institutional Review Board:

• Research Administration Newsletter

Other Helpful Links:

• Research Appropriate for Expedited Review
• Research That May Be Exempt from Subsequent Review
• The Hastings Center for Bioethics
• The National Archives and Records Administration Code of Federal Regulations
• Oregon State Law Search
• Public Health Service Office of Research Integrity
• Clinical Trials
• Oregon Law on Genetic Research
• Washington State Department of Social and Health Services

PeaceHealth Institutional Review Board