This Procedure Establishes the Process to Conduct Annual Tasks Related to the HRPP

1. PURPOSE
2. This procedure establishes the process to conduct annual tasks related to the HRPP.
3. This procedure begins every year in July.
4. This procedure ends when evaluations and corrective actions are completed.
5. POLICY
6. The subject outreach program for enhancing the understanding of subjects, prospective subjects, and communities is accomplished by making “BROCHURE: Should I Take Part in Research (HRP-900)” available to the public.
7. RESPONSIBILITY
8. The [Organizational Official] delegates individuals to carry out these procedures.
9. PROCEDURE
10. Obtain updated résumés or curricula vitae from each IRB member and HRPP staff member or confirmation that there has been no change.
11. Evaluate in consultation with the [IRB Executive Chair] and [HRPP Administrator] as appropriate:
12. General performance of the HRPP, such as:
13. Feedback from investigators, research staff, sponsors, and subjects
14. The subject outreach plan
15. Results of regulatory audits
16. Results of continuous improvement activities
17. New requirements
18. Compliance with policies and procedures
19. Compliance with regulatory requirements
20. Status of action items from previous reviews
21. HRPP resources for:
22. Space
23. Personnel
24. HRPP educational program
25. Legal counsel
26. Conflicts of interests
27. Quality improvement
28. Number of IRBs relative to the volume and types of research reviewed
29. Thecomposition of IRBs relative to “WORKSHEET: IRB Composition (HRP-430)”
30. Completion of training by IRB members, chairs, vice-chairs, and staff
31. The knowledge and performance of each IRB member, chair, vice-chair, and staff
32. Consult with the [IRB Executive Chair] on the performance of IRB members and HRPP staff members.
33. Whether IRB members, IRB chairs, IRB vice-chairs, and HRPP staff members have completed required training
34. The effectiveness of the subject outreach plan
35. Provide a copy of the evaluation to the [Organizational Official].
36. Take actions as needed to:
37. Reallocate, add, or modify HRPP resources
38. Modify the number of IRBs
39. Modify the composition of IRBs
40. Remove individuals with persistent knowledge and performance gaps
41. Correct knowledge and performance gaps of individuals
42. Arrange for individuals to take missing training
43. Modify the subject outreach plan
44. Modify policies and procedures
45. Provide additional training or modify existing activities, and
46. Provide each individual with a summary of the individual’s evaluation
47. Send a thank you letter to each IRB member, IRB chair, and IRB vice-chair and if applicable, copy the individual’s supervisor.
48. Update IRBregistrations at
49. Update organizational registrationsmore than four years old at
50. REFERENCES
51. 21 CFR §56.106 and §56.107
52. 45 CFR §46.107 and 45 CFR §46 Subpart E

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