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Table 4 TIDES/RETIDES IRB initial application information

From: Human subjects protection issues in QUERI implementation research: QUERI Series

TIDES Study
Site* IRB type IRB required changes? Approval Type Time Elapsed‡
A VA in-house No Exempt 32
B VA in-house No Exempt 67
C University Yes1 Expedited 75
D University No Expedited 9
E VA in-house Yes2 Expedited 5
F University Yes3 Full 7
VA in-house No Full 82
University Yes4 Expedited 38
I University No Expedited 5
     Average = 35.55
ReTIDES Study
F University Yes5 Full 22
I University N/A Non-human research 5
J University No Exempt 3
K University No Exempt 20
University Yes6 Expedited 30
L VA in-house Yes7 Expedited 14
A VA in-house No Exempt 6
M VA in-house No Exempt 14
     Average = 14.25
  1. * Site identification codes are uniform, showing both new sites for ReTIDES and some TIDES sites not (yet) participating in ReTIDES.
  2. † We experienced no variance between review type preferred and actual approval type granted.
  3. ‡ In days, starting with submission date, ending with approval date (weekends, holidays included).
  4. § From IRB G Investigator Guide & Instructions booklet: "No research is exempt from review and there are no "expedited" reviews."
  5. ¶ This was the only site that required an electronic submission.
  6. 1 Concerns included: consent form alterations, include contact information in mailing, survey data storage, patient information protocol, number of interviews, and adding written consent at local level.
  7. 2 Concerns included: changes to allow better informed consent decision-making, protocol on frequency of subject contact, advance phone call consent, telephone interview protocol, recording interview protocol, time estimated for interviews, why patients were being interviewed, and obtaining consent.
  8. 3 Concerns included: consent obtained to access patient data registry, justification for exemption of worksheet data forms, how does VA encrypt medical records, number discrepancy, terminology issues, protocol regarding the movement of paper data, oral consent procedure, clarification of anonymous/confidential, changes to worksheets, who has data access, confirm study codes are not SSN, how is questionnaire used, and typographic errors.
  9. 4 Concerns included: typographic errors and further justification for no consent.
  10. 5 Concerns included: coercion as possible risk, determining coordinating center, providing a consent form if requested by subject, and how participation is/is not related to job description, including text about participating not affecting job security.
  11. 6 Concerns were administrative and related to the electronic submission process.
  12. 7 Concerns were administrative.