Does Being a Compliance Manager Make Me the Bad Guy?
isbscience.org/news/2012/01/20/does-being-a-compliance-manager-make-me-the-bad-guy/
By Chris Witwer
Nature.com recently published an article about research misconduct at a Chinese research institution. Dr. Mu-ming Poo, Director of the Institute of Neuroscience in Shanghai, is quoted saying, “Very few people in the funding agency or in the scientific community are willing to be the 'bad guy' and enforce the regulations.”
Wait! Bad guy? That’s what I do for a living – enforce the regulations! Am I a bad guy?
No, I'm not. When I accepted the title “Compliance Manager” three years ago, I expected scientists to run screaming down the halls away from me anytime I approached. But they don’t. Quite the opposite.
My role at ISB includes: human subjects protections, export compliance, responsible conduct of research, and most recently, conflicts of interest. I’m also a non-scientific member of the Institutional Biosafety Committee (IBC). And I get called with other unexpected questions like how to handle calls from people who want to have their genomes sequenced; whether we could allow a research subject to co-author a paper; or whether we can make genome sequences available to the public, and if so, how?
The role I most enjoy is “human subjects protections,” which at ISB means acting as the liaison between scientists and the Institutional Review Board (IRB). The IRB determines whether our research involving people – and their tissues or data – is being conducted ethically.
With few exceptions, all human research must receive IRB approval before the research project begins. Since I am bilingual and speak both English and “regulatory,” I help ISB scientists craft research protocols that satisfy the IRB’s requirements. Then I track and maintain the required documentation throughout the course of the study. Sometimes when the research is over, I get to read newspaper articles about the results. (Click here for a fine example.)
With all of the rules I ask people to follow and all the time, effort, and paperwork associated with them, it’s a real wonder that scientists don’t actually run from me. Instead, they seem to consider me a resource, someone who can help protect ISB’s research enterprise through following both federal rules and ethical norms. And sometimes pushing the envelope just a bit.
About Chris Witwer: Chris is a Certified IRB Professional who has worked in the field of human subjects protections since 2003. The former Texan (is there any such thing?) holds a degree in English Literature from the University of Texas-Austin. She lives in Wallingford with her partner Laura, and two feline children whose DNA have not yet been sequenced.
