Check out the latest TRI news in the July TRIbune. This issue features new efforts to track the quality of TRI’s services to researchers, a story about a College of Pharmacy team’s promising TRI-supported radiation therapeutic, and the latest TRI-cited publications.
July 2015
Amy Jo Jenkins, M.S., C.C.R.P., C.C.R.A., C.C.R.C., at the UAMS Translational Research Institute (TRI), and Lyndsey Avery, C.C.R.P., R.A.C., in the UAMS Office of Research Regulatory Affairs (ORRA), are the recipients of the international Society of Clinical Research Associates (SOCRA) 2015 Chapter Chairperson Recognition Award for their work as co-chairs of the Arkansas SOCRA chapter.
This marks the fourth year in a row – and each year of its existence – that the Arkansas SOCRA chapter has won the award, which recognizes the chapter for offering the most continuing education hours for clinical research professionals of any chapter around the globe. The UAMS chapter offered 29.7 continuing education credit hours from June 1, 2014, to May 31, 2015. The group’s continued success can be attributed to support from TRI, ORRA, and the UAMS Office of Research Compliance and its members who actively participate in sponsored activities, Jenkins said
“Everyone in our research community is very excited to see Amy Jo and Lyndsey earn this award,” said TRI Director Laura James, M.D. “Their achievement demonstrates a commitment to research quality that is unparalleled.”
The award will be presented at the SOCRA Annual Conference in Denver, Sept. 18.
SOCRA developed a certification program to create an internationally-accepted standard of knowledge, education, and experience by which clinical research professionals are recognized as certified clinical research professionals (CCRP®s) in the clinical research community.
The continuing education hours offered by the Arkansas SOCRA chapter help research staff at UAMS and other sites earn or maintain their Certified Research Specialist (CRS) certification.
The CRS certification program, administered by the UAMS Office of Research Compliance, ensures an understanding of, and respect for, the principles of research integrity and the protection of those who participate in research. Although the certification is not required by all departments, UAMS research employees routinely complete the 26 hours of coursework and the comprehensive CRS proficiency exam.
The UAMS Translational Research Institute (TRI) has approved research pilot study awards for seven researchers totaling about $350,000.
The annual awards of about $50,000 each are made to studies with the strongest likelihood of leading to improved health and health care. For the first time this year, pilot awards were also offered for studies that address common barriers to research, such as the development of tools or approaches that could be used in the future by other researchers.
“The Translational Research Institute is excited about the potential findings that will be generated from this year’s group of pilot awardees,” said Laura James, M.D., institute director. “The awards span diverse areas ranging from better approaches to identify cancer using state-of-the-art detection systems to understanding how a particular drug class could improve the treatment of depression. In addition, for the first time, a portion of our pilot awards will focus on developing methods and tools that can help facilitate research for others in the future.”
Also a first this year, TRI invited community and professional stakeholders to participate in the evaluation of the pilot studies alongside scientific reviewers. The practice is in keeping with the translational research goal of ensuring that studies have stakeholder engagement, meaning the input of lay people, clinicians and professionals in the health industry.
The 2015 pilot awardees and their project titles are:
Laura Hutchins, M.D., College of Medicine, Department of Internal Medicine, Hematology: Development and implementation of video assisted process for the UAMS tissue biorepository and procurement service
Magomed Khaidakov, M.D., Ph.D., College of Medicine, Department of Internal Medicine, Gastroenterology: Sessile serrated adenomas/polyps – search for biomarkers of malignant potential
Il-Young Kim, Ph.D., College of Medicine, Department of Geriatrics: Role of dietary protein intake on whole body protein in the elderly
Tamara Perry, M.D., College of Medicine, Department of Pediatrics: Exploring the effects of sleep patterns and physical activity on asthma in adolescents with wrist-worn smart devices
Ronald Salomon, M.D., College of Medicine, Department of Psychiatry: Ketamine effects on dorsal raphé function in depression
Scott Warmack, Pharm.D., College of Pharmacy, UAMS Northwest Campus: Participant preferred dissemination methods
Vladimir Zharov, Ph.D., D.Sc., College of Medicine, Department of Otolaryngology: Photoacoustic diagnosis of circulating clots in cancer patients
In its mission to ensure that it provides high quality and diverse translational research services, the Translational Research Institute (TRI) recently conducted a survey of researchers and staff that revealed a high level of satisfaction with TRI services.
The online survey went to 135 employees who used TRI’s research services portal (TRIservices@uams.edu) and yielded 69 completed surveys from researchers at all TRI Hub sites: the main UAMS campus, Arkansas Children’s Hospital and its Research Institute, the UAMS Northwest Campus, and the Central Arkansas Veterans Healthcare System.
Overseen by Beatrice Boateng, Ph.D., director of TRI’s Evaluation Program, the survey was conducted one year after the email portal was introduced. She noted that the survey only includes researchers and staff who used the portal to request services.
“The survey report helps capture the breadth of services offered by TRI and shows that TRI staff are committed to helping UAMS investigators achieve their research goals,” Boateng said.
On the question of “the extent to which services received were ideal” respondents scored TRI at 8.17 on a 1-10 scale, exceeding its benchmark of 8.
Graph shows the level of satisfaction with services provided by TRI.Graph shows the level of satisfaction with services provided by TRI.
The responsiveness of TRI staff to requests also slightly exceeded the goal. On a 1-7 scale, survey respondents gave TRI staff responsiveness a 6.08.
The survey also produced a number of positive comments about TRI programs and staff. Examples include:
Community Engagement: “I participated in the Community Review Board process with Dr. (Kate) Stewart and Ms. (Camille) Hart. They were both extraordinary in their help and generous with their time.”
Recruitment Unit: “Ashley (Sides) was wonderful and did a great job recruiting …”
Mock Study Section: “The mock grant review was excellent.”
Regulatory Affairs: “Regulatory affairs are managed in a very timely and efficient fashion.”
Graph shows services that were sought via TRIservices@uams.edu during the survey period.Graph shows services that were sought via TRIservices@uams.edu during the survey period.
On TRI employees:
“(Dr.) Laura James was outstanding in her willingness to work with me one on one and to give straight-forward feedback.”
“Donna (Mattingly) went out of her way to help accommodate our training program.”
“Michael (Charles) Bailey did an outstanding job. Very prompt, helpful, resourceful, very nice to work with. I would specifically request him again!”
“Kudos to Amy Jo Jenkins who organized an internal review for an RO1 proposal. The TRI put together a highly qualified team to review the proposal and they gave excellent feedback and suggestions on how to improve the proposal.”
TRI will frequently seek feedback from researchers and staff for continuous improvement of TRI services to ensure that TRI is responsive and provides resources for evolving research needs.
Help is available for all research needs through TRI’s research services portal: TRIservices@uams.edu.
The Western States Consortium, which includes the UAMS Translational Research Institute (TRI) and three other institutions, is inviting pilot award applications for collaborative studies among the institutions.
In addition to TRI, the consortium members are the University of New Mexico, Kansas University Medical Center, and the University of Utah, all recipients of Clinical and Translational Science Awards (CTSA) from the National Institutes of Health (NIH) National Center for Advancing Translational Sciences (NCATS).
The purpose of the pilot awards is to promote inter‐institutional collaboration across the CTSA consortium by funding innovative, translational research projects that involve two or more of these CTSA institutions. Awards of up to $25,000 will be provided by each participating institution. The total funding available for a particular collaborative project will depend on the number of participating institutions and the level of funding that each institution devotes to the program.
The application deadline is 5 p.m., Sept. 1, 2015. Read the Request for Applications (RFA) document. Send completed applications via e‐mail in one PDF file to Kelly Bulloch at kwbulloch@uams.edu. Questions may also be directed to her email.
The 2015 inter-institutional RFA is the third funding opportunity by the Western States Consortium.
“This is a great opportunity for UAMS faculty to showcase their collaborative spirit with three of our sister CTSAs,” TRI Director Laura James, M.D., said.
Applications are being solicited from all faculty members—senior as well as junior investigators—for pilot projects that will exemplify the CTSA mission of developing clinical and translational research, to promote and support the “bench to bedside to community and practice and back” goal of the NIH.
The UAMS Translational Research Institute (TRI), in partnership with the UAMS Office of Research Compliance (ORC), recently helped increase participation in UAMS’ Certified Research Specialist (CRS) Program from 100 to 170 employees, thanks to a supplemental training grant from the National Institutes of Health (NIH) National Center for Advancing Translational Sciences (NCATS).
The 59 percent increase over a six-month period came as TRI and ORC introduced progressive, high-level training opportunities to encourage seasoned investigators and research staff to pursue ongoing research education at an advanced level. As part of the effort, all training sessions are being offered via live WebEx and courses have been converted to an online format via LearnOnDemand, including: Writing Standard Operating Procedures, Advanced Research Ethics, Expanded Access to Investigational Drugs, and Data Collection.
“Expanding participation in the program has fostered an environment of confidence and provided increased numbers of research staff with the peer support needed to carry out the human subjects’ studies in their respective departments,” said TRI’s Amy Jo Jenkins, M.S., who led implementation of the new training approaches in partnership with Darri Scalzo, UAMS’ Research Compliance Officer.
The CRS program, managed by the ORC, requires that participants maintain Collaborative Institutional Training Initiative (CITI) Human Subjects Research training, complete 28 hours of relevant coursework, and pass a comprehensive proficiency exam. Graduates of the program earn the “CRS” designation and maintain their certification status by completing 6 contact hours in applicable coursework in subsequent years. TRI continues to require its research support staff complete and maintain CRS certification and other departments within the institution have also adopted CRS certification as a job requirement for certain research-related positions.
Also as part of the training grant, TRI co-sponsored a day-long workshop in basic human subjects research training and offered advanced training opportunities on topics such as data collection, research ethics, expanded access to investigational drugs, genetic and genomic research, 21 CFR Part 11, in-vitro diagnostics, recruitment, and research fraud and misconduct.
In addition, TRI is pursuing the purchase of the Association of Clinical Research Professionals’ (ACRP) eLearning Modules and plans to work with the ORC to incorporate the Good Clinical Practice (GCP) activities as a requirement in the CRS program. The modules will be available to all investigators and research staff at TRI Hub sites (Arkansas Children’s Hospital and its Research Institute, Central Arkansas Veterans Healthcare System and the UAMS Northwest Campus).
Melisa Laelan chuckled about her reaction to the first major study of a diabetes intervention tailored to her community of Marshall Islanders in northwest Arkansas.
“I was so excited I was literally jumping because this model could be exactly what we need in our community,” said Laelan, a co-investigator on the $2.3 million UAMS study funded by the Patient Centered Outcomes Research Institute (PCORI).
After 10 years in the U.S. Army, Laelan settled in Springdale in 2005, becoming the only U.S. certified court interpreter for the Marshallese. She is the founder and director of the Arkansas Coalition of Marshallese, which advocates for the area’s 10,000-plus Marshallese, and a member of the Arkansas Minority Health Commission. Her inspired work on behalf of the largest community of Marshall Islanders in the U.S. has been the subject of a 2012 feature story in the New York Times, and last fall she was named to the 2014 “40 Under Forty” class by the Northwest Arkansas Business Journal.
The New York Times article notes that Laelan is a royal princess “far from her Pacific Island home, presiding instead over a landlocked realm of grain silos and poultry processors.” Many of her people, the article said, “are adrift in a culture that confounds them.”
“I feel obligated to protect my people,” she told the Times.
The Marshall Islands were contaminated with radiation during U.S. nuclear weapons testing in the 1940s and 1950s, forcing many to flee their homeland. Since 1986 the Marshallese have been allowed to live, work and study in the U.S. without a visa or permanent resident card. They were drawn to northwestern Arkansas after word spread that jobs were available in the region’s poultry plants.
Marshall Islanders love the western processed foods introduced after World War II, Laelan said, but it has contributed to a diabetes epidemic. Limited data shows the diabetes rate among Marshall Islanders in northwest Arkansas is anywhere from 20-50 percent. That compares to an 8 percent national average. Pearl McElfish, M.B.A., director of research for the UAMS northwest Arkansas campus, notes that the law excludes the Marshallese from government health care programs.
Prior to the PCORI award, Laelan and UAMS researchers like McElfish and Peter Kohler, M.D., principal investigator on the PCORI award and vice chancellor for the UAMS campus in northwest Arkansas, had forged collaborative ties through other UAMS research and outreach projects. These included a Translational Research Institute (TRI) pilot award and a TRI-sponsored Marshallese Community Review Board. Those efforts as well as biostatistics support from TRI helped secure the PCORI award.
Empowered by PCORI’s emphasis on true partnerships between researchers and communities, Laelan represents a relatively new model for research. Marshallese stakeholders like Laelan compelled UAMS researchers to modify key pieces of the PCORI application to make it a better fit for their culture. For example, the community insisted that its proposed Diabetes Self-Management Education apply to whole families rather than individuals because Marshallese families share the same foods at mealtime.
Laelan facilitates the many interactions between researchers and the families participating in the research.
“Bottom line, we want to educate these families how to eat right,” she said. “My role is to make the process easier for the researchers and the families.”
Recent findings by UAMS’ Anthony Goudie, Ph.D., a graduate of the Translational Research Institute’s (TRI) KL2 Mentored Career Development Program, were reported in Pediatric News, a publication that reaches nearly 55,000 pediatricians nationwide.
In the study of risk factors for recurrent Clostridium difficile infection (rCDI) in 43 children’s hospitals in the United States, Goudie found that typical risk factors such as “high-risk” antibiotics for adult inpatients are not risk factors for children inpatients. He also said he was surprised to find that children covered by Medicaid were more likely to have rCDI than those on private insurance. His findings, which resulted from the first known study of its kind involving pediatric hospitals, were presented at the annual meeting of the Pediatric Academic Societies in San Diego. Read the Pediatric News story.
Check out the latest TRI news in the May TRIbune. This issue features exciting new evidence-based research mentor training at UAMS, a profile of a community co-investigator, and the latest TRI-cited publications.
Please join us for a webinar on the SBIR/STTR program at NIH/NCATS.
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