Research Appropriate for Expedited IRB ReviewIND (Drug) Regulations – 21 CFR Part 312IDE (Device) Regulations – 21 CFR Part 812
Office of Human Research Protections Main page
Additional OHRP commonly used links:
'Engaged in Research', OHRP Guidance documentHuman Subjects Regulations, Decision Chart
Guidance Topics
Information: Special Protections for Children in ResearchOHRP (45 CFR 46) FAQ pageResearch Involving Coded Private Information or Biological Specimens
Research Use of Stored Data or Tissues, OHRP
Reviewing & Reporting unanticipated Risks to Subjects or others
Guidance on the Genetic Information Nondiscrimination Act - NEW
Guidance for IRBs, Clinical Investigators and Sponsors Guidance - Investigator Responsibilities - Protecting the Rights, Safety and Welfare of Study Subjects - NEW
