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Bridges to Translation offers funding for pilot projects

As part of its mission to accelerate discoveries to benefit human health, Penn State Clinical and Translational Science Institute will award funding to support five to 10 pilot pilot projects through its Bridges to Translation award.

The translation of biomedical and health discoveries to application is a long and complex process with high costs and substantial failure rates. As such, the institute seeks to fund pilot projects that build linkages and overcome roadblocks at any stage in the translational process.

Special consideration will be given to projects that focus on development or applications addressing social and environmental determinants of health, specifically as these releate to rural and other vulnerable populations who experience health disparities. This topic includes, but is not limited to:

  • Social determinants
  • Environmental determinants
  • Phenomic determinants
  • Study of and/or interventions focused on diseases of despair (Case and Deaton, PNAS, 2015)
  • New or new applications of methodologies including telemedicine, community-engaged research, big data modeling, etc., in research on the determinants of health
  • Population health and patient-centered outcomes research

Letters of intent for the next round of Bridges to Translation funding are due by 5 p.m. Dec. 2, 2019. Selected proposals will be invited to submit a full application.

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RFA: Clinical and Translational Science Institute Bridges to Translation Pilot Project Funding

Required letter of intent due date: 5 p.m. Dec. 2, 2019
Notication of approval to apply based on letter of intent: Dec. 20, 2019
Application due date (invited applicants only): 5 p.m. Feb. 3, 2020
Expected funding decision: May 31, 2020
Anticipated award date: Sept. 1, 2020 (funding is available when all regulatory approvals are secured)

Introduction Expand answer

Penn State Clinical and Translational Science Institute seeks applications for pilot projects that build connections across health, biomedical sciences and disciplines that contribute to improved health including engineering and architecture.

The institute develops, implements and makes available to the community at large new methods to promote health and to predict, prevent, and effectively treat human disease.

The translation of biomedical and health discoveries to application is a long and complex process with high costs and substantial failure rates. The CTSI seeks to fund pilot projects that build linkages and overcome roadblocks at any stage in the translational process, including but not limited to:

  • Projects that move research from one translational phase to the next (e.g., T1 to T2)
    • T1 – Translation to Humans
    • T2 – Translation to Patients
    • T3 – Translation to Practice
    • T4 – Translation to Population Health
  • Projects that seek to develop novel technologies, tools, or processes and procedures, including collaborations with industry
  • Projects focused on multidisciplinary collaboration between basic scientists and clinical investigators, across departments and campuses, and/or pairing of senior investigator with junior investigator
  • Projects focused on dissemination and implementation of evidence-based programs, policies and practices
  • Projects that develop novel statistical methods or models to analyze data, including population health
  • Projects designed to speed up the process of translation including training for clinical research staff, team science/mentoring programs, patient recruitment initiatives, regulatory and ethics training and increasing efficiency of regulatory (including governmental) processes
  • Projects focused on integration of translational science across its multiple phases and disciplines within vulnerable populations and across the lifespan
  • Projects that focus on the ethical challenges involved with translational research teams
  • Projects that focus on training and education of translational research
  • Projects that propose to gain additional external funding based on the results of the pilot

The institute will provide up to $300,000 to support between five and 10 interdisciplinary, multi-investigator projects. Awards will be capped at a $50,000 budget.

Projects must be able to be completed within 12 months of receiving full approval and funds.

Successful applications will describe how the project will advance clinical and translational science. Also, given the enabling capacity of engaged communities in the translation process, applications should specify plans for community involvement, with community being defined broadly (e.g., patients, health care providers, community organizations, industry, government, educators, researchers and other groups within and beyond the University). Community connections also might include plans for outreach and dissemination beyond the scientific community.

Eligibility Criteria Expand answer

The Principal Investigator (PI) must hold a Penn State faculty appointment. This includes faculty members at all Penn State campuses and colleges. Proposals from multi-disciplinary, cross-campus teams will be most competitive. Junior faculty are encouraged to apply with an established co-investigator.

In addition, to be eligible, each project must include:

  • A compelling statement of the project’s translational potential and a description of the community or communities the project will serve.
  • A research plan with defined next steps beyond the pilot funding – potential for external funding, product development and/or dissemination.
  • A detailed budget with justification. Limited salary support is available for faculty; no more than $10,000 (fringe is not included in the $10,000 limit) annually may be allocated to faculty salaries for a given project. (Additional funds may be budgeted for research coordinators, research techs, nurses, graduate student salaries/wages, etc.)
  • A detailed project timeline of 12 months. (Progress reports are required every six months throughout the course of the project and will include follow-up to determine project impacts following the award period.)
  • Willingness to provide data about your research team to the Clinical and Translational Science Institute’s Team Science initiative for the purpose of tracking and feedback. This includes the completion of surveys and brief interviews of research team members.

Funds may not be used to support:

  • Student- or postdoctoral fellow-led research (portions of stipends are permitted for postdocs and graduate students working directly on a faculty team’s pilot project)
  • Tuition
  • Funding for activities typically supported by departments and colleges (e.g., travel to conferences, basic software purchase, publication costs)
  • Faculty summer salary (where applicable)
Criteria for Review Expand answer

Reviewers will consider each of the five review criteria here to assess merit.

  • Significance: Does the project address an important problem or critical barrier to improving health and/or healthcare? Is the project’s translational potential clear and compelling? Does the project involve any special emphasis topics (i.e., determinants of health as these relate to rural populations and/or health disparities involving other vulnerable populations)?
  • Innovation: Does the project challenge or shift current research or practice paradigms, advance novel concepts, approaches/methods, instrumentation or interventions, or apply these in novel ways?
  • Approach/scientific rigor and reproducibility: Are the procedures and analysis plans justified and appropriate to accomplish the specific aims? Will the project provide the foundation for a competitive proposal for external funding and dissemination? How does the proposed project address the concepts of rigor and reproducibility per the NIH definition?
  • Investigators: Do the PI and collaborators have the expertise needed to conduct the project? Do the investigators capitalize on differing disciplinary perspectives?
  • Collaboration: How does the proposed project benefit from the collaboration of investigators? Is there a new member of the investigative team? Are the disciplines represented complementary, and does the research plan appear to build on the expertise of the entire team? Does the team leverage expertise from multiple disciplines, investigators at different career points, and across the University? Is the community connection for the project clear and well-described?
Letter of Intent Process Expand answer

The application for pilot study funding is a two-step process: first, a letter of intent, and then, a full proposal (upon invitation) based on review of the letters of intent.

The following guidelines apply to the letter of intent, which has a two-page limit:

Page 1

Proposal title and names/degrees and institutional affiliations of all investigators involved in the project.

Page 2

Specific aims, stating concisely:

  • the goals and expected outcomes of the proposed research;
  • a statement of the translational significance of the project and how that scientific knowledge will translate into health impact; and
  • how the pilot study will lead to substantive extramural funding (e.g., a NIH R01, R21, or comparable grant).

How to Submit

Due date: 5 p.m. EST Dec. 2, 2019.

Applicants will be notified by Dec. 20, 2019, with a decision as to whether or not their proposals have been chosen to move forward to the second tier of the application process.

Submit letter of intent as a single PDF file titled as follows: PILastName-LetterofIntent-B2T6-ReceiptDate (e.g., Sauder-LetterofIntent-B2T6-12022019) to CTSI@pennstatehealth.psu.edu.

Full Application Process Expand answer

The full application process is to be followed if invited to submit following the letter of intent. Be sure to see page limitations for each section.

Remember that reviewers may not have specific expertise in the project area. Therefore, proposals should be written for a broad academic audience.

Cover page (one page)

  • Title of proposal
  • Names of principal investigator, co-investigators and collaborators (include degree, departments and college)
  • Lay abstract (300 word maximum): Provide a succinct overview of the proposal, including how the proposal will address the translational roadblock. Assume that reviewers do not have technical knowledge in a specific field. Avoid or explain technical jargon, field-specific terminology and acronyms.

Introduction (one half-page or less)

Include this only if the project is a resubmission of previously considered Bridges to Translation pilot proposal.

  • Explain the changes made to the proposal based on prior reviews and/or progress since the last submission. This introduction should be a concise and succinct description to allow for reviewers to evaluate the proposal based on previous reviewer comments.

Body of application (limit five pages)

Specific aims: List the specific aims and the rationale for each.

Significance/innovation: Describe how addressing the study aims will promote the translation of scientific knowledge into health impact; describe how the aims, methods, etc. are innovative.

Approach/scientific rigor and reproducibility: Describe the activities that will be undertaken to address the study aims; include description of how scientific rigor and reproducibility will be ensured.

Community engagement: Specify plans for community connections, with community being defined broadly (e.g., patients, health care providers, community organizations, industry, government, educators, researchers, other groups within and beyond the University).

Investigators and environment: Describe the qualifications of the investigative team, the role each team member will perform, and resources in the environment that will support the conduct of the study. Indicate if this is a new team or if there is a new member of the team. Describe multidisciplinary and, if included, the cross-campus collaborations within the team as well as whether the team includes both junior and senior colleagues.

Timeline, anticipated outcomes and future plans: Describe the project timeline over the 12-month period of requested funding. Plans for specific products and outcomes should be specified, including dissemination of results. Examples include: presentations at institute events, grant submissions, papers submitted or the development of a new interdisciplinary team for future grant submissions. For external funding, include potential sponsor(s) (e.g., specific NIH institute) and the expected date for submitting the first application.

Literature cited (no page limit)

Include appropriate literature citations.

Institute resources to be used (no page limit)

The following services are available through Penn State Clinical and Translational Science Institute and can be listed in this section of the application:

  • Clinical Research Center (University Park and/or Hershey)
  • Biostatistics, epidemiology and research design consultation
  • REDCap (data collection and storage)
  • i2b2 (data discovery)
  • Electronic medical record data
  • Recruitment and retention consultation
  • Innovative trial design consultation
  • Ethics consultation
  • Community engagement consultation
  • Team science consultation
  • Other (specify)

See details here.

Budget and justification

  • Provide an itemized budget and budget justification including salaries, fringes, and other expenses, etc. (IAFs will not be used.) No more than $10,000 (direct salary) may be allocated to faculty salaries in any project year. Fringe is not included in the $10,000 limit. (Funds may be budgeted for research coordinators, research techs, nurses, graduate student salaries/wages, etc.) Use of the SIMS budget is preferred. An acceptable template is available upon request.
  • As part of the budget justification, describe the roles and experience of the investigators and any other personnel included in the proposal.
  • F&A costs (indirects) are not provided.

Also provide the name, email address and phone number of the PI’s departmental budget coordinator.

Biosketches

Provide NIH biosketches for the PI and each co-investigator and/or collaborator. See biosketch format and tips via the Research Concierge.

How to Submit

Due date (if invited): 5 p.m. Feb. 3, 2020

Submit the full application as a single PDF file titled as follows: PILastName-Bridge2Translation6-ReceiptDate (e.g., Sauder-Bridge2Translation6-02032020) to CTSI@pennstatehealth.psu.edu.

Format and Submission of Proposals Expand answer

Proposals should be single-spaced, in Arial 11-point font, left-aligned with half-inch margins. Appendices should not be included. The proposal must be complete when submitted and include all items noted elsewhere in this RFA.

Interested investigators are encouraged to consult with the institue’s Informatics, Biostatistics, Community Engagement, and/or Ethics core areas at least two weeks prior to submission. To request a consultation, submit a CTSI service request form.

Submissions must be emailed to CTSI@pennstatehealth.psu.edu as single PDFs using the appropriate naming scheme described elsewhere in this RFA.

For projects that will be funded, additional “just-in-time” information will be required. This will include a signed letter from the department head/chair or vice chair or vice dean for research as well as a note from each collaborator that acknowledges their participation (email is acceptable) if not already included in the application. This will also include Institutional Review Board (IRB) and/or IACUC approval as relevant, along with conflict of interest information.

NIH/NCATS has new guidelines regarding a prior approval process for any funded project that includes Human Subjects. This will require additional documentation and time (generally less than 30 days), so take this into account when planning the timeline of the project.

Finally, the institute’s Community-Engaged Research Core (CERC) will review the funded applications and make suggestions to strengthen community engagement within the proposal. The PIs will have a chance to discuss and implement these suggestions offered by the CERC. Additional funds required for implementation will be offered to specific projects as recommended by the CERC.

The PI and/or key personnel of the submitted application must agree, if called upon, to serve as reviewers of institute proposals for future rounds of pilot study funding and will be encouraged, where appropriate, to present their work at the annual ACTS Conference or related venues.

Additional Information

Questions about this pilot project funding opportunity should be sent to CTSI@pennstatehealth.psu.edu.

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