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RFA Announcement: Pilot Awards for Clinical Translational Studies

February 06, 2017

The mission of Georgetown-Howard University Center for Clinical and Translational Science (GHUCCTS) and the national Clinical Translational Science Award (CTSA) programs includes the promotion of interdisciplinary research that translates basic findings into clinical applications, clinical research into community practice and the generation of advances that contribute to improving the process of research. It is also our goal to implement research that will have a high impact on underserved populations, including minorities, people with disabilities, and older adults. Additional priorities recently indicated by the agency that administers CTSAs, the National Center for Advancing Translational Science (NCATS) (see https://ncats.nih.gov/ctsa), further emphasize interaction and collaboration of the 62 CTSA hubs spread throughout the United States (see https://ctsacentral.org).

2017 Pilot Translational and Clinical Studies (PTCS) Funding Priorities

For the third year of our 2nd competitive 5 year award GHUCCTS leadership has decided to prioritize the topic categories that are specified in the NCATS’ Collaborative Innovation initiative. Applications that address one or more of these topic areas, and have a compelling plan for leveraging study results into an external application, particularly one that involves other CTSA sites, will be given priority for funding selection. We recommend consideration of the UO1 Collaborative Innovation program in formulating these plans (see https://grants.nih.gov/grants/guide/pa-files/PAR-15-172.html, for full elaboration of topic areas and guidelines). The overlapping topic areas for this pilot program RFA are:
• Development and implementation of innovative community engagement methods and technologies including research aimed at engaging minority, vulnerable, or other understudied populations;
• Improving the consent process, (e.g. simplifying and reducing the length of consent forms; ensuring that the consent forms are culturally sensitive; making the consent process more user-friendly through the use of visual aids or recorded video);
• Innovative education and training initiatives that emphasize competencies rather than degrees, training in multi-disciplinary team science, regulatory science, entrepreneurship and/or experiential learning;
• Adapting technology and methodology that has been successful in other domains to address challenges in clinical and translational research;
• Innovative studies or trials that use mobile technology and web- or phone- based communication to obtain outcomes and/or measures;
• Research that brings together a new type of team;
• Innovative clinical research designs, such as adaptive designs, serial “n of 1” design, or other approaches to small populations for evaluating interventions;
• Innovative methodologies that address translational research roadblocks specific to pediatric, geriatric, or other populations throughout the lifespan including new ways to measure outcomes or validate biomarkers relevant to those populations;
• Innovative approaches to the implementation of precision medicine.

Funding Opportunity Description
Award Amount: up to $40,000 (includes Institutional cost share)
Duration: 1 year
Note: The above-referenced funding mechanism require a 50% cost-share with the applying institution.

Review Criteria
Applications will be peer reviewed and evaluated on the following criteria: • Relevance to the above priority themes/categories
• Use of an interdisciplinary approach. Representation of researchers with expertise in basic and clinical sciences and/or populations, services/patient oriented outcomes, and the likelihood of effective collaborations will be evaluated. The project per se may be interdisciplinary either in its conceptualization and/or application. (Consider going outside of your institution if required expertise is more readily available at other GHUCCTS (Georgetown University, Howard University, MedStar, DC Veterans Administration Medical Center, and Oak Ridge National Laboratory or other CTSA hubs).
• Promising direction for future extramural funding Clearly describes how proposed aims will provide opportunities for future externally funded applications, including but not limited to the Collaborative Innovation mechanism.
o Priority will be given to proposals that present a plan for future collaboration with institutions at other CTSA hubs preferably with documentation of their interest. Consider the Collaborative Innovation mechanism CTSA U01 Award for future application plans.
• Collaborations between junior and senior investigators. For experienced investigators, utilization of junior investigator/trainees; for junior investigators, adequate/appropriate mentoring and consultation.
• Approach Will the proposed methods achieve the aims?
• Significance If successful will the project move the field forward? Does the proposed project answer an important translational research question?
• Innovation Could apply to the approach, technology or its application to a novel focus.
• Translation Can the project be generalized to other settings?
Requirements for All Applications
Applying for support will require electronic submission of:
• A limit of four (4) pages (single spaced, 11-point font, 0.5-inch margins) for description of Aims, Background and Clinical and Translational Impact, Supporting Preliminary Studies, Design and Methods. If the study involves human subjects a description of human subject considerations is not subject to this limit.
• Current NIH biographic sketch for each investigator and/or mentor(s).
• Budget and budgetary justification clearly identifying consortium budget details and total by using NIH budget page (Form Page 4) (no more than four pages – salary support for PIs is not an allowable cost, but salary support for research personnel is allowable). Justification should include all identified investigators responsibilities toward achieving project aims. Templates for budget and budget justification are included in the application.
• Assurance from the applicant’s institution’s executive leader for GHUCCTS as well as a division chief and/or department chair supportive of the proposed pilot study, assuring that appropriate time and resources will be made available to successful applicants. (standard form provided in application)
• Consistent with NIH policies, IRB or IACUC approval or exemption, as well as conflict of interest review will be required prior to transmission of funds and project implementation. Because of the short time line we strongly encourage preparation of regulatory documents as soon as possible.

Applications are due by : Friday, March 10th 2017

Applications Submissions are on-line: PTCS Program Application

Additional Information
New requirements for funded pilot grants
GHUCCTS is funded through a CTSA grant from NIH's National Center for Advancing Translational Sciences (NCATS). NCATS has instituted a new policy requiring the review and approval of all GHUCCTS pilot grants involving human subjects research prior to GHUCCTS funds being utilized. Therefore, if your proposal is funded and involves research with human subjects, GHUCCTS will require additional documentation to send to NCATS. NCATS expects to complete their review in less than 30 days. The NCATS review can occur concurrently with the IRB review; however, final NCATS approval is contingent upon IRB approval

Requests for information, including clarification about GHUCCTS resources available for pilot studies and questions about the preparation and submission of applications for pilot studies, can be obtained from the GHUCCTS PCTS administrator: Yejide Obisesan, HU CTSA Navigator (yejide.obisesan@howard.edu; 202-806-9481)