EMHR Home
instructional materials
course registration
case compendium
instructor's materials
bibliographies
regulations
code of ethics
links
sponsors
 

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