Stuart Leland began work as Princeton’s first director for research integrity and assurance on Aug. 15. The new office oversees the University’s research work and ensures compliance with human, animal and biological research regulations. Before coming to the University, Leland worked in animal welfare compliance for the pharmaceutical company Merck & Co. The Daily Princetonian spoke with Leland about the relationship between research and regulation, his past experience overseeing research and the University’s history of alleged animal abuse violations.
The Daily Princetonian: What are some of the challenges of opening and leading a brand new office at the University?
Stuart Leland: There is a precedent at other institutions. Princeton is forward-thinking in its approach to compliance. I think that many institutions have had offices of compliance for years. Smaller institutions maybe did not need them, as they did not have research programs big enough to call for it. Princeton, maybe because it’s Princeton, saw a need to create this office to address human subject matter, animal research, biosafety and conflicts of interest. The challenges are — rather, the big challenge for me is going to be determining the path of compliance while maintaining Princeton’s ability to perform innovative world-class research on humans, animals, etc. The regulations are the regulations, but the way they are applied can, in part, be determined at the institutional level. My challenge is to understand the research and culture and then to find that balance.
DP: Is there necessarily an adversarial relationship between cutting-edge research and compliance?
SL: Great question. I think that there is a healthy tension. There needs to be a mutual understanding from where we are coming from. Regulation exists for a reason, and it usually does because of past human activity that has not always been above board. I want to understand what the research needs are, but at the same time, I need to protect the University.
DP: You have a bachelor’s degree in animal science from Cornell and doctor of veterinary medicine degree from UC Davis. Can you tell me about choosing these courses of study?
SL: Well, being a vet was always my goal. I was a California resident and, much like many of the students here, I wanted to spread my wings. I chose Cornell specifically because I thought it had a very strong program in animal science.
I have a respect for animals — certainly it started out as a love. I have a great respect for them. The use of animals in our society is very complex: We use them for food, clothing, sport, entertainment and research.
DP: Can you tell me about how your experience with research and compliance in the pharmaceutical industry affects your position here at the University?
SL: Well, my first job was at another Ivy League school — the University of Pennsylvania — but it is true I have a very strong pharma background. Of necessity, pharma tends to put a lot of weight on compliance. The reason it’s important for pharma to be compliant is that their branding is sort of the ultimate tool in selling a product. When you think of a company like Merck, you want it to evoke not only a world-class company but also an ethical and moral company from a compliance perspective. On a smaller scale, Princeton has an equally vested interest in its own branding. Much of what I have learned about why we should be compliant is to help maintain the stellar integrity and reputation of the institution, which reflects upon the research that is done here.
DP: Have researchers been receptive to your office? How have you influenced the research process as of now?
SL: I think the researchers have been very receptive to my presence and the development of my office. I think Princeton researchers are like all researchers — they want to do the right thing. The nuance is in the balance of the interpretation and the implementation of the regulations.
For example, some research requires prior approval by a review board, and some research doesn’t. One example of where I have helped is in defining that. I would make a plug for what is a major mission of Princeton — undergraduate research. Regarding the senior thesis, some of those students may propose research involving human subjects, animals, recombinant DNA or biohazards. I would like them to think of me and my office as a resource to come to for advice on putting proposals together.
DP: The records I could find show that in the last two years the University’s animal labs have been cited for 21 instances of non-compliance with the Animal Welfare Act by the U.S. Department of Agriculture. How does your office interpret that figure?
SL: It’s certainly a challenge, one of the challenges my office is looking at, but I do feel that this is something in the past, and I think Princeton has been forward-thinking in ensuring these sorts of things do not happen again. I want to make sure that people know the concept of my office was put into place prior to these findings, but it’s taken some time to put into place. I would like to note that our last inspection had zero findings.
DP: Do you think the citations accelerated the pace with which your office was put into place?
SL: Many years ago Princeton had this concept. They acted responsibly and timely. In my opinion, they are not related. I know many people have tried to draw that conclusion. I wasn’t there, but that is not what I believe.
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