Program 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

Apply

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

Part 1: Supporting Documentation
Part 2: Research Proposal
Allowable and Unallowable Costs
Review Process

Application Guide

Definitions of Translational Research vs. Translational Science
A more in-depth explanation of translational science as explained by NIH/NCATS:
Can you give a more specific example of the difference between translational research and translational science?