Meet Professor Doolittle, a biologist and chair of Genetics at Zoo U.
After studying genetic mutations in small-ear pigs to better understand coat color variation for breed preservation and development, Doolittle and his post-doc invented a genetic test and launched a startup called PigMentation. The post-doctoral co-inventor runs PigMentation’s day-to-day business operations; she receives no salary from PigMentation but receives equity in the company. Doolittle is the chief technology officer. Like many faculty startups, PigMentation licensed the technology from Zoo U to begin commercialization. Due to the fact that the company does not have a laboratory yet to scale the technology, funds were raised by PigMentation to establish a sponsored research agreement with the university to support R&D in Professor Doolittle’s lab on campus. The company ultimately hopes to receive a National Institutes of Health STTR award and subcontract to Zoo U to supplement further development.
In addition, Doolittle received additional research funding from a Hungarian agricultural company to study color variation in a large population of Mangalitsa pigs, the “Kobe Beef of Pork, ” in Hungary. As part of this project, he partnered with an institution in Hungary as part of a collaborative research program that allows U.S. students to work in the lab overseas and Hungarian students to come to the U.S. Before kicking off the project, Doolittle will purchase 1,500 units at $179 per unit from PigMentation to do the first phase of the study.
How many potential disclosures should Professor Doolittle make to Zoo U? How much potential risk does Doolittle present?
- External Consulting, Employment and Professional Activities
- Pending Relationships
- Related Party Interests
- Research Conflict of Interest
- Conflict of Commitment
- Dual Employment
- Foreign Influence
If you selected every disclosure listed in Professor Doolittle’s case, you are correct. But do you think Doolittle understands each little detail of his scenario and who manages that risk across the university? Is it the research compliance office, contracts and grants, human resources, legal or his department?
And even if he succeeds in disclosing it all, can each individual office manage their part without introducing a certain level of risk to the professor, the university and the funding agency?
While Professor Doolittle’s case is complex, it’s not farfetched. Better managing risk for cases like Doolittle’s is top of mind for university compliance operations right now. As the regulatory environment becomes increasingly complex, there is more at stake today than what senior investigators are used to, and that creates risk.
“There are more regulations than in the past, there is more scrutiny. We’re not the same University we were 20 years ago,” said Lauri Ruiz, senior assistant in the University of Houston’s Office of General Counsel. “If researchers have an NIH grant, for example, they have to comply with federal regulations as well as state and institutional regulations.”
In addition to changing and expanding regulations, there is also enhanced enforcement of the rules, said Ruiz, making it critical for universities and their researchers to comply. The problem: It’s hard to know every single detail that needs to be disclosed.
“There are a lot of people with good intentions, but they may not know about the rules,” she said.
And then there’s the matter of doing it.
“Faculty want to do the right thing, but they don’t get around to disclosing it all,” said Kirstin Holzschuh, executive director of Research Integrity and Oversight at UH. “If we know about it, we can manage it before it becomes a problem.”
To complicate the matter, many universities like UH have offices across the institution that manage specific disclosures, making it more difficult for researchers to know what to disclose where.
“Universities tend to be very siloed and faculty get confused about what they have to do to be compliant, ” said Susan Koch, chief compliance officer at UH. “There is a significant need for universities to make a seamless, cohesive process that is easy for faculty to follow.”
According to Koch, Ruiz and Holzschuh, many top research institutions may have this process fixed for faculty, as they have been in the business of major research operations for many years now. For rising universities such as the University of Houston, compliance operations are scrambling to keep up with their university’s rapidly growing research and innovation enterprises — in addition to expanding regulations.
“It would be ideal to have a centralized operation that intakes all disclosures and works with specific university offices to manage certain aspects of a researcher’s case,” said Holzschuh. “But like many institutions, UH does not have the resources to support that kind of operation yet, so we have to find a different solution.”
Holistic risk management
Much like we go to our primary care provider who reviews our overall health before referring us to specialists to solve specific problems, university compliance should work the same way. Centralized compliance management may be the future, but it’s not quite possible for many universities at the moment.
“We have to find a way to move forward in a thoughtful way based on our available resources,” said Koch. “These are compliance challenges that are being discussed across higher education — everyone is trying to make strides in this area.”
To address this challenge at UH, the University has launched a compliance initiative to streamline all university disclosures and ensure that all touchpoints and processes are more understandable for faculty to follow.
Led by Koch, Institutional Compliance teamed with the offices of General Counsel and Research Integrity and Oversight to form a cross-disciplinary committee to consolidate the disclosure intake and management processes, as well as provide institutional training.
“We’re setting up a communication structure so that silos are no longer silos, ” she said.
Specifically, the UH team is working on a multiphased-approach that will involve the development of a user-friendly web portal that will prompt faculty to fill out certain disclosures based on their individual case. The tool will work by taking faculty down a decision tree, triggering a set of actions they need to take. Based on how they answer certain questions, faculty will be directed toward the disclosures they need to file.
“We want to design it in such a way that it is easy for faculty to navigate complex issues,” added Ruiz.
In addition to creating the disclosure portal, the team plans to update disclosure forms, streamline processes and workflows, reevaluate who has oversight, and design education and training to ensure compliance.
“The old paper-based processes don’t work anymore,” said Koch. “People can’t locate what form they need, so our processes need to be advanced.”
And while modernizing and simplifying the process for faculty is a great first step, the team is already thinking about how to better manage the process on the backend in a more centralized manner.
“We’re hoping to eventually have a central repository of disclosed information so that compliance teams across the university have access to the same information,” said Holzschuh. “It’s difficult to manage a case piecemeal, because all of the small details are very interconnected.”
The team will also make a major investment to “up their game” to better educate and communicate with faculty — and all those who support university research, including research staff and leadership.
“We are excited about the portal that will help faculty fill out the forms,” said Holzschuh. “But education is key.”
The big idea
In the coming year, the Professor Doolittles at the University of Houston — and hopefully other institutions across the nation — will better understand what disclosures need to be filed through simple, clear processes, thanks to the hard work and ingenuity of our university compliance teams. This could not be of greater importance, according to Ruiz.
“This just isn’t the university coming up with random things to create roadblocks,” she said. “Non-compliance with federal and state regulations could result in jail time and millions of dollars in penalties sanctioned against the University.”
To be quite frank, it’s in all of our best interest to comply with regulations — and make the processes easy to follow, especially if we want to continue to demonstrate our academic research integrity, keep monies in the university piggy bank and keep our people out of “the pen.
Source: University of Houston: Navigating compliance in on-campus research and innovation