By turning complex rules into practical guidance, this team protects researchers, their data, and the Institute’s mission
By Jessica Leff
Wyss researchers are working to protect patients from the consequences of diseases by developing better diagnostics and therapeutics, and trying to keep our planet safe by creating eco-friendly solutions focused on remediation, resilience, and reinvention. But, as they move towards cutting-edge breakthroughs, who is protecting them?
The Wyss’ small-but-mighty Compliance Team works tirelessly to ensure our researchers are shielded from threats to their intellectual property (IP), that their data doesn’t fall into the wrong hands, and that their grant opportunities aren’t compromised by failure to follow guidelines. They safeguard the Institute’s reputation and uphold standards of research integrity. Each member of this dynamic duo has a distinct role in protecting our community and the Institute’s funding and reputation.
Minimizing risks so researchers can reap maximum rewards
There are several different aspects of research compliance. One that’s particularly relevant at the Wyss because of the translational nature of the work is conflicts of interest. A conflict of interest arises when someone’s professional and personal financial interests clash, potentially affecting their objectivity or judgment. For example, when a faculty member starts a company, Director of Research Compliance and Integrity, Katrin Duevel, Ph.D., ensures it doesn’t affect how their research team at the Wyss designs, conducts, and reports their research at the Wyss.
Duevel began her career in research administration as an intern at the Allen Institute and Harvard before taking on a full-time position at Harvard University Faculty of Arts and Sciences, then joining the Wyss.
Director of Clinical Research and the Clinical and Translational Research Core, Dionna O. Roberts Williams, M.S., M.P.H., shares, “Katrin is incredibly instrumental in helping to identify, disclose, and create management plans for researchers who have financial conflicts of interest (FCOIs) associated with specific clinical research protocols. These processes are essential to mitigate actual or perceived undue influence in research and to ensure that study participants are fully informed when conflicts exist.”
Another consideration is research security, which involves protecting data and IP. Whenever researchers have international interactions, whether it’s sharing material and information, starting a new collaboration, or traveling overseas, Duevel conducts an export control review to confirm data can be shared safely without an export license. Failure to comply could result in significant fines and even criminal charges.
This also extends to scholars from around the world who come to conduct research at the Wyss. Academic Affairs Manager, Laura Falloon, explains, “I work regularly with Katrin on compliance matters for onboarding hires, those currently here, and offboarding. The Compliance Team’s support is essential to my work, as a huge part of my job is to ensure international colleagues are coming here safely and following all of the rules that the Wyss and Harvard have in place.”
The Compliance Team’s jobs become more complex by the day with endless new requirements from the federal government. They work hard to make sure the Wyss is equipped to meet the challenges.
Duevel acknowledges that there are many policies to keep track of in this complicated landscape, but they ultimately exist to protect researchers. She clarifies, “Usually, compliance is driven by something that went wrong in the past. The government or Harvard comes up with policies, so these things don’t happen again.” It’s her job to keep track of everything and convey that to the researchers, making it as easy as possible for them to adhere to policy.
Director of Research Administration, Keleigh Quinn, explains, “The Compliance Team’s jobs become more complex by the day with endless new requirements from the federal government. They work hard to make sure the Wyss is equipped to meet the challenges.”
Recently, Duevel has also been working more on data management, making sure that Wyss data is properly stored and accessible so others can reproduce it. This is becoming an increasingly important area of work, as the Wyss teams are generating rich biological datasets through our newly-launched AI DataHub, where reusable, well-managed data can support AI and machine learning applications in biomedicine and sustainability. Also, a newer part of Duevel’s job is ensuring research integrity, which involves investigating any allegation of research misconduct to assess if there has been fabrication, falsification, or plagiarism.
Manager of Sponsored Research Compliance, Cori O’Brien Chisholm, reviews all sponsored programs, sponsored projects, and grant applications for compliance with the requests for applications and Institute and Harvard University policies. She explains, “PIs put in a vast amount of work to prepare a proposal, and we don’t want an idea for potentially lifesaving science withdrawn from review because they didn’t follow formatting guidelines.”
O’Brien Chisholm started her career in research administration in 2001 at Massachusetts Eye & Ear, working her way up from a staff assistant to the Administrative Manager of Ophthalmology Research, and then came to Harvard nine and a half years ago.
Science is really powerful for improving people’s lives. If I do my job correctly and take care of the details and administrative work, that frees up more time for the scientists to contribute to the benchwork and make breakthroughs in the lab.
She also works closely with the Office of Sponsored Programs (OSP) to review and negotiate both funded awards and unfunded research collaboration agreements. Once the agreement is executed, she works with the pre-award awards management team in the OSP on the logistics, such as clearing approvals, setting up account strings, and obligating funds to spend. Compliance here is important in preventing unallowable charges, audit findings, or the removal of charges. She ensures that researchers understand the compliance requirements, such as reporting and budget restrictions, and works with the Sponsored Team to help ensure adherence.
O’Brien Chisholm reflects, “I’m not a scientist, but science is really powerful for improving people’s lives. If I do my job correctly and take care of the details and administrative work, that frees up more time for the scientists to contribute to the benchwork and make breakthroughs in the lab.”
Meet the team
Duevel is a biologist by training. After her postdoctoral fellowships, she worked on technology translation at Dana-Farber Cancer Institute before transitioning to research administration. She joined the Wyss in 2017. In addition to her official job responsibilities, Katrin is an active member of the Wyss Green Team.
Something even most of her colleagues don’t know is that she has low vision. She explains, “Because of that, I often don’t recognize people from further away in the hallways. I enjoy being involved in the community and never want to come across as rude if I don’t greet them from afar.”
O’Brien Chisholm joined the Wyss about two and a half years ago after serving as the Associate Director of Finance in the Department of Environmental Health at the T. H. Chan School of Public Health.
Within the last year and a half, O’Brien Chisholm took up watercolor painting. She likes to paint on small surfaces that she turns into jewelry. She’s already done two craft fairs and recently lent her talents to the Institute, leading a watercolor magnet painting workshop. She observes, “There’s a unique sense of community here that’s not a given at other places.”
Connecting the dots across Harvard
While the Wyss Compliance Team has only two members, they are deeply integrated into Harvard’s broader compliance ecosystem. Duevel has a dotted line to the Office of the Vice Provost for Research (OVPR) and is part of a group of export-control and conflict-of-interest administrators across the University. Together, they make decisions and develop policies for the entire organization.
That collaboration is reciprocal, as Duevel is willing to help her colleagues across the University when needed. Roberts Williams remembers, “At one point, Harvard SEAS experienced significant delays in FCOI review, which delayed some research activities for several weeks. Katrin volunteered to assist her SEAS counterparts and conducted a comprehensive review of the pending conflicts for Wyss PIs with primary SEAS appointments. She cleared the backlog thoroughly and efficiently, allowing research activities to resume without further delay.”
The central office O’Brien Chisholm works most closely with is OSP. She knows which agreements are still missing information, and can reach out directly to PIs or the Wyss Sponsored Research Team. In standing bi-weekly meetings with the grants and contracts officer at OSP, her institutional knowledge helps them to determine which projects to prioritize. She also connects with the Office of the Vice Provost for Research about limited submissions and applications that meet the criteria for Provost review.
O’Brien Chisholm is the only person at Harvard who sits in both a department or institute and the central OSP, and she sees a reason for that: “The Wyss has a unique outlook in that they value the people and relationships necessary to get things done quickly.” Duevel adds, “Our ties to the central offices keep the Wyss from being just one of the many organizations they have to deal with.”
Quinn elaborates on the value O’Brien Chisholm’s unique position brings, “Cori provides an invaluable service to the Sponsored Team. She acts as a liaison between our team and the OSP, helping to review terms and conditions and conducting thorough reviews of all proposals to ensure compliance and that we are submitting the best possible proposal. She also handles other types of agreements, tracks equipment terms, and assures that all necessary approvals are in place. We literally could not function as a team without her.”
Building a visible factory
More locally, the Compliance Team frequently collaborates with others across the Institute. Building relationships is essential because they can only get pulled in and notified about potential compliance concerns when they know what is happening.
Thankfully, collaboration is built into the fabric of the Wyss. O’Brien Chisholm explains, “The Wyss has a very nice group of people who are willing to work together and help each other. There are a lot of subject matter experts whom you know you can go to if you need them, and who will bring us in when necessary.”
Director of Research Operations, Michael Carr, C.S.P., shares an example: “I was looped in on a consumables order one of the labs wanted to purchase with a grant and send overseas to a collaborator, something I haven’t been asked about before. Katrin provided prompt and clear guidance, so we could tell the researcher the most compliant and fastest way to achieve their goal.”
This isn’t a given everywhere, but the Wyss is small enough that people know each other, and breaking down silos is part of the Institute’s ethos. “Other compliance professionals I know sometimes struggle to find information from other teams, whereas I am sitting among people with different functions all of the time,” Duevel points out. “When I start a new project, or something comes up, and I have to do some fact-finding, I can literally just turn around and talk to people or meet them easily. I really like that.”
O’Brien Chisholm explains, “There’s this concept of hidden factories, which are behind-the-scenes activities that consume time and resources, such as a workaround used to bypass a broken system. In other places, you need to know the hidden factories of who the effective people are, and it slows things down. The Wyss’ administrative groups are much more transparent. We’re more of a visible, efficient factory full of well-oiled machines.”
Not a want, but a need
When asked what others should know about their team, Duevel replies, “We are here to help researchers. Compliance is not a nice-to-have; it’s a must. We’re not an obstacle or a hindrance; we want to make it as easy as possible for researchers to do what’s required by Harvard or the government.”
O’Brien Chisholm agrees, adding, “I want to help researchers have the best application possible that goes out the door, positively reflecting on them, their PI, the Wyss, and Harvard broadly.”
We are here to help researchers. Compliance is not a nice-to-have; it’s a must…We want to make it as easy as possible for researchers to do what’s required by Harvard or the government.
The team advises researchers to reach out early and often during their weekly office hours, via Teams, or by email.
In the end, both want to do their part to protect the Institute and its researchers. Falloon reflects, “There is a fitting picture of an owl in Katrin’s cubicle. She has a bird’s-eye view of the needs and interests of the Wyss at large and protects its mission. The Compliance Team is a crucial part of the Wyss, and we are lucky to work with them.”