IRB Resources and Guidance

Informed Consent

• FAQ's
• Informed Consent Checklist
• Informed Consent Tips
• Legally Effective & Prospectively Obtained Informed Consent
• Medical Lay Terms for Use in Preparing Consent Forms
• Non-English Speakers and Informed Consent
  

Confidentiality

• Archived Data & Confidentiality: Direct & Indirect Identifiers
• Certificates of Confidentiality

Internet Research

• APA Guidance on Internet Research
• Association of Internet Researchers - Code of Ethics

Other Guidance

• Are you "Engaged" in Research?
• Cash Incentives:  Procedure and Payment Form
• NIH Policy for IRB Review on Grant Applications
• Prisoner Research Review
• Guidelines for Defining Public Health Research and Public Health Non-Research
• Subcontracting Human Subjects Research

Other Links

Human Subject Federal Regulations
45 CFR 46 / “The Common Rule”
Expedited Categories
FDA Regulations
Other Federal Regulations That May Apply to Human Subjects
Family Educational Rights & Privacy Act (FERPA)
Protection of Pupil Rights Amendment (PPRA)
Certificates of Confidentiality

Federal Oversight Agencies
Office for Human Research Protections
FDA Center for Drug Evaluation and Research (CDER)
FDA Center for Devices and Radiological Health (CDRH)
DHHS Office of Research Integrity

Federal Agencies with human research regulations
Central Intelligence Agency
NASA
National Science Foundation
National Institutes of Health
U.S. Agency for International Development
U.S. Department of Agriculture
U.S. Department of Commerce
U.S. Department of Defense
U.S. Department of Education
U.S. Department of Energy
U.S. Department of Housing & Urban Development
U.S. Department of Justice
U.S. Department of Transportation
U.S. Department for Veterans Affairs
U.S. Environmental Protection Agency
U.S. Food and Drug Administration
U.S. Produce Safety Commission

Guidance and Educational Materials
AAAS Internet Report
The Belmont Report
Certificates of Confidentiality – NIH Kiosk
IRB Member Guidebook
Inclusion of Women and Minorities in Research
Inclusion of Children in Research
OHRP’s Common Findings of Non-Compliance
OHRP Compliance Determination Letters
“Recommendations on Public Use Data Files” – National Human Subjects Protections Advisory Committee Report