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University of Houston: Navigating Compliance in Campus Research and Innovation

Meet Professor Doolittle, biologist and holder of the Chair of Genetics at Zoo U.

After studying genetic mutations in small-eared 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 postdoctoral co-inventor manages the day-to-day business operations of PigMentation; she receives no salary from PigMentation but receives shares in the company. Doolittle is the Chief Technology Officer. Like many faculty startups, PigMentation has licensed Zoo U’s technology to begin commercialization. Since the company does not yet have a lab to scale the technology, funds have been raised by PigMentation to establish a sponsored research agreement with the university to support R&D in Professor Doolittle’s lab on the campus. The company ultimately hopes to receive an STTR award from the National Institutes of Health and outsource to Zoo U to complete further development.

Additionally, 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 has partnered with an institution in Hungary on a collaborative research program that allows American students to work in the lab abroad and Hungarian students to come to the United States. United. Prior to initiating the project, Doolittle will purchase 1,500 units at $179 per unit of PigMentation to do the first phase of the study.

How many potential disclosures should Professor Doolittle make to Zoo U? What potential risk does Doolittle present?

  1. External advice, employment and professional activities
  2. Pending Relationships
  3. Interests of related parties
  4. Conflict of interest research
  5. Commitment conflict
  6. Duplicate
  7. Foreign influence
  8. Licence

If you selected all of the disclosures listed in the case of Professor Doolittle, you are correct. But do you think Doolittle understands every little detail of his storyline and who handles that risk across the university? Is it the Office of Research Compliance, Contracts and Grants, Human Resources, Legal or its department?

And even if it succeeds in divulging everything, can each individual office manage its share without introducing some level of risk to the professor, the university and the funding agency?

Risky business

Although Professor Doolittle’s case is complex, it is not far-fetched. Better risk management for cases like Doolittle’s is currently a priority for university compliance operations. As the regulatory environment becomes increasingly complex, there is more at stake today than senior investigators are used to, and that creates risks.

“There are more regulations than in the past, there is more control. We are no longer the same university as 20 years ago,” said Lauri Ruiz, senior assistant in the Office of the General Counsel at the University of Houston. “If researchers have an NIH grant, for example, they must comply with federal regulations as well as state and institutional regulations.”

In addition to changing and expanding regulations, there is also better enforcement of the rules, Ruiz said, making compliance by universities and their researchers essential. The problem: It’s hard to know every detail that needs to be disclosed.

“There are a lot of people out there with good intentions, but maybe they don’t know the rules,” she said.

And then there is the matter of doing it.

“Faculty wants to do the right thing, but they fail to disclose everything,” said Kirstin Holzschuh, executive director of research integrity and oversight at UH. “If we know that, we can deal with it before it becomes a problem.”

To complicate matters, many universities like UH have offices at the institution that handle specific disclosures, making it harder for researchers to know what to disclose and where.

“Universities tend to be very siloed, and professors don’t know what they need to do to be compliant,” said Susan Koch, UH’s chief compliance officer. “It is important that universities have a consistent and consistent process in place that is easy for professors to follow. »

According to Koch, Ruiz and Holzschuh, many top research institutions may have this process fixed for professors, as they have been in the major research operations business 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 businesses, in addition to expanding regulations.

“It would be ideal to have a centralized operation that collects all disclosures and works with specific university offices to manage certain aspects of a researcher’s case,” Holzschuh said. “But like many institutions, UH does not yet have the resources to support this type of operation, so we need to find a different solution.”

Global risk management

Just as we go to our primary care provider who examines our general health before referring us to specialists to resolve specific issues, university compliance should work the same way. Centralized compliance management may be the future, but it’s not quite possible for many universities right now.

“We have to find a way to move forward thoughtfully within our available resources,” Koch said. “These are compliance challenges that are discussed in higher education – everyone is trying to make progress in this area.”

To address this challenge at UH, the University has launched a compliance initiative to streamline all academic disclosures and ensure that all touchpoints and processes are more understandable to faculty.

Led by Koch, Institutional Compliance has partnered with the Offices of General Counsel and Research Integrity and Oversight to form an interdisciplinary committee to consolidate admissions and disclosure management processes, as well as providing institutional training.

“We are putting in place a communication structure so that silos are no longer silos,” she said.

Specifically, the UH team is working on a phased approach that will involve the development of a user-friendly web portal that will prompt professors to complete certain disclosures based on their individual case. The tool will work by taking teachers through a decision tree, triggering a set of actions for them to take. Depending on how they answer certain questions, professors will be directed to the disclosures they need to file.

“We want to design it in a way that it’s easy for professors to navigate complex issues,” Ruiz added.

In addition to creating the disclosure portal, the team plans to update disclosure forms, streamline processes and workflows, reassess who has oversight, and design education and training to ensure compliance.

“Old paper processes don’t work anymore,” Koch said. “People can’t locate the form they need, so our processes need to be advanced.”

And while modernizing and simplifying the process for faculty is an important first step, the team is already thinking about how to better manage the process behind the scenes in a more centralized way.

“We hope to eventually have a central repository of disclosed information so that university compliance teams have access to the same information,” Holzschuh said. “It’s difficult to manage a case piecemeal, because all the little details are very interconnected.”

The team will also make a major investment to “up its game” to better educate and communicate with faculty – and everyone who supports academic research, including research staff and management.

“We’re excited about the portal that will help teachers fill out forms,” ​​Holzschuh said. “But education is the key.”

The big idea

Over the coming year, Professor Doolittles at the University of Houston – and hopefully other institutions across the country – will better understand what disclosures should be filed through simple and clear processes, thanks to the hard work and ingenuity of our university compliance teams. It couldn’t be more important, according to Ruiz.

“It’s just not the university coming up with random things to create roadblocks,” she said. “Failure to comply with federal and state regulations could result in jail time and millions of dollars in sanctioned penalties against the University.”

To be quite frank, it is in all of our interests to comply with regulations – and to make processes easy to follow, especially if we are to continue to demonstrate our integrity in academic research, to keep the money in the college piggy bank and keep our people out. of “the pen. “

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This article originally appeared on The Big Idea from the University of Houston. Lindsay Lewis, the author of this article, was previously executive director of communications for the UH Division of Research.

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