Administrative Updates
Inside UNC Research: Looking after the wellbeing of animals
By , January 17, 2024
Tracy Heenan has been the director of the Office of Animal Care and Use for 30 years.
In 1994, Tracy Heenan was an associate at a small animal veterinary practice when she heard about a newly created position at UNC-Chapel Hill that piqued her interest. At the time, the number of Carolina’s research initiatives involving animals was small, and the care and use programs had been established for only a few years.
Since then, Heenan, who is also a professor in the Department of Pathology and Laboratory Medicine within the School of Medicine, has been instrumental in growing OVCR’s Office of Animal Care and Use (OACU), the managing office of the University’s Institutional Animal Care and Use Committee.
UNC Research spoke to Heenan about the evolution of OACU and what researchers should know about the resources available to them.
How has your position changed over the years?
It was a totally different world back when I started. It was just me — I was the office. Since then, we’ve added training programs and grown our staff to include 10 full-time positions. As the overall animal program at UNC-Chapel Hill has grown, so has our office.
I’ve had the great fortune of working with wonderful supervisors who were flexible and gave me full responsibility for making changes or adding to our program. Some additions were necessary due to external regulations for animal care and use and the compliance areas that have developed. I have also had the benefit of working with capable and engaged OACU employees who have been instrumental in shaping the program.
What accomplishment are you most proud of?
I’m most proud of starting the laboratory animal coordinator program. It is unique to Carolina, and other institutions across the country have modeled their programs after it.
I thought it was important to develop a robust hands-on training program for researchers working with animals, so in 1998 I started an initiative and hired my first training and compliance coordinator to provide this training. It then became a UNC-Chapel Hill requirement that every researcher who would touch or work with animals had to attend formal training classes and be certified.
In conjunction with this requirement, we developed the laboratory animal coordinator program. Every investigator laboratory that works with animals is required to have a coordinator who receives didactic animal-use training from my office and gets a certification of their proficiency. They are then allowed to train other lab members and serve as a liaison for the IACUC, OACU, and the investigator laboratory.
How does your office work with the Institutional Animal Care and Use Committee (IACUC)?
OACU supports IACUC in its regulation and compliance efforts. While IACUC is the overall authority on animal care and use at the University, the committee requires help with the day-to-day logistics of ensuring that all federal policies, accreditation standards, and institutional requirements are being met. This includes working closely with the Division of Comparative Medicine, which manages the day-to-day care and medical treatment for animals, and Environment, Health, and Safety, which is responsible for managing the safety of employees working with animals.
Every six months, we help inspect all animal housing facilities, including investigator labs where animal work is conducted and procedure locations. In addition, my office has three main operational units to support the work of the IACUC: education and oversight, protocol administration, and grant congruency.
What do you want researchers to know about your office?
Investigators have a huge amount of administrative burden. In many respects, the IACUC requirements can feel like a lot. We understand that, and we want researchers to know that although we are a compliance office, we don’t want to represent a roadblock or burden. We want to be helpful, answer questions, facilitate research, and help investigators succeed.
Permalink: Inside UNC Research: Looking after the wellbeing of animals
Earlier:
By , December 12, 2023
A message to the research community on research compliance.
Dear UNC Research Community,
We are pleased to announce important updates to our clinical research compliance services. Effective immediately, the Clinical Research Compliance Office (CRCO) is the new, central point of contact for all Investigational New Drug (IND) and Investigational Device Exemption (IDE) compliance requirements from the Food and Drug Administration (FDA).
Key Points:
- Point of Contact:
- The Office of the Vice Chancellor for Research (OVCR) has worked with TraCS to transfer support for all matters related to IND and IDE compliance to the Clinical Research Compliance Office.
- For any questions or assistance regarding IND/IDE submissions to the FDA, please reach out to the Clinical Research Compliance Office at ClinResComp@unc.edu.
- The CRCO will provide support to UNC researchers in the preparation or review of:
- Initial IND or IDE applications
- Annual progress reports
- Responses to FDA inquiries
- Institutional Oversight:
- The CRCO is committed to ensuring appropriate institutional oversight of commitments made under investigator-sponsored INDs and IDEs.
- The CRCO will work closely with researchers to uphold compliance standards and facilitate successful interactions with the FDA.
- Resources:
- OVCR has temporarily contracted with Advarra to provide additional subject matter expertise and administrative support while the CRCO fills vacant positions.
- Please reach out to the CRCO who will coordinate with Advarra to ensure responsive timelines and accurate advice to ensure that investigators have the best support services available.
Please feel free to contact the CRCO for any further clarifications or assistance. We are dedicated to supporting your clinical research endeavors and maintaining the highest standards of compliance.
Thank you for your continued commitment to advancing scientific discovery and improving patient care.
Sincerely,
Quinton Johnson
AVC for Research Compliance
Office of the Vice Chancellor for Research
Permalink: Important updates to clinical research compliance services
By , December 6, 2023
A message from the Vice Chancellor for Research
Several months ago, we announced a new initiative to address research data management needs across the University with the establishment of a new Research Data Management Core (RDMC). We are now pleased to provide the following exciting announcements on the RDMC’s progress: the appointment of Jonathan Crabtree as the core’s inaugural director, the rollout of the RDMC website, an update to RDMC service support, and fee information.
RDMC Inaugural Director
Reporting to Senior Associate Vice Chancellor for Research Andy Johns, Crabtree will shepherd the RDMC into existence, drawing on several decades of data archival systems experience directing the Odum Institute’s Research Data Information Systems group.
Crabtree has worked at UNC-Chapel Hill for more than 30 years. During his time at the Odum Institute, he helped to establish a highly skilled team of developers and support staff responsible for building and maintaining data archival systems for social science research data, including the UNC Dataverse, which is now being used by researchers across the University and beyond. He was also involved in establishing the Global Dataverse Community Consortium, an organization that supports archives built on the Dataverse Project worldwide. He is the current chair of the CoreTrustSeal board, an international body providing certification and review for data repositories based on the Core Trustworthy Data Repositories Requirements.
Crabtree has an undergraduate degree in economics and master’s and doctorate degrees from the UNC School of Information and Library Science, focusing on trusted digital repositories.
RDMC Website
The new RDMC website is now live and includes guidance on getting started with research data management, planning for the data that will result from a grant-funded project, and navigating the parts of the pre-award process that pertain to research data management, including budgeting.
In addition to this guidance, the RDMC site maintains a knowledge base related to concepts, procedures, and other information related to research data management. There is also a service portal that makes it easy to request help or consultation with a member of the RDMC staff. Soon, several other applications currently under development will be made available to aid in understanding data management best practices and planning for data management throughout the lifecycle of a project. These will include a repository finder and a set of interactive tools that walk investigators through the research data lifecycle.
For more information, please visit the site at https://researchdata.unc.edu.
RAMSeS IPF Screen Rollout
Effective December 1, you may notice as you log into RAMSeS that there is a new screen in the internal processing form (IPF) to collect information about the research data projected to result from funded research programs. This upgrade to RAMSeS will enable the RDMC, Office of Sponsored Programs (OSP), School of Medicine’s Sponsored Programs Office (SOMSPO) and others within UNC Research administration to better understand data management needs across campus and implement the plans that are increasingly being required for inclusion with grant applications by funder mandate.
For help with any part of filling in the requested information in the IPF while planning grants, please visit the RDMC website for guidance. You may also request support in the RDMC service portal by clicking on the “Need Help?” button at the top of the page.
RDMC Fee
Beginning November 2023, a new data management fee will be applied to most funded research projects, regardless of sponsor, to fund the critical infrastructure required to support research data management needs for the University. Specialized projects and projects with very large-scale data may require additional and tailored support that can be borne as direct costs on a project-by-project basis. A full listing of services covered by the RDMC fee is available on the RDMC website.
The new RDMC fee (expensed on account 559011) will apply to monthly modified total direct cost (MTDC) expenditures at 0.38%. The RDMC fee will be allocated to projects as part of month-end ConnectCarolina processes and should reflect on project financials by the first week of the following month. We encourage all research teams to continue budgeting for the RDMC fee during the pre-award process and follow guidance from OSP and SOMSPO.
Please join us in welcoming Jonathan Crabtree and the Research Data Management Core to the UNC Research family. Together, we look forward to managing our data resources to the maximum benefit for the UNC community and the society we serve.
Permalink: Updates on the Research Data Management Core Support and Resources
By , November 14, 2023
Laura Sandt and Caroline Mozingo have been appointed permanent co-directors of the Highway Safety Research Center, bringing a combined 33 years of experience in driving success in research, outreach, and operations.
As leaders of the Highway Safety Research Center (HSRC), Laura Sandt and Caroline Mozingo will equally share oversight and managerial responsibility of the center, including activities related to fiscal management, human resources, strategic planning, and coordination with University leadership. Other areas will be divided, with Sandt overseeing research strategy and implementation, and Mozingo leading strategic communications, partnerships, and operations.
Sandt and Mozingo have served as interim co-directors of the center for the past two years, establishing this effective and successful shared leadership model. UNC Research spoke to the pair about their career, research, and goals for HSRC.
How did you get involved with highway safety research?
LS: I was first introduced to highway safety research when I was completing my undergraduate degree at Texas A&M University and began working as a research assistant helping to prepare manuscripts for a research center that focused on transportation. The subject matter interested me so much that I decided to pursue a career focusing on transportation and injury prevention. I came to UNC-Chapel Hill to join the master’s program in City and Regional Planning (DCRP) in the College of Arts and Sciences, and from there I got my PhD in Epidemiology from the Gillings School of Global Public Health.
CM: I’m a communicator by training (UNC Hussman School of Journalism and Media grad here) who initially joined HSRC because I wanted to work on research projects and safety programs that positively impacted real people and communities. The passion of my HSRC colleagues and our partners — we call it the HSRC Family — paired with the challenge and importance of our projects is what keeps me here.
How has your role changed at HSRC?
LS: My role has changed a lot since I began here in 2004 as a graduate research assistant. My early years at HSRC were focused on developing a foundational knowledge of the transportation field, public health approaches to injury prevention, and growing my research and analysis skills. As co-director, I still have the opportunity to lead research, but my focus is on finding strategic ways to achieve our center’s broader mission, which is to improve road safety in the U.S. and reduce the burdens placed on disadvantaged communities by cultivating multidisciplinary research, education, and professional development.
CM: I was initially hired to work on a project geared toward improving safety for kids walking and biking to school. Over the past 14 years, I’ve worked on projects across almost every transportation topic you can think of — from teen driver safety to roadway design issues for engineers to training for practitioners — most of which had an application and impact on real people and communities. While I still do some of that work, more of my time is now spent working to support HSRC staff and thinking about how to build relationships and partnerships for researchers and the center as a whole.
Why is highway safety research important?
LS: People use the transportation system literally every day, often without thinking of it. Because it’s so mundane, we often take it for granted. But we still see more than 40,000 people killed each year on our nation’s roadways, and we have a lot of work ahead of us to understand and address the root causes of traffic violence.
CM: Highway safety is a challenging and exciting research field that impacts the safety — and lives — of so many people every single day. Whether you’re getting from one place to another by car, bus, bike, foot, or by some other mode of transportation, research can be used to help make that trip safer.
LS: The transportation field is also very dynamic and rapidly changing, with huge disruptions happening in the last decade such as ridesharing systems like Uber, micro-mobility systems like e-scooters, and vehicle electrification and automation systems like what we see with Tesla. The innovations demand that researchers keep pace in order to understand the impact of these changes on roadway safety, health, and quality of life for our society.
What are your goals for HSRC?
LS and CM: We’re thrilled to take on the co-director roles at HSRC. In ongoing conversations with center researchers and colleagues, we’ve already defined some clear priorities, including:
- continue supporting the great people and the great work being done at HSRC;
- grow collaborations and partnerships for multidisciplinary transportation research and expand HSRC’s connections to UNC System researchers, faculty, and students;
- expand efforts to train and place future professionals in transportation careers; and
- foster opportunities for increased community engagement, specifically through road safety programs we’re involved with across North Carolina.
We strive to help more people make the connection between transportation and community issues such as access to health care, equity, climate change, and others. Our ultimate goal is to increase the number of people who are aware of road safety issues and are part of efforts to implement evidence-based programs and related research.
We also have a big milestone coming up in 2025: 60 years in operation! We plan to make the most of that accomplishment.
What would you like people to know about HSRC?
LS: HSRC is internationally respected as a transportation safety research center, with collaborators in the Netherlands, Sweden, New Zealand, Australia, Canada, and elsewhere. We have research partners across the U.S., and we work with dozens of North Carolina communities to provide data, research, transportation safety best practice, and technical assistance to support local safety programs. We welcome the opportunity to collaborate with and serve the UNC-Chapel Hill community as well.
CM: HSRC researchers have a lot to bring to the interdisciplinary research table at Carolina. We have smart, passionate people working on projects in so many different areas — improving vehicle crash data and emergency room data, community engagement in rural N.C. communities, car seat safety, older drivers, teen drivers, and equity in transportation. If you think there may be some overlap in our areas of study, please reach out and connect with us.
Permalink: Inside UNC Research: Moving highway safety research forward
By , November 14, 2023
A message from Andy Johns, Office of the Vice Chancellor for Research senior associate vice chancellor for research, Blossom Damania, School of Medicine Boshamer Distinguished Professor and vice dean for research, and Ian Buchanon, UNC Health chief care innovation officer.
Please join us in congratulating Shakira Henderson on her acceptance of the deanship of the College of Nursing at the University of Florida (UF). She will be departing Carolina at the end of November to assume her new responsibilities, which also include serving as associate vice president for nursing education, practice, and research for UF Health.
Henderson has served as assistant vice chancellor for clinical research since April of 2022. She held this joint appointment within the Office of the Vice Chancellor for Research in addition to serving as vice president for research with UNC Health and as clinical research integration officer with the UNC School of Medicine (SOM). While she held these roles, she provided seamless integration of clinical research management across all three entities.
We will greatly miss her leadership. Henderson provided invaluable support to the campus community through spearheading the launch and Phase 1 development of the ONE UNC Clinical Research initiative, a joint effort between the University and UNC Health to transform the clinical research administrative processes to be more synergistic, efficient, and effective. Phase 1 of the initiative concluded in June, and working groups are actively making progress on Phase 2, which includes pilot proposal development.
ONE UNC Clinical Research is an exciting opportunity that will accelerate our efforts to grow our clinical research across campus. As Henderson steps down, Laura Viera and Michael Sledge will transition into leading the initiative on an interim basis until a permanent replacement is named. Viera currently serves as the as co-director of SOM’s Clinical Research Support Office, and Sledge is vice president and chief business officer of the SOM’s Clinical Research Alliance. Both are very familiar with ONE UNC Clinical Research, having served on the steering task force for the effort.
Again, please join us in congratulating Shakira on her exciting new role and supporting Laura and Michael as they step into overseeing ONE UNC Clinical Research.