Key Dates
Launch: March 6, 2024
Due: April 23, 2024
Closed
For more information:
Email UsProgram Rationale
In this funding cycle, NIH/NCATS (NIH National Center for Advancing Translational Sciences) required all Clinical and Translational Science Centers (CTSCs), including Harvard Catalyst, to identify and then mitigate roadblocks that impede health-related research at their institutions.
One of the blocks defined at Harvard was the problem of “limited access to and participation of diverse populations in research,” a problem common to many institutions performing clinical and translational research.
A recent ideation challenge offered to the Harvard community identified as under-addressed numerous issues that contribute to failures of inclusivity related to participation in clinical research studies. In response to this feedback, this Request for Applications (RFA) is focused on the broad topic of improving inclusivity in research studies with an emphasis on overcoming classes of obstacles identified by our own community, which include a range of disabilities and socio-economic barriers.
Goals
This RFA seeks innovative pilot translational science initiatives aimed at augmenting inclusivity of clinical trials at all levels of engagement, including enrollment and participation.
Specifically, the focus is on characterizing and addressing obstacles faced by individuals or groups in accessing or participating in clinical research studies, with the goal of fostering a more inclusive and representative research landscape.
In addition to issues that have and continue to receive attention, such as race and gender, our community highlighted the obstacles experienced related to sensory, mobility, and cognitive disabilities, and impediments imposed by locoregional or socioeconomic circumstances.
Limited awareness within the research community regarding such impediments and their potential remediation can further create additional obstacles.
Translational Science
The term “translational science” and its relation to “translational research” may be new or unclear to many potential applicants. Translational research is defined by NIH/NCATS as “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 case of a target or disease, translational science is focused on the general case that applies to any target or disease. A key tenet of translational science is to understand common causes of inefficiency and failure in translational research projects for example incorrect predictions of the toxicity or efficacy of new drugs, lack of data interoperability, ineffective clinical trial recruitment.”
A more extensive statement and examples of the difference between translational research and translational science are provided in the Application Guide below.
Description
Examples of topics that would be responsive to this RFA include but are not limited to the following:
- Pilot approaches that could lead to new analytic frameworks, strategies, interventions, or changes in practice to address the persistent racial disparities in kidney transplantation.
- Characterization of the frequency or nature of sensory, mobility, and cognitive disabilities or other impairments or limitations as a deterrent to access, enrollment, and participation in clinical trials.
- Validation of existing or pilot deployment of novel aids, interventions, or other supports for those with sensory, mobility, and cognitive disabilities or other impairments or limitations, the goal of which is to increase capacity to access, consider, consent, and participate in clinical trials.
- Development or validation of approaches to mitigate or eliminate obstacles to research participation conferred by socioeconomic constraints (e.g. limited access to necessary transportation, wifi access, childcare, or limited job flexibility).
- Studies of novel approaches that address participation in clinical trials or validation of trial results in special populations. For example, prisoners, pregnant women, and those suffering from neurocognitive diseases.
- Innovative characterization of or pilot interventions or approaches to the cultural and linguistic sensitivity and competency of trial recruitment, enrollment, and conduct practices.
- Proposed addition of a translational science component to an existing clinical trial, such as studying why patients cancel/miss required study appointments or characterizing physical or socioeconomic aspects of participation that were challenging or limiting.
Key Dates
Launch: March 6, 2024
Full application due: Extended to April 23, 2024
Funding Decisions Announced: late May 2024
Anticipated Funding Start Date: July 2024
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.
For questions regarding eligibility, contact the Harvard Catalyst Pilots program at reactor@catalyst.harvard.edu prior to writing and submitting an application.
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 their 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.
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
Please use this naming convention: PIFirstName_PILastName_Admin_Docs
For each institution that will receive funds, the following forms must be completed:
- Detailed budget for one year.: PHS 398 Form Page 4, or other similar form.
- Documented institution 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: Harvard Medical School.
- Please remember that each site requesting funds will receive a separate award agreement to provide the funding; pass-through subawards are not allowed.
- Narrative Budget Justification from each site requesting funds.
- Statement of Work: A brief statement describing the work to be performed at each institution
Proposals that incorporate a more condensed timeline with intensified effort or activity are also welcome and should be detailed as such in the detailed budget. The $25,000 – $50,000 budget range over no more than one year is intended to provide opportunities for funding highly focused pilots requiring greater effort over a shorter time frame as well as proposals of more limited scope. If more than one site will share the budget, the combined total should not exceed $50,000 and each site is required to submit a separate budget page.
Indirect costs (or F&A) will be granted in addition to the requested direct costs.
For allowable and unallowable costs, please see below for more information.
Note: Each site requesting funds will receive a separate award agreement to provide the funding; pass-through subawards are not allowed.
- An NIH style biosketch is preferred, but any professional style CV is acceptable. Biosketches/CV should be provided for the PI, Co-Is and significant collaborators. An eRA Commons ID is requested for all PIs and Co-Is.
- Lay Project Summary: Include a summary in lay language (200 words maximum). This summary should be brief, clearly written and free of complex scientific jargon, such that non-academic specialists can understand it. Lay summaries may be shared with community stakeholders during the review process and help reviewers understand the accessibility and potential impact of the proposal.
Harvard Catalyst is supported by a Clinical and Translational Science Award Program and is therefore required to submit documentation of IRB approval or exemption to the funder, NIH/NCATS, for each pilot project that involves human subjects or protected data prior to funding.
Some pilot translational science research 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.
NCATS requires all related IRB documentation at least 90 days before the project start date. To accommodate this timeline, we strongly encourage IRB submission as soon as possible.
Please use this naming convention: PIFirstName_PILastName_Scientific
- Scientific Proposal (to be uploaded as a separate PDF): Text length, with exception of the Title and Abstract, is not specified by section. The total proposal (sections 1-5 below) should not exceed 5 pages, not including an additional page for references. Use Arial, black, size 11 point only. Applications (covering items 1-5 below) should be single-spaced, with 0.5 inch margins. All figures and tables must be included in the body of the application and count towards page limits. Appendix material will not be accepted.
- Project Title and Scientific Abstract (250 words maximum): Clearly state the aim or question to be addressed. Summarize how this grant will support such. The importance of the project to the problem of improving inclusivity in any phase of clinical trial conduct and thereby improving human health should be made clear.
- Overview and Background: Briefly restate the research objective, question or hypothesis to be tested. The reader should be able to discern how this is a translational science and not a translational research project (see Application Guide, below, for the NIH/NCATS definition). This should be made apparent through the context and nature of the proposed work and does not need to be addressed by an explicit statement. The importance of the project to the problem of improving inclusivity of clinical trial initiatives should be clear. This overview should summarize why the pilot project is important and innovative, the limitations of current knowledge, and how this problem will be addressed. Include sufficient background information to provide context for grant reviewers. Briefly review relevant current status of work in the field and how the pilot proposal will advance that knowledge.
- Project Details: Provide specific and detailed information about your proposed project. Describe the use of human subjects, if any, and whether such use requires IRB review; infrastructure including databases or cores to be used and their availability and readiness for use; the means of evaluating the data or conclusions; other resource requirements; and the timing for both the various steps and overall project completion. You must address the feasibility of completion within the grant period. This award is restricted by NIH/NCATS to <1 year and cannot be extended. For research involving human subjects, describe plans for recruiting participants. Proposal funding will not begin until all IRB reviews, including that by NIH/NCATS, are completed.
- Future Plans: This is a one-time pilot grant award. While additional funding through this mechanism is not available, please briefly state projected next steps beyond the scope of this one-year pilot grant 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.
All pilot awards will carry full indirect costs/F&A in addition to their $25K-$50K direct cost budgets.
Please see these websites for more information:
Allowable Costs – General NIH Cost Principles apply.
Unallowable costs – can be found on this website.
Completed applications submitted by 11:59 pm EDT on April 23, 2024, 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?
Application Guide
This RFA seeks translational science proposals that aim to expand the inclusivity of clinical trial participation, with a focus on identifying and addressing barriers faced by individuals or groups in accessing or participating in clinical research studies.
As the concept of translational science (TS) and its connection to the more commonly known translational research (TR) may be unfamiliar to some applicants, NIH/NCATS offers these definitions:
Translational research (TR) is defined by NIH/NCATS as “the endeavor to traverse a particular step of the translational process for a particular target or disease. Whereas translational science (TS) is the field that generates innovations that overcome longstanding challenges along the translational research pipeline. These include scientific, operational, financial, and administrative innovations that transform the way that research is done, making it faster, more efficient, and more impactful.”
- Translational science aims to understand the common factors contributing to inefficiencies and setbacks in translational research endeavors.
- Examples of these setbacks include inaccurate predictions of drug toxicity or efficacy, issues with data compatibility, and suboptimal clinical trial recruitment.
- Many of these challenges transcend specific targets, diseases, and therapeutic areas. Therefore, advancements in translational science hold the promise of elevating the efficiency and efficacy of translational research.
- The ultimate goal is to improve overall health, extend life expectancy, and reduce the burdens of illness and disability. Much like any scientific discipline, translational science aims to elucidate universal operating principles, to transform translation from an empirical and phenomenological process into a predictive science.
The following is an example provided by NIH/NCATS
- An example of a traditional translational research project would be an investigator aiming to assess the efficacy of a specific drug in improving outcomes for diabetes by recruiting a sufficient number of participants using established recruitment methods to evaluate the drug’s effectiveness and its potential benefits for the diabetes community.
- In contrast, an investigator exploring the barriers to recruitment in clinical research while simultaneously assessing the efficacy of a specific drug in improving outcomes for diabetes will incorporate a strategy to improve the recruitment of an underserved population. In this case, the TS investigator and TR researcher, are both testing the efficacy of a diabetes drug.
However, the key difference is that the TS investigator could be collaborating or only be focusing on addressing challenges in the recruitment processes and optimizing their outcomes.
Additionally, NCATS has a website explaining the translational science principles.
For more information on translational science and scientific and operational principles of translational science, please see
- Advancing translational science education. Faupel-Badger JM, Vogel AL, Austin CP, Rutter JL.Clin Transl Sci. 2022 Nov;15(11):2555-2566. PMID: 36045637.
- Opportunities and Challenges in Translational Science. Christopher P Austin. Clin Transl Sci. 2021 Sep;14(5):1629-1647. PMID: 3398240.