CTSA Program Diversity, Re-training, Re-integration, and Re-entry Supplements

Applications must be submitted electronically as described in PA-23-189 and NOT-OD-21-134.

Prepare applications using the SF424 (R&R) forms associated with the chosen package. Please note that some forms marked optional in the application package are required for submission of applications for this announcement. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate required and optional forms, with the following additional guidance:

R&R Cover Form

• Select “Revision” in the “Type of Application” field.

Application Information Guidance

• Project Title

  • The project title should be the same title as the parent award.

• Project Period

  • If awarded, the budget period for the supplement will sync with the budget period of the parent grant (e.g., UL1 or UM1 award) during the first 12 months. For example, if the parent grant budget period ends on June 30 of each year, and the supplement is awarded starting March 1, then the first budget period of the supplement will be only 4 months, March 1 – June 30 of the same year, and the second budget period will be a full 12 months, July 1 – June 30 (of the next year). In addition, please note that any one budget period must be 12 months or less. Please configure your budget request accordingly.

• Senior/Key Personnel

  • List the PD/PI of the UL1/UM1 award as the first person (regardless of their role on the supplement activities). The UL1/UM1 award principal investigator should have the role category of “PD/PI.”
  • List the Diversity/Re-Entry/Reintegration candidate to be supported through this supplement as the second person. Select “Other” for the Project Role and enter “Candidate” in the Other Project Role Category.
  • Do not include other Sr/Key persons from the parent project unless they are directly involved in the candidate's research directly involved in the candidate's research or training experience.
  • Candidates for supplement support must have an eRA Commons account and the candidate's Commons Username must be entered in the Credential field.
  • Under the Degree field, designate the candidate's current educational/career level using one of the abbreviations from the bulleted list below (e.g., “Grad” for a predoctoral candidate). Enter the relevant abbreviation and no additional text. Because a candidate's compensation level is determined by his or her current educational/career level, this information is required.
    • Grad – Predoctorate
    • PD – Postdoctorate
    • Fac – Faculty
  • In keeping with NIH's goal of gaining a better understanding of the size and characteristics of the biomedical research workforce, described in NOT-OD-13-097, Diversity supplement candidates are encouraged to provide demographic and educational or applicable degree information in their eRA Commons Personal Profiles.

• Project Summary/Abstract (Description) (not to exceed 1 page)

  • Summary or abstract of the funded parent award or project.
  • A separate project summary of the parent award and for the Diversity/Re-Entry/Reintegration project can be included, but together cannot exceed 1 page.

• Project Narrative (not to exceed 3 sentences)

  • Describe the relevance of this research to public health in, at most, three sentences. For example, applicants can describe how, in the short or long term, the research would contribute to fundamental knowledge about the nature and behavior of living systems and / or the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.

• Research Plan (not to exceed 10 pages)

  Overall, the candidate’s strengths and weaknesses and short- and long-term goals should be stated in the Research Plan. The plan must be focused on the development of the candidate’s skills and providing the support structures needed to transition into the next phase of the biomedical training/career pathway. It should be clear from the application how a Diversity supplement will impact and add value to the candidate’s training, mentoring and career development experiences. The Research Plan should also provide a brief overview of the CTSA Program resources the candidate will use and a plan for how they will be incorporated into their research training plan.

  • Specific Aims (not to exceed 1 page): Description of the Specific Aims of the entire supplement, including the career development aims.
  • Research Strategy (not to exceed 4 pages): Description of the candidate’s proposed research strategy within the scope of the funded parent award or project. Organize the Research Strategy section using the following sections: Significance, Research Aims, Innovation and Approach. Applicants are encouraged to use NIH’s guidance for fellowships or career development applications.
  • Mentoring Plan (not to exceed 3 pages): A mentoring plan for the candidate must include a plan for the candidate to contribute intellectually to the research; to enhance the candidate’s research skills and knowledge regarding the selected area of biomedical, behavioral, clinical or social sciences; and to interact with other individuals on the parent UL1/UM1 grant that will contribute to their research and career development plan. It also must provide evidence regarding translational research in the selected areas of biomedical, behavioral, clinical or social sciences.
    • In addition, the Mentoring Plan must demonstrate that the CTSA Program UL1/UM1 PD(s)/PI(s) are willing to provide appropriate mentorship.
    • The mentoring plan must include a description on developing an individual development plan for the candidate (see NOT-OD-14-113).
    • The selected mentor(s) should be an active investigator in the area of the proposed research, committed to the career development of the candidate, and able to directly supervise the candidate’s research. Candidates are encouraged to identify more than one mentor, (i.e., a mentoring team [or advisory committee]), because this is deemed advantageous for providing expert advice in all aspects of the research career development plan.
    • Additionally, a plan for the candidate’s next source of funding is required.
    • Objectives for helping the candidate transition to the next stage of his/her research career (e.g., routine meetings, supervision in writing, publishing, etc.).
    • Details of the mentor-candidate interactions: The plan should go well beyond simple supervision plans or stating that the candidate will attend seminars or meetings. The career development plan should be structured, specific and stage-appropriate for the candidate and include parameters, such as the frequency of meetings, topics to be discussed, and how progress will be monitored.
  • Summary of mentoring experience of the CTSA Program UL1/UM1 PI and selected mentors (not to exceed 1 page). If a team of mentors is proposed, the team structure should be well-justified for the mentored training plan and the roles of the individual members appropriate and clearly defined.
  • A timeline for the research and career development experiences proposed (not to exceed 1 page).
    • Include an individualized career development plan that is consistent with the goals described in candidate’s personal statement, the candidate’s short- and long-term career aspirations, and the proposed mentored research experiences.
    • A timeline in Gantt-style format delineating specific research milestones and other activities that will facilitate progress toward independent research funding (i.e., anticipated publications, grantsmanship workshops, timeframe for grant application submissions) is strongly encouraged. Grant applications should be career stage-appropriate (see Choose an Award by Career Stage).

• Project/Performance Site Locations

  • Include the primary site where the proposed supplement activities will be performed. If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided.

• Biographical Sketches

  • Include a biographical sketch for all personnel that will contribute to the research mentoring (PI/PD, candidate, mentors and collaborators). The biographical sketch should follow NIH guidelines.
  • The biosketch of the PI and mentors should include:
    • A personal statement that describes a commitment to (1) diversity, (2) training, mentoring and promoting inclusive and supportive scientific research environments, and (3) supporting mentee participation in activities required to identify and transition into careers in the biomedical research workforce that are consistent with the mentees’ skills, interests and values.
    • Include a table of current and previous mentees, their degree(s), career level at time of mentorship, and their subsequent career/professional outcomes. Inclusion of the percent of individuals mentored whose background is consistent with the Notice of NIH’s Interest in Diversity (NOT-OD-20-031) is encouraged. The primary mentor should have a successful track record of mentoring individuals at the candidate’s career stage and be appropriate for the needs of the candidate.
    • Evidence of scientific achievement or interest.
    • Any source(s) of current funding.
  • The biosketch of the candidate should include:
    • Research experience that demonstrates the candidate’s translational science research interest and experience. Include published manuscripts and those in preparation.
    • If Re-Entry, the length of and reason for any career hiatus and a description of how the candidate has kept current or attempted to keep current in their field.
    • Research objectives and career goals: The candidate should discuss how the planned activities are related to or will facilitate achievement of their future career goals, outlining his/her short- and long-term research objectives and include evidence of scientific achievement or interest in the area of clinical and translational science research.
    • All candidates must provide their ORCID iD (Open Researcher and Contributor Identifiers) to allow for greater long-term tracking of applicants. (Additional information about the ORCID iD can be found at NIH NOT-OD-19-109.) The ORCID iD should be placed in the Contributions in Science section.

• A Proposed Budget for the Entire Project Period

  • Applicants should follow the instructions as indicated in the FOA. Only include funds requested for the additional supplement activities. Note that the expected time commitment of the candidate on the project must adhere to the FOA requirements.
  • The requested time of the entire project should be two years to provide an optimal career development experience for the candidate (see the CTSA Program FAQs for Diversity Supplements).

• Candidate Eligibility Statement (not to exceed 1 page)

  A signed statement from an institutional official establishing the eligibility of the candidate for support under this program. The statement must include:

  • Citizenship: Clearly presented information on citizenship of the candidate. Supplement awards are limited to citizens or non-citizen nationals of the United States or to individuals who have been lawfully admitted for permanent residence in the United States (i.e., in possession of Permanent Resident Card, Form I-551) or some other legal evidence of admission for permanent residence at the time of application.
  • Eligibility under the funding opportunity: A description of how the appointment of this specific candidate would further the goals of the Diversity, Re-Entry or Reintegration Supplement funding opportunities (NOT-OD-21-134 or PA-20-222). The strength of this statement will be considered by the NIH administrative review committee along with all other material provided. If a candidate received a prior NCATS Diversity supplement award, regardless of career stage, they are not eligible to apply for a second NCATS Diversity supplement award.
    • Eligibility for Diversity supplements: The statement must clearly establish the basis (e.g., race, ethnicity, disability, or disadvantaged status) for the candidate’s eligibility as an individual from an underrepresented background consistent with the Notice of NIH’s Interest in Diversity (NOT-OD-20-031). Institutions are encouraged to identify candidates who will enhance diversity in the biomedical research workforce. The Diversity supplement is designed for individuals from groups underrepresented in the biomedical sciences, including racial and ethnic minorities, persons with disabilities and individuals from economically and educationally disadvantaged backgrounds who wish to pursue a career in clinical and translational science research.
    • Eligibility for Re-Entry supplements: The statement must describe the nature and duration of the career interruption. In general, the duration of the career interruption should be at least one year and no more than eight years. Examples of qualifying interruptions would include a complete or partial hiatus from research activities for child rearing; an incapacitating illness or injury of the candidate, spouse, partner or a member of the immediate family; relocation to accommodate a spouse, partner or other close family member; pursuit of non-research endeavors that would permit earlier retirement of debt incurred in obtaining a doctoral degree; and military service. The program is not intended to support additional graduate training and is not intended to support career changes from non-research to research careers for individuals without prior research training. Generally, the candidate should be in complete or partial hiatus from research activities at the time of application and should not be engaged in full-time paid research activities. Preference will be given to candidates with a complete hiatus from research activities.
    • Eligibility for Reintegration supplements: The statement must certify eligibility consistent with the notice and state that a new, safe research environment has been identified for the candidate. Candidates with doctoral degrees and graduate students seeking to transition out of unsafe research environments because of discriminatory and unlawful harassment are eligible to apply for Reintegration supplements to continue research training as soon as a new and safe research environment has been identified.
  • Protected time: A statement indicating that the candidate would receive a minimum of 75% protected time. As a reminder, less than 75% (but not lower than 50%) effort for certain clinical specialties (e.g., surgical and procedure-intensive specialties) is considered on a case-by-case basis.
  • Career level: Intended academic/career level of the candidate during the requested supplement support. For candidates who are investigators developing independent research careers, the institution should include the position of the candidate, including the title, the duration, a brief description and any institutional commitment.

• Other Project Information

  • IRB and IACUC:
    • If applicable, attach PDF documents in the “Other Attachments” field indicating that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Name the documents “IACUC Documentation.pdf” and/or “IRB Documentation.pdf”. Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects’ involvement is planned for the supplement.
  • Home Institution Approval:
    • Under unusual circumstances where the applicant and mentor would be at a site other than the grantee institution, an appropriately signed letter from the institution where the research is to be conducted must also be submitted. The request must be signed by the CTSA Program UL1/UM1 PD/PI, the candidate and the appropriate institutional business official.
  • Sub-Recipient Approval:
    • If any of the research is to be conducted at an organization other than the grantee institution, an appropriately signed letter from the institution where the research is to be conducted must be submitted. The request must be signed by the candidate, the CTSA Program UL1/UM1 and the Subsite PD/PI, and the appropriate institutional business official.
  • Reasonable Accommodations:
    • If the request is for a supplement based on disability, the institution should indicate what, if any, reasonable accommodations the institution has supported or plans to provide along with a full description of how any additional support for the accommodation might be used. The relationship of the proposed accommodation to the proposed project must be described.

Review Process

Applications are administratively reviewed by NCATS program staff. Program staff will examine the appropriateness of the research project, career development plan and mentorship as they relate to the candidate’s career goals. The strength of the PI/PD’s demonstrated commitment and contributions to enhancing diversity, equity, inclusion and accessibility in the biomedical sciences will be considered. Applications will also be reviewed for relevance to the NCATS mission to transform the translational science process and the goals of the CTSA program. In addition, a second level of review is conducted by NCATS and DCI leadership before final funding decisions are made.

Decisions will be based on the potential of the proposed research and mentorship to enhance the candidate’s professional development, program balance and availability of funds. In general, NCATS will make funding decisions within 12 weeks of the published receipt date (September 15). During fiscal years when NIH is operating under a continuing resolution, there may be a delay in funding decisions.

Applicants receive notification of administrative supplement funding approval via an official Notice of Award. Supplement award decisions are not appealable. No announcement or commitment of funding support should be made prior to receipt of the official Notice of Award. The program official of the parent grant will notify the PDs/PIs on applications that are not approved for funding and may provide application feedback, upon request.

Considerations for Prioritizing Applications

1. Is the training and mentoring plan specifically tailored to the needs of the candidate? What is the potential impact and added value of the supplement to the candidate’s training, mentoring and career development experiences?
2. Is the research project considered clinical and translational science? Are the proposed research question, design and methodology of significant scientific and technical merit? Is the research plan relevant to the candidate’s research career objectives? Is the research plan appropriate for the career stage? Is the plan appropriate for advancing the candidate in a research career in clinical and translational science? Can the supplement project feasibly be performed within the proposed time frame?
3. What is the likelihood that the proposed career development and research plan will enhance the candidate’s potential for a productive, independent scientific research career in clinical and translational science?
4. What is the mentor’s commitment to mentees’/trainees’ scientific and professional development and career progress within the biomedical research enterprise? What is the degree to which the mentor engages in mentoring especially involving groups underrepresented in biomedical research? Does the mentor engage in service-oriented efforts beyond the needs of their own research programs? Has the mentor received awards or recognition for outstanding mentorship? Are there demonstrable positive outcomes and a meaningful impact of mentoring?
5. Strength of prior training and how it relates to the objectives and long-term career plans of the candidate. Does the candidate have the potential to develop as an independent and productive clinical and translational science researcher? How well does prior training relate to the candidate’s current objectives and long-term career plans? How well will the candidate be integrated in the hub’s infrastructure? To what extent will the candidate interact with key investigators?
6. Hub‘s commitment to enhancing diversity, equity, inclusion and accessibility in the biomedical sciences, and any past or present leadership, mentoring and outreach activities to enhance diversity, equity, inclusion and accessibility, especially involving groups underrepresented in the biomedical research enterprise. Strength of the hub’s demonstrated contributions to enhancing diversity, equity, inclusion and accessibility in the biomedical sciences.

Eligibility

• Who is eligible to be supported by a Diversity Supplement?

  • Institutions are encouraged to identify candidates who will enhance diversity on a national basis. The Diversity supplement is designed for individuals from groups underrepresented in the biomedical sciences, including racial and ethnic minorities, persons with disabilities and individuals from economically and educationally disadvantaged backgrounds who wish to pursue a career in clinical and translational science research. Principal investigators of UL1/UM1 mechanisms may request supplemental funds to improve the diversity of the biomedical research workforce by supporting and recruiting graduate and health professional students, individuals in postdoctoral training and/or investigators developing independent research careers in clinical and translational science. Supplemental awards are limited to citizens or non-citizen nationals of the U.S. or to individuals who have been lawfully admitted for permanent residence in the U.S. (i.e., in possession of a Permanent Resident Card, Form I-551).
  • If a candidate received a prior NCATS Diversity supplement award, regardless of career stage, they are not eligible to apply for a second NCATS Diversity supplement award.
  • A “new” Diversity supplement for the same diversity trainee and the same training plan is not allowed under any circumstances if the original diversity supplement application received an NCATS award. Extensions of Diversity supplements are not permitted.
  • An individual who has received previous funding from NIH as an independent PD/PI on a research grant (e.g., R01, R03, R21), as the project leader on a component of a program project or center grant (e.g., UL1, UM1, P01, P50, G12), or as PD/PI on an individual research career development award (e.g., K01, K02, K07, K08, and K23), or as a Scholar on an Institutional Career Development Award (K12, KL2) is not eligible as a Diversity supplement candidate.

• Are women considered underrepresented and therefore eligible for a Diversity Supplement?

  • According to NIH’s Interest in Diversity notice, women are underrepresented at senior faculty level in biomedical fields. Applicants must provide a convincing case that women are underrepresented at the candidate’s career stage and in their field of study (e.g., physics, chemistry, computer science, surgery).

• Are persons with disabilities eligible for Diversity Supplements if they are not a member of an ethnic or racial minority group?

  • Yes. The institution/university must provide a signed statement establishing the eligibility of the candidate for support under this program. If applicable, the PI/mentor should describe any reasonable accommodations that are needed and how the training and mentoring plan would address these needs.

• Can a candidate for the Diversity supplement be supported by Public Health Service (PHS) grant funds at the time of application?

  • Yes, under certain circumstances, candidates conducting clinical and translational science research projects may be supported by PHS funds at the time of application, however, if the supplement application is meritorious and the candidate will be supported via the Diversity supplement the candidate must not have effort on other PHS funded grants.
  • If the candidate is supported by an institutional training grant (T32 or TL1, etc.) at the time of application, they may not be transferred to supplemental support prior to completion of the expected period of training on the program. The CTSA Program UL1/UM1 PD/PI should contact NCATS program staff to discuss such a situation before submitting an application for a Diversity supplement.

• How does the availability of KL2/K12 or TL1/T32 slots at the CTSA Program hub affect eligibility for a Diversity supplement?

  • The CTSA Program is strongly committed to the appointment of individuals from diverse backgrounds to Institutional Mentored Career Development Awards (KL2/K12) and to Institutional Training Awards (TL1/T32) as these provide a clear, mentored program and strong oversight for training students. As both the KL2/K12 and the TL1/T32 components require plans for recruitment and retention to enhance diversity it would be expected that programs would attempt to fill KL2/K12 and/or TL1/T32 slots with scholars or trainees from diverse backgrounds first and then have the opportunity to request additional support from the supplement program. Note that supplement appointments do not count toward the KL2/K12 or TL1/T32 number of scholars or trainees approved by NCATS Advisory Council; however, the supplement may not be awarded if the KL2/K12 or TL1/T32 appointment slots are not filled or if the hub appears not to be strongly committed to the appointment of individuals from diverse backgrounds to the KL2/K12 or TL1/T32. It is possible that the timing of appointments and the applicants’ availability may restrict the appointment on the KL2/K12 and/or TL1/T32 and the supplement may be used prior to or instead of the appointment on the KL2/K12 and/or TL1/T32. There may be other situations that may be justified. If there are unused slots on the KL2/K12 or TL1/T32 components at the same career level of that of the Diversity supplement candidate, it would be difficult to justify the supplement request. Hubs are encouraged to justify any relevant situation to explain particularities.

• Under the NCATS CTSA Program, which grant mechanisms are eligible for these supplements and how much time can be requested?

  • Active NCATS UL1/UM1 cooperative agreements are eligible for Diversity supplements. Institutional Career Development Core (KL2/K12) Training Core (TL1/T32) programs are not eligible, however, the Program Director/Principal Investigator (PD/PI) of these programs and/or the mentor(s) of the candidate can work with the UL1/UM1 PI to apply. Supplements to CCIA grants will not be considered.

Overall Application Questions

• Who submits the application, the person to be supported or the PI of the grant?

  • The CTSA Program UL1/UM1 PD/PI and the grantee institution must submit the application on behalf of the candidate.

• When should an application be submitted?

  • Applications are due September 15 (or the following business day if September 15 falls on a holiday or weekend) of each year for consideration of funding for the current fiscal year. Applications will be evaluated, and decisions will be made within 12 weeks, but funding decisions can be influenced and delayed by other factors, including the availability of funds. Therefore, consultation with the NCATS Program Official (PO) assigned to the parent grant and NCATS scientific contacts for these funding opportunities is advised prior to submitting an application. Since it can take up to 12 weeks to review an application and reach a funding decision, applications submitted in the current fiscal year that receive a favorable review will be funded in the same fiscal year, as long as funds and time remain available. If funds are no longer available, applications may be held for funding in the following cycle. Requested start dates should be prospective, align with the budget start date of the UL1/ UM1 grant and allow sufficient time for review of the request.

• How should an application be submitted?

  • Applicants are required to follow the submission instructions as described in the funding opportunity announcements. Each CTSA Program hub is allowed to submit up to two Diversity supplement, two Re-Entry, and two Reintegration supplement applications. However, there should be only one candidate for each application. Applicants are encouraged to alert the PO and Grants Management Specialist once the application has been submitted.

• Will NCATS consider supporting more than one Diversity, Re‑training, Re‑integration, and Re‑entry Supplement from a CTSA Program hub?

  • Yes. NCATS will consider supplemental support for more than one individual from a CTSA Program hub at all levels of training. Each request must be strongly justified and include assurances that each candidate will receive appropriate mentoring. NCATS requires that applications for individual candidates be submitted as separate applications.
  • NCATS will accept up to two applications from any one CTSA Program hub award, for each of the diversity, re-entry and Reintegration Supplements for review consideration during a fiscal year.

Budget

• Can a PI request equipment for reasonable accommodations for a disabled candidate under the Diversity Supplement?

  • Yes. Funds may be requested to make changes or adjustments in the research setting that will make it possible for a qualified individual with a disability to perform the essential functions associated with his/her role on the project. The accommodations requested under this program must be directly related to the performance of the proposed role on the research project and must be appropriate to the disabilities of the individual. Some types of accommodations that might be provided under these awards include: specialized equipment, assistive devices and personnel, such as readers, interpreters or assistants. In all cases, the total funds for accommodations requested from the supplement must be reasonable in relationship to the direct costs of the parent grant and the nature of the supplement award.

• How much time can be requested for a supplement candidate?

  • The request cannot exceed the length of time remaining for the UL1/UM1 grant project period. Potential no cost extensions are not considered as length of time remaining for these requests. A grant must have at least two years remaining in order to request a supplement for a graduate student, postdoctoral fellow, or investigators developing independent research careers to provide an optimal career development experience for the candidate. The requested time should be two years and the research training experience is to be tailored to the candidate’s proposed research project, training and mentoring plans.

• Can a PI's/mentor’s salary be requested on a Diversity Supplement / Re‑training, Re‑integration, and Re‑entry Supplement?

  • No, under the existing funding opportunity announcements, a PI's/mentor’s salary is not an allowable cost on a Diversity supplement.

• What are the allowable costs for investigators developing independent research careers?

  • For investigators developing independent research careers, the supplement will provide up to and no more than $100,000/year for salary, plus additional fringe benefits. Salary and fringe benefits must be in accordance with the salary structure of the grantee institution and must be commensurate with the individual’s level of effort devoted to the project. Additional funds of up to $10,000 may be requested for supplies and travel. Equipment may be purchased but requires prior approval of the NIH awarding component. Costs should be strongly justified and based upon need but may not exceed $150,000 direct costs for an application for an investigator developing an independent research career.

Mentors and Mentoring Plan

• Who would be an eligible mentor under the UL1/UM1 cooperative agreement?

  • The CTSA Program UL1/UM1 contact PD/PI is required to be listed as the first person on the Senior/Key Personnel form. However, additional mentor(s) are expected to be required to support the research training and career development of the candidate. Additional mentor(s) should be listed as key personnel, provide a biosketch, and be integrated into the career development plan for the candidate. All additional mentors must be clearly associated with the CTSA Program hub (may be key personnel, mentors of KL2/K12 and/or TL1/T32 programs, etc.).

• What should be included in the PI's/mentor’s training and mentoring plan?

  • Training and mentoring plans should be customized to the individual candidate's strengths and weaknesses, gaps in previous training, and short- and long-term goals should be stated within the training plan. The plan must be focused on the development of the candidate’s skills and provide the support structures needed to transition into the next phase of the biomedical training/career pathway. It should be clear from the application how a diversity, re-entry and Reintegration supplement will impact and add value to the candidate’s training, mentoring, and career development experiences. The plan should specifically focus on how the training and mentoring plan will best position the candidate for a career in clinical and translational science. In addition, the PI/mentor should indicate how the individual will be supported after the supplement ends, including any plans for helping the candidate to apply for independent support, and how the candidate will successfully transition to the next stage of their career.

• What should be included in the PI's/mentor’s personal statement?

  • The PI/mentor should state his/her personal philosophy of training and commitment to promoting diversity and describe his/her track record of successfully mentoring trainees from underrepresented backgrounds at the career stage of the candidate.

Research Strategy

• The UL1/UM1 mechanism is a cooperative agreement and does not directly fund research projects. What types of research projects can be proposed that would fall under the scope of the parent award?

  • Mentors and their candidates must propose to conduct high quality clinical and translational science research, similar to the type of research that would fall under the purview of the CTSA Program hubs’ pilot project, KL2/K12 or TL1/T32 programs. The aims of the candidate’s project can be complimentary to, but not overlapping with, the aims of an existing federally funded or foundation grant. The research plan should address specific skills, responsibilities, and activities that demonstrate increasing independence as researchers. The application should include a timeline for next steps towards obtaining independent research funding.

• Are clinical trials allowed under this funding opportunity?

  • This funding opportunity is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.
  • Does your human subjects research study meet the NIH Definition of a clinical trial?

• Is research with human subjects or vertebrate animals allowed under this funding opportunity?

  • Yes. The supplement adheres to the same NIH policies for human subjects research and vertebrate animals as the parent grant. However, depending on the candidate’s career stage, the supplement provides little to no costs for research to be conducted by the candidate. If the project is conducting research that was not described under the original U application and did not undergo review, it will undergo NCATS review of the research. See the parent funding opportunity for further instructions about required supporting documentation.

Other

• How should a Supplement awardee be supported once the Supplement ends?

  • The mentor and applicant institution are encouraged to assist the supplement awardee to identify and transition to additional means of support appropriate for their stage of development. An appropriate transition plan to another means of support should be included in the application. This should be included as part of the training and mentoring plan. Examples include support through research grants, appointment to an institutional training grant or receipt of an individual fellowship, etc.

• What is expected time commitment for the Supplement?

  • For most long-term investigators, the awardee must commit at the minimum 9 person months, equivalent to 75% full-time professional effort, directly to their research project and career development activities. Less than 75% (but not lower than 50%) effort for certain clinical specialties (e.g., surgical and procedure-intensive specialties) is considered on a case-by-case basis. The remaining effort can be devoted to additional research, teaching, clinical work, or other efforts complementary to career development of the awardee. NIH provides some salary support as part of the supplement award, and often institutions will supplement the salary of these award PIs up to a level that is consistent with the institution’s salary scale.

• What should be included in the candidate's personal statement?

  • The candidate should describe their long-term education and career goals and why they wish to pursue a research career in clinical and translational science.

• What are the chances of success in obtaining funding?

  • Applications that are considered to be strong have a high success rate. However, the supplement programs are competitive programs and there may be more applications than funds available.