WS3 - Are We and They Doing It Right? Building an Effective Monitoring Program for Ongoing Oversight of Regulatory Compliance

Workshop Materials (slides/handouts) can be found here.

Research and research oversight are complicated. The challenges of providing ongoing oversight to human/nonhuman animal protocols and HRPP/IACUC approvals have continually grown because of the increasing complexity of the research, institutional and public pressures, and changing regulations. What has not changed, however, is the institution’s responsibility to maintain oversight through its HRPP Weand animal care and use program. Implementing a program of QA/QI can fill a compliance gap while also serving as a pathway for providing ongoing education for researchers and HRPP/IACUC staff. Such a program of QA/QI would have two dimensions: a postapproval monitoring (PAM) program that provides ongoing study oversight and a program of monitoring HRPP/IACUC determinations and documentation. Through interactive presentations and discussion, speakers will address different avenues for developing and implementing ongoing study oversight through a PAM program and how to use PAM visit results as part of an ongoing programmatic evaluation; and how to integrate monitoring of HRPP and IACUC determinations and documentation into a broader PAM program.