The only thing better than forming an in-house IRB certification study group is forming a multi-institutional IRB certification group, according to a pair of IRB managers who found good results with their three-institution CIP study group.
Sarah Marie Huban, MA, CIP, CHRC, human protections program and research regulatory affairs manager at Children’s Healthcare of Atlanta, and Sarah Clark-Worley, MPH, CIP, senior IRB coordination manager, research compliance office, Stanford University in Palo Alto, CA, designed the 10-week study group program to cover the following topics:
• Intro. Overview, handouts, reference materials.
• Week 1. Overview and office organization: covering minimal risk, Belmont Report principles, IRB history and oversight, IRB administration, IRB audits, IRB fees.
• Week 2. Organizing the IRB committee: defining the roles of the IRB chair, IRB committee, and IRB meetings.
• Week 3. Review categories: going over exempt categories, expedited categories, research, human subjects, compassionate use, emergency use, and waiver of consent in emergency medicine.
• Week 4. Initial review and committee meetings: covering initial submission review, including study design and quality, study populations, recruitment, etc.; community consultation, privacy, confidentiality, meeting preparation, and meeting procedures.
• Week 5. Informed consent: explaining witness signature, deception, waiver of consent, waiver of documentation, beneficence, and informed consent evaluation feedback tool.
• Week 6. Continuing review: defining amendments, adverse event reporting, unanticipated events, related or possibly related events, serious events, data safety monitoring board, non-serious and non-continuing noncompliance, serious or continuing noncompliance, and study closure.
• Week 7. Administrative and regulatory issues: going over HIPAA, private health information, de-identified data, Federalwide Assurance, investigational new drugs, and a variety of other terms and concepts.
• Week 8. Study populations: focusing on vulnerable persons, criteria for waivers of consent, subpart D exemption limits, fetus research, exceptions to father signature requirement for fetus research, pregnancy, parent assent, Subpart C, prisoners, and minimal risks.
• Week 9. Issues based on study design or category: covering component analysis, ethnographic research, definition of medical device, humanitarian use device, investigational device exemption, non-significant and significant risk determinations, anonymous, anonymized, and Phase 1 trials.
• Week 10. Review/practice exam: reviewing the foundations and concepts of IRB practice, organizational and personnel knowledge, IRB functions and operations, and records and reports.