The Data Security Ancillary Committee (DSAC) assists the Institutional Review Board (IRB) by reviewing data management plans for new studies (and modifications to existing studies when requested) to safeguard the privacy, confidentiality and security of identifiable and other sensitive study data.
- Reviews initial studies collecting, storing, and transmitting identifiable information (including protected health information (PHI)) when:
- The study uses a database or registry containing personally identifiable information (PII) and/or PHI.
- The study involves the sharing of PHI, PII, limited data sets (LDS) or other identifiable data outside the University of Miami and such data are not being shared pursuant to a legally appropriate agreement.
- The study uses an application (app) or device such as a tablet, watch or other wearable that collects identifiable information.
- Membership of DSAC includes representatives from the Office of the Vice Provost Research and Scholarship (OVPRS) Research Privacy and Data Brokers, University IT Security, and UHealth Privacy Office
- Studies may be assigned for ancillary committee review by either the study team or the Human Subjects Research Office (HSRO).
The impact of the DSAC’s determinations on the IRB’s review process varies:
- Typically, final IRB approval is contingent on all ancillary groups concluding their review.
- In some instances, the IRB will not finalize its review without documentation of approval by critical review entities.
- Documentation of approval by an ancillary review group is provided to the researcher in IBISResearch.
- DSAC Committee usually meets on Tuesdays and Fridays. Submissions received by close of business the day prior to a meeting will usually be included in the subsequent agenda for review.
