Goal #3: Address health needs of populations

An opioid overdose is an incredibly dangerous moment – and not only in the initial moments of the overdose. Even when someone survives an overdose, they face a high risk of suffering from another overdose in the coming days, weeks, and months.Micha Belden and Chris Shea with the Implementation Science Methods Unit at NC TraCS are currently leading a study on post-overdose response teams, or PORTs, in North Carolina. They want to help local officials, first responders, law enforcement, and other stakeholders create and run post-overdose response teams that fit their community’s needs and prevent overdose deaths.Read the <a target="_blank" rel="noopener noreferrer" href="https://tracs.unc.edu/index.php/news-articles/2458-learning-how-local-teams-can-cooperate-to-stop-overdoses">full story</a>

North Carolina Translational and Clinical Sciences Institute

TraCS Research Support; photos of Micha Belden and Christopher Shea

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University of North Carolina at Chapel Hill

NC TraCS researchers are helping local officials and healthcare providers in North Carolina understand how rapid-response teams can prevent overdose deaths.

Learning How Local Post-overdose Response Teams Can Cooperate to Stop Overdoses

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Goal #7:  Training and career support programs for translational scientists

The UNC Eshelman School of Pharmacy has received funding from the National Institutes of Health to launch the&nbsp;<a target="_blank" rel="noopener noreferrer" href="https://pharmacy.unc.edu/fellowship/c3-drug-delivery-predoctoral-t32-training-program/">C³ Drug Delivery Predoctoral Training Program</a>, a new cross-institutional T32 program designed to prepare the next generation of scientists to translate drug delivery innovations into real-world therapies.The program brings together UNC-Chapel Hill, North Carolina State University (NC State)&nbsp;and North Carolina Agricultural and Technical State University (N.C.&nbsp;A&amp;T), the nation's largest HBCU,&nbsp;to train PhD students to move drug delivery innovations from concept to clinic to commercialization&nbsp;(C³).&nbsp;The T32 program is part of the&nbsp;<a target="_blank" rel="noreferrer noopener" href="https://tracs.unc.edu/">NC TraCS Institute</a>&nbsp;at UNC-Chapel Hill. NC State and N.C.&nbsp;A&amp;T are longstanding NC&nbsp;TraCS&nbsp;partners helping advance the NCATS vision of delivering more treatments to all people more quickly.&nbsp;Read the <a target="_blank" rel="noopener noreferrer" href="https://tracs.unc.edu/index.php/news-articles/2462-eshelman-tracs-collaboration-launches-drug-delivery-training-program">full announcement</a>

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A new cross-institutional T32 program designed to prepare the next generation of scientists to translate drug delivery innovations into real-world therapies launches at UNC-Chapel Hill, NC State University, and N.C. A&T.

NC TraCS and UNC Eshelman School of Pharmacy Collaboration Launches Drug Delivery Training Program

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Goal #4: Improve clinical research

For one University of Minnesota Duluth researcher, bringing a study from idea to implementation felt like a monumental climb. Often, simply knowing where to begin and who to go to can be the biggest barrier to moving a great idea forward."The process was quite challenging for me personally," says Mark Zmudy, PhD, an Associate Professor with the College of Education and Human Service Professions. "I’d look at these massive applications and sometimes not even know what was being asked. It felt like the only way to move a study forward was for two acts of Congress to pass and the stars to align."Two years later, those initial barriers are gone, replaced by endless possibilities. The secret wasn't a change in federal law or a lucky break. It was what Dr. Zmudy calls an "amazing discovery": he didn't have to do it alone.Everything changed when he connected with the Clinical and Translational Science Institute (CTSI) at the University of Minnesota, where Dr. Zmudy found comprehensive support at every step.The team introduced him to research experts at the Clinical Research Support Center (CRSC), where CTSI and its collaborators offer a wide range of services and consultations to support any research that impacts human health and wellbeing. There, research experts helped develop his protocol, orient him to the right Institutional Review Board (IRB) forms, draft consent forms, and much more.<h2>Nature as a tool for healing</h2>Dr. Zmudy teaches adventure education and outdoor pursuits, and his research is rooted in the healing power of nature. He strives to create instructional environments for outdoor adventure and physical education that are genuinely inviting to all people.“For various reasons, there are people for whom going on another camping trip can be a source of post-traumatic stress," Dr. Zmudy explains. "I think that’s a complete disaster, and something that could be avoided with intentional, thoughtful, purposeful, heartfelt teaching practices aimed at creating a sense of belonging for all participants."In his research, Dr. Zmudy works to create outdoor education programs that resonate with more students and to use adventure as a tool for breaking down barriers.It aligns with the growing “Nature as Rx” movement, in which people are increasingly being “prescribed” time in natural settings to improve physical and mental health and well-being.“Over the past several years, it seems that a pretty high percentage of our incoming students now come to college with some sort of anxiety, depression, or attention disorder problem that they need help with,” Dr. Zmudy says. “Students are usually pretty open about this.”But to bring these "Nature as Rx" intentions to life, Dr. Zmudy first had to navigate the world of research compliance and start-up.<h2>From “stuck” to streamlined</h2>Dr. Zmudy’s transformation began when he met the Clinical and Translational Science Institute’s research navigators, who listened to his needs and pointed him to the University resources that could best help.That included connecting him with <a target="_blank" rel="noopener noreferrer" href="https://ctsi.umn.edu/services/study-planning-protocol-support">clinical research specialists</a>, who provided dedicated support throughout the protocol and study planning process at no cost to him.They didn't just give him a map; they demystified the entire landscape, providing tailored guidance that met Dr. Zmudy exactly where he was.Right away, the clinical research specialists helped Dr. Zmudy discover that some of his projects likely did not constitute human subjects research. Those projects were submitted to the IRB via a much shorter determination form and determined not to be human subjects research. This meant that neither additional IRB review nor IRB approval was required."I wouldn’t have known that if I had just tried to fill out the 40-plus-page application in the first place," Dr. Zmudy says. "How many hours and weeks and months would I have wasted waiting for something I didn’t even need?”<h2>Strengthening the science</h2>Clinical research specialists also reviewed Dr. Zmudy’s research, providing concrete feedback and offering suggestions to help limit protocol-related IRB stipulations and streamline study start-up.“They are amazingly willing to give me feedback and say, ' Here, you need to fix this, and here's how to fix it,'” recalls Dr. Zmudy. “I would have never figured out some of this stuff on my own.”Feedback also strengthened the study’s scientific rigor.“CTSI’s clinical research specialists helped me figure out the scientific part of designing the study,” adds Dr. Zmudy. “They gave me a lot of ideas on the kinds of questions I could and should be asking in my qualitative interviews, so it ties back to validated theories and frameworks.”<h2>Handling the heavy lifting</h2>When it came time for IRB submission, Dr. Zmudy was referred to <a target="_blank" rel="noopener noreferrer" href="https://ctsi.umn.edu/services/regulatory/regulatory-specialists">regulatory specialists</a>, who helped draft consent forms, submitted materials to ETHOS, and fielded clarifying questions from the IRB."CTSI did the consent form for me," says Dr. Zmudy. "That process would have been a bit of a barrier, given the administrative requirements involved in the consent process."<h2>Scaling new heights</h2>Dr. Zmudy’s research portfolio has expanded at a pace he once thought impossible. Since his first meeting with the Clinical and Translational Science Institute two years ago, he confesses to going "a little bit haywire," successfully moving five studies through the pipeline.The process has been remarkably quick and seamless: of his five IRB submissions, each review passed through without a single stipulation or resubmission—only a few clarifying questions.This high-volume output includes three social-behavioral protocols and two “not human subjects research” determinations, all of which involved collaboration with clinical research and regulatory specialists from the Clinical and Translational Science Institute. He currently manages five active, IRB-approved studies and has found a new level of confidence in his work.“I can’t say enough about how amazing the service from CTSI has been, and how kind the people have been. They take things that are a mystery to me, and make them very understandable,” says Dr. Zmudy. “I would give them five stars every time.”<h2>The human impact</h2>Beyond the five-star reviews, the real impact is seen in those the research aims to benefit: the students.One participant in Dr. Zmudy’s study—which focused on designing outdoor experiences that better resonate with Native American students—highlighted the personal impact of the approach:"When I am in a space that isn’t very connected to the land or nature, I don’t feel as engaged. When you learn those outdoor skills with other people, it’s a way to bond. It’s cool to learn those new skills and then take them with you."<h2>Paying it forward</h2>Dr. Zmudy hopes to help other researchers avoid some of the pitfalls he faced early on. Now, when he onboards new faculty in his role as associate department head, he ensures they start their research careers on the right foot."I tell them: Don’t be five years in and struggling. There’s a whole world of support at our fingertips. CTSI will revise your forms and handle the submission for you, so you can clear the approval step with minimal hassle. Every time I share that with faculty, the reaction is always the same, ‘Count me in, I want that.'"

University of Minnesota Clinical and Translational Science Institute

Canoeing in the Bagley Nature Area with a push pole made for collecting wild rice

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University of Minnesota

For one University of Minnesota Duluth researcher, bringing a study from idea to implementation felt like a monumental climb. Everything changed when Mark Zmudy connected with research experts at the University of Minnesota’s Clinical and Translational Science Institute. They helped develop his protocol, orient him to the right Institutional Review Board (IRB) forms, draft consent forms, and provide comprehensive support at every step. Since then, his research portfolio expanded at a pace he once thought impossible. 

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Learning How Local Post-overdose Response Teams Can Cooperate to Stop Overdoses

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