IRB-ness is getting raised to a new level of CYA absurdity. They can’t get enough paperwork to make them happy. Bleagh.
The anonymized message below is being sent on behalf of the Office of the Big Kahuna for Research and Graduate Education.
Dear Research Colleagues,
XX University researchers perform extensive human subjects research, with about 3,400 active non-exempt human subjects studies, 2,000 investigators and about $188 million dollars in annual grant expenditures. The results of human subjects research have yielded countless benefits to society, and it is critical that researchers at XX continue to have the resources and support needed to conduct high quality, safe, and ethical research in this increasingly complex and highly regulated area.
The Office of the Big Kahuna for Research & Graduate Education is launching a Post-Approval Monitoring (PAM) Program to provide increased education and guidance for researchers who have received Institutional Review Board (IRB) approval. The PAM Program will offer researchers guidance and best practices to implement their IRB approved research in ways that protect research participants, ensure the ethical conduct of research, and validate the reliability of research results.
The PAM Program’s goal is to facilitate research by ensuring it is implemented in a manner consistent with the approved protocol and applicable policies and regulations. To that end, IRB approved studies may be selected for post approval monitoring. During a monitoring visit, a post-approval monitor will review how research is being conducted, and provide researchers with helpful feedback and tools for self-evaluation of research practices. More information on how research will be selected for monitoring and other useful resources can be found here (deleted).
As XX researchers continue to engage in ever more innovative and diverse research, the PAM Program will help ensure that XX continues to remain a leader in all categories of human subjects research. I’d like to thank the leadership of the University and the Human Research Protection Program for their continued support and funding of this crucial resource for researchers.
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