Although the IO will likely contact the investigators and indicate his
displeasure with the situation and the requirements for the reinstatement of
the protocol, the IACUC has a continuing obligation to provide oversight to
the Dr. Bigdolah project and to make sure that the remedies required by the
IACUC are carried out in full.
The IACUC should also help the IO remember to
submit the required documentation of the resolution of the non-compliance
issues to the USDA and to the OLAW. When all IACUC required solutions, additional IO required remedies (if
there are any) are implemented, the IACUC can vote to reinstate the protocol
to active status at a convened meeting. It is likely that a positive vote will be accompanied by
increased oversight of all the Bigdolah protocols by the IACUC.
Dr Bigdolah
and his research group will likely be visited more frequently by the BTU
Post Approval Protocol Monitor.
We would be happy to hear your thoughts on this case and the issues presented. How would your IACUC handle this type of non-compliance.