Resources
Coordination Core. The overall goal of the Coordination Core is to provide ‘one-stop shopping' for investigators desiring to participate in translational research, to coordinate and form Multidisciplinary Translational Teams; to facilitate clinical and translational research by identifying project needs, allocating resources, and monitoring progress; and to increase throughput and efficiency of translational research, by identifying and overcoming rate limiting resource barriers for CTSA core activities and eliminating possible duplications of effort.
All proposals must be in the NIH PHS 398 format, please see the attached link for instructions and forms: PHS 398 Grant Application
Contact: CTSA@utmb.edu or x72872 (CTSA)
Pilot and Collaborative Studies. The need for faster development and application of new diagnostic tools, treatments and preventive strategies is driving the institutional transformation pursued by the ITS, and makes the efficient and rapid translation of basic and pre-clinical discoveries into clinical practice imperative. The complexity of progression from a clinical question to a marketable product or validated therapy underscores the central role of the Pilot and Collaborative Studies resource in this process. These activities will significantly contribute to the overall goals of the ITS and ICTSA by identifying and supporting highly innovative translational research projects, and providing support for career development.
Contact: Glenn Ostir, PhD
Biomedical Informatics. The Bioinformatics and Medical Informatics programs have been aligned to mutually leverage their activities and resources to provide optimal response across the entire Informatics spectrum to CTSA translational research teams. Recognizing that informatics is an essential enabling contribution to Multidisciplinary Translational Teams, we are facilitating a shared mission within the informatics community at UTMB actively engaging other quantitative science components including Biostatistics and Computational Biology. This new structure will enable Biomedical Informatics not just to become a leader in the translational research enterprise at UTMB but also with our strategic partners institutions. Our current growth phase is particularly focused on the development of the skills and infrastructure to manage large-scale relational databases encompassing the full range of health and science information from the electronics medical record to the genomics and proteomics laboratory information management systems. Our goal is to be a key member of a multi-institutional federated data management and analysis network devoted to translational research. Our primary partner in this effort is the School of Health Information Sciences at the UT Health Science Center in Houston.
To this end, we have developed a partnership with UTMB Information Services (IS) for the purpose of providing hardware, software and network support to the computational and quantitative research and informatics community. We are actively growing our cadre of experienced IS professionals that are embedded with the research community. This team is called the Research Informatics Service Core (RISC), and provides expertise that that spans the full hardware, software, and data management spectrum as it relates to research computing and we will be adding new members as we progress. Biomedical Informatics, thus transformed, is now poised to rapidly ascend to the next level of professional capabilities that will make us an outstanding partner in our Translational Research enterprise.
Contact: Bruce Luxon, PhD
Chris Mast, MD
Novel Methodologies. The Novel Methodology resource will stimulate development of research approaches, tools, and technologies broadly applicable to problems in human health. UTMB has invested substantially in cores and centers to perform basic and clinical research leading to therapeutics, diagnostics and vaccines. The NMC will play a critical role in this process by identifying and supporting innovations that transform the research environment, and by fostering academic-industry partnerships that are most likely to translate basic discoveries into new classes of biomedical products and practices.
Contact: David Gorenstein, PhD
Biostatistics and Design. The Biostatistics and Design resource includes two teams with distinct expertise and functions: a Design and Biostatistics Team, and a Data Management Team. The Design and Biostatistics Team will provide a team of biostatisticians and epidemiologists to implement optimal study designs based on state-of-the-art statistical methods, by aiding the optimal design of clinical experiments to ensure adequate power and precision, and use of appropriate statistical models to analyze translational projects. The Data Management Team will develop special-purpose data files for capture of clinical study forms and information for statistical analyses.
Contact: Dan Freeman, PhD
Regulatory Knowledge and Support. Translational research is difficult to get underway and potential investigators become discouraged. Few academic investigators have an understanding of the intricacies involved in comprehensive regulatory management. Academic health care centers, in attempting to manage this complexity, have established programs that focus more on compliance than support. In the absence of centralized support services, bewildered investigators spend needless time attempting to find help or trying to decipher the regulations on their own.
The Regulatory Knowledge and Support resource will facilitate the conduct of translational and clinical research from the regulatory perspective, improving compliance and efficiency. It will also provide a structure for the evaluation of existing programs for regulatory management and the development of innovative new programs. These areas addressed include the protection of human subjects, ethical conduct of research, maintenance of animal welfare, compliance with Food and Drug Administration rules and regulations, and federal grant management.
Contact: Toni D'Agostino
Participant and Clinical Interactions Resources. The General Clinical Research Center will be re-configured into a Participant and Clinical Interaction Resources Core, whose goal is to transform the physical and human infrastructure for clinical and translational research at UTMB. Its goal is to create a central high intensity clinical research site at UTMB, develop anetwork of flexible collaborative disease-associated clinical research sites in the UTMB Area Health Centers, establish a participant recruitment resource to provide subjects of all ages, genders and ethnicities for clinical research, develop and implement a sample preparation and repository laboratory, serve as a venue and training facility for clinical research education, and as a “home” for multidisciplinary research support personnel.
Contact: Don Powell, MD
Community Engagement and Research. The ITS Community Engagement and Research resource seeks to develop collaborative research partnerships with local communities, enhance trust in clinical and translational research, serve as a site for integration of community engagement activities, facilitate training in methods for community research and establish long-term relationships with community-based groups.
Contact: Sharon Petronella, PhD,
Elizabeith Reifsnider, PhD
Translational Technologies and Resources. The Translational Technologies resource will lower barriers that currently prevent application of post-genomic tools to clinical research. We seek to enhance innovative patient-oriented research studies by providing facilitated application of multidimensional, high-throughput genomics and proteomics tools and seek to develop mentored interpretation of the results. The TTC will integrate and build on established UTMB institutional cores already employing high-throughput technologies. The immediate endpoint of these “multi-omic” technologies is to allow translational investigators to identify robust biomarkers or genetic polymorphisms related to human disease.
Contact: Melinda Moore, PhD,
Kevin Rosenblatt, MD, PhD
Research Education, Training and Career Development. The Research Education, Training and Career Development resource will provide a coherent and theoretically grounded education on translational research to trainees at multiple levels, from predoctoral trainees to faculty. We will facilitate the acquisition of basic knowledge and skills that are essential for clinical and translational research and will provide educational resources to multidisciplinary translational teams and their members. To this end, we are developing an integrated T32 pre- and post-doctoral training programs in translational research as well as a mentored “K12” program for junior faculty development and support.
Contact: Ken Ottenbacher, PhD
Ethics and Support. The Ethics and Support resource will generate a strategic alliance between ethics and science in the translational environment. As part of the culture shift we envision, investigators will become as intellectually engaged in research into ethical issues surrounding translational research as in scientific issues of study design and data collection. If a translational study raises ethical concerns, researchers will be eager to investigate those issues systematically. Moreover, ethics investigation, deliberation, and innovation will involve clinicians, humanities scholars, research participants, and communities in addition to translational researchers and their scientific peers.
The Ethics and Support Resource provides a Research Ethics Consultation Service (RECS) to research clinicians, scientists, research teams, and community members. The primary mission of the UTMB RECS is to promote integrity in research practice and to offer advice and support regarding ethical values, questions, and social concerns that arise in contemporary research settings, including the clinical and translational environment. The RECS does not merely provide ethical expertise to researchers, but rather is a collaborative venture in which practitioners of science and ethics scholars work together to inform and strengthen core values and best practices in research. Beyond compliance with regulations, the RECS seeks to deepen UTMB’s commitment to professionalism, trust-building, and to the principles of respect for persons, beneficence and justice. Ethics consultants are available by phone and in-person to provide investigators and their teams in individualized, real-time expertise and problem-solving strategies. Typical ethical issues arising in the clinical translational environment include questions regarding obligations inherent in the informed consent process, requirements to protect research participants’ rights, safety and welfare, standards of disclosure of research risks, inadvertent bias, and conflicts of interest, duties related to the security and integrity of data, complexities regarding appropriate scientific authorship and publication of results, and overall scientific integrity.
If you have a doubt, concern, question or any issue at all that you think someone trained in clinical research ethics might be able to help you with, then this service is here for you. To request a consult, you may contact the director of this service, Dr. Michele Carter at (409) 772-1208.
Contact: Michele Carter, PhD
