Guidance Documents
Does My Project Need IRB Review
Research with Human Subjects Conducted by Students
Human Subject Regulations Decision Charts
IRB Guidance – Exempt Category 1
IRB Guidance – Exempt Category 2
IRB Guidance – Exempt Category 3
Templates
Consent Template Expedited and Full Board
Agreement to Participate Template
Legally Authorized Representative Consent Template
Letter of Introduction for Student Project Involving Human Subjects
Useful Links
URI Environmental Health and Safety
DHHS Office of Human Research Protections (OHRP)
DHHS Regulations for the Protection of Human Subjects (Common Rule, 45 CFR 46)
FDA Policy for the Protection of Human Subjects (21 CFR 50 and 56)
NIH Certificates of Confidentiality
NIH Policy and Guidelines on the Inclusion of Children in Research
NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research