IRB Membership

• IRB Membership Roster (excel doc)

IORG, FWA and IRB Assurance Number

• IORG: 0003644
• FWA: 00007700
• IRB Assurance Number 00004328

Regulations, Policies, Guidance Documents

• Belmont Report (web)
• Nuremberg Code (web)
• 45CFR46 Common Rule (web)
• International Compilation of Human Research Standards (web)

OHRP Guidance Documents on the following subjects (web)

• OHRP’s Compliance Oversight Procedures for Evaluating Institutions
• Engagement of Institutions in Research
• Financial Relationships and Interests in Research Involving Humans Subjects: Guidance for Human Subject Protection
• Guidance on Continuing Review
• Guidance on Institutional Review Board Review of Clinical Trial Websites
• Guidance on the Use of Expedited Review Procedures
• Human Subject Regulations Decision Charts
• Individual Investigator Agreement
• Informed consent:
  • Tips
  • Checklist
  • Legally Effective and Prospectively Obtained
  • Non-English speakers
• IRB Review of Applications for HHS Support
• Reporting Incidents to OHRP
• Research Involving Coded Private Information or Biological Specimens
• Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events
• Prisoner Research

OHRP Draft Guidance on Engagement of Institutions in Human Subjects Research (web)

Reviewer Checklists

• Criteria for IRB Approval of Research (word doc)
• Expedited Review Checklist (word doc)
• Exempt Research Checklist (word doc)
• Modification Review Checklist (word doc)
• General Requirements for Informed Consent Checklist (word doc)
• Subpart C – Prisoner Research Checklist (word doc)
• Subpart D – Research Involving Children Checklist (word doc)
• IRB Authorization Agreement Template (Suffolk University as IRB of Record) (word doc)
• IRB Appointment Letter Format (word doc)
• OHRP Sample Report of Non-Compliance (word doc)