Administrative Updates
Inside UNC Research: Rethinking research compliance
By Carleigh Gabryel, April 15, 2024
Compliance-related services are being reorganized to better help researchers navigate regulations and meet requirements.
As Carolina’s research enterprise grows, the Office of the Vice Chancellor for Research (OVCR) continues to evaluate how the administration can effectively facilitate the research process. As part of this evaluation, compliance efforts are being updated to better meet the needs of investigators.
UNC Research spoke to Assistant Vice Chancellor for Research Compliance Quinton Johnson and newly appointed Clinical Research Compliance Director Valorie Buchholz about their strategy for streamlining the program.
Compliance imperative
“Our goal is to support our faculty and staff so they can conduct the research that’s important to them and the citizens of North Carolina,” Johnson says.
Carolina’s research enterprise receives a significant amount of federal funding, which requires strict adherence to various regulations and policies, especially when it comes to the development of new drugs and devices. This comes under the purview of the FDA, whose regulatory framework is extremely complex.
“The FDA-regulated space is high-risk,” Quinton says. “These project requirements are unique because you have to get it right from the beginning. You need to collect good data, store it appropriately, and document it properly. It’s a wholistic lifecycle of developing intellectual property.”
To support the numerous FDA-regulated projects at UNC-Chapel Hill, OVCR’s compliance team is undergoing some changes.
Organizational changes
Moving forward, Johnson will oversee three compliance-related offices within OVCR — Export Control, Science and Security, and the newly created Clinical Research Compliance, which will be taking over responsibilities from the Office of Clinical Trials.
A new position is being created within the Clinical Research Compliance Office (CRCO), which Buchholz leads, to manage multiple areas including compliance related to GXP — a catchall for Good Manufacturing Practice, Good Clinical Practice, and Good Laboratory Practice. Additionally, Clinical Trials Quality Assurance and ct.gov will also fall under CRCO.
“We want to change the structure in a way that makes true offices and positions out of what was disparate subject matter experts before,” Buchholz says.
OVCR’s compliance team will also help support the ONE UNC Clinical Research initiative as it grows, bringing together personnel from NC TraCS and the School of Medicine’s Clinical Research Support Office to develop a facilitative structure for investigators and their teams.
While CRCO establishes the scalable infrastructure needed to navigate the evolving research and regulatory environment, Carolina will partner with Advarra to ensure there is no gap in services. These changes will help compliance programs achieve the goal of providing internal support to investigators at any point in the research process.
Looking forward
Compliance leaders are working to bring together groups across campus to provide the research community with resources to help understand and adhere to best practices.
“We’re looking at areas where we may have service gaps and figuring out how to mitigate those,” Buchholz says. “We’re meeting with leadership, faculty, and staff to get their perspective of where they might see compliance needs.”
While Buchholz and Johnson say centralization is a goal, some of their key partners will always be faculty and staff associated with study teams across the University. By pooling resources, providing guardrails, and having easily accessible subject matter experts, clinical research teams can better fulfill compliance responsibilities for their projects.
Permalink: Inside UNC Research: Rethinking research compliance
Earlier:
By , March 13, 2024
This is a message from Vice Chancellor for Research Penny Gordon-Larsen.
Dear Colleagues,
Today I am sharing the news that Stephen Hursting will be stepping down as director of the UNC Nutrition Research Institute in Kannapolis, NC, effective April 1, 2024. On that date, Deborah Tate will assume interim directorship of the institute.
Tate holds a faculty appointment at NRI, is a professor in the nutrition department, is co-principal investigator of the NIH’s Nutrition for Precision Health UNC Clinical Center (co-located in Chapel Hill and at the NRI), and directs the Communication for Health Applications and Interventions Core. She is an internationally recognized behavioral scientist who studies precision nutrition, obesity, diabetes prevention, and digital health interventions.
Hursting will remain a faculty member in the joint Department of Nutrition at the UNC Gillings School of Global Public Health and School of Medicine, leading his lab in Chapel Hil making advances in research on the mechanisms of certain cancers. His research is making significant advances in understanding the effects of obesity on cancer as they are strengthening work in precision nutrition.
The NRI acts as a significant economic catalyst for Kannapolis. Its presence on the North Carolina Research Campus fosters job creation, with estimates suggesting close to 1,000 positions stemming from campus activity. This has demonstrably revitalized Kannapolis’s economy following a period of industrial decline. As a global leader in precision nutrition research, NRI investigators study the role of nutrients in preventing disease, diet-related health behaviors, risk factors for disease, the effect of the environment and genes on disease outcomes, and the impact of gene-nutrient interactions.
The mission of the NRI is of critical value to the University and to our state. It provides invaluable community engagement, conducts field-leading research, and contributes to the economic development of the region. As such, I would like to thank Steve for his leadership over the last three years, and I look forward to working with Deb through this transition.
Permalink: Leadership transition at the UNC Nutrition Research Institute
By , February 12, 2024
This is a message from OVCR Research Science and Security, Office of Sponsored Programs, and School of Medicine’s Sponsored Programs Office.
The Office of Science and Technology Policy (OSTP) recently released new requirements to all federal agencies governing Current and Pending (Other Support) and Biosketch documents (also known as Common Forms). The agencies were tasked with incorporating these new requirements into their processes and announcing agency-wide implementation dates.
Key Highlights of the New Federal Requirements:
- New requirements apply to all senior/key personnel
- Continues the heavy focus on international activities/affiliations
- Standardizes the requirements for both Current and Pending (Other) Support and Biosketch documents across all agencies with minimal exceptions
- Consulting activities now count towards “conflict of commitment” and have three new definitions that will need to be applied to determine if an activity should be disclosed
- Prohibits senior/key personnel from participating in malign foreign talent programs
- Better defines In-Kind resources
- Both documents will require senior/key personnel certification
Training:
A pan-campus working group is currently developing training materials related to the new requirements, which will be available to all faculty and staff across campus. The training, once ready, will be hosted on the Office of Sponsored Programs website.
Agency Implementation Dates:
To date, only two federal agencies have released implementation dates, with two more acknowledging that they will incorporate the new requirements into their policies and procedures at some point in the future. Details below.
- National Science Foundation: NSF will implement the new requirements for all proposals submitted or due on, or after, May 20, 2024. SciENcv, a research profile system, will play an integral role.
- National Institutes of Health: NIH will implement the new requirements in January 2025 using the standard templates released with the requirements. They will then transition to SciENcv, to align with NSF, in May 2025.
- National Aeronautics and Space Administration: NASA has announced they will incorporate the new requirements into their Grants Policy Manual but does not have an implementation date set yet.
- Department of Energy: DOE has announced that they are currently negotiating with OSTP to implement the new requirements. We believe this is because they want to make changes to the requirements in order to meet legislative/appropriation requirements. They do not have an implementation date set yet.
As more information is received, and training materials becomes available, we will provide another update. Additional information can also be found on the NSF website at https://www.nsf.gov/bfa/dias/policy/nstc_disclosure.jsp.
Should you have any immediate questions, please feel free to reach out to Brian Collier, Director of Research Science and Security at bcollier@email.unc.edu.
Permalink: New Federal Current and Pending (Other) Support and Biosketch Requirements Coming Soon
By , February 9, 2024
UNC-Chapel Hill’s Generative AI Committee, which is comprised of representatives from every academic unit, has released guidance on how to responsibly and ethically use tools like ChatGPT and Gemini. A subcommittee led by Eric Everett, director of research integrity, ethics, and education within OVCR, has crafted specific recommendations for the research community.
This guidance applies to faculty, staff (SHRA and EHRA non-faculty), students (undergraduate, graduate and professional), guest researchers (e.g., unpaid volunteers, interns, and visiting scholars), collaborators, and consultants involved in research occurring under the auspices of the University.
The guidance covers information on the following:
- The limitations and risks of using generative AI in research
- Principles on which to base the usage of the technology
- Frequently asked questions and resources for citation
“Please review this guidance and integrate it into your research and scholarly practices, tailoring it as necessary to suit your specific discipline and accepted research and scholarly practices within your discipline,” says Everett. “Mentors and supervisors should have regular conversations with mentees and other research trainees about the intended use of generative AI in their research programs.”
Given the rapid pace of advancements in generative AI, Everett anticipates this guidance to continue to evolve. If you have any questions or feedback, please do not hesitate to reach out.
Permalink: Inside UNC Research: Generative AI in research
By , February 8, 2024
This is a message from Vice Chancellor for Research Penny Gordon-Larsen.
Today I am sharing the news that Steve Marshall will be stepping down as director of the UNC Injury Prevention Research Center (IPRC), effective March 1, 2024. After more than a decade at the helm of IPRC, he will be returning to his faculty position in the Department of Epidemiology within the UNC Gillings School of Global Public Health and will continue his research activities with the center.
Beth Moracco, IPRC’s current associate director, will serve as the center’s interim director beginning March 1. Between February 12 and March 1, Marshall and Moracco will work together to efficiently transition leadership of the center.
For more than 30 years, researchers at IPRC have addressed vital societal issues including domestic abuse, car crashes, traumatic brain injury, home and workplace safety, and opioid overdose — and have worked closely with practitioners to change policies and save lives.
Under Marshall’s leadership, IPRC expanded in size and increased its impact while maintaining continuous funding as a CDC Injury Control Research Center. Additionally, he oversaw hundreds of research projects that have improved the lives of people in our state and beyond. We are grateful for his years of service, talent, and dedication to the field of injury and violence prevention.
Moracco has served as associate director of IPRC since 2017 and brings more than 15 years of experience in higher education leadership to her new role. She is also an associate professor in the Department of Health Behavior at Gillings and is the chair of faculty at the University.
Please join me in thanking Steve for his service to IPRC and Carolina, and in supporting Beth in her new role.