Regulations and Guidance
Regulations
45CFR46: Protection of Human Subjects (Common Rule); Department of Health and Human Services (OHRP)
21CFR50: Protection of Human Subjects; Department of Health and Human Services (FDA)
21CFR56: Institutional Review Boards; Department of Health and Human Services (FDA)
45CFR.160 & 164 HIPAA Privacy Rule; Department of Health and Human Services (OCR)
Guidance and Policies
Guidance: Office of Human Research Protections
Guidance: Issues to Consider in Intervention Research with Persons at High Risk for Suicidality (National Institute of Mental Health)
NIH Policy for Data and Safety Monitoring
Further Guidance on a Data and Safety Monitoring
for Phase I And Phase II Trials
Guidance: Research Involving Individuals with Questionable Capacity to Consent (National Institutes of Health)
Guidance from the Office of Research Integrity
Guidance from the Department of Education
Guidance from the Food and Drug Administration
Guidance from the National Science Foundation
Institutional Review Board (IRB) Guidebook Online: Office of Human Research Protections
Certificates of Confidentiality Kiosk
Other Government Links