A A A Print
 

Announcement: 2018 Pilot Awards for Clinical Translational Studies

March 06, 2018

The missions of the Georgetown-Howard Universities Center for Clinical and Translational Science (GHUCCTS) and the national Clinical Translational Science Award (CTSA) programs highlight the promotion of interdisciplinary research that translates basic research findings into clinical applications, clinical research into community practice, and improving the process of research. It is also our goal to implement research that will benefit underserved populations, including minorities, people with disabilities, and older adults. The National Center for Advancing Translational Science (NCATS), the agency that administers CTSAs, has recently indicated additional priorities , (see https://ncats.nih.gov/ctsa), further emphasizing the interaction and collaboration of the 62 CTSA hubs spread throughout the United States (see http://ctsa.ncats.nih.gov/).

Application Due Date: April 16th, 2018 11:59pm

Link to Application

2018-2019 Pilot Translational and Clinical Studies (PTCS) Funding Priorities


We will continue to prioritize topic categories 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. For details regarding this National initiative see: https://grants.nih.gov/grants/guide/pa-files/PAR-18-244; htmlhttps://grants.nih.gov/grants/guide/notice-files/NOT-TR-18-013.html;   https://grants.nih.gov/grants/guide/notice-files/NOT-TR-18-017.html

Summary of priority topics:

  • Innovative community engagement methods and technologies including research aimed at engaging minority, vulnerable, or other understudied populations;
  • Improving the consent process
  • 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;
  • Use of mobile technology and web- or phone- based communication to obtain outcomes and/or measures in studies;
  • 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;
  • Innovative approaches to the implementation of precision medicine;
  • Engaging individuals with Opioid Use Disorders in research and clinical care while developing effective models of care delivered within medical settings of interest;
  • Development of mobile technology, web- or phone-based communication, and other devices and platforms to deliver and support the treatment of Opioid Use Disorders and to help prevent opioid overdoses; 
  • Innovative approaches to implementing, sustaining, and paying for effective interventions  to address Opioid Use Disorders;
  • Innovative approaches to incentivize and engage clinicians in clinical research on models of care that are effective in screening and managing Opioid Use Disorders in medical settings of interest.

Eligibility

Applicants must have a full-time faculty appointment at one of the GHUCCTS institutions (Howard, Georgetown, DCVA Medstar, ORNL). Each application should identify a Contact PI that will be responsible for coordinating and submitting the application. Research teams can include collaborators who are not GHUCCTS affiliated.

Funding Opportunity Description

  • Award Amount: up to $40,000 (includes Institutional cost share)
  • Duration: Funds must be spent by March 31st 2019.
  • A 50% cost-share with the applicant institution is required.

Requirements for Applications

Abstract (200-word limit)

Narrative A limit of four (4) pages (single spaced, 11-point font, minimum 0.5-inch margins) for description of i)aims, ii) background and clinical and translational Impact, iii) supporting preliminary studies, iv)design and v) methods. If the study involves human subjects the description of human subject considerations is not subject to this limit. References do not count towards the 4-page limit. Include the contact PI’s name at the top of each page and consecutively number all pages in the applications at the bottom of each page

Biosketches Current NIH biographic sketch for each investigator and/or mentor.

Budget Guidelines

Budget: Funding will be provided for items essential to the conduct of the project.  The budget should identify budget details and total by using NIH budget page (PHS 398Form Page 4) located in the application. A separate budget is needed for each participating institution and subcontract.

Budget Justification: Budget justifications should include all the roles and responsibilities of all personnel (paid and unpaid) and details on the purpose of all non-personnel cost requested.

  • Allowable Costs: Laboratory supplies, small equipment (if deemed essential to the conduct of the project), participant costs, consultants, research support personnel (salary/wages & fringe benefits), use of institutional/core and GHUCCTS services, and travel necessary to perform research.
  • Unallowable Costs: PI salary support or faculty collaborators, office supplies, meals or travel for conferences, professional education or training, and indirect costs,  
  • Cost-Sharing: 50% institution cost-share is required.
  • Budgets should not include indirect/F&A costs. Salary/wage totals for allowable personnel should follow fringe benefits guidelines for your institutions.

Departmental and GHUCCTS Executive Approval

Before submitting a PTCS grant application, the PI and any Co-PI that will be requiring institutional cost share are required to obtain approval for submission from his/her departmental chair or division chief and the GHUCCTS executive at their institution, with assurance that appropriate time and resources will be made available to successful applicants. A form is provided in the application packet. GHUCCTS executive contacts are as follows:

Howard Executive: Dr. Thomas Mellman (tmellman@howard.edu)

Georgetown Executive: Dr. Joseph Verbalis (verbalis@georgetown.edu)

DCVA Executive:  Dr. Marc Blackman (Marc.Blackman@va.gov)

MedStar Executive: Dr. Neil Weissman (Neil.J.Weissman@Medstar.net)

ORNL: Dr. Kristina Thiagarajan (thiagarajakd@ornl.gov)

 IRB/IACUC & Human Subjects

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.

Although Institutional Review Board and/or Institutional Animal Care & Use Committee approval is not required prior to application submission, we strongly encourage preparation of regulatory documents as soon as possible.  If human subjects are to be involved in the proposed project, provide a description of their involvement, specific risks to subjects who participate, and protection against those risks. Describe any sources of samples/specimens that will be obtained from human subjects as part of their participation. Provide assurance that the project will reviewed and approved by the IRB.

Applications will not be considered complete without all components.

Applications Submissions are Online: Link to Application

Online Application: Submission is online. The completed application and signed forms (institutional support documents) are due by April 16th, 2018 by 11:59pm.

Applications must be submitted using the templates provided in the application. Copies of the application templates can be downloaded from the GHUCCTS website: Pilot Translational and Clinical Studies

Review Criteria and Process

Applications will be peer reviewed and evaluated on the following criteria:

  • Relevance to the above priority themes/categories
  • Use of an interdisciplinary approach. (Consider going outside of your institution if required expertise is more readily available at other GHUCCTS institutions (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.
  • 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.

Additional Information

GHUCCTS Resources for Project/Proposal Development:

The GHUCCTS is offering free consultation services, which may be helpful to you in your proposal development.  Topic areas for advice include but are not limited to: protocol development, study design, biostatistics, feasibility assessment, recruitment plan, community engaged research best practices, integration of culturally and linguistically competent approaches, inclusion of diverse populations, etc.   Please utilize the links below for more information:

GHUCCTS Programs & Resources

Biostatistical Support Services

Clinical Research Units: HU & GU

Community Engagement Services Contact: Florencia.Gonzalez@Howard.edu

Recruitment Services

Protocol Development

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.

Contact

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