The goal of the TBS Program is to provide the training necessary for predoctoral students and postdoctoral fellows (MDs and PhDs) to become the next genertion of leaders in translational biomedical research. Emphasis will be placed on teaching trainees how to building interdisciplinary collaborative research programs by providing them with dual mentership in translational research.
The TBS program complements five existing PhD programs at GUMC including: Biochemistry and Molecular Biology, Cellular Biology, Interdisciplinary Program in Neuroscience, Pharmacology, and Tumor biology and five existing PhD programs at HUCM including: Anatomy, Biochemistry, Microbiology, Pharmacology, and Physiology. Eligible students will broaden their education through a career development plan (CDP) in human health and disease that includes a didactic curriculum, exposure to clinical medicine, dual preclinical science and clinical mentorship and career enhancement skills, which will be tailored to each trainee based on their prior training and research and career interests. Similarly, eligible postdoctoral fellows will enrich their postdoctoral fellowship training.
To ensure trainee competency in human health and disease and rigorous methodology that promotes minimizing bias in experimental design and reporting, the trainee in conjunction with their mentors works together to design the trainee's CDP, which includes five components: 1) didactic education in human health- and disease-related aspects including technical skill development and research methodology; 2) exposure to clinical medicine through mentored rotations in clinics and/or in-patient services; 3) research training in preclinical and clinical translational research via dual mentorship; 4) training in leadership, team science, communication, networking, negotiation, and time management; and, 5) individualized career guidance and acquisition of career-specific skills. The CDP is tailored to each trainee's prior background and experience, and interests. Trainee strengths and weaknesses are assessed using a standardized rubric that focuses on research skills (experimental design, ethics, research methodology, statistics, and reporting), technical skills (disciplinary knowledge, technical abilities with instruments/equipment, etc.), and collaborative skills (consulting, hiring, presentations, grant preparation, consortium development, etc.). Short- and long-term goals are set, identifying new needed skills or techniques and those that require improvement. Specific objectives are indicated and a timeline is created for the training period.
Course Descriptions CLTR-500 Research Ethics with Human Subjects (Course Director: Kevin Fitzgerald, SJ, PhD; 3 Credits; Fall Semester). This interactive case-based course explores ethical considerations and issues pertaining to scientific research, especially biomedical research with human subjects. Issues regarding scientific integrity, ethical research design and implementation, and research involving special populations are analyzed. Certification of training in the protection of human subjects is accomplished during progression through the material. The foundational principles of the Belmont Report underlying the responsible conduct of research are explored fully in the core content areas of human subjects research, conflicts of interest and commitment, collaborative science, data acquisition, management, sharing, and ownership, publication practices and responsible authorship, mentor/trainee responsibilities, peer review, and research misconduct. The course is designed to help participants become comfortable with the language and literature of research ethics through the analysis of stakeholder interests and perceptions using case studies presenting moral dilemmas in research ethics. The application of federal regulations to particular cases is probed in depth. CLTR-501 Introduction to Biostatistics in Clinical Research (Course Director: Nawar M. Shara, PhD; 3 Credits; Fall Semester). This course provides a foundation for current and future thinking in terms of practical aspects of the importance of biostatistics in conducting clinical research and thereafter translating its findings. One purpose of this course is to make the student aware of the complexities of the relationships between biostatistics and clinical research, particularly as they pertain to decision making. This course provides students a scientifically oriented perspective on the types of information that is integral for the proper design and conduct of clinical research. The goal is to improve students’ conceptual understanding of the differences and similarities among the different inferential tests, and the appropriate use of statistical tests. Assessments target articulation of arguments and decisions involving, or based on, fundamental aspects of biostatistics in the context of medical research. PRISM software (GraphPad) is used extensively. CLTR 506 Study and Clinical Trial Design (Course Director: John C. Pezzullo, PhD; 2 Credits; Spring Semester). This course builds upon the introductory statistics concepts and skills developed in the first term, extending them to practical application in study and clinical trial design and interpretation. Topics include structural aspects of clinical trials, protocol design, randomization and blinding, issues of error, bias and hypothesis testing, selecting and working with trial outcome variables, issues in safety versus efficacy trials, power and sample size calculations, secondary subgroup and exploratory analysis.
INDIVIDUALIZED AND FLEXIBLE TRAINING: Depending on individualized needs, the trainee will complete specific courses to meet the required competencies. In addition, trainees can enrich their didactic training with courses selected based on interest and the type of translational science career path the trainee plans to pursue. In addition, the trainee has the option of completing a 15-credit hour certificate or the full MS degree (33 credit hours). For pre- and postdoctoral fellows pursuing the MS in Clinical and Translational Research, the timetable of course work will be adjusted so that degree requirements can be met within a 2-year period rather than within one year. The TBS program is committed to preparing graduates for careers at the nexus of translational research in academic medical centers; clinical research organizations, pharmaceutical or medical device industries; government at the city, state or federal level, foundations, and businesses. Thus, the TL1 leadership in conjunction with the trainee's mentors will work closely with each trainee to create the optimum educational experience in translational biomedical research based on task analysis. For example, if a trainee wants to pursue a career at the Food and Drug Administration (FDA), then specific courses appropriate to the trainee’s research direction would be incorporated such as PHAR-620 Introduction to Regulatory Science.
Selected Examples of Elective Courses PHAR-620 Introduction to Regulatory Science (Course Director: Kenneth Dretchen; 2 credits; Fall Semester). Regulatory science is an applied scientific discipline that generates and makes use of evidence-based knowledge to inform decision-making about the safety and benefits of medical products. This survey course will examine the myriad issues that arise in the field of regulatory science, and will introduce students to fundamental principles of regulatory science, describe the differences between regulatory science and regulatory affairs, and provide an overview of the innovative clinical research tools of regulatory science. Building upon the FDA Strategic Plan: Advancing Regulatory Science at FDA (August 2011), individual classes will focus on the eight priority areas defined by the FDA as necessary for advancing regulatory science. Expert lecturers from Georgetown University and the FDA will present case studies, best practice examples, and guide discussion of key issues. CTLR-507 Epidemiologic Methods (Course Director: Pamela L. Carter-Nolan, PhD, MPH; 3 Credits; Spring Semester). This course provides an overview and introduction to epidemiology, particularly as it relates to the design, interpretation and importance of clinical and population research. Topics include understanding association and causality; cross-sectional studies and surveys. The design, analysis, and interpretation of case-control and cohort studies are emphasized together with sources of bias in both contexts. Other topics include population attributable risk; confounding factors; effect modification (interaction); analysis for confounding and interaction. This course builds on the multivariate analysis techniques and analyses for sensitivity, specificity, and screening that will be introduced in the introductory biostatistics course. CLTR-505 Social and Behavioral Aspects of Public Health (Course Director: Carla Williams, PhD; 3 Credits; Fall Semester). This course covers the following public health competencies: 1) appreciating the role of social and community factors in both the onset and solution of public health problems; 2) familiarity with the causes of social and behavioral factors that affect health of individuals and populations; 3) knowledge of basic theories, concepts and models from a range of social and behavioral disciplines that are used in public health research and practice; 4) application of ethical principles to public health program planning, implementation, and evaluation; 5) specification of multiple targets and levels of intervention for social and behavioral science programs and/or policies; 6) identification of individual, organizational and community concerns, assets, resources, and deficits for social and behavioral science interventions; 7) application of evidence-based approaches in the development and evaluation of social and behavioral science interventions; 8) familiarity with the merits of social and behavioral science interventions and policies; 9) understanding steps and procedures for the planning, implementation, and evaluation of public health programs, policies and interventions; and, 10) knowledge of critical stakeholders for the planning, implementation, and evaluation of public health programs, policies, and interventions. CLTR-800 Introduction to Community Engagement in Research (Course Director: Carla Williams, PhD 3 Credits; Fall Semester). This course introduces students to principles of community engagement in research and offers the necessary foundation for conducting research with diverse communities. Topics include: defining community engagement and its guiding principles; role of community engagement in translational research; community-engaged research
processes and methods; evaluation of community-academic research partnerships; and ethics in community engagement; and research resources for further study and skill development. It will cover the following competencies (adapted from Michigan State University's new Graduate Certification in Community Engagement): 1) understand and apply knowledge of community, culture, and social determinants of health; 2) evaluate, select, implement, and monitor processes in engaging diverse communities, developing partnerships and networks, and cultivating sustainable collaboration; 3) illustrate and practice principles of mutual benefit, capacity-building, and co-learning; 4) employ effective strategies for communication and management of community-partnered research; 5) use community-engaged research methods; 6) demonstrate ethical practice in community research; 7) employ effective dissemination strategies and use multiple approaches and tools for partnership evaluation; 8) become aware of resources for continued study and skill building in community engaged research; and, 9) understand community-engaged scholarship for academic advancement. CLTR-801 Cultural Competency in Translational Research (Course Director: Souzan Hawala-Druy, MPH, BSN; 3 Credits; Spring Semester; HUCM). This inter- professional/interdisciplinary course is designed to help students increase awareness and knowledge of how the delivery and acceptance of health care may be influenced by social, cultural, and environmental factors and increase the delivery of culturally competent care (individuals, families, communities, institutions) to reduce health disparities. Students will be introduced to how to craft respectful, reciprocal, and responsive effective interactions across diverse cultural boundaries. The course will utilize cultural concepts; theories and models; cultural assessment; critical thinking; and evidence-based practice appropriate for developing knowledge. Students will be able to analyze cultural factors that facilitate and hinder communication (researcher/participants & inter-professional team from diverse professions and cultures) in recruiting research participants. CLTR-802 Elimination of Racial and Ethnic Disparities in Health (Course Director: Kimberly Henderson, PhD; 3 Credits; Spring Semester; HUCM). There is convincing evidence that health disparities limit the length and quality of life of many members of racial and ethnic minority groups. The public health profession has taken as one of its major challenges the need to eliminate these health disparities within the next decade. By the end of this course, students will be expected to: 1) understand minority health and health disparities from an historical, political, economic, social, and environmental perspective; 2) appreciate how the intersection of race, ethnicity, gender, socio-economic status, sexual orientation and other social factors may exacerbate disparities; 3) realize the challenges in the measurement of minority health and health disparities; 4) understand the role of cultural competence and health literacy in health promotion and disease prevention; and, 5) identify knowledge gaps and where future research is necessary and possible.
Seminars: TBS trainees will be required to attend the following seminars: CLTR 503 Core Clinical Research Seminars (Seminar Director: Jason G. Umans, MD, PhD; Fall - Spring, monthly; 1 Credit): This series anchors the entire TBS curriculum and supplements both coursework and mentored research by bringing together TBS trainees with KL2 Scholars and students in the GHUCCTS certificate or master’s program in Clinical and Translational Science to: 1) share issues and challenges in design and execution of clinical and translational research; 2) host monthly presentations by outstanding clinical investigators; 3) host monthly presentations by outstanding translational investigators; and, 4) provide a forum for a monthly interdisciplinary journal club. An added benefit of this course is the stimulation of cross-disciplinary approaches and collaborations among GHUCCTS faculty and trainees.
Oak Ridge National Laboratory Translational Science series (Seminar Director: Jason G. Umans, MD, PhD; 0 Credit; Fall - Spring, monthly): This web-based series is organized by Oak Ridge National Laboratory and focuses on critical topics in biomedical translational research including biological and nanoscale systems, computational biology and bioinformatics, metabolomics, and systems genetics. This provides the trainees with training in rigorous innovative new technologies in translational science. Windows into Translation (Seminar Director: Kathryn Sandberg, PhD; 0 Credit; Fall - Spring, monthly, GUMC): This series brings together a basic scientist and clinical investigator both of which present their research interests on a topic of mutual interest though from differing perspectives and areas of expertise. Once both investigators present, a lively discussion with the audience ensues. This forum provides trainees with a broad background in transdisciplinary translational research. Deans Interdisciplinary Conference Rounds (Conference Director: Teletia Taylor, PhD; 0 Credit; Fall - Spring, monthly; Alternating GUMC/HUCM): This series brings together clinical investigators from different areas of medicine to discuss their research. This forum provides trainees with a broad background in multi-disciplinary clinical research. TBS Trainee Forum (Seminar Director: Kathryn Sandberg, PhD; 0 Credit; Fall - Spring, monthly; Alternating GUMC/HUCM): TBS trainees will attend a data presentation series where trainees present their own research in both platform and poster forums in conjunction with relevant journal articles in translational research in their individual area of research interest. This forum will promote a "TBS identity" among predoctoral students and postdoctoral fellows and serve as vehicle for teaching oral communication and presentation skills as well as critical thinking and problem solving across multiple disciplines. Documentation: Seminar Directors or their surrogates will document attendance at these seminars. Frequent absentees can be considered grounds for "failure to progress" and dismissal from the program.
Clinics and in-patient services: Trainees will receive an individualized clinical experience that will be tailored to their research interests and can include a specialty- based outpatient clinic (4 clinic visits), a community-based clinic (4 clinic visits), consult service (daily, 2 weeks) and/or hospital rounds (daily, 2 weeks) depending upon their research interests. For example, a trainee studying language processing with Dr. Michael Ullman (Department of Neuroscience, GUMC) could attend an Alzheimer's clinic with Dr. Scott Turner (Department of Neurology, GUMC). A trainee studying mechanisms of PPARin renal transport Dr. Lee (TL1 co-Director) could attend an outpatient dialysis clinic with Dr. Christopher Wilcox (Division of Nephrology and Hypertension, GUMC). A trainee studying growth factors and angiogenesis with Dr. Anton Wellstein (Department of Oncology, GUMC) could attend hospital rounds on an oncology suite. A trainee studying mechanisms of addiction could attend rounds with Dr. Robert Mickey, or a suboxone treatment study with Dr. Tanya Alim at HU, Department of Psychiatry. Documentation: The clinical mentor will document completion of the mentored rotations in outpatient clinics, community-based clinics, consult service and/or hospital rounds and this documentation will be included in the annual trainee progress report.
Examples of dual mentored projects In an example of bench to clinic, Amrita Pai, a predoctoral student in the Biochemistry PhD program at GUMC is investigating ovarian hormone regulation of hypertension. Her primary mentor is Dr. Kathryn Sandberg (GUMC) and her secondary mentor is Dr. Jason Umans (MHRI). One component of her research involves studying ovarian hormone regulation of T cell genes in a rat model of postmenopausal hypertension in Dr. Sandberg's lab. Another component of her research involves isolating T cells from ovarian hormone deficient women who have normal blood pressure or who have early diagnosed hypertension and studying how specific T cell subsets are differentially regulated by ovarian hormone deficiency. These studies on specific T cell subsets in women are conducted in collaboration with her secondary mentor, Dr. Umans and are informed by her animal experiments (i.e., bench to clinic). The program also trains MD fellows who are familiar with clinical research but have little experience with basic science. In an example of clinic to bench, a psychiatry fellow applying for a postdoctoral position with Dr. Thomas Mellman (Dept. Psychiatry, HUCM) to study posttraumatic stress disorder could apply to the TBS program and include in the fellow's CDP a joint project with Dr. Dexter Lee (Dept. Physiology, HUCM) to study blood pressure regulation in an animal model of fear conditioning and posttraumatic stress. This animal study would be an example of clinic to bench research. Alternatively, a trainee with a clinical focus could develop a plan to apply knowledge to community policy (type 2 translation, clinic to community). Additional types of pairing include two investigators that conduct human subject research from a preclinical and clinical perspective. For example, a trainee could work with
Drs. Alexander Dromerick (neuroplasticity and stroke) and Rhonda Friedman (psycholinguistics) to study speech in patients after a stroke. Other opportunities for T2 type translation projects exist. For example, a project could involve studies of how to improve hypertension awareness in the community with Drs. Carla Williams (community engagement) and Thomas Obiesisan (hypertension and cardiovascular disease) serving as mentors.
LEADERSHIP AND TEAM DEVELOPMENT SKILLS Leadership Training: All predoctoral students and postdoctoral fellows will participate in professional development and leadership training workshops throughout their tenure in the program. The TBS workshop series entitled Strategies for Success (Workshop Director, Dr. Sandberg) covers topics including effective Oral and Written Communication Skills, Time Management, How to Negotiate, The Value of Networking, Navigating Group Dynamics, Leading a Team of Equals and Subordinates, and, Managing Disputes. These workshops are interactive and provide hands on experience through role-playing. For example, trainees will present their two-minute "elevator" speech on their research project and receive feedback from their peers and mentors or negotiate a job position with a participating department chair. Trainees will also be encouraged to attend professional development seminars and workshops offered through GHUCCTS institutions and national societies as well as specialized professional development seminars (e.g., those that target women or under-represented minorities) or to the individual needs of a trainee (e.g., Writing workshops). Team Science: The TBS team science plan dovetails to the GHUCCTS team science approach including education in team science; best practices in team science; stimulating and enhancing multi-disciplinary teams; and, collaboration with CTSA national consortium initiatives. Each trainee will have hands on experience with team science through their dual mentorship project. Trainees will also be encouraged to initiate new collaborations among TBS faculty as part of their training in how to engage collaborators. In addition to the draw of inter-disciplinary science, faculty will be motivated to participate since trainees will be funded and because these new projects could lead to additional funding through institutional cross-disciplinary funding opportunities and extramural funding.
CAREER GUIDANCE Individualized Development Plans (IDP): The CDP for all trainees includes an IDP that helps trainees leverage their expertise and interests to develop a plan that will lead them to a rewarding and productive career. In addition to articles and resources, trainees will self-examine their skills, interests and values using the interactive online career planning tool provided by the Federation of American Societies for Experimental Biology (FASEB) for graduate students and postdoctoral fellows1. As part of each CDP, strategic goals will be individualized and monitored. In addition, trainees will participate in quarterly TBS workshop series, entitled, Scientific Careers (Workshop Director: Dr. Lee) that brings successful individuals who work in diverse areas of translational biomedical science including Wall Street analysts, science policy gurus, patent agents, journalists, consultants, biopharmaceutical company executives, entrepreneurs, executive search specialists, public relations experts, and top-flight sales reps. This workshop will help guide the trainee in developing their CDP to ensure they receive the training they need to make them most competitive for the career path in translational science that they intend to pursue.
Externships: Some trainee CDP's will involve an externship in industry, community health centers, non-government agencies including foundations, CTSA hub partners or with other organizations to provide them with exposure to training opportunities that will prepare them for their career of choice. In this regard, being located in the nation’s capital provides rich opportunities for externships since this is the home for government agencies and many businesses and foundations have a home in the District of Columbia. Furthermore, trainees have opportunities for externships through existing relationships with local biotech companies that were established to offer students externships through the Masters Program in Biotechnology2, and through relationships established with senior staff at the FDA through the GUMC Center of Excellence in Regulatory Science and Innovation (CERSI)3, which brings together regulators from the FDA with experts in science and medicine from GUMC, professional development from GUMC and MedStar Health, law and health economics from Georgetown University Law Center, and continuing education and School of Continuing Studies.
Each trainee must identify at least one mentor who has a track record of current or recent funding and the resources to conduct the proposed research. Both mentors must demonstrate commitment to the trainee. A plan for securing funding for an optional third year of training should be described within the mentors' letter of support and the Career Development Plan (CDP). Mentee must be employed by the mentor as a full-time employee with pay and benefits for at least one month prior to TL1 Award at their institute.
Yes, if at least one component of your proposal contains human subject research as in the following examples: observational or mechanistic or therapeutic research in humans that complements an animal research project; measuring biomarkers such as the level of a specific metabolite in a human population analysis of a severity marker in clinical use; secondary analysis of a large database obtained from human subjects; research utilizing electronic health records; and, clinic to community projects or vice versa.
No. Your research project can focus completely on human subjects.
No. You will need an additional human subject component as described in Q2 above.
• Candidates must be a US citizen, non-citizen national, or a US permanent resident; • Applicants must be able to commit to 1 full year in the TBS Program, though priority will be given to those able to commit to 2 full years; • No applicant may have a US government training award including a National Research Service Award for more than 2 years at the time of award activation; • Applicants must have a primary mentor from a GHUCCTS institution who has sufficient research funding and resources to support the applicant’s research for at least two years at the time of award activation; • All candidates must demonstrate a commitment to translational biomedical research.
• Pre-doctoral students who have completed their qualifying exams in PhD programs at Howard or Georgetown Universities and are in good standing. Note: Students with more than 4 years of National Research Service Award (NRSA) support are ineligible to apply for funding through the TL1 mechanism. • Post-doctoral fellows who have a primary appointment at Georgetown or Howard Universities, a MedStar Institution or the Washington VA Medical Center. Note: Postdoctoral fellows with more than 2 years of NRSA support are ineligible to apply for funding through the TL1 mechanism. Postdoctoral fellows must have full-time employment at a GHUCCTS institution for at least one month at the time of award activation.
To be eligible for funding via the TL1 grant, a trainee must be a citizen or non-citizen national of the U.S., or must have been lawfully admitted to the U.S. for permanent residence. Proof of status will be need at time of appointment.
Yes, as long as they have passed their admission to candidacy for the PhD component at the time of the award.
Strictly speaking, no; however, preference will be given to predoctoral students who have passed their qualifying exams within the past year and postdoctoral trainees with 0-3 years of experience.
No. Wait till the next application cycle.
The TL1 grant will provide predoctoral students with the NIH standard stipend of $24,816 year for all years of experience: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-036.html
Post-doctoral fellow salaries follow NIH guidelines: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-036.html
Note: Similarly, to every predoctoral student and postdoctoral fellow funded by a National Research Service Award (NRSA) training grant, the difference between the PhD student's stipend or postdoctoral fellow's salary and the TL1-funded component cannot be made up from another federal grant since this is how NIH defines "cost-sharing" and no cost-sharing is allowed on NRSA grants. For example, if a mentor wants to pay their postdoctoral fellow with 1 year of experience more than $50,376, that mentor can only use non-US government funds to make up the difference. However, will need to work with TL1 Director for approval.
TL1 will fund up to two years.
Note: Similarly, to every predoctoral student and postdoctoral fellow funded by an NRSA training grant, total NRSA support is limited to 5 years for predoctoral trainees (6 years for dual-degree training, e.g., MD/PhD, DO/PhD, DDS/PhD, AuD/PhD, DVM/PhD), and 3 years for postdoctoral fellows. The NIH provides eight levels of postdoctoral stipends to accommodate individuals who complete other forms of health-related training prior to accepting a Kirschstein-NRSA supported position. (The presence of eight discrete levels of experience, however, does not constitute an endorsement of extended periods of postdoctoral research training.) see NIH policy on this matter http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-048.html
Pre-Applications DUE May 1, 2019. Final Applications DUE August 1, 2019
No, this is an optional submission. Those who submit a pre-application will receive feedback from the TBS/TL1 review committee
Discuss this with your mentors.
Yes. You will need two mentors to complement different aspects of your project. You will need to provide a mentorship plan with both mentors.
The TL1 application requires all of the components of an F30 (MD, PhD candidate), F1 (PhD candidate) or F32 (postdoctoral fellow) NRSA application.
Follow directions under How to Submit on the TL1 website http://www.translationalbiomedicalscience.org/program.html
Follow directions under How to Submit on the TL1 website http://www.translationalbiomedicalscience.org/program.html
Yes, NRSA awards support research training experiences in specified areas of biomedical, behavioral and clinical research, in order to help ensure that a diverse and highly trained workforce is available to assume leadership roles to advance the national’s biomedical and clinical research agenda. NRSA awards provide stipends to trainees for subsistence support or to defray expenses during the period of training; they are not compensation for services rendered. Therefore, NRSA trainees are not considered employees of that University/Institute and are not eligible to receive employee health insurance or other employment benefits from that University/Institute. NRSA grants are of a fixed duration, and there is no guarantee or expectation that NRSA trainees will be employed by that University/Institute following the expiration or termination of the NRSA grant. The NIH Grants Policy Statement has specific requirements for NRSA grants and is available here: http://grants.nih.gov/grants/policy/nihgps/HTML5/section_11/11_ruth_l._kirschstein_national_research_service_awards.htm
Yes, you can be terminated if you do not comply with NIH Policy, do not meet the expectations of the TBS Program, and/or your institutes policies.
Per NIH, trainees are required to pursue their research training full time. Full-time is generally defined as devoting at least 40 hours per week to research training activities, or as specified by the awardee institution in accordance with its own policies. Beyond the full-time training, NIH recognizes that Kirschstein-NRSA fellows and trainees may engage in part-time employment incidental to their training. Fellows and trainees may spend on average, an additional 25% of their time (e.g., 10 hours per week) in part time research, teaching, or clinical employment, so long as those activities do not interfere with, or lengthen, the duration their NRSA training. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-095.html