2023-2024 CFAR Developmental Core Traditional RFP

The below Traditional Developmental Award funding opportunity is an open solicitation for proposals on any HIV-related topic in alignment with NIH funding priorities. In addition, the Developmental Core periodically posts Notices of Special Interest (NOSIs) in UNC CFAR priority areas.

A NOSI for a Secondary Data Analysis of specific databases shares the timetable of this RFP and can be found on the RFP tab of the CFAR Developmental Core webpage.

CFAR Traditional Developmental Award Request for Proposals

The University of North Carolina Center For AIDS Research (CFAR) Developmental Core is soliciting HIV-related proposals for small grants for up to one year (ending by 12/1/24) to support emerging> (new and early stage) HIV investigators or experienced investigators new to HIV research. Please note that we cannot fund clinical trials as defined by NIH.

Recipients of this Award will be well-positioned to incorporate pilot data from their proposed research question into a larger R21 or R01 NIH grant proposal. In addition to the generation of pilot data to enhance a future NIH grant application, Awardees are expected to produce a manuscript for publication from study data. The success of the UNC CFAR is measured in large part by the number of subsequent NIH grants that our Developmental Awardees receive as PI (not co-I) while affiliated with the UNC CFAR via employment at UNC-Chapel Hill, FHI 360, RTI International, NCCU, NC A&T, or WSSU. See the section on ELIGIBILITY below for more details.

RFP Schedule

• Obtain necessary Core reviews and letters of support to submit with application
• Application Due Date: Monday, October 2, 2023
• CFAR Scientific Review: October-November 2023
• Earliest Notification of Award:
  December 1, 2023
• Actual start date may be delayed if required approvals are delayed; see below.
• Period of Award: Funding expires on December 1, 2024, regardless of date of Award notification

Email application package as .pdf attachment to: cfar_rfp@med.unc.edu.

Start dates for funded Awards depend on timing of receipt of the following:

• Projects involving vertebrate animals require UNC IACUC, which may be obtained after Award notice
• Projects involving human subjects require UNC IRB approval, which may be obtained after Award notice
• Projects involving clinical research entailing greater than minimal risk to the subjects and/or international research additionally require NIH clearance(s) for the project. The CFAR Developmental Core Manager will provide guidance to Awardees on and facilitate the NIH clearance process after Award notice.

AWARD: Up to $50,000 for up to one year; $60,000 if the application is a collaboration coming out of the CFAR Scientific Working Group, Carolinas United to End HIV (must include a letter of support from the SWG chair). Because funds release and study implementation is contingent on UNC IRB, international ethics committee (if applicable), and NIH approvals, the funding will only be initiated once all necessary approvals are obtained and
all forms are submitted to the CFAR Developmental Core, and can only be guaranteed through December 1, 2024. Awardees will have a deadline of three weeks from notification of Award to submit applications to their IRB(s) and all non-IRB forms to the Developmental Core. Subsequent NIH approval can take up to several months (worst case scenario).

PI salary support is now allowed for ALL ESI applicants. The amount should be carefully considered and thoroughly justified and fall within the total budget limitations. As the application and amount of time that the applicant needs to be devoted to the proposed project is being developed, keep in mind that 10% LOE equals one half day a week, and 20% LOE equals one full day a week, and prepare the budget justification accordingly. Applicants are not required to request salary support and all justifications including salary support will be thoroughly reviewed.

All ESI Awardees will be required to complete an IDP to review with their primary CFAR mentor. The Developmental Core will provide an IDP template if needed.

ELIGIBILITY:

• PI must be employed by UNC-Chapel Hill, FHI 360, RTI International, or one of the following North Carolina-based historically black colleges or universities (HBCU): NCCU, NC A&T University, or WSSU. International investigators and other NC Triangle-based investigators with a strong connection to one of the above may also be eligible; such investigators should contact the Developmental Core to determine eligibility before applying.
• Applicants must meet one of the following criteria:
  1. NIH-defined new or early stage investigators who have never received an NIH R01 or R01–equivalent (R23, R29, R37, DP1, DP2, DP5, RL1, R35-MIRA, RF1, and U01) award in HIV/AIDS
  2. Established investigators new to HIV research (i.e., have received at least one non-HIV-related NIH R01 or R01-equivalent award)
• New or early stage investigator applicants must be actively mentored by an established investigator in the HIV field (i.e., someone with previous HIV-related independent R01-equivalent NIH funding). If it is a new mentoring relationship, the mentoring should begin during the writing of the application. This must be evident in the application itself, including appropriate letters of support.
• Established investigators who are new to the HIV field must be collaborating with a senior HIV investigator. This must be evident in the application itself, including appropriate letters of support.
• International applicants must be actively collaborating with at least one mentor who is faculty at UNC-CH or a UNC CFAR member at an affiliated institution (FHI 360, RTI) in the development of their application. This must be evident in the application itself, including appropriate letters of support.
• Applicants must have a terminal degree (e.g., PhD, MD, PharmD, etc.).
• Applicants on T32 grants are not eligible.
• Applicants with a current K award must have documented NIH pre-approval.
• Applicants must be eligible to serve as the Principal Investigator (PI) on National Institutes of Health (NIH)-funded grants. Accordingly, university-based applicants must be a faculty member.
• Former CFAR Developmental Awardees may apply, however, they are unlikely to be funded again. Their applications will be judged in part by the success and outcomes of their previous Award. Previous Awardees should contact the Developmental Core before submitting a new application.
• Please note: Awardees are expected serve as the PI on follow-up NIH grants! NIH does not consider follow-up NIH funding that goes to anyone *other* than the Developmental Awardee as PI an outcome of the Award.

Please contact Developmental Core to discuss your eligibility if you have questions. In addition, reach out to us if you need help identifying mentors and/or collaborators.

MENTOR REQUIREMENTS

The likelihood of a Developmental Awardee’s success increases substantially with the involvement of an available, engaged, and knowledgeable mentor. To be eligible to serve as a primary mentor, a researcher must have served as PI on an R01 or R01 equivalent grant. The Developmental Core requires all ESI Awardees have at least one mentor in an area that is relevant to the Developmental research. Mentors are expected to have an active role in both the planning of the application and all stages of the Award’s implementation. The Awardee and mentor(s) will sign a contract after the Award notification in which they commit to meeting at least twice monthly, although they are strongly encouraged to meet weekly. Challenges encountered during the research should be discussed and response strategies developed with the mentor. All ESI Awardees will be required to complete an IDP to review with their primary CFAR mentor; the Developmental Core can provide one if needed. Therefore, a CFAR mentoring relationship is a serious commitment and pivotal to the Core’s provision of support to ESIs.
There will be a mentorship orientation meeting for those whose mentees’ applications for CFAR funding is successful.

REVIEW CRITERIA

Proposals will be reviewed by senior investigators on the following criteria:

• Alignment with NIH HIV/AIDS Priority Areas and UNC CFAR funding priorities (defined in Funding Priorities, below)
• Overall scientific merit
• Standard NIH criteria of significance, innovation, approach, environment, and ability of investigator to carry out Award (described below)
• Specific and narrowly focused application with realistic goals
• Potential for generating future NIH funding
• Potential for drawing investigators from other fields into AIDS research
• Potential for developing new interactions between or among CFAR investigators
  • Priority will be given to collaborative proposals that extend the scope of current CFAR activities across multiple participating laboratories/institutes. Collaborative proposals will be evaluated on the scientific merits of each individual component of the project, as well as the overall integration of the components.
• Appropriateness of the budget and budget justification
• Proposals from women and minority investigators will be given special consideration in the review process.

Awardees will be notified in writing. All applications are subject to NIH approval and all applicants will receive a written review of their proposals, regardless of funding.

Significance: Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Innovation: Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (exclusion) of children, justified in terms of the scientific goals and research strategy proposed?

Environment: Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Investigator ability: Are the PIs, collaborators, and other researchers well suited to the project? Do they have appropriate experience and training? If the project is collaborative or multi-PI, do the investigators have complementary and integrated expertise; is the leadership approach, governance, and organizational structure appropriate for the project? Is there evidence of strong and appropriate mentorship?

Potential for future related NIH funding: Is there a clear vision for how the proposed work will build toward specific independent research that is aligned with NIH HIV funding priorities for the investigator?

EXPECTED PROJECT OUTCOMES

• Peer-review publication
• Independent NIH funding (i.e., R21, R01, and R01 equivalent awards) directly related to the Developmental Award, with the Developmental Awardee serving as the NIH PI.
• Partway through their funding period, Developmental Awardees may be required to present long-term research plans related to their Developmental research at a forum to senior CFAR investigators. Resulting feedback and questions will then inform the implementation of their research, with the goal of stronger preliminary data and analysis in order to ultimately support a successful NIH funding application.

FUNDING PRIORITIES

Given that the CFAR will ultimately be judged on the success of its Awardees (defined by NIH as independent NIH funding as PI while associated with the CFAR), Developmental applications will be prioritized based on the alignment of proposals with NIH funding priorities.

APPLICATION

Applications should contain the following components and be submitted in .pdf format.
Proposal must be single-spaced with at least ½” margins and written using 11 point Arial font.

1. The completed CFAR Small Grant Cover Page (available on the UNC CFAR Developmental Core RFP tab), which includes:
   • Applicant information
   • A project summary describing why this application is innovative and/or important

2. Project proposal including:
   • one page of Specific Aims
   • up to four pages of Research Strategy, including sections to address Significance, Innovation and Approach.

3. A separate References section (not included in four-page limit)
4. For new, early stage, and/or international applicants, identification of proposed mentor – an HIV researcher who has been PI on an NIH R01 or R01 equivalent grant – and explanation of the mentor’s role on the project, starting with during the application process. For established investigators new to HIV, an established HIV investigator collaborator must similarly be included and described.
5. If application contains multiple PIs, a separate Project Leadership Plan, per NIH guidelines, must be included (not included in four-page limit).
6. A current NIH Biosketch for all key personnel
   • NIH biosketch sample, format, and instructions

7. Budget (“Detailed Budget for the Initial Budget Period”) on NIH 398 form page and Budget Justification. Applicants may request up to $50,000 (or $60,000 if applying on behalf of a CFAR SWG) in total direct costs for one year.

Restrictions:

• Award funds may not be used to support conference travel or food/drinks. Awardee salary is now allowed. See “AWARD” information above.
• See FAQ on the UNC CFAR Developmental Core RFP page for guidance concerning indirect costs.

8. Separate Human Subjects section (not included in four-page limit)
9. Letter of support from the applicant’s proposed mentor(s), outlining the mentor’s proposed role in the project and connection to the applicant.
10. Additional letters of support are strongly encouraged if applicable (e.g., to verify access to clinic populations, for collaborators, etc.)
11. All applications must include a separate document thoroughly explaining how the proposed work aligns with the NIH funding priorities. This document should include a plan outlining how the proposed work will lead to NIH funding, a timeline for seeking such funding, the NIH Institute or Center from which they anticipate seeking funding, and the type of grant they plan to pursue (maximum of one page, not part of four-page limit).
12. If the application overlaps with or duplicates any aspects of a pending NIH proposal submitted by the PI, include a copy of the Specific Aims page for the proposal(s) and anticipated review dates.
13. A cover letter may be submitted if desired.

14. NEW AND EARLY STAGE INVESTIGATORS ONLY: Required letters of support resulting from specific consultations are listed below. These consultations should be held in the later stages of application process. Before arranging them, please ensure that your mentor agrees that your proposal is ready for this type of review.

• If you plan to use qualitative methods, the UNC CFAR Social and Behavioral Sciences Core can provide you with a free Qualitative Methods Consultation to review your proposal. This is strongly encouraged, as the consultation and resources the CFAR can provide will strengthen your application. To schedule your free consultation, you must submit a service request (directions at the bottom of the RFA) no later than three weeks before the application deadline. If you choose not to submit a letter of support from the Core for an application using qualitative methods, include a paragraph explaining that choice (not included in the four-page limit).
  

• If you plan to use quantitative methods, the CFAR Biostatistics Core can provide you with a free consultation to review your proposal’s methodology. A letter documenting this pre-submission statistical/informatics review will be required of all applications with quantitative methods.
  To schedule your free consultation, you must submit a service request (directions at the bottom of the RFA) no later than three weeks before the application deadline.
• Applications involving human subjects will be required to have an accompanying letter from Tania Hossain, CFAR Regulatory Head, documenting a discussion of the project’s ethics and human subject involvement. To schedule a meeting with Tania, you must contact her via email no later than three weeks before the application deadline.

Projects Involving Clinical Trials:
Projects involving clinical research (e.g., observational studies or sub-studies using existing data from an ongoing clinical trial) may be funded by the CFAR.

Unfortunately, CFARs are unable to fund clinical trials. The NIH definition of a clinical trial is very broad. Some investigators conducting human subjects research may not be aware that NIH considers their study to be a clinical trial. For guidance, click here.
Double-check whether your plan is considered a clinical trial before submitting a proposal.

Applicants considering submission of proposals that might be considered clinical trials are also strongly encouraged to seek advice from the Developmental Core before submitting a proposal.

Additional notes:

Involvement of other UNC CFAR Cores is strongly encouraged whenever applicable.

Issues related to Rigor and Reproducibility should be addressed in application.

NIH provides excellent general guidance on grant-writing.

Here’s more help from NIH in avoiding common grant–writing mistakes and some tips for new investigators.

Contact the Developmental Core if you would like us to help you seek input or assistance from a CFAR Core Director.

CONDITIONS OF AWARD

• CFAR Developmental Core Awards provide funding for up to a one-year term, ending no later than December 1, 2024 for this funding round. A no-cost extension may be possible if a project experiences extenuating circumstances but must be approved by the CFAR Developmental Core Director. Funds may not be used on other research or activities/resources unrelated to the approved project.
• PIs will submit a progress report for the NIH each spring. Short quarterly “check-ins” will be submitted to the Development Core for internal use. In addition, PIs may be asked to present their research progress and plans for follow up funding to UNC CFAR leadership approximately six months into the Award.
• All publications and manuscripts derived from CFAR funding must:
  • Be linked to the UNC CFAR grant by our grant number during the publication process
  • Obtain a PMCID (which is different from a PMID!) upon publication
  • And ideally, acknowledge UNC CFAR support by grant number (P30AI50410) in the Acknowledgements or Funding section of the text
• Please note: prior to funding, PI must forward a copy of all relevant Institutional Biohazard, Animal Care and IRB approvals to the CFAR Developmental Core. If the project involves human subjects and the institutional IRB Committee or NIH has deemed the study “more than minimal risk,” PIs must submit additional documents, including a comprehensive SOP, to receive NIH clearance before funding is released, which will be coordinated by the CFAR Developmental Core. **Keep these requirements in mind when developing a project timeline and allow time to put together a comprehensive packet for review by NIH as well as time for the NIH review itself.** The Core will provide specific instructions and templates to assist you.

OTHER CFAR SERVICES

Besides direct funding, the UNC CFAR has numerous Cores (HIV/STD Lab Core, Clinical Pharmacology/Analytical Chemistry Core, Clinical Core, Social and Behavioral Sciences Research Core, International Core, and Biostatistics Core) that can assist with HIV-related research projects. They have the ability to do assays (HIV/STD Lab, Pharmacology), assist with consultation in developing questionnaires (Clinical, Social and Behavioral Science), and review any grants you plan to submit to outside agencies. Descriptions of these services can be found on the UNC CFAR website, where you can also submit a request for those services on individual Core pages.

All Early Stage Investigators who are eligible to apply for a CFAR Award of any kind are also eligible for membership in the CFAR Developmental Cohort, and ESI Awardees automatically become members. Contact the Core Manager for more information or to join the Dev Cohort.

SUBMITTING CFAR SERVICE REQUESTS FOR PRESUBMISSION REVIEWS

Step 1: Go to the CFAR website: https://unccfar.org/

Step 2: Select the “Request a Service” button.

Step 3: Register for a CFAR account and username (you will use this for all future Core Service Requests).

Step 4: Select the “Social and Behavioral Sciences” or “Biostatistics” option for question 1.

Step 5: Continue to fill out the form with services requested.
Please be sure to include the proposed title for your Developmental Award application.

For additional information, please contact the Developmental Core at cfardevcore@med.unc.edu.
All questions are welcomed.