Institutional Translational Research Training Program (T32 - Clinical Trial Not Allowed)

PAR-24-108

he purpose of the Institutional Translational Research Training Program is to support comprehensive training within an environment rich in translational research in which trainees will conduct basic, disease-related studies with an understanding of the requirements for translating discoveries into viable therapies. These programs should prepare advanced graduate students, postdoctoral fellows and/or fellowship-stage clinicians to become successful scientists equipped to pursue neuroscience research that is informed by translational considerations and principles.

The explosion of novel experimental techniques and technological advances has made it increasingly possible to correct and modify the biological events associated with disease. Translation of basic discoveries to clinical application (“bench to bedside”) requires a close collaboration between basic scientists and clinical investigators. Equally important, however, is an understanding of the overall process and specific practices required for designing projects with the potential for advancement through the translational pathway from basic discovery through the intellectual property and regulatory processes to clinical application. NINDS supports a number of programs intended for researchers to advance their translational projects towards human clinical trials (PAR-21-122, PAR-21-123 , PAR-21-124). Whereas opportunities and funding for translational neuroscience research are growing, there is a dearth of training of scientists who understand what is required to do translationally-relevant basic research. This initiative will address the need for earlier and better preparation for scientists to conduct and lead translationally-relevant research projects.

This NOFO is specifically for institutional translational research training.

NINDS is committed to supporting T32 programs that address basic, clinical, translational or a combination of approaches in any area of research across the NINDS mission. Applications for all types of innovative programs are encouraged and will be accepted under the NINDS Institutional Research Training Program (PAR-24-126 ).

It is critical that applicants contact the individuals listed under Agency Contacts (Section VII) for preapplication guidance and to confirm the mission relevance of their application with the Scientific Research Contacts for the participating Institutes prior to application submission.

The proposed institutional research training program may complement other ongoing research training and career development programs at the applicant institution but must be clearly distinct from related programs currently receiving Federal support.

Program Considerations

Overall Program

Training programs responsive to this funding opportunity should be designed to increase the depth and breadth of trainee expertise within a thematic area. Programs should consist of an integrated set of activities that will both unify a cohort of trainees and expand their expertise beyond what would occur in the absence of the program. For training grants supported under this funding opportunity, a well-developed program 1) has a programmatic purpose and a scientific theme, 2) provides activities created to address that purpose that go beyond the standard activities (e.g. journal club, departmental seminars) associated with research career development  and 3) will have programmatic activities that bring together faculty and trainees with a broad spectrum of expertise, the integration of which has the potential to stimulate innovative ideas and solutions to scientific problems. The fundamental benefit of an institutional, T32-funded training program is to create a rich, theme-driven environment that stimulates innovation, drives trainee focus on the highest standards of scientific rigor, and provides multiple opportunities for practice in scientific communication. Thus, in most cases, the creation of a T32-funded training program should benefit trainees who are not directly supported financially by the grant as well as those who are.

Programs should create novel and/or expanded research training experiences and activities; they are not intended to simply support trainees to conduct research. Education in career skills (e.g. grant-writing, oral presentation) although a critical component of all programs, is not sufficient to constitute a T32-funded training program. Moreover, the activities that constitute the program should be specifically designed to achieve the stated thematic purpose of the training program, and not simply be cobbled together from existing activities that the institution or department offers.

Training PDs/PIs are encouraged to develop institutional training programs that will expose trainees to a diversity of scientific approaches, systems for study and tools and technologies. The training provided should enhance the trainees’ ability to conceptualize and think through research problems with increasing independence. Moreover, programs should foster a culture in which trainees draw from a broad knowledge obtained from both neuroscience and other disciplines to address their research questions.

Programs may support predoctoral students, PhD postdoctoral fellows, fellowship-stage clinicians, or any combination of trainees from these three groups. For institutions that also have MSTP programs and intend to support MD/PhD students with this funding opportunity, the PD/PI should ensure that the majority of trainees supported by the program are those seeking a PhD rather than an MD/PhD.

Training grants that will support both predoctoral students and postdoctoral fellows should have a single program in which both groups of trainees participate and interact. The program may include shared and different activities, but they must occur in the context of an integrated program in which both predocs and postdocs benefit from the interaction, programmatic activities and collaborative possibilities that the program creates.

Institutional research training grants must be used to support a program of full-time research training. Within the full-time training period, research trainees who are also training as clinicians must devote their time to the proposed research training and must confine clinical duties to those that are an integral part of the research training goals. The program may not be used to support medical training leading to the MD, DDS, or other clinical, health-professional training. Similarly, trainees may not accept NRSA support for clinical training that is part of residency training leading to clinical certification in a medical or dental specialty or subspecialty. It is permissible and encouraged, however, for clinicians to engage in NRSA-supported, full-time postdoctoral research training even when that experience is creditable toward certification by a clinical specialty or subspecialty board.

Short-term training is not allowed under this PAR.

Translational Training

Programs supported under this funding opportunity are expected to equip trainees with research expertise and an understanding of the principles and practices involved in translating basic research discoveries to clinical applications. Moreover, programs should help expand the community of basic and clinical researchers working in teams to address research problems with an eye toward development of viable therapies. To these ends, programs should be housed in an environment that supports ongoing neuroscience research projects across the basic-clinical spectrum that are informed by, and conducted with reference to, translational principles, and should

• provide cross-disciplinary training designed to facilitate an understanding of translationally relevant issues related to basic mechanistic studies, and an understanding of fundamental biological mechanisms that contribute to diseases/disorders being studied in the clinical arena;
• provide training in how to advance from fundamental biological mechanisms that contribute to diseases/disorders toward therapies and diagnostics;
• provide exposure to team research in which basic scientists are actively engaged in collaborative research projects with clinical investigators engaged in early-stage therapeutic trials;
• integrate faculty who are actively engaged in translational research and have experience advancing therapies/devices to the clinic and demonstrated successful collaborations/interaction with industry;
• provide formal education in translational processes and practices necessary to advance from fundamental biological mechanisms that contribute to neurological diseases and disorders, toward therapies and diagnostics. This training should bring awareness to trainees of the issues involved in translating discoveries into therapies in the context of their own research.  Topics may include

o   preclinical activities (e.g. proof of concept studies, safety and toxicity studies, device design considerations, regulatory approval, manufacturing principles that lead to FDA approval for IND or IDE),

o   first-in-human clinical trial design to test target engagement and/or proof of concept,

o   intellectual property, technology transfer and entrepreneurship,

o   securing funding and establishing collaborations with industry.

Programmatic activities to achieve this training may include clinical exposure and opportunities for formal engagement with clinical faculty, patients and end product beneficiaries; cross-discipline training; internships with pharmaceutical or biotech companies; boot camps, symposia, workshops or annual retreats that provide education in aspects of the translational process (e.g. regulatory issues, technologies, etc.) and that allow for interactions with experts in translational processes; training to develop skills for communicating with stakeholders (e.g. elevator pitches for lay audiences, shark tank pitches for investors, bi-directional communication with advocacy groups).

Programs should ensure that each trainee has an advisory committee composed of faculty with expertise across the bench-to-bedside research progression, and with expertise in the translational process.

Experimental Design and Statistical Methodology

Experimental Design: Programs must ensure that trainees understand the principles of rigorous experimental design such that appropriate controls are considered, sources of bias are avoided and rigorous approaches to data collection and analysis are utilized (i.e. blinding, determination of appropriate sample sizes, randomization, objective pre-determination of exclusion criteria, etc.). Ideally programs will engage the entire cohort and faculty and trainees in group discussions of experimental design and analysis as they apply to each trainee’s individual research project as well as approaches to increasing the robustness of scientific findings.

Statistical Methodology: Programs should ensure that each trainee is equipped with a solid understanding of statistical methodology relevant to neuroscience research. Ideally, trainees will develop a depth and breadth of statistical understanding that will enable them to adapt and appropriately apply statistical approaches as their experimental repertoire changes. Programs must ensure that all trainees have a solid understanding of the value and proper use of statistics, including an understanding of the many types of scientific failures that can occur due to inappropriate application of statistical tests. An introductory course in statistics is not sufficient to achieve these goals.

Statistical Training and Support

It is critical that trainees understand that statistical considerations are vital not only for analysis of data but for designing experiments and experimental approaches. To help trainees develop an understanding of the many contexts in which statistical considerations come into play, programs should incorporate the expertise of a statistician (or other faculty with expert knowledge of statistical principles) into the training program. Funds may be requested for up to 1.2 person months effort to support a faculty-level statistician to play a fully integrated role in the training program. It is envisioned that the supported statistician will contribute to educating the trainees on statistical issues in scientific inquiry, such as, for example, a rigorous understanding of p values, Bayesian vs frequentist methods, the problems encountered with multiplicities, "p-hacking", the differences in acceptable statistical treatment of exploratory and hypothesis-testing studies, etc. Critically, it is expected that the supported statistician will actively participate in regular programmatic activities such as research presentations and journal clubs to lend strong statistical expertise to discussions. Finally, inclusion of a statistician in the program will provide the opportunity for all trainees to consult with an expert in statistics, together with their mentor(s), about their experimental plans, experimental design, determination of appropriate sample sizes for their studies, methods required for proper analysis of their anticipated data set, etc.

Whereas the statistician is encouraged to create mini-workshops or courses, funding will not be provided simply to support a statistician to teach a course.

Application budgets are not limited, but need to reflect the actual needs of the proposed project.

Please contact the program director.

May 25, 2024 

Tish Weigand, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Email:  letitia.weigand@nih.gov