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Tufts CTSI Pilot Studies Program

Request for Applications

Tufts Clinical and Translational Science Institute (CTSI) is pleased to announce that the application period is now open for the 2014 Pilot Studies Program. Selected projects will be funded for one year, beginning July 1, 2014 and ending June 30, 2015. To download this Request for Applications, click here.  

Applications are due on Friday, January 17th 2014 at 5:00PM.

Any required regulatory documents are due to Tufts CTSI by March 5, 2014 at 5:00PM.

This Request for Applications includes a single solicitation for three award categories:

  1. Catalyst
  2. Multi-site Catalyst
  3. Methods Development

The Pilot Studies Program

The mission of Tufts CTSI is to identify, stimulate, and expedite innovative clinical and translational research, with the goal of improving the public’s health. To reach this goal, we link scientists and scholars from a wide range of disciplines to clinical investigators, policy makers, and industry and community leaders to collaborate on innovative clinical and translational research. Tufts CTSI cultivates this collaboration and innovation by offering education, research expertise, and financial support to investigators. One example of this financial support is the Tufts CTSI Pilot Studies Program, which provides researchers with critical project development and preliminary study support.

Types of Awards

Catalyst Awards

Catalyst Awards are intended for interdisciplinary research teams of at least two investigators representing the basic, clinical, and/or applied sciences. The Principal Investigator must have a Tufts University faculty appointment.

The objective of Catalyst Awards is to develop sufficient preliminary data to secure future extramural funding. Applicants must have a preliminary hypothesis underlying the research and a defined plan and timeline for seeking extramural funding (i.e., R01 or P01 awards, SBIR awards with industry collaborators, or equivalent). Catalyst Awards will be made for up to $30,000 per award and include direct costs only.

Multi-site Catalyst Awards

This mechanism applies to the following four site categories:

  • Tufts University and Tufts Medical Center Affiliated Hospitals, Schools and Centers
  • Brandeis University Heller School and Schneider Institutes
  • Northeastern University Bouve College of Health Sciences
  • RAND Corporation

In order to stimulate multi-site catalyst collaborations at the above four site categories in this round of funding, Tufts CTSI will consider applications from up to three entities, with a budget allocation up to $30,000/site (e.g., a three-site pilot could request a budget of up to $90,000) and include direct costs only. The multi-site catalyst awards should follow the same guidelines as the above catalyst awards at each site. These awards will need to make a clear case as to how translational research is linked across sites as well as how the entire project will plan to seek extramural funding across all sites. To confirm your collaboration meets the multi-site criteria, and to confirm multi-site catalyst funding eligibility, please contact pilots@tuftsctsi.org.

Methods Development Awards

Methods Development Awards are intended for interdisciplinary teams of at least two investigators. The Principal Investigator must hold a Tufts University faculty appointment. Interdisciplinary teams are encouraged, however a single investigator proposal will be considered if appropriately justified.

The objective of Methods Awards is to develop a new translational research method that will lead to future extramural funding. Clinical and Translational Science Awards (CTSAs) exist to impact health by promoting research that translates basic biomedical research from bench to bedside (T1), from bedside to practice (T2), and that impacts generally available medical care and public health measures and policy (T3 and T4). CTSAs also develop novel research methods in translational research. Tufts has a long history of methodological innovation across the T1-T4 spectrum, and Tufts CTSI strives to build on this in service of its dual mission.

Methods Development proposals should have a preliminary hypothesis for developing a new translational research method and a defined plan for seeking extramural funding. Awards will be made for up to $30,000 per award and include direct costs only.

Budget and Funding Requirements

Allowable Costs

For all awards, funds may be used as direct costs for investigator and support staff (such as research assistants and technicians) salary and fringe benefit costs; clinical support; laboratory research supplies; or for assistance with biostatistics and biomedical informatics. Salary support for existing personnel must be justified and include a description of past support and plans for future support after the Tufts CTSI funds are exhausted.

Unallowable Costs

Generally, unallowable costs include:

  • General office supplies and expenses, telephone, data plans, internet, etc.
  • Clinical equipment
  • Computers, laptops, other electronics (unless specifically required and justified – if approved, must be purchased within the first 90 days of project, and be returned to Tufts CTSI at the end of the approved project period)
  • Graduate program tuition, stipends or fees
  • Meals or hospitality (including alcohol)
  • Membership dues, professional fees, rent
  • Postage and mail
  • Budget over-expenditures
  • Other items generally considered “facilities and administrative” expenses.

Cost Sharing

Cost sharing for investigator salaries is discouraged and will be allowed only with written approval of both the appropriate department chair and administrator (please see FAQs for more information).

Subcontracts

Subcontracts, if necessary, should be budgeted separately in the research proposal.

Carryover, Extensions and Over-Expenditures

Carryover of expenses is not allowed. Funds not expended by June 30, 2015 will be retained by Tufts CTSI. No extensions are allowed. An assignment account must be provided to cover any over-expenditure.

Eligibility

Interdisciplinary Team

Eligible applicants are interdisciplinary research teams whose Principal Investigator is a full-time faculty member of a Tufts CTSI academic partner institution at the rank of Assistant Professor or above. Other team members can include faculty members from all Tufts CTSI member institutions and researchers from Tufts CTSI-affiliated community partners. For assistance in finding appropriated Tufts CTSI affiliated collaborations, please feel free to contact a Tufts CTSI navigator. The investigators must represent distinct disciplines and bring synergistic skills that are relevant to the work described across departments and schools. Junior investigators are encouraged to apply and to collaborate with senior researchers. Each member of the research team (except for community partners) must have an eRA Commons Username to meet federal reporting guidelines.

Translational Research

Tufts CTSI seeks to support projects that can move development of a treatment or technology along the translational pathway (from bench to bedside, from bedside to clinical use, and from clinical use to public benefit and policy), bringing the study approach closer to achieving health impact. Tufts CTSI is especially interested in projects that accelerate this translation and demonstrate such progress, as well as innovative projects that use novel research methods. Please note: Clinical Trials beyond Phase IIA will not be considered for pilot funding.

Regulatory Approval

If a project involves human or animal subjects, the appropriate application for IRB and/or IACUC approval must be submitted. Once awardees are notified of funding, they will have ten business days to submit their regulatory paperwork. All IRB/IACUC submissions are due by April 7, 2014 to facilitate approval by the grant start date. Awards for successful applications may be withdrawn if 1) regulatory submissions are not made by April 7, 2014, or 2) final IRB and/or IACUC approval has not been granted by the project start date of July 1, 2014. Applicants are strongly advised to attend an IRB Drop-in Session especially if they are new to Tufts or new to the submission process. Multi-site Catalyst Award applicants are strong encouraged to speak with the Tufts IRB office to discuss any barriers when working with multiple IRBs. Sessions at the Tufts Health Sciences Campus are held every Tuesday from 2:00 to 4:00 PM in the IRB offices on Tupper 1. In addition, individuals are also welcome to call or drop in anytime to talk or make an appointment for a consultation.

How to Apply

There are two phases in the application period: a Letter of Intent and a final application. The Letter of Intent period is designed to begin the collaborative planning for project development, required protocol development, and budget discussions. A total of seven weeks is allotted for application development from the date of this announcement. The deadline for online submission of a Letter of Intent is December 2, 2013 at 12:00 PM (Noon).

  1. The Letter of Intent will be used to plan for application review. The Letter of Intent is available: http://www.tuftsctsi.org/Registration/PilotLetterOfIntent.aspx  
  2. An online application will be made available to applicants on December 9, 2013. Prior to this date, general application instructions will be available. The online submission and the signed face sheet are due to Tufts CTSI by January, 17, 2014 at 12:00 PM (Noon).

Scientific Review Criteria

Each application will be reviewed according to the following criteria:

Significance – quality and merit of the proposed research project.

  1. Does the project address an important problem or critical barrier to progress in the field?
  2. If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?
  3. How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventive interventions that drive this field?

Innovation – clinical design and/or use of novel methodology. High-risk, high-reward proposals are encouraged.

  1. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches, methodologies, instrumentation, or interventions?
  2. Are the above concepts novel to one field, or novel in a broader sense?
  3. Is a refinement, improvement, or new application of the above concepts proposed?

Investigators – qualifications of the research team to carry out proposed research.

  1. Are the investigators/collaborators and other researchers well-suited to the project?
  2. Is there complementary, cross-disciplinary representation of expertise and institutions?

Environment – the overall resources and environment to be used, including the availability of Tufts CTSI resources and services to support the work proposed.

  1. Will the scientific environment in which the work will be done contribute to the probability of success?
  2. Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed?
  3. Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Approach – the relevance to CTSA and Tufts CTSI objectives, including having a clear translational path and explicit relevance to human health.

  1. Are the overall strategy, methodology and analyses well-reasoned and appropriate to accomplish the specific aims of the project?
  2. Are potential problems, alternative strategies, and benchmarks for success presented?
  3. If the project is in the early stages of development, will the strategy establish feasibility, and will particularly risky aspects be managed?
  4. Are appropriate IRB, IACUC, or other regulatory approval documents submitted, and is there a clear plan for full compliance with all federal, state, and institutional policies, rules, and guidelines regarding biomedical ethics?

Catalyst and Multi-site Catalyst Awards will have the following additional review criteria:

  1. Is the proposed project feasible as a basis for future R01- or P01-type applications?
  2. Can the preliminary data that support the proposed project, including data from the literature, be used to develop hypotheses?
  3. Are plans for future funding clearly outlined?
  4. Has a strong case been made in regard to translational research?

Methods Development Awards will have the following additional review criteria:

  1. Is the proposed method novel, with a very high likelihood of being successfully developed during the award’s one-year time frame?
  2. Do the methods enable an approach to research that is new, otherwise was not possible, or was less effective with current methods?
  3. Are plans for future funding clearly outlined?

Grant and Funding Review

The funding recommendation is made independently from the scientific review. A funding recommendation will be made by the review committee based upon available funds and the funding level required for study implementation.

Investigator Agreements upon Funding

All pilot applicants are expected to comply with the following agreements if and when they are funded:

Progress Tracking

The Scientific Training and Review Committee provide scientific support for funded pilot investigators, to aid in their successful conversion to research funding. At the time of the award, a Committee member is assigned to each pilot as the project “coach” to provide scientific and logistical support. At four-to-six months post-award, grantees are required to meet with the entire Committee to present on the progress and challenges faced during their pilot activities. Each grantee also must present their plans for subsequent grant submission based upon findings. At month 12-to-15, each funded pilot investigator is required to make a second presentation to the Training and Review Committee, open to the broader scientific community.

Reporting

Award recipients will be required to submit:

  • Interim quarterly reports:
    • October 1, 2014
    • January 1, 2015
    • April 1, 2015
    • A final report on the project, due to Tufts CTSI on August 1, 2015.

    Publication Requirements

    All publications resulting from pilot studies must comply with the NIH Public Access Policy (http://publicaccess.nih.gov/sponsored.htm). Guidelines for citations are available at http://www.tuftsctsi.org/Library/How-to-Cite-Tufts-CTSI.aspx.
    The Tufts CTSI grant number is UL1 TR001064.

    Future Pilot Review Commitment

    Pilot awardees are expected to serve as reviewers for the Tufts CTSI Pilot Studies Program for 2015.

    Questions?

    Two online Pilot Studies Program RFA Information Sessions will be available:

    To register for either session, please email pilots@tuftsctsi.org.

    In addition, please send all questions to pilots@tuftsctsi.org or call 617-636-CTSI (2874).

    Summary of Key Dates

    Pre-Award

    Online Information Session  November 13, 2013 (8am) 
    Online Information Session  November 18, 2013 (4pm) 
    Letter of Intent Due  December 2, 2013 
    Application available  December 9, 2013 
    Final Application Due  January 17, 2014 at 5:00PM
    Regulatory Documents Due March 5, 2014 at 5:00PM
    Awards Announcement  March 24, 2014 
    Regulatory Submission Deadline  April 7, 2014

    Post-Award

    Pilot Project Award Begins  July 1, 2014 
    Quarterly Reports Due   
        First  October 1, 2014 
        Second  January 1, 2015 
        Third  April 1, 2015 
    Award Period Ends June 30, 2015 
    Final Project Report Due  August 1, 2015 
    Midcourse STRC Presentation  Winter 2015       
    Final Pilot Studies Symposium Fall 2015