Ancillary Review Board Process
The protocol application forms contain questions about the use of biosafety, chemical safety and radioisotopes. Depending on these questions are answered, the protocol must be reviewed by separate committees specializing in an area of medicine, such as radiation. The business rules are described in the table below. In this case the ‘ancillary’ review process is required for the protocol to be activated. Ancillary review does not replace the IACUC review process, but happens in parallel with other required board reviews.
In the workflow process, there is a point person established for each ancillary committee and this person will receive an e-mail notification once a protocol has been assigned for ancillary review. It will be the responsibility of that point person to log into Insight to retrieve the necessary protocol information for review. The review process will be handled outside of Insight, in the same manner in which it is handled today. After the SRAC receives the final determination from the ancillary board, either via e-mail or fax, the SRAC administrator will enter the ancillary committee’s action and any necessary notes. The possible outcomes from the ancillary board review are disapproved, approved, deferred or requires modifications.
The Ancillary board notified is dependent on how the user answers the following question on the Hazardous Agent Administration and Use form:
Ancillary Board Name
|
Business Rule |
Assigned To |
Biosafety
|
If hazard is “Biological” |
MGH Biosafety |
Chemical Safety
|
If hazard is “Chemical” |
MGH Chemical |
Radioisotope
|
If hazard is “Radioisotope / Radionuclide” |
MGH Radioisotope |