CTSA Program FAQs for Re-Entry Supplements


Who is eligible to be supported by a re-entry supplement?

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.

Can a candidate for the re-entry supplement be supported by PHS funds at the time of application?

Yes, candidates that are supported by PHS funds in an administrative capacity and are not conducting research activities are eligible to apply. Candidates must meet all other eligibility criteria and circumstances as described in the funding opportunity announcement. 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. Candidates who have begun the re-entry process through a fellowship, traineeship, or similar mechanism are not eligible for this program. The PI of the parent grant should contact NCATS program staff to discuss such a situation before submitting an application for a re-entry supplement.

Can a candidate for the re-entry supplement be managing a clinical workload at the time of application?

Yes, candidates that are managing a clinical workload full time and are not conducting research activities are eligible to apply. The aim of these supplements is to encourage such individuals to re-enter research careers within the mission of NCATS and the goals of the CTSA program.

The program is not intended to support career changes from non-research to research careers for individuals without prior research training. Candidates must meet all other eligibility criteria and circumstances as described in the FOA. The CTSA Program UL1 PD/PI should contact NCATS program staff to discuss such a situation before submitting an application for a re-entry supplement.

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

Active NCATS UL1 cooperative agreements are eligible for re-entry supplements. Institutional Career Development Core (KL2) Training Core (TL1) 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 PI to submit an application.

How much time can be requested for a supplement candidate?

The request cannot exceed the length of time remaining for the UL1 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 to request a supplement. The requested time should be two years and the research training experience should be tailored to the candidate’s proposed research project, training and mentoring plans.

The UL1 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 be conducting 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 program, KL2 or TL1 programs.

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

The CTSA Program UL1 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 and/or TL1 programs, etc.).

Will NCATS consider supporting more than one 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 under the re-entry research supplement for review consideration during a fiscal year from any one CTSA Program hub award.

Can a PI's/mentor’s salary be requested on a re-entry supplement?

No, under the existing funding opportunity announcements, a PI's/mentor’s salary is not an allowable cost on a re-entry 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 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.

What is expected time commitment for the re-entry supplement?

Administrative supplements provided under this program may be for either part-time or full-time (equivalent to 12 person-months) support for the candidate, and all supported time is to be spent updating and enhancing research skills. Proposed part-time appointments may not be less than 50% effort (equivalent to 6 person-months).

How should an awardee be supported once the re-entry supplement ends?

The mentor and applicant institution are encouraged to assist the supplement awardees to identify and transition to additional means of support appropriate for their stage of development. An appropriate plan for this transition to additional means of support must be included in the application. Examples include support through research grants, appointment to an institutional training grant or receipt of an individual fellowship, 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, and gaps in previous training should be addressed. 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 describe his/her track record of successful mentoring in clinical and translational science at the career stage of the candidate.

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

The candidate should describe his/her education and long-term research training, mentoring, and career development needs and why they wish to pursue a research career in clinical and translational science.

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

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

When should an application be submitted?

Applications are due November 1 (or the following business day if November 1 falls on a holiday or weekend) of each year for consideration of funding for the current fiscal year, which always ends on September 30. Applications will be evaluated and decisions will be made within two to three months, 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 your application. Since it can take up to 10 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 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 announcement. Each CTSA Program hub is allowed to submit up to two re-entry supplements/applications. However, there should be only one re-entry candidate for each application. Use the NCATS-specific guidance in developing your application. Applicants are encouraged to alert the PO and grants management specialist once the application has been submitted.

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 review of the research by NCATS. See the funding opportunity for further instructions about required supporting documentation.

How are re-entry supplement applications reviewed?

Applications are administratively reviewed by NCATS program staff. Program staff will evaluate supplement applications to determine the overall merit using the review criteria outlined in the funding opportunity announcements. Program staff will look at the appropriateness of the research project, career development plan, and mentorship as they relate to the candidate's career goals. In addition, emphasis is placed on the quality of the mentoring and training plan and the likelihood that the candidate will be successful at the next stage of their career.

What are the chances of success in obtaining funding?

Applications that are considered to be strong have a high success rate. However, the re-entry supplement program is a competitive program and there may be more applications than funds available.