RESEARCH COURSE The IRB Process CDR Timothy Donahue, MC, USN

1. National Naval Medical CenterDirectorate for Professional EducationClinical Investigation Department RESEARCH COURSE The IRB Process CDR Timothy Donahue, MC, USN “The National Naval Medical Center is an approved provider of continuing nursing education by the Navy Medicine Manpower, Personnel, Training and Education Command, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation.”

2. Disclosure Statement This CE/CME activitydoes not have commercial support,and has no conflicts of interest. Research Course

3. Learning Objectives • Introduction: IRB process, membership, functions, operations and regulations. • The informed consent: basic components and necessary elements required by the IRB • Requirements of 32 CFR – “Seven Sisters” 4. Helpful Tips for Successful Transitioning Through the IRB Process Research Course

4. Learning Objective 1Introduction: IRB process, membership, functions, operations, and regulations • Functions • Administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution which it is affiliated • Functions independently but in coordination with other committees • Scientific Review Panel (SRP) Research Course

5. IRB Membership • Minimum of at least 5 members but can be increased to meet the needs of the institution - Need to ensure that at least one member whose primary concern is in the scientific area - Need one member who is not scientifically trained - One member who should not be affiliated with the institution - Need to balance IRB membership to include a wide variety of gender, ethnicity and representation of specialty areas, especially as it relates to vulnerable populations • Pediatrics, Obstetrics, TBI, etc. Research Course

6. IRB Regulations • Basic IRB Regulations • NNMC Guidelines • DOD Requirements • 45 CFR • Federal Policy for protection of Human Subjects • 32 CFR • DOD Policy beyond 45 CFR • Additional restrictions regarding human subject research • Vulnerable population precautions • Subparts • Subpart B • Subpart D Research Course

7. Learning Objective 2 The Informed Consent Document: • Informed consent is governed by the principle of respect to an individual’s right to choose • The informed consent must contain language or information that will be relevant to the subject’s decision on whether or not they want to participate • 8th Grade level! Research Course

8. Informed Consent The following items need to be included within the body of the informed consent • Procedures of the study • Potential risks & benefits • Assurances that participation in the research is voluntary (no coercion) • Protection of confidentiality • Questions of the study Research Course

9. Informed Consent • What will being a research subject involve and how long will the study last? • Specific topics to be investigated • Is this a deviation from the standard of care? • What is the standard of care? • Alternatives treatment available • Explanation of what blinding & randomization procedures are being employed and exactly what they are Research Course

10. Informed Consent • Potential risks & benefits of the study • Medical, psychological, social, and economic harms and benefits should be described in lay terms • The probability and magnitude of harms & benefits should be given Research Course

11. Learning Objective 3Requirements of 32 CFR: The Seven Sisters • Risks to subjects are minimized • Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result Research Course

12. Learning Objective 3Requirements of 32 CFR: The Seven Sisters • Selection of subjects is equitable • Informed consent will be sought from each prospective subject or subject’s legally authorized representative Research Course

13. Learning Objective 3Requirements of 32 CFR: The Seven Sisters • Informed consent will be appropriately documented • When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects Research Course

14. Learning Objective 3Requirements of 32 CFR: The Seven Sisters • When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data Research Course

15. Learning Objective 3Requirements of 32 CFR: The Seven Sisters • Subparts B and D: • Extra protections for vulnerable populations and children • Children • Prisoners • Pregnant women • Mentally disabled persons • Economically or educationally disadvantaged persons Research Course

16. Learning Objective 4Helpful Tips for Successful Transitioning Through the IRB Process • Follow the proposal guidelines • State the hypothesis in a sentence or two • Stay focused on the topic • Keep the experiment simple Research Course

17. Helpful Tips for Successful Transitioning Through the IRB Process (cont.) • Outline the dependent variables • Describe the methods clearly • Emphasize the importance of the work • Show awareness of the pitfalls • Provide alternate plans Research Course

18. In a Nutshell The proposal should be written and organized in a manner which makes the reviewer’s job effortless. Be aware of the “Seven Sisters” as you craft your proposal Research Course

19. Anatomy of a Well Written Proposal START HERE FINISH Research Course

20. Anatomy of a Poorly Written Proposal Start Start Finish???? Research Course

21. References • OPRR Protecting Human Research Subjects; Institutional Review Board Guidebook. United States Department of Health & Human Services 1999. NIH • Dyrbye LN, Mechaber AJ, Eacker A et al. Medical education research and the IRB review: an analysis and comparison of the IRB process at six institutions. Acad Med 2007; 82 (7): 654-60 • Pech C, Cob N, Cejka JT. Understanding institutional review boards: practical guidance to the IRB review process. Nutr Clin Pract 2007; 22 (6): 618-28. Research Course

22. Questions ??? Research Course

23. Thank You! My contact information: Timothy Donahue, M.D. Chair, IRB Department of Urology, NNMC Email: timothy.donahue2@med.navy.mil Phone: 301-295-6558 Research Course