/ SOP: Annual Tasks
Document No.: / Edition No.: / Effective Date: / Page:
HRP-141 / 001 / 15 Jul 2015 / Page 1 of 2
  1. PURPOSE
  2. This procedure establishes the process toconduct 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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