Billie Kyriakides, Assistant Director
The Clinical and Translational Annual 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.” The program is a component of the UL1 TR002548-02 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, 2020.
- Carry-over of funds is not allowed.
The Clinical and Translational Science Collaborative (CTSC), in its new pilot program for this cycle of the CTSC renewal, is committed to supporting technologies and methodologies with the potential to impact human health. As such, Annual Pilots will be prioritized for projects that have the potential for moving ideas and/or technologies towards patients (or to a later stage of translation), including innovative research methodologies and novel devices, diagnostics, or therapeutics, in all disciplines of biomedical research. 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.
It is expected that pilot awards will lead to publications in a peer-reviewed journal and the submission of high-quality applications competitive for funding by NIH, the Agency for Health Care Research and Quality, the Department of Defense, the Patient-Centered Outcomes Research Institute (PCORI), and/or national or local foundations or other peer-review based funding agencies.
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 also eligible and encouraged to apply. Applications from individuals of under-represented minorities are highly encouraged. Applicants should design studies that meet some of all of the following criteria:
- 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
- Sound hypothesis, research methodology and statistical considerations
- Good track record in research or innovation for the applicant and/or the co-investigator(s)
- Likelihood of leading to future independent funding and scientific publication
- Integration or impact of community engagement principles into protocol design
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 secretarial 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.
Inclusion of Co-Investigators
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 Facilities
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 lead to efficient use of resources and support of inter-institutional, clinical translational research in the City of Cleveland. CTSC/CCTRP projects are expected to have a Biomedical Engineering faculty member as a Co-Investigator. If you have questions about the CCTRP funding, please contact our office.
Application Submission Process
Application Submission Process for Invited Proposals/due date January 31, 2019, via InfoReady.
The submission deadline is 11:59 PM on January 31, 2019. Only those applicants with approved LOI’s will be invited to submit a full application.
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) will be uploaded to the Research Proposal section. The research proposal will include:
- Description of the study hypothesis, design, expected results, expected timeline, and feasibility
- Relevance and benefit to the CTSC/Translational Research.
The Research Proposal must be added as an attachment to the proposal section. Applications submitted incorrectly will be returned to the applicant for revision. The appendix is limited to 5 pages. No abstracts.
Translational Research Types
T0 Research incorporates a broad area of pre-clinical approaches designed to inform an investigator about a pathway, pathophysiology, or treatment approach. Examples of experimental methods used for this purpose are animal models of human disease, human blood or cell lines, development of questionnaires, computational models, and human physiological studies, all which are directed at mechanisms and presentations of human disease.
T1 Research translates discoveries made at the bench to first testing in humans. Typically these studies (case studies, phase 1 and 2 clinical trials) take place at the patient bedside in an academic medical center. The focus of these studies is to determine what care actually works.
T2 Research is the second phase of the translation process and builds on the clinical efficacy work conducted in the first phase of the translation process (T1). It translates results from early clinical studies to controlled observational studies and phase 3 clinical trials for bedside patient care and health decision-making.
T3 Research is in the third phase of the translation process and builds on the clinical efficacy work conducted in the second phase of the translation process (T2). It translates results from T2 research into clinical practice.
T4 Research is the fourth phase of the translation process and builds on the results of the third phase translation process (T3). T4 Research will help identify the best approach to reach clinicians and patients nationwide so that they will not only understand the new treatment but will start to use it.
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: https://clinicaltrials.gov/ct2/manage-recs/fdaaa
- 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 in a relatively short span of time.
- 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 Kyriakides, 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, 4UL1TR0002548, 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.
New Requirements from NIH and NCATS for the CTSC Pilot Program
The federal Protection of Human Subjects regulations recognize that certain research applications may be submitted to a sponsoring agency with the knowledge that human subjects will be involved during the period of support, but definite plans for this involvement cannot be described in the application. This situation is referred to as "delayed onset human subjects’ research" in the NIH Supplemental Grant Application Instructions. As noted in the NIH Grants Policy Statement (GPS), after award and prior to the involvement of human subjects, the grantee must submit to the NIH awarding Institute/Center (IC) for approval.
- Documentation such as the scientific protocol or revised research timeline, as required by the funding IC.
- New or revised human subjects section (see the NIH Supplemental Grant Application Instructions that are part of the NIH competing application guide) that clearly describes risk, protections, benefits and importance of the knowledge to be gained by the revised or new activities.
- New or revised Inclusion Plans for Women, Minorities, and Children, if applicable.
- New or revised Inclusion Enrollment report(s), if applicable. (Note: This action would occur in the Inclusion Management System accessible through the eRA Commons).
- New or revised Data and Safety Monitoring Plan (DSMP) and Board (DSMB), if applicable.
- Certification that Key Personnel have taken appropriate education in protection of human subjects, if not provided previously.
- Certification of Federal-wide Assurance (FWA) (if not previously provided) and IRB approval of the IC approved plans will be required before the newly proposed human subjects activities can begin.
Institutions with award mechanisms that allow them to use a portion of their budget to select and conduct new human subjects research projects ("pilot projects") are responsible for ensuring that the selected projects follow all relevant regulations and policies including those governing the involvement of human subjects in research, including obtaining prior approval from the institutional IRB.
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 Kyriakides, 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.
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.|