UR CTSI Translational Science Scholar Award Request for Applications

For projects with a start date of July 1, 2027. CTSI will be awarding awards with NIH funding and institutional funds for the CTSI Translational Science Scholar Award.

Please note that all University of Rochester Medicine CTSI Translational Science Scholar Awards are contingent on NIH and/or institutional funding conditions, constraints, and requirements.

Vision: Recipients of the Clinical and Translational Science Institute (CTSI) Translational Science Scholar Award program will become the next generation of national translational scientists, who will have the knowledge, skills, and abilities to innovate and transform translational sciences from discovery to implementation and dissemination and beyond.

Mission: The CTSI Translational Science Scholar Award will align with the Clinical and Translational Science Institute and CTSA Consortium, and implement a high-quality, team-science-based research career development program for early career translational scientists.

Note: To better reflect the range of funding sources that support our scholars, we have updated our program name from the CTSI Career Development Award to the CTSI Translational Science Scholar Award. All scholars will now be recognized as CTSI Translational Science (TS) Scholars, with two designations: NIH K12 TS Scholars for those supported by the NIH K12 award, and Institutional TS Scholars for those supported by institutional funds. This renaming approach provides clarity, strengthens program identity, and ensures consistent communication while recognizing all scholars as valued members of the translational research community.

Program Description

The CTSI Translational Science Scholar Award is a two-year program funded by the Clinical and Translational Science Award (CTSA) Program from the National Institutes of Health, and by the University of Rochester School of Medicine and Dentistry. The CTSI Translational Science Scholar Award is designed to offer early career postdoctoral scholars advanced training in translational science research aligned with CTSA Program goals of advancing therapeutics (drugs, devices, and preventatives), clinical interventions, and behavioral modifications to improve health. The program offers flexible learning models to engage postdoctoral scholars in team science, individual development plans, advanced research training, and career guidance to those committed to pursuing a career in clinical and translational research.

Scholars will be expected to develop and implement a research experience supervised by a mentor team. The research project should be designed as a pilot project to set the stage for an individual K- award application, or to establish a foundation for a subsequent individual R-award application. The goal of the program is to promote the successful transition of CTSI Translational Science Scholars to an independent career as a clinical and translational investigator, generally by means of an individual K- or R-award. Scholars are required to commit to devoting 75% effort to their Translational Science Award (or 50% for candidates who practice in certain procedure-based medical specialties.

The program has devised three training specializations that capitalize on institutional strengths and priorities, including: a) Clinical Trials, b) Dissemination and Implementation, and c) Digital Health/Emerging Artificial Intelligence in Translational Science. Prospective scholars are encouraged, but are not required, to take advantage of one of the three specializations. If applicants are interested in one of the three training specializations, they are encouraged to contact the Director or Co-Directors of the specialization via email during the application process.

Clinical Trials

Dr. Christopher Palma

URochester has unique strengths in conducting and coordinating multicenter clinical trials, with several onsite, regulatory-compliant clinical and/or data coordination centers, including the Center for Health + Technology (CHeT). The overarching goal of the clinical trials specialization track is to foster the development of Scholars who are qualified to submit investigator-initiated protocols to the increasing number of research networks (e.g., PCORI NET, SIREN, StrokeNet, and the CTSA TIN). A sample curriculum may include design of clinical trials, recruitment and retention, FDA and regulatory processes, advanced topics in novel study design, virtual research visits, emerging statistical methods, innovations in outcome measurement, novel recruitment approaches of representative populations, community engagement, emerging research ethics topics, and design of multicenter trials.

Dissemination and Implementation Science

Drs. Kevin Fiscella and Reza Yousefi-Nooraie

Dissemination and Implementation is the science and practice of how evidence-based interventions and policies are effectively translated, distributed, and implemented in real-world settings. Training in this specialization pathway should include education and experience in research that adapts the core elements of implementation science to accelerate translational science and improve population health, including coursework on health systems and participatory research. These scholars will also be expected to engage with the Learning Health Systems program and the UR Quality Institute.

Digital Health/Emerging Artificial Intelligence in Translational Science

Dr. Erika E. Ramsdale

URochester has deep research expertise and leadership centered on digital health, including the Center for Heath + Technology (CHeT) investigating novel therapeutic interventions using innovative digital health technologies, URMC Health Lab, developing novel data science tools and methods to address the healthcare system needs, and the Goergen Institute for Data Science and Artificial Intelligence (GIDS-AI), a University-wide hub for interdisciplinary research in health analytics, AI, and novel methods and tools. Training proposed in this specialization pathway may include education in: AI and Machine Learning tools in health care research; mathematics; computer science; remote monitoring of individuals’ medical disorders; treatment adherence; integration of multimodal data (including EHR data); and developing digital measures as novel endpoints.

See also:

• University of Rochester Medicine Clinical and Translational Science Institute
• CTSI Research Education Programs

Support Provided

During the two-year award period, CTSI Translational Science Scholar Award recipients will receive:

• A stipend or salary to help support the proportional effort required to participate in the program. The CTSA Program will pay 75% salary support up to a maximum of $90,000 per year, contingent on available funds. Therefore, the Scholar’s home department may be required to supplement the support in accordance with institutional guidelines. Salary supplementation may be from extramural sources, except that no federal funds may be used for this purpose. These funds will be audited by the Office of Research Accounting and Costing Standards (ORACS) yearly.
• Typically, up to $27,000 of non-salary support per year (as funding permits and subject to change based on changes in annual budget), which can be used for research, tuition, travel expenses, educational materials in support of the scholar’s career development plan, or other costs related to the scholar’s research project. If you are taking formal coursework, please utilize the URochester tuition waiver first, and then apply the CTSI Translational Science Scholar Award for the difference.
• Please note: your project must be supported only with the funds provided by the Translational Science Scholar Award. Awardees are not permitted to mix and match sources of funding; projects may not be funded partially by grant funding and partially by institutional funding.
• Those appointed as postdoctoral clinical or research fellows receive benefits as defined by the University of Rochester School of Medicine and Dentistry’s Office of Graduate Medical Education (see their Benefits/Contract for Trainees webpage). Those appointed as faculty receive benefits as defined by the University of Rochester (see the University of Rochester Total Rewards website).

Other Important Details

If applicants do not follow the instructions in this RFA, the application will not advance to review.

• K12 appointment forms for candidates with a pending independent K application will not be approved by NIH/NCATS. Therefore, if you are considering applying for another award, it's essential to notify us as soon as possible and ensure your second-year appointment has been fully processed by NCATS before submitting any new applications.
• CTSI Translational Science Scholar Award appointment start, and end dates must coincide with these dates to receive NIH funding and are not flexible.
• CTSI Translational Science Scholar Awardees are expected to attend the annual meeting of the Association for Clinical and Translational Science (ACTS), typically held in the spring in Washington, D.C. Grant funds may be used for this purpose.
• Candidates selected for either the Institutional TS award or the NIH K12 TS Award may be eligible to apply to the NIH Loan Repayment Program; any faculty who has >50% of their time allocated for research may also be eligible, and we encourage these applications.

Important Dates

• Monday, August 10, 2026 - 5 p.m. Eastern Time – Submit Letter of Intent for review
• Friday, August 21, 2026 – Invitation to submit applications
• Monday, October 5, 2026, 5 p.m. Eastern Time – Submit application packet
• Friday, January 29, 2027 – Notification of recipients
• Appointment Period (2 years):
  • Institutionally Funded Award
    • July 1, 2027, through June 30, 2028 – Year 1 of the Award
    • July 1, 2028, through June 30, 2029 – Year 2 of the Award
  • K12 Funded Award
    • October 1, 2027, through September 30, 2028 – Year 1 of the Award
    • October 1, 2028, through September 30, 2029 – Year 2 of the Award
    • K12 TS scholars’ appointment start and end dates must coincide with these dates to receive NIH funding – and they cannot be extended or changed.
• Note: The funding source for each trainee is determined during the review process. Applicants will be notified upon acceptance.

Program Contacts

For more information about the CTSI Translational Science Scholar Award, please contact:

General inquiries

Rachel Hillhouse
Research Education Academic Administrator, CTSI
Rachel_Hillhouse@urmc.rochester.edu

Andrew Thomas
Director of Research Education, CTSI
Andrew_Thomas@urmc.rochester.edu

Financial and budgetary inquiries

CTSI Finance Team
CTSI_Finance@URMC.Rochester.edu

Inquiries regarding other programmatic issues

Jin Xiao, DDS, PhD
Director, K12 Scholar Program, CTSI
Professor, Department of Dentistry, URMC
Jin_Xiao@urmc.rochester.edu

Inquiries regarding degree or certificate programs offered through the Department of Environmental Medicine and Public Health Sciences

David Rich, ScD
Professor and Vice Chair, Education, Department of Environmental Medicine and Public Health Sciences
david_rich@urmc.rochester.edu

Training Specialization Contacts

Dissemination and Implementation Science

Kevin Fiscella, MD, MPH
Professor, Department of Family Medicine
Kevin_Fiscella@urmc.rochester.edu

Reza Yousefi-Nooraie, MSc, PhD
Associate Professor, Department of Environmental Medicine and Public Health Sciences
Reza_Yousefi-Nooraie@urmc.rochester.edu

Digital Health/Emerging Artificial Intelligence in Translational Science

Erika Ramsdale, MD
Associate Professor, Department of Medicine, Hematology/Oncology
Erika_Ramsdale@URMC.Rochester.edu

Clinical Trials

Christopher Palma, MD, ScM
Associate Professor, Department of Medicine
Director of the Clinical Research Center, CTSI
Christopher_Palma@urmc.rochester.edu

Admissions

Eligibility

To be eligible to apply to the CTSI Translational Science Scholar Award, applicants must define and participate in a translational research or science project. Translational research is the process of turning observations from the laboratory, clinic, and community into interventions that improve the health of individuals and the public, focusing on the translational process for specific diseases. Translational science is the field of investigation focused on understanding the scientific and operational principles underlying each step of the translational process to refine the process of turning observations in the laboratory, clinic, and community into interventions that improve the health of individuals and communities. The focus of translational science is not on specific diseases but "what is common among them". Applicants can propose either translational research or translational science projects. For more information on translational science, please visit our website.

Note: The CTSA Program is funded by the National Center for Advancing Translational Sciences (NCATS). With the signing of the 21st Century Cures Act (Cures Act) into law in December 2016, the Public Health Service (PHS) Act was amended to allow NCATS to support clinical trial activities through the end of phase II for all diseases or conditions, and through the end of phase III for a rare disease or condition. Please refer to NCATS notice (NOT-TR-18-025) for more information.

Qualifications

Other qualifications for the CTSI Translational Science Scholar Award include:

• A doctoral-level degree in a health discipline that can be applied to clinical or translational research. These degrees include, but are not limited to MD, DO, DMD, DDS, DPH, PharmD, PhD, as well as EdDs in a clinically relevant field, such as biostatistics, epidemiology, behavioral science, and nursing.
• US citizen or permanent resident. Individuals on temporary or student visas are not eligible.
• Scholars must reside in either the Finger Lakes or Western New York regions and be ready to attend multiple in-person meetings throughout the year.
• Must be an early-stage investigator committed to advanced training and a career in translational science research aligned with the CTSA Program's goals of advancing therapeutics (drugs, devices, and preventives), clinical interventions, and behavioral modifications to improve health.
• Scholars may have had support on an NRSA grant (F or T) or an NIH small grant (R03).
• Commitment to the two-year program within the stated award period and an additional department-supported third year dedicated to continued translational research if scholars have not obtained NIH individual K grants by the completion of the two-year program. During this time, at least 75 percent of the scholar’s full-time professional effort must be devoted to the program. The remainder of the time may be devoted to developing other clinical or academic pursuits that are consistent with the objectives of developing a career as an independent clinical or translational researcher. Certain clinical specialties may have less than 75 percent effort -- but no less than 50 percent effort -- if sufficiently justified (e.g., surgical specialties requiring 50 percent direct patient care time to keep up surgical skills).
• Postdoctoral fellows may apply for a faculty position, but this position should not be contingent on receiving the CTSI Translational Science Scholar Award. Letters of Support from department chairs must indicate this explicitly.

Exclusions

Please read this section carefully. We are aware that it is important for early-stage investigators to leverage funding opportunities, when possible, particularly K-awards. Our review process is timed so that notifications to applicants will arrive at least two weeks before the NIH K-award submission cycle deadline. This is done to make it possible for applicants not receiving a CTSI Translational Science Scholar Award to still be able to apply for other K-awards from the NIH. Please also note:

• At the time of application, scholars must NOT have a pending application for any other PHS mentored career development award (e.g., K01, K08, K22, K23) that duplicates any of the provisions of the CTSI Translational Science Scholar Award. A candidate who is already in the process of applying for an independent mentored career development grant, a P01 grant, or an R01 grant is likely too senior for the CTSI Translational Science Scholar Award.
• Former or current PDs/PIs on any NIH research project grant (this does not include NIH small grants [R03], exploratory Developmental [R21], or SBIR, STTR [R43, R44 grants])) or equivalent non-PHS peer-reviewed grants that are over $100,000 direct costs per year, or project leaders on sub-projects of the Program project (P01) or center grants (P50) are NOT eligible to participate as Scholars.

Application Process

Positions

Two or more positions are available annually and have a start date of July 1, 2027, and October 1, 2027. However, the number of positions is subject to change depending on NIH and Institutional funding.

Timeline

• Please submit your intention to apply by filling out the CTSI Translational Science Scholar Award Letter of Intent (LOI) Form by 5:00 p.m. Eastern Time on Monday, August 10, 2026. If you have questions about the LOI, please contact Research Education Academic Administrator, Rachel Hillhouse, or Research Education Director, Andrew Thomas.
• LOIs will be reviewed, and invitations to submit a full application will be sent out no later than Friday, August 21, 2026 (see details in Step 2 below).
• Invited applicants must submit the full application packet through our online application system by 5:00 p.m. Eastern Time on Monday, October 5, 2026. Instructions and a submission link will be provided after the letter of intent is received.

A Note for Applicants: Utilize CTSI Research Methods Forum

It is strongly recommended that, prior to applying for the CTSI Translational Science Scholar Award, you sign up to present your proposed research at the interactive CTSI Research Methods Forum, where you will receive feedback from its multidisciplinary team of experts about strengthening the quality and rigor of your proposal. The forum is held virtually twice per month and is an ideal resource for junior investigators. Additional ad hoc sessions can be arranged if needed.

Please contact Kimberly Marino to schedule a session.

For more information on the forum, contact Jim McMahon.

How to Apply

If applicants do not follow the instructions in this RFA, the application will not advance to review.

Step 1

Identify a primary mentor and co-mentor(s). One of the most important steps in applying is to identify a multidisciplinary mentor team. Your primary mentor should be located at the University of Rochester. You and your primary mentor should determine appropriate co-mentor(s) in other disciplines that will bring valuable expertise to your career development and research proposal. For assistance in identifying a primary mentor and one or more co-mentors, see the informational links below. You may contact the CTSI Research Help Desk for assistance in identifying potential mentors. See also: Research Departments and Centers at the University of Rochester.

Step 2

By 5:00 p.m. EST on Monday, August 10, 2026, notify the CTSI of your intent to apply by submitting your LOI and supporting documentation using the redcap link provided. This information allows us to better plan the review process and assist potential applicants as necessary.

The submission form will ask for:

• Your name, email address, home address, doctoral degrees, current department, and position in that department
• Names and specialties of your primary mentor and co-mentor(s)
• Name of your department administrator responsible for your financials
• A working title for your proposed project, and two or three sentences describing your anticipated research proposal
• A draft of your Specific Aims page (limit 1-page)
• NIH biosketches for yourself and your primary mentor in the Common Form (SciENcv must be used to prepare the biosketches). *Submission of a biosketch that does not follow the latest NIH guideline will disqualify the applicant.

All materials are required for submission of the LOI. LOIs and accompanying materials will be reviewed and scored by a team of senior faculty, and by Friday, August 21, 2026, meritorious submissions will receive invitations to submit the full application.

Please submit your LOI and supporting materials through the Letter of Intent (LOI) Form. If you have any questions, please contact the Research Education Academic Administrator, Rachel Hillhouse, or the Research Education Program Director, Andrew Thomas.

Step 3

Complete the required documentation. To apply, you will need to submit the application materials listed below. Resubmissions must include a cover letter detailing how you addressed prior reviewer comments. Please follow NIH guidelines for grant style, content, and format contained in the NIH Application Guide.

1. Your NIH biosketch in the Common Form (NIH format sample and forms available online). Do NOT submit a CV. Prepare your personal statement to be relevant to your mentored career development proposal.
2. NIH biosketches in the Common Form for your mentors. Mentors should edit their personal statements on their NIH biosketches to describe their specific role in your award and career development.
3. Research Career Development Plan (RCDP)
   1. The candidate and the mentor are jointly responsible for the preparation of the career development plan. (3-page limit, excluding references).
   2. Provide a summary of your career path to date. This should include a critical self-appraisal of your training needs and a description of how the mentor team will meet your needs. Please refer to NCATS Translational Science Education Resources for information on translational science skills and the CTSA Program’s core and special-interest clinical and translational research competencies.
   3. Describe a plan: (1) that shows a logical progression from prior research and training experiences to the training and research experiences that will occur during the award period; (2) that justifies the need for further career development; and (3) that utilizes the relevant research and educational resources of the institution.
   4. Describe the training you are seeking and how the training by the Scholars Program will help you achieve these goals. Regarding the proposed training plan:
      1. You should address your commitment to the foundational curriculum (see Appendix).
      2. Select additional coursework and programs to best support your individual background, discipline, and career objectives. Scholars can choose from the CTSI educational programs and coursework that span the translational research spectrum.
      3. If you are interested in aligning your individualized training curriculum to one of the three training specializations (Clinical Trials, Dissemination and Implementation Science, or Digital Health/Emerging Artificial Intelligence in Translational Science), you should contact the Director or Co-Directors for that specialization.
   5. Describe your professional responsibilities/activities, including other research projects, beyond the minimum required 75% effort commitment to the award. Explain how these responsibilities/activities will help ensure career progression to achieve independence as an investigator conducting clinical and translational research.
   6. Provide plans and timing of submission for subsequent funding, including K- or R-series mechanisms, or equivalent, as appropriate to training and research needs. A timeline is often helpful.
4. Mentored Research Plan. A sound research project that is consistent with the candidate's level of research development and objectives of his/her career development plan must be provided (4-page limit, excluding references). Organize the research plan as indicated in the NIH Form PHS 398, following instructions for the Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods. The candidate should consult with mentor(s) regarding the development of this section. While planning the scope of your research project, keep in mind that the project must be supported only with the funds provided by the award. Studies that involve early-stage clinical trials (biomedical and behavioral intervention studies) must include a description of the plan for data and safety monitoring of the research and adverse event reporting to ensure the safety of subjects (see NIH Grants Policy Statement, section 4.1.15.6). All research data generated by the award must comply with the NIH Data Management and Sharing Plan.
5. The following 3 letters of support:
   1. Letter from proposed primary mentor detailing his/her support of and commitment to the applicant and the proposed research and training plan. The letter should include the mentor's qualifications, including prior experience in supervision, training, and successful mentoring of clinical/translational researchers. The letter should also include how often the mentor plans to meet with the candidate, and confirm that adequate space, facilities, and resources will be made available for the successful completion of the research project. The letter should describe how the proposed research fits into the mentor's research program, including a description of the role of the applicant in the research. The primary mentor letter should not exceed two pages.
   2. A letter of recommendation from at least one proposed co-mentor, but no more than 3 letters of recommendation in total. The co-mentor must be in a different discipline than the primary mentor. This letter must include the co-mentor's assessment of the candidate's qualifications and potential for future success. The letter should also indicate the co-mentor's qualifications, including experience in providing similar mentorship and research expertise. The co-mentor letter should not exceed one page. You may submit up to three (3) recommendation letters.
   3. A letter of nomination from the Chair of the candidate’s Department or Director of the candidate’s Center, including explicit assurances that non-research responsibilities will be restricted to no more than 25% of the scholar’s time (or 50% for certain procedure-based specialties such as surgery). It is critical that the Department Chair or Director of the candidate’s Center is aware of the scholar’s responsibility for their program to ensure adequate time is protected for project research. To avoid confusion, be sure to work with your Chair to outline the specific expectations for the 25% that is not funded by the award. The letter should also comment on plans for further career development of the candidate after the period of the Scholar award and should address the candidate’s motivation and likelihood to become an independent investigator. Specifically, the Department Chair or Director must include in their letter a guarantee of support for the Scholar’s third year to have protected time and resources for continued research, following the completion of the two-year CTSI Translational Science Scholar award. For Postdoctoral applicants: Please be sure that your department chair provides explicit assurance that promotion to a faculty position is not contingent upon you receiving a CTSI Translational Science Scholar Award.
6. Current and pending other support in the Common Form, other than this award, for you and your mentors.

Step 4

You must submit the required materials listed above through our online application system no later than 5:00 p.m. Eastern Time on Monday, October 5, 2026. Supplementary material will not be accepted. You must notify the CTSI immediately of any revisions or updates to your current or pending other support that occur between submission of your application and the date of official notification of CTSI Translational Science Scholar Award status. Failure to notify the CTSI of such changes in a timely and accurate fashion may disqualify you from the CTSI Translational Science Scholar Award.

Step 5

For Accepted Applicants: In late January, all applicants will receive notification from the program team about the outcome of their submission. If you are offered a CTSI Translational Science Scholar Award, you will be asked to provide the following to help with administrative preparation for the award:

1. A financial analysis, signed by both your Department Chair/Center Director and your department’s research administrator, documenting the financial impact of the award on the Department/Center. The analysis will calculate supplemental funds required by the Department to support the Scholar’s salary, if any, based upon current and anticipated applicant salary information for the two years of the award. The applicant must contact Andrew Thomas, CTSI’s Research Education & Career Development Director, who will provide a standard financial analysis template.
2. Overview of expected spending, using the standard NIH PHS 398 Form Page 4. Please provide, to the best of your knowledge, any purchases you anticipate making during your appointment period that will require CTSI Translational Science Scholar Award funds. A detailed budget will let us know in advance if there are any planned purchases that are unallowable on the award. A budget justification detailing why the planned expenditure will support the success of the project needs to be included.

Application Review Process and Criteria

Each application will be reviewed initially for completeness and eligibility.

Applications will be reviewed by the Recruitment/Selection Committee using a similar format, numerical scoring system (1-9), and template used for NIH Career Development awards. In addition to an overall impact score, reviewers will give a separate score for each of the five following criteria in the determination of scientific and technical merit: 1) Candidate, 2) Career Development Plan/Career Goals & Objectives/Plan to Provide Mentoring, 3) Research Plan, 4) Mentor(s), Co-Mentor(s), Consultants, Collaborators, and 5) Environment and Institutional Commitment to the Candidate. Faculty reviewers with a significant conflict of interest will not be allowed to review.

Notification of Recipients

Notification of recipients: By Friday, January 29, 2027.
Award start date: July 1, 2027, or October 1, 2027

Requirements if Funds are Awarded

Annual and Final Progress Reports

An annual progress report is due in March of the first year during the Scholar’s term of appointment. Renewal of the award in year 2 is contingent upon presentation of a satisfactory progress report. An annual progress report is also due in March of the second year during the Scholar’s term of appointment. Additionally, a final research report and a final expenditure report are due within 60 days following the closing of the grant term.

Publications

All NIH K12 TS scholar publications that benefit in whole or in part from support provided by the CTSI must do the following:

1. Comply with the NIH Public Access Policy: Note that the peer-reviewed version must be made publicly available without any embargo period on the official publication date. Assistance with the compliance process is available through the Miner Library.
2. Acknowledge CTSI grant funding using this language: “The project described in this publication was supported by the University of Rochester CTSA award number K12 TR005444 from the National Center for Advancing Translational Sciences of the National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.”

All Institutional TS scholar publications that benefit in whole or in part from support provided by the CTSI must do the following:

1. Comply with the NIH Public Access Policy: Assistance with the compliance process is available through the Miner Library.
2. Acknowledge CTSI funding using this language: “The project described in this publication was supported by the University of Rochester Medicine Clinical and Translational Science Institute (CTSI). The content is solely the responsibility of the authors and does not necessarily represent the official views of the CTSI.”

Clinical Trials

If the proposed research project involves a clinical trial, the awardee will be required to promptly inform the CTSI of all adverse events that are serious, unexpected and related to participation in research. Further guidance is available on the Office for Human Research Protection website. In addition, most clinical trials must be registered in clinicaltrials.gov. For more information about registration requirements, see the CTSI’s Regulatory Support pages.

To satisfy expectations of NCATS, the funder of the CTSA program, award recipients conducting an NIH-defined Clinical Trial must complete the Good Clinical Practice (GCP) training module available through the Collaborative Institutional Training Initiative (CITI) before conducting human subject research. Documentation that this training has been completed by all members of the study team must be on file with the CTSI Research Education Academic Administrator prior to enrollment of the first research subject.

Research Involving Human Subjects or Vertebrate Animals

For K12-supported trainees, if the proposed research project involves human subjects or vertebrate animals, the NIH requires that the CTSI obtain explicit approval from the NIH before the research can begin. Accordingly, IRB or UCAR approval documentation and other materials must be submitted to the NIH at least 30 days prior to the project start date. CTSI personnel will work with awardees to meet these requirements.

For institutionally funded projects, IRB or UCAR approval must be on file with the CTSI office prior to the start of research.

Single IRB for Multi-Site Projects Using the Same Protocol

For K12-supported trainees, if the same protocol will be used to conduct your human subjects research at multiple sites, NIH requires the use of a single IRB. Office for Human Subject Protection staff will provide guidance in this process.

2 CFR 200 Procurement Principles Training

All University of Rochester Principal Investigators on the project and each person who initiates purchases must provide documentation that they have completed the 2 CFR 200 Procurement Principles training available in MyPath.

ORCID IDs

All key personnel on the research project must obtain an ORCID ID, which provides a persistent digital identifier that the investigator owns and controls, and that distinguishes the investigator from every other researcher.

Appendix. Elements of the Foundational Curriculum

Rigorous Research Training

Coursework in Ethics and Professional Integrity (IND506)

This course is only offered in the fall semester, and you must enroll in IND 506 during the first year of your appointment. This course is required of all clinical and basic science postdoctoral fellows in the School of Medicine and Dentistry. The course features 10 sessions consisting of lecture/case study presentations followed by small-group discussions that provide information on the various topics that the National Institutes of Health consider essential for the responsible conduct of research. Specific topics include the ethical issues underlying human experimentation and related conflicts of interest, animal experimentation, the mentor-mentee relationship, scientific misconduct and plagiarism, collaborative and team science, and publication/authorship. The course also introduces approaches for improving rigor and transparency with the goal of enhancing research reproducibility. This is a non-credit-bearing course that cannot be applied to any degree program in the School of Medicine and Dentistry.

Good Clinical Practice (GCP) Training

Scholars engaged in clinical trials will receive GCP training. Scholars will complete an online GCP training program (via the Collaborative Institutional Training Initiative) that has been approved by the URochester Office for Human Subject Protection. NIH requires all funded “investigators and staff who are involved in the conduct, oversight, or management of clinical trials” to be trained in Good Clinical Practice. The policy further requires Investigators to take a refresher GCP training course every three years. The course is available through the CITI training platform.

Team Science Training

Team Science Course (PM 403)

This course introduces Scholars to the concepts, practice, and challenges of team science and collaborative research environments. Scholars will be exposed to both team science initiatives and the science of team science, presented through practical examples from local research teams and researchers, with a focus on the practical implications of a team science approach to biomedical research that requires large-scale data analysis.

Grant Preparation Activities

Participate in and Present at the Research Methods Forum

Each Scholar will be required to regularly attend, participate in, and present at the bi-weekly CTSI Research Methods Forum. The Scholars will present at the Research Methods Forum to obtain feedback on the appropriateness of specific aims (both scope and clarity), the strength of preliminary data, and the rigor of research methods. In addition to core Research Methods Forum faculty, additional specific faculty attendees will be invited to participate in each session, based on the discipline and content of the presenter’s research. Following the presentation, members of the Forum will continue to provide Scholars with feedback and support by reviewing grant proposals and study protocols to improve the rigor and transparency of the proposed work.

Grantsmanship course (PM 438)

The Grantsmanship course will teach Scholars how to identify funding opportunities, prioritize potential grant opportunities, present a research project/program in a grant application, and navigate and complete the application process.

CTSI Coaching and Leadership Development Program (CLDP)

The CLDP led by Dr. Karen Wilson to provide coaching and leadership training, will expand to include CTSI Translational Science Scholars. The goal is to provide each trainee with personalized coaching in leadership skills and research career development, with an emphasis on understanding their leadership style. The standard coaching will be six-monthly, 50-minute sessions. At the end of the coaching engagement, Scholars will complete assessments of their career satisfaction and barriers pre- and post-coaching, as well as an evaluation.

Other Professional and Scientific Management Skills

2 CFR 200 Procurement Principles

It is a CTSI requirement that all Scholars take the 2 CFR 200 Procurement Principles in My Path. This module is meant for any person who has been delegated authority to purchase goods or services for a federally funded project at the University of Rochester.

Rochester Early-Stage Investigator Network (RESIN) Workshops

To leverage a greater breadth of existing resources at the University of Rochester, as well as strengthen the community of early-stage faculty, a group of leaders from various departments across the medical center joined together with the existing leadership of URochester K-Club, the Junior Faculty Biomedical Research Association, the URochester Office of Faculty Development, and the CTSI Research Education branch to create the Rochester Early-Stage Investigator Network (RESIN). RESIN works across departments and centers to optimize and support training for early-stage investigators spanning the translational spectrum, including both past and current scholars. RESIN helps early-stage investigators develop the skills and knowledge to innovate and improve the efficacy and efficiency of translation, from discovery to implementation and dissemination within the Learning Health System and beyond. RESIN activities complement, and do not replace, individual department and center efforts to support early-stage investigators. The bi-monthly workshop has included hands-on workshops and seminars, such as: Conducting Clinical and Translational Research: How the CTSI Can Help; Starting Your Lab: How to Hire your First Employee; How to Talk to a Biostatistician or Bioinformatician; Preparing and Presenting an Elevator Speech; Art of Writing a Good K Grant; Social Media to Maximize Research Exposure; and includes a yearly mock NIH Study-Section that occurs during the CTSI’s annual Translational Research Day event, which also provides opportunities for networking with fellow translational science scholars and other early stage faculty. Other important resources and a schedule of events can be found on the CTSI’s RESIN web page.

Association for Clinical and Translational Science Annual Conference (ACTS)

Scholars will be expected to attend at least one Annual Conference of the Association for Clinical and Translational Science during their two-year appointment.

NIH AI Policy

Please note that the NIH will not consider applications that are either substantially developed by AI or contain sections substantially developed by AI to be original ideas of applicants. If the detection of AI is identified post-award, NIH may refer the matter to the Office of Research Integrity to determine whether there is research misconduct while simultaneously taking enforcement actions, including but not limited to disallowing costs, withholding future awards, wholly or in part suspending the grant, and possible termination.

Foreign Components

Projects or research activities cannot involve a foreign component as defined by NIH. Please note that the NIH now considers most instances of co-authorship with an investigator at a foreign site to be a foreign component.