Program Rationale
NCATS (NIH National Center for Advancing Translational Sciences) requires all Clinical and Translational Science Centers, including Harvard Catalyst, to use translational science methodologies to identify and mitigate roadblocks impeding health-related research at their local institutions. Through multiple outreach formats across Harvard University schools and affiliated hospitals, Harvard Catalyst identified multiple roadblocks that faculty and other employees felt limited the breadth and impact of research on human health. These formed the basis for initiatives proposed in Harvard Catalyst’s current NCATS award and several are addressed by this pilot opportunity.
Description
In accord with the above mandate, this RFA seeks studies that explore or demonstrate how a range of processes, assessments, models, or modifications can inform clinical translational research more generally, rather than asking for proposals focused on a specific aspect of a highly defined clinical question or setting.
General guidance from NCATS includes:
- Development of new research methodology and/or new technologies/tools/resources that will advance clinical translational science (CTS) and thus increase the efficiency and effectiveness of translation.
- Early-stage development of a new therapy/technology with generalizable application to an identified translational roadblock.
- Demonstration in a particular use case(s) that a new methodology or technology advances translational science by making one or more steps of the translational process more effective or efficient.
- Dissemination of effective tools, methods, processes, and training paradigms.
- Feasibility/proof of concept studies to support future CTS projects.
- Secondary analysis of existing data (e.g., projects using the National COVID Cohort Collaborative (N3C) Data Enclave).
The Translational Roadblocks
Innovative pilot proposals should address one of the roadblocks below. Under each roadblock, you will find examples of responsive topics. These are only examples and are not intended to limit the range of applications.
Research and clinical data need to be connected, and their access democratized
- Pilot approaches to new ways of consolidating or integrating available public databases for research purposes – such as publicly available clinical trials data (e.g. YODA Project website), Federal or institutional data and other potential sources of more closely held organizational, corporate, or statewide data.
- Projects integrating EPIC-based data with external data source(s).
- Approaches to data reutilization.
- Novel integrations of clinical data from wearables, e.g., with geographic or other data streams.
- Novel uses of data from ClinicalTrials.gov or NIH data streams/datasets such as the COVID Collaborative NC3 Data Enclave.
The clinical and translational (CTR) workforce must be grown to address emerging opportunities in CT research.
- Multidisciplinary pilots that integrate non-health services researchers into design or analysis of translational research questions (e.g., climate scientists, commercial advertising experts, public school educators or curriculum developers).
- Development or assessment of new (e.g., certificate, degree or industry-based) training programs or existing opportunities (e.g., academic or other employer programs) preparing healthcare allied or adjacent colleagues for clinical research opportunities.
- Novel evaluation tools that leaders can use to assess and address the competencies and weaknesses of individuals and potential teams (e.g., experience, training, problem-solving and communication skills).
Insufficient mechanisms exist to support implementation of CTR evidence into practice.
- The proposed addition of a generalizable translational science component to an existing clinical trial (e.g., studying why patients cancel/miss required study appointments or characterizing physical or socioeconomic aspects of participation that are challenging or limiting).
- Studies that validate or pilot deployment of existing or novel aids, interventions or other supports for those with physical or socioeconomic constraints on research participation, with the goal of increasing the capacity to access, consider, consent, and participate in clinical trials.
- Studies of novel approaches that address participation in clinical trials or the validation of trial results in special populations, e.g., pregnant women, those suffering from neurocognitive disease.
- Pilot studies examining the role of inclusion and exclusion criteria, for common conditions and their therapies, on pharmacokinetics, trial outcomes, results communication and adoption.
- Pilot studies or models for incorporating life-choice (religious beliefs, dietary practices, exercise) and common physiologic variables (e.g., hormonal status, HgbA1c) on treatment tolerance, study adherence and completion and clinical outcomes.
Translational Science
The term “translational science” and its relation to “translational research” may be new or unclear to many potential applicants. These differences are summarized by NIH/NCATS as follows:
Translational research is the endeavor to traverse a particular step of the translational process for a particular target or disease. Translational science is the field of investigation focused on understanding the scientific and operational principles underlying each step of the translational process.
Whereas translational research focuses on the specific challenges associated with a particular target or disease, translational science is focused on general hurdles applicable to many targets, diseases or classes of problems.
A key tenet of translational science is to understand common causes of inefficiency and failure in translational research projects (e.g., incorrect predictions of drug toxicity or efficacy, lack of data interoperability, ineffective clinical trial recruitment). A more extensive statement and an example of the difference between translational research and translational science is provided in this RFA’s Application Guide below.
Key Dates
Launch: Monday, November 2, 2026
Applications Due: Wednesday, January 6, 2027
Eligibility
This is an open call for proposals. Any investigator with an innovative idea related to the purpose of this RFA is welcome to apply. We welcome pre-submission discussions regarding your ideas for a proposal and their responsiveness to the RFA. For questions regarding eligibility or a pre-submission discussion, contact the Harvard Catalyst Pilot Program at grants@catalyst.harvard.edu as early as possible.
Principal Investigator (PI) Eligibility
Faculty holding Harvard University titles of instructor, assistant professor, associate professor, or professor are eligible to apply without endorsement. However, while this RFA encourages applications from junior or mid-level investigators and from multidisciplinary teams, the PI must have independent space or resources (e.g. personnel), needed to accomplish the proposed goals. If you do not, you must produce a letter from your department/division chief or equivalent verifying your appointment title, status at Harvard and departmental/divisional support of the application. Those with other titles or at other stages of training should reach out to discuss eligibility or whether they are more appropriately served by Co-Investigator status or by linkage to an existing program. Please note that multiple PIs are not allowed, but you can have any number of Co-Investigators.
Co-Investigator (Co-I) Eligibility
A Co-I is a substantial contributor who helps conceive of the experimental idea, contributes to the intellectual development of the project, and/or designs the study or part thereof (e.g., scientific or technical details), and will be involved in the study throughout the funding year. Co-Is can be from any institution; however, if you are working with a Co-I from a non-Harvard affiliated institution, please provide justification for how their external expertise adds to the project.
Trainees (e.g., students, clinical trainees and fellows, postdoctoral fellows), visiting and adjunct faculty, and those with pending faculty appointments at the time of submission may serve as Co-Is if their contribution to the project is substantial.
A Co-I is not required, nor is there a limit to the number of Co-Is listed on an application. While researchers may submit only one application as PI, with sufficient justification they may appear as a Co-I on multiple applications.
Application Process
Part 1 – Supporting Documentation (uploaded as single a PDF)
Please use this naming convention: PIFirstName_PILastName_Admin_Docs
Administrative Documents: For each institution receiving funds, the following forms must be completed. All documents in this section should be merged and uploaded as one PDF.
- Documented institutional approval: PHS 398 Face Page, or Statement of Intent to be signed by institutional official. One face page/SOI per site requesting funds. Prime PI: Lee Nadler, Prime Site: HMS.
- Statement of Work: Please describe the work to be performed at each institution. Statement of work should include all individuals listed on the budget, including roles and responsibilities. Please also include project goals, specific aims, and methodology, if applicable. Statement of work is required for the sub-award process.
- Detailed budget for one year: PHS 398 Form Page 4, or other similar form.
- Narrative Budget Justificationfrom each site requesting funds.
- Biosketch: Professional biosketches/CVs should be provided for the PI, Co-Investigators and significant collaborators. An NIH style biosketch is highly preferred but a professional CV in another format can be used. An eRA Commons ID is requested for all PIs and Co-Is.
Note on IRB: Harvard Catalyst is supported by an NIH/NCATS Clinical and Translational Science Award and is therefore required to submit documentation of IRB approval or exemption to the funder for each pilot project that involves human subjects or protected data prior to funding. Delay in provision of this documentation will delay the start date of funding.
Some pilot translational science will fall into the category of Quality Assessment or Quality Improvement (which is exempt) or meet other exemption criteria. We advise applicants to discuss the requirement for IRB approval or provision of a letter of exemption from this requirement with their institutional IRB staff early during the application process.
If IRB approval, IACUC approval, or both are required and have not been obtained, please indicate the status of and the plans for obtaining approval. Funds will not be released without documentation that the necessary approvals have been obtained. The strength of the plan for obtaining the necessary approvals will be assessed as part of the review process.
Part 2 – Scientific Proposal (uploaded as single a PDF)
Please use this naming convention: PIFirstName_PILastName_Scientific
Scientific Proposal: The total proposal should not exceed 5 pages, not including an additional page for references. Text length, with exception of the Project Overview/ Abstract, is not specified by section. Use Arial, black font color, and a font size of 11 point only. Applications should be single-spaced, with 0.5-inch margins. Any figures and/or tables must be included in the body of the application and thus count towards page limits. Appendix material will not be accepted.
The scientific proposal should include the following subsection titles:
- Project Overview/Abstract (200 words maximum): State the problem your project addresses and how it aligns with the objectives of this funding opportunity.
- Rationale/Background: This section should highlight how the project addresses a significant problem or overcomes a critical barrier in translational science, defines the gaps in current knowledge, and states how the project will address them. Provide sufficient background to give context for reviewers, including a concise review of the status of the field and how the pilot proposal will contribute to advancing knowledge. The reader should be able to clearly understand how this work qualifies as translational science (refer to the NIH/NCATS definition in the Application Guide). Additionally, describe how the project’s processes, assessments, models, or modifications could contribute to the advancement of subsequent clinical translational research.
- Research Strategy and Feasibility: Provide specific, detailed information about your proposed project. Explain the evidence that supports the feasibility of your approach and identify any potential challenges.
- If your research involves human subjects, describe their involvement, briefly outline participant recruitment plans and whether IRB review is required. Include details about any necessary infrastructure, such as databases or cores, its availability, along with any other resource requirements. Outline the methods for data evaluation.
- Additionally, provide a timeline for the various project phases and overall completion, clearing addressing the feasibility of finishing within the grant period. Note that this award is limited to one year by NIH/NCATS, with no extensions allowed. Funding will not commence until all IRB reviews, including NIH/NCATS approval, are finalized.
- Innovation: Briefly describe what makes your project innovative or unique in its approach and how it will advance the boundaries of current research or practice.
- Impact: Briefly explain how your project could contribute to advancements in your field or lead to improved outcomes. Additionally, describe how it aligns with NCATS’ mission to advance translational science.
- Implementation Plan: Briefly describe how the results of the study may translate into a paradigm/intervention/tool to improve a process or outcome. Describe any established frameworks, such as those from implementation science, that you are using to systematically identify factors and barriers.
- Future Plans: As this is a one-time pilot award, additional funding through this mechanism is not available. Briefly state projected next steps (eg. implementation, validation) if the project is successful and additional resources were obtained.
- Dissemination Plans: One of the core components of Harvard Catalyst’s commitment to community engagement is to have our awardees consider how they would disseminate the results of their study beyond peer-reviewed journals. As everyone is potentially a clinical research participant, briefly state how study findings would be communicated to and for the benefit of expert, peer and lay audiences.
- References: Limit to one additional page.
Completed applications submitted by January 6, 2027, with all required documents, will undergo administrative review. All proposals that are complete and responsive to this RFA will be reviewed by Harvard faculty with both broad and topic specific expertise. Questions that may be considered include, but are not limited to, the following:
- Does the proposed project address the goals of the RFA?
- Is the project technically feasible and achievable in a one-year funding period?
- Do the investigators have the requisite skills and resources to carry out the project successfully?
- Does the project have the potential to define a problem so that future work can address it innovatively or does it, in and of itself, answer a need?
General information about Harvard Catalyst, Harvard University’s Clinical and Translational Science Center, which is funded by NIH/NCATS (National Center for Advancing Translational Sciences), can be found here.
For all inquiries regarding the suitability of a proposal, the application process, or eligibility, please contact us at grants@catalyst.harvard.edu.
Administrative FAQ
If funded, having an approved IRB protocol, or one that is in process, significantly cuts down the delay to the start date once you are awarded. All studies designated human subjects need to go through an additional NCATS prior-approval which takes up to 30 days from when they receive the documents.
The form needs to be submitted at the time of submission and signed by an institutional official. Please let us know ASAP if you cannot get the PHS 398 form signed by emailing us. If any required documentation is absent at the time that reviewers are assigned, such studies will not be sent for review.
Please indicate Harvard Medical School as the sponsor. If completing a Statement of Intent instead, the prime PI is Lee Nadler.
We do not require a Facilities and Other Resources or Equipment page.
Box 13 on PHS 398 Face Page requires a signature from the grants administer at your institution. This must be completed before submission.
Multiple PIs are not allowed, but you can have any number of Co-Is. 1% effort is fine for a PI.
Letters of support are only required for PIs who are not currently an instructor, assistant professor, associate professor, or professor. If you are not, in one of the above-named categories, you must produce a letter from your department/division chief or equivalent verifying your appointment title, status at Harvard and departmental/divisional support of the application.
Letters of support are not required for Co-Is or any other team member. Biosketches for all significant contributors can be provided in the document upload section of the application.
Minimum 1% effort is required. How and if you use that would be up to you and your post-award grants manager. Generally, awards do not exceed 15% PI maximum effort, but there are potential exceptions. In the event you anticipate dedicating greater than 15% effort, please email us for approval.
Pilot awardees are able to collaborate with other institutions. In this case, Harvard Catalyst will directly issue a separate award to any collaborating institutions. Admin documents should include collaborating sites when applicable (See question 7 for more details). There should be only one application submission with the main PI and each Co-I listed.
There should be an additional budget justification for expenses at the collaborator site. There should be narrative justification from each site for all expenses, including salary support, other direct costs, as well as the applicable indirect costs. Please note that all institutions have different rates for IDC which should be applied accordingly. Our Finance team may request an updated copy of the institution’s F&A Agreement. We can facilitate discussion with our Harvard Catalyst financial team if that would be helpful.
Consultant costs are allowed.
Indirect costs (or F&A) are allowed and awarded at your site’s negotiated rate for research and are calculated on the MTDC base. The $50,000 cap applies to the total Direct costs only. IDC will be awarded in addition to this amount. Our Finance team may request an updated copy of the institution’s F&A Agreement.
The PR site will most likely have their own negotiated IDC rate as they are a US territory. The University of PR has a negotiated rate, but to be sure check with the co-investigator’s home institution – if not the University of Puerto Rico.
As a post-doc you are eligible to submit a proposal as PI. However, we would need a letter from your Department Chair that supports your application and confirms that you will be promoted to Instructor and that that promotion will occur within 12 months of the RFA application deadline.
There is no specific template required for the SOW. It is a high level and brief (no more than a paragraph or several bullet points) description of the work you propose.
Unfortunately, at this time, activities supported by this CTSA Pilot Award must be performed within the United States, as defined in the NIH Grants Policy Statement, including the 50 states, the District of Columbia, and U.S. territories and possessions.
The Pilot award may not support a foreign component or international research collaboration. No significant scientific element or segment of the pilot project may be performed outside the United States, whether or not award funds are spent abroad. A foreign institution or organization, or a researcher acting on behalf of a foreign institution or organization, may not participate in the conduct of the funded project, receive award funds or project resources, or contribute to its scientific work. This restriction applies to foreign research sites, data collection or research activities abroad, and project-related use of foreign facilities or collaborators.
The PI must disclose any proposed foreign involvement (not already directly precluded by the above )—including an activity that could result in a foreign collaborator’s contribution to a project publication—to the CTSA Pilot Program before the activity occurs. No such activity may proceed without prior written approval from the Pilot Program and the institutional authorized official, and any sponsor approval required by the applicable award terms. Routine procurement of commercially available goods or services is not, by itself, a research collaboration, but must comply with the award’s terms and institutional policy.
No. The Harvard Catalyst CTSA does not support any NIH-defined Clinical Trials.
How to tell if your Human Subjects study is considered a Clinical Trial:
If the answers to all four questions below are yes, this study meets the definition of a Clinical Trial.
- Does the study involve human participants?
- Are the participants prospectively assigned to an intervention?
- Is the study designed to evaluate the effect of the intervention on the participants?
- Is the effect that will be evaluated a health-related biomedical or behavioral outcome?
However, please note that Basic Experimental Studies in Humans (BESH) are no longer considered Clinical Trials . If your study is BESH, then YES – you can apply under this Pilot opportunity.
Here is more on how to answer the 4 questions above if the study is BESH:
https://grants.nih.gov/policy-and-compliance/policy-topics/clinical-trials/besh