Ancillary Review Board Process
The protocol application forms contain questions about the use of drugs / biologics / dietary supplements, ancillary drugs, medical devices, non-hospital ancillary devices, radiation and nursing requirements. Depending on the questions 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 Full or Expedited 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 individual will receive an e-mail notification once a protocol has been assigned for ancillary review. It will be the responsibility of this point person to log into Insight to retrieve the necessary protocol information for review. After the HRO receives the final determination from the ancillary board, either via e-mail or fax, the HRO admin will enter the ancillary committee’s action and necessary notes.
The possible outcome from the ancillary board review is Disapproved, Approved, and Deferred and requires modifications.
Ancillary Board Name
|
Business Rule |
Assigned To (Based on Performance Site) |
Investigational Drug Service/ Research Pharmacy Committee
|
If Drug form or Ancillary Drug forms are completed, they will be assigned to ancillary board. |
BWH Investigational Drug Service
MGH Research Pharmacy |
Biosafety
|
If Drug form is completed and ‘Biologic’ is checked for Type of Agent. |
BWH Biosafety
MGH Biosafety |
Radiation Safety Committee
|
If Ionizing or Non-Ionizing Radiation forms are completed. |
BWH Radiation Safety Committee
MGH Radiation Safety Committee |
Biomedical Engineering (PHS)
|
If Medical Device or Non-hospital device form is completed and the device is electrically powered. |
PHS Biomedical Engineering |
Nursing
|
If Nursing form is completed. |
BWH Nursing
MGH Nursing |