Billie Edgar, Assistant Director
The Clinical and Translational Pilot Award Program is funded through the NIH National Center for Advancing Translational Sciences, which defines translation as “the process of turning observations in the laboratory, clinic and community into interventions that improve the health of individuals and the public — from diagnostics and therapeutics to medical procedures and behavioral changes.” (https://ncats.nih.gov/translation) The program is a component of the UL1 TR002548 Clinical and Translational Science Awards from the National Institute of Health (NIH).
- Up to six grants will be awarded with budgets limited to $50,000 in direct costs.
- Research proposed in the application must be accomplished by April 30, 2021.
- Carry-over of funds is not permitted.
The Clinical and Translational Science Collaborative (CTSC) is committed to supporting technologies and methods/processes with the potential to impact human health. Annual Pilots will be prioritized for projects that have the potential for moving ideas and/or technologies towards patients. This includes drug and device development, interventions, and research methods and processes in the translational space, including implementation science. As such, these applications are more akin to familiar funding competitions such as the Case-Coulter Translational Research Partnership, the Taipei Medical University Innovation program, or Ohio Third Frontier funding mechanisms than has been the case in the past. In that vein, the ability of applicants to clearly enunciate the proposed activities that move ”observations/associations” towards “patient-centric outcomes” will be essential in the review process.
Eligibility and Criteria for Review
The PI is required to be a CWRU full-time faculty member (or the equivalent) from CWRU, Cleveland Clinic, MetroHealth, University Hospitals, or Louis Stokes Cleveland VA Medical Center and eligible to be a PI for a NIH grant.
Scholars currently enrolled in the KL2 Clinical Scholar Program are encouraged to apply. Applications from individuals of under-represented minorities are highly encouraged. Applicants should address some or all of the following criteria as part of their application:
- Multidisciplinary; connecting basic and clinical science in a team based approach
- Potential to address critical questions about the method or technology in a relatively short span of time
- Track record in research or innovation for the applicant and/or the co-investigator(s)
- Community engagement principles reflected in the study design
- Impact on special populations (e.g. children, minorities, elderly, vulnerable…etc.)
Case Western Reserve University will serve as the fiscal entity through which CTSC and CTSC/CCTRP funds will be distributed and administered. The amount of the pilot award will be dependent on the scope and type of the project. Awards may involve the incorporation of novel methodologies for translational studies and use of CTSC resources. Awardees are encouraged to supplement awards with additional private and institutional funds.
Maximum of $5,000 in salary support for each investigator (must be at least two interdisciplinary investigators). Budget must be well justified. No funds will be provided for administrative personnel, office equipment and supplies, computers, tuition, travel, purchasing and binding of periodicals and books, dues and membership fees in scientific societies, honoraria and travel expenses for visiting lecturers, recruiting and relocation expenses, office and laboratory furniture, rental of office or laboratory space, per diem charges for hospital beds, non-medical or personnel services to patients, construction or building maintenance, or major alterations.
Principal Investigator Credentials
The PI is required to be a full-time faculty member (or the equivalent) from Case Western Reserve University, Cleveland Clinic, MetroHealth, University Hospitals, or Louis Stokes Cleveland VA Medical Center and eligible to be a PI for a NIH grant.
Number of PIs
Only one investigator can be named as PI. Additional collaborating investigators will be named as co- investigators. Co-PIs are not permitted.
An investigator may be listed as PI or Co-investigator on any number of applications. However, an applicant may only receive one Award as Principal Investigator or co-investigator. If awarded an Annual Pilot, you are ineligible to receive another Annual Pilot for at least two years.
Proposals from new investigators are strongly encouraged. For the purpose of this RFA, a new investigator is defined as a faculty member or equivalent who is not tenured and who has not been a faculty member at Case or any other institutions for more than six years in aggregate. The review panel can assign extra weight to a proposal from a new investigator to enhance opportunity for funding.
Transdisciplinary Investigators and Team Science
Applicant should consider including co-investigators from different schools or colleges or institutions. If the co- investigators are from the same school, college or institution, they must be from different departments and justification made in the application that the project is indeed interdisciplinary and new. In addition, the proposal must clearly present the intellectual contribution by each investigator. A project where one of the investigators is simply providing access (to data, specimens, or patients) is less acceptable than one where there is knowledge or skill sets that enhance the research.
Utilization of Core Facility
If a CTSC Core is utilized, detailed documented consultation from the specific CTSC Core director or his/her designee for that CTSC Core is required. Justification for use of the CTSC core(s) must be included in the LOI.
More than one proposal per faculty member serving as a co-investigator may be submitted; however, a faculty member is only eligible to receive one award as a co-investigator.
Change of Institutions/Transfers
Recipients may not transfer these awards to another institution or to another individual. Reallocations in the approved budget require prior written approval before expenditure. Awardees are required to give 90 days’ notice of any change in Institution, and funds will be prorated when an applicant leaves the Institution within any funding year.
Clinical and Translational Science Collaborative and Case Coulter Translational Research Partnership Funding
The CTSC and CCTRP will provide joint funding to faculty for Annual Pilot Projects that will support of inter-institutional, clinical and/or technological translational research in the City of Cleveland. CTSC/CCTRP projects are expected to have a Biomedical Engineering faculty member as an integral Co-Investigator. If you have questions about the CCTRP funding, please contact our office.
Application Submission Process
Investigators interested in submitting applications to the Annual Pilot Program must first submit a Letter of Intent (LOI) to the CTSC Scientific Review Committee (SRC). The purpose of the LOI is to determine if the proposed research aligns with the aims of the Annual Pilot Grant Program. Investigators submitting a proposal appropriate to the goals of the Annual Pilot Grant Program will be invited to submit a full application.
The LOI is a short summary of the proposal (one page maximum) that must include the following:
- Project site(s)
- Names/affiliations of PI, Co-Investigators and collaborators
- A brief overview of the project and how the award funds would be utilized and distributed.
- Scientific Question/Hypothesis of the study – This section should be about ¼ of a page and should describe the overall hypothesis and scientific question.
- Innovation/Translation – This section should be about ¼ of a page and describe how your project is translational, what is taking it beyond basic research to the next level.
- Feasibility – This section should be about ¼ of a page and describe the feasibility of your study. Can you accomplish your milestones in the time allowed with the funds provided and the resources available? If there are potential roadblocks or concerns with accomplishing your milestones, please address them in this section.
- Project Milestones – This should describe the project plan in about ¼ page. For the scope of this project we suggest 2-3 milestones that can be achieved with the budget allowed (up to $50,000) and in the time frame selected (up to 1 year). Please include an estimate of how long each milestone will take, and why it is critical to the development of your technology.
Submit the LOI via the online grant submission system.
The submission deadline is 11:59pm on October 15th (or the first following Monday if October 15th falls on a Saturday or Sunday)
Application Submission Process for Invited Proposals/due date January 31, 2020.
The submission deadline is 11:59pm on January 31, 2020. Only those applicants with approved LOI’s will be invited to submit a full application via the InfoReady Grant Management System.
Submissions must be made by the PI or on behalf of the PI through PI’s InfoReady account.
Submissions made under anyone else’s name will not be accepted.
Completeness of Application
Complete applications will consist of:
- The on-line submission
- eRA commons username of the PI
- Short summary of the work directed to the lay public (500 characters)
- Dollar amounts of other support currently available to all investigators
- NIH Biosketches of the PI and all co-investigators
- Active IRB and/or IACUC approval letter (if applicable). If required, no exceptions.
- Letter(s) of reference from CTSC Core program director or his/her designee documenting the PI’s consultation with Core management if a CTSC Core Program is being utilized
- Detailed budget and budget justification. Details must include costs per unit x number of units needed and/or cost per hour and number of hours required. Applications lacking sufficient budgetary detail will be returned to the applicant.
- Research proposal (see details below)
- References and figures may be uploaded as a PDF or Word document in the Appendix section of the application.
- Letter of support from PI’s department to ensure the investigators have sufficient protected research time and facilities to conduct the proposed research.
- Failure to submit ALL documents before 11:59 pm EST of submission date constitutes an incomplete application. Incomplete applications will not be reviewed.
The research proposal (maximum 5 pages based on Arial font size 11, ½” margins) must be uploaded as a PDF within the application. The research proposal will include:
- Background and significance
- Preliminary studies
- Description of the study hypothesis, design, expected results, expected timeline, and feasibility
- Relevance and benefit to the CTSC/Translational Research and a plan for and probability that this project will lead to extramural funding.
Upload the Research Proposal into the application as a PDF document. The appendix is limited to 5 pages. No abstracts.
Review Process – Application
- All awards that will involve “Applicable Clinical Trials” are required to register on clinicaltrials.gov before enrollment of the first subject. For additional information about registering clinical trials visit: http://prsinfo.clinicaltrials.gov/fdaaa.html
- Recipients of the pilot awards must adhere to Federal, State, and local guidelines with respect to scientific conduct of research, conflict of interest policies, human subject participation, and use of animals, hazardous or radioactive materials, and recombinant DNA in their research studies.
- The CTSC SRC will review proposals. When appropriate, external reviewers will be asked to participate in the review process by the CTSC SRC.
- Reviewers will rate the proposal according to the NIH Scoring Scale and provide comments as appropriate to the Committee via InfoReady.
In making a decision, the Committee will take into consideration the following with the heaviest weighting given to items 1-5.
- Overall rating of the proposal.
- Significance, originality, scientific merit and translational nature of the proposed project.
- Feasibility, the ability to perform the proposed research within the timeframe allotted.
- Likelihood that completion will provide the basis for future successful funding and/or operational success within the CTSA framework
- Meets the NCATS requirement that supports technology and methodologies with the potential to impact human health.
- Budget justification.
- Partnership goals of the proposal in regard to inter-institutional, inter-departmental and inter-generational partnerships.
The review committee would like to emphasize the importance of (a) providing a plan for CTSC resource use or enhancement; (b) specifying plans for how the project will lead to funding from other federal and non-federal granting agencies.
Proposals will be reviewed and either approved or disapproved. All applicants receive feedback from blinded peer reviewers. Disapproved projects may be re-submitted to the next Annual Pilot Grant Period.
Grantees are required to submit an interim report at 6 months and a final report no later than 60 days after the award end date that summarizes major activities and research findings. The CTSC Pilot Grant Program will also contact the awardees on an annual basis (or more frequently as NIH requirements dictate) to request information concerning the funding status of the research initiated with the CTSC award as well as related publications for a period of ten years after the end of the funding period or until the line of research has concluded. Awardees may be asked to present their findings at an annual CTSA retreat.
A copy of any manuscripts or abstracts accepted for publication/presentation, which contains any results found using funds from the CTSC should be sent to Billie Edgar, Director of the CTSC Pilot Program upon notification of acceptance.
Support from the CTSC MUST be acknowledged when findings are reported, published or publicity is given to the work. All pilot award recipients must agree in writing to cite the CTSC award on all publications resulting from funds provided from the CTSC to the investigator making it possible to publish. Please include the following text: “This publication was made possible by the Clinical and Translational Science Collaborative of Cleveland, UL1TR0002548 from the National Center for Advancing Translational Sciences (NCATS) component of the National Institutes of Health and NIH roadmap for Medical Research. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH." It is imperative to note that ALL publications resulting from this award obtain a PMCID as mandated by the NIH’s public access policy.
Any current or past awardee that does not acknowledge publications and research as a result from this award will not be eligible for future funding or support from the CTSC.
Public Access Policy Reminder - The Director of the National Institutes of Health shall require that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine's PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication: Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law.
Awards are made with the understanding that the CTSC will receive written notification of the filing of a patent application for any discovery made based on work funded by these awards.
In accord with NIH policy, all primary research data generated with CTSC support will be available for sharing no later than the acceptance for publication of the main findings from the final data set. Even if primary research data are stripped of all personal identifiers, it is possible for deductive disclosure of subjects with unusual characteristics. Therefore, in order to maintain privacy (per HIPAA), data and associated documentation will be available only under a data-sharing agreement that provides for: 1. a commitment to using the data only for research purposes and to NOT identifying any individual participant; 2. a commitment to securing the data using appropriate computer technology; and 3. a commitment to destroying or returning all data after analyses are complete. The data sharing agreement will also require acknowledgement of the CTSC as the source of data and will request pre-release review of any presentations or publications by the CTSC PI (or the PI who generated the primary data). Agreement to provide financial support for itemized specific expenses of data sharing may also be required in the data sharing agreement.
Requirements from NIH-NCATS for the CTSC Pilot Program
IRB and IACUC Approvals: All IRB and IACUC protocols must be approved prior to expenditure of funds.
Delayed Onset Human Subjects Research: The NIH requires that the CTSC obtain explicit approval from the NIH for any pilot-funded research involving human subjects. Accordingly, the IRB-approved protocol and other materials must be submitted to the NIH at least 45 days prior to the project start date. CTSC personnel will work with awardees to meet these requirements.
Prior Approval of Vertebrate Animals Research: The NIH requires that the CTSC obtain explicit approval from the NIH for any pilot-funded research involving vertebrate animals. IACUC approval documentation and other materials must be submitted to the NIH at least 45 days prior to the project start date. CTSC personnel will work with awardees to meet these requirements.
Use of Application Information
The CTSC will not distribute information about submitted proposals to anyone without the applicant’s permission except to the individuals assigned to review the application. However, the CTSC may ask the applicants for permission to use the title of their application and/or the lay summary for promotional purposes. Permission will be obtained in writing and applicants have the right to decline if they so choose. Please contact Billie Edgar, Director of the Pilot Program with any questions you may have about this.
Service as a Reviewer
Awardees will be included in a list of researchers to serve as potential reviewers on future CTSC Pilot Grants. Depending upon your specialty and area of expertise, you may be contacted by the Pilot Program Director to review applications.
Translational Research Types
Basic research involves scientific exploration that can reveal fundamental mechanisms of biology, disease or behavior. Every stage of the translational research spectrum builds upon and informs basic research. NCATS scientists typically do not conduct basic research; however, insights gained from the Center’s studies along the translational spectrum can inform basic research.
Pre-clinical research connects the basic science of disease with human medicine. During this stage, scientists develop model interventions to further understand the basis of a disease or disorder and find ways to treat it. Testing is carried out using cell or animal models of disease; samples of human or animal tissues; or computer-assisted simulations of drug, device or diagnostic interactions within living systems.
Clinical research includes studies to better understand a disease in humans and relate this knowledge to findings in cell or animal models; testing and refinement of new technologies in people; testing of interventions for safety and effectiveness in those with or without disease; behavioral and observational studies; and outcomes and health services research. The goal of many clinical trials is to obtain data to support regulatory approval for an intervention.
The clinical implementation stage of translation involves the adoption of interventions that have been demonstrated to be useful in a research environment into routine clinical care for the general population. This stage also includes implementation research to evaluate the results of clinical trials and to identify new clinical questions and gaps in care.
In this stage of translation, researchers study health outcomes at the population level to determine the effects of diseases and efforts to prevent, diagnose and treat them. Findings help guide scientists working to assess the effects of current interventions and to develop new ones.
Annual Pilot Budget Requests Guide
|Category of Expense||Allowable Request on Pilot Project?|
|Expenses in Obtaining a Visa||No|
|Graphics, Photography Charges||No|
|Indirect Costs||Will be added by the CTSA administrative office in accordance with the negotiated F&A rate agreement|
|Lab Tests - Clinical||Yes, justify and verify the costs with the laboratory|
|Lab Tests - Research - Core Services||Yes, justify and verify the costs with the laboratory|
|Principal Investigator/Co-Investigator Salary/Fringes||Maximum of $5,000 (before fringe benefit costs) in salary support of each investigator. Note: established investigators are ineligible for this support|
|Technical Support Personnel (study coordinator, lab tech, nurse, procedure tech, student)||Yes, up to $20,000/year (before fringe benefit costs) to support research assistants or personnel|
|Publication Costs and Reprints||No|
|Receptions and Meals||No|
|Scientific Meeting Fees and Expenses||No|
|Service Contracts for Equipment Maintenance||No|
|Software Packages||Yes, if unavailable and essential to the project. Strong justification required.|
|Space Alterations and Renovations||No|
|Stipend for Medical Students||Only if they are research personnel|
|Subject Participation Reimbursement||Yes|
|Lab Supplies, Disposables||Yes, provide detailed justification; must be relevant to the proposed research and must be "consumed" by the project|
|Telephone Long Distance (related to the project)||No|
|Travel - Domestic or Foreign||No|
|Uniforms, Wearing Apparel||No|
|ANY NON-LISTED ITEM OR CATEGORY||Please contact the CTSC office.|