Determination Criteria 45 CFR 46.102(f)
Multi-site research studies often include one or more "coordinating centers" or "central laboratories" or "reading centers." As pointed out in the coordinating center guidance document. These coordinating centers may vary widely in degree of oversight, and the vast majority of these will require either an expedited or full board review.
The following application is limited to coordinating or reading centers, or central laboratories, in which staff receive no identifiable information from the individuals whose data or specimens are being studied. For example, certain data centers may receive either de-identified data or specimens, or (more likely) data which has linkage codes the data center does not have access to the linkage codes (the codes are maintained at the clinical site where the data were originally collected). Because staff at the data center have neither interacted nor intervened with the individuals providing the data or specimens, and because they will not be obtaining private, identifiable information, this data center protocol would qualify for “no human subjects” involvement, according to 45 CFR 46.102.f.
This class of data center necessarily has no oversight over the conduct of the study at the local clinical sites; it is not involved in auditing activities at the local sites (including auditing of source documents), it is not involved in the development of consent forms at the local sites, it does not keep a listing of subject names linked to ID numbers, nor does it ever contact subjects (e.g., to schedule appointments, obtain additional follow-up information, etc.).
- No identifiable information is sent to this data coordinating center
- If linkage codes are recorded with these data or specimens, the person or group responsible for recording linkage codes is completely independent of this data coordinating center
- No staff members at this data coordinating center will have access to those identifiers
- No staff member at this data coordinating center will interact with individuals whose data or specimens are sent to the center
- The data coordinating center has no administrative oversight over clinical sites
If the data center (or similar ancillary center) meets the above criteria, select Data/Ancillary Coordinating Center for Exempt Review for OSIRIS question CC1.0.