Most Common Reasons for Returned Protocols
1. Incomplete submissions
- Required faculty advisor/mentor signatures missing (NOT department chair)
- Failure to list all “investigators” (including faculty advisor, volunteers)
- Failure to provide documentation of human subjects training for all investigators (NIH, CITI, other institution, BUMC class)
- Failure to submit a Project Specific Conflict of Interest disclosure (PSD) for all investigators
- Funded—to the Sponsored Programs Office
- Unfunded—to the CRC-IRB
- Missing attachments, i.e., thesis/doctoral prospectus survey instruments, questionnaires, etc.; recruitment materials (flyers, emails)
2. Student doesn’t understand anonymous vs. coded data—misuse of the term “de-identified”
- Anonymous implies that there is no way that the student can trace or deduce the identity of the subjects in the study. There is no master code list that links identifiers to subjects. Anonymity is required for a protocol to obtain exempt status.
- Coded data implies that the data can be traced back to specific subjects.
- De-identified data is used loosely to imply either anonymous or coded data, and the use of the term is therefore discouraged.