Investigator and Investigator Staff Human Subjects IRB Survey % of Responses

1= Strongly Agree

2 = Agree

3 = Neither

4 = Disagree

5 = Strongly Disagree

NA = Not Applicable

                % of Responses

1. I am familiar with IRB Application forms. 65 35 6 2 2 0

2. The IRB staff is very helpful to me and is able to answer questions. 45 35 12 5 2 1

3. The MUSC IRB cycle time for reviewing and approving research projects is equal to or better than the turnaround at other research facilities.

11 26 22 14 9 18

4. IRB procedures are readily available in case I have any questions about current procedures. 23 37 25 6 4 4

5. I do not receive IRB application deadlines for my department. 13 16 7 19 42 4

6. I do not receive useful feedback on research proposals I have submitted to the IRB. 6 11 19 28 28 6

7. Human subjects are better protected because the MUSC IRB reviews proposed research projects. 41 34 16 4 2 2

8. It is difficult to get valid information from the IRB staff regarding application requirements. 2 9 15 37 34 3

9. IRB reviewers usually identify only trivial or insignificant nonconformities with proposed research projects. 7 26 28 25 10 4

10. I receive timely feedback on research proposals I have submitted to the IRB.

20 39 21 12 5 3

11. My training on IRB procedures was adequate. 10 22 27 15 9 17

12. The IRB application form is easy to understand and to use. 13 44 29 10 2 2

13. IRB deadlines for submitting applications are reasonable. 16 48 18 8 7 3

14. I value reviewer comments. 25 32 26 9 5 5

15. If the IRB requests minor changes to the protocol or informed consent it adds a long delay to IRB approval. 15 19 20 30 11 5

16. Cycle times for IRB review and approval are appropriate. 12 42 21 13 11 1

17. The human subject requirements on the IRB application form are difficult to comprehend. 4 11 22 44 16 3

18. I understand adverse event reporting requirements. 21 46 14 10 3 8

19. I am familiar with IRB for Human Subjects application procedures and review procedures. 29 50 15 5 1 1

20. The IRB review does not enhance protection of human rights. 2 2 12 36 46 1

21. I receive reviewer comments far enough in advance to prepare responses prior to the IRB review meeting. 7 27 25 15 9 17

22. IRB procedures are complicated and adequate training is not available.

5 15 27 39 12 3

23. Status, position, and funding of the PI within the institution effects IRB approval and handling of research projects. 8 10 20 28 19 15

24. IRB application requirements exceed NIH and FDA requirements.

5 12 33 20 10 20

25. I would be willing to spend 4 hours each week on IRB reviews. 7 10 11 18 49 6

Summary of results:

1. Improve handling of reviewer comments and required changes.

2. Concern about cycle times.

3. Additional training opportunities required.

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