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Tufts CTSI Pilot Studies Program

2012 PILOT STUDIES PROGRAM REQUEST FOR APPLICATIONS

Tufts Clinical and Translational Science Institute (CTSI) announces the opportunity to submit an application for the next round of Pilot Studies Awards. The one-year awards will have a project start date of May 1, 2012 and end date of April 30, 2013. The number and type of awards will be based on the distribution among meritorious applications in the mechanisms described below.  For 2012, there is a single solicitation for three award categories:

  1. Planning
  2. 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 conducting 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 planning and preliminary study support.


Types of Awards

Planning Awards

Planning Awards are intended for interdisciplinary research teams of at least two investigators representing the basic, clinical, and/or applied sciences. At least one investigator must have a Tufts University faculty position. Planning Awards are designed as small awards to encourage new collaborative efforts and the development of new hypotheses or methods. The goal of Planning Awards is to make projects eligible for Catalyst Awards or other translational pilot programs.  Planning Awards will be made from $1,500 to $10,000 per award, including direct costs only, for the initiation of collaborative ventures and refinement of hypotheses.

Catalyst Awards

Catalyst Awards are intended for interdisciplinary research teams of at least two investigators, representing the basic, clinical, and/or applied sciences. At least one investigator must have a Tufts University faculty position. The objective of Catalyst Awards is to develop sufficient preliminary data to secure future extramural funding. Thus, the collaborators must have developed a preliminary hypothesis underlying the research and must have a defined plan for eventually 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.

Methods Development Awards

Methods Development Awards are intended for at least one investigator that holds a Tufts University faculty appointment.  Interdisciplinary teams are encouraged.  Clinical and Translational Science Awards (CTSAs) facilitate the translation of basic biomedical research findings from bench to bedside (T1) and bedside to practice (T2) into impact on 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.  Thus, proposals should have a preliminary hypothesis for developing a new translational research method as well as a defined plan for seeking extramural funding for additional research and dissemination.  Methods Development Awards will be made for up to $30,000 per award and include direct costs only.

 

Pilot Awards Comparison Chart

Criterion/Requirement  Planning  Catalyst  Methods Development
Product (Outcome)
  • Preliminary hypothesis
  • Defined plan for next steps in funding
  • Preliminary data
  • Defined plan for extramural funding
  • Preliminary data on new translational method
  • Defined plan for extramural funding
Interdisciplinary Team Yes Yes Desirable
At least one Tufts faculty member Yes Yes Yes
Preliminary Hypothesis No Yes Yes
Next Steps Intramural funding Extramural funding Extramural funding
Amounts Up to $10,000 Up to $30,000 Up to $30,000

 

Budget and Funding Requirements

Allowable Costs

For all awards, funds may be used as direct costs for investigator salaries, support staff such as research assistants and technicians, 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
  • 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 and Extensions

Carryover of expenses is not allowed.  Funds not expended by April 30, 2013 will be retained by Tufts CTSI.  No extensions are allowed.


Eligibility

Interdisciplinary Team

Eligible applicants are interdisciplinary research teams in which the principal investigator is a full-time faculty member of Tufts University at the rank of Assistant Professor or above.  Other team members can include eligible faculty members from all Tufts CTSI member institutions and researchers from Tufts CTSI-affiliated community partners. 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 investigator 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. Particularly attractive will be innovative projects that will accelerate this translation and demonstrate such progress.

Regulatory Approval

If a project involves human or animal subjects, the appropriate application for IRB and/or IACUC approval should be submitted as part of the pilot application paperwork (they should not be submitted directly to IRB, IACUC, or IBC office).  Awards for successful applications may be withdrawn if final IRB and/or IACUC approval has not been granted by the project start date of May 1, 2012.  Assistance from IRB, IACUC, IBC, and Research Design Center personnel will be made available to interested applicants between October 11, 2011 and November 18, 2011.


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 ten weeks is allotted for application development.

  1. A Letter of Intent is required and due to be submitted by e-mail by Friday, October 28, 2011 at 12:00 PM (Noon).  The Letter of Intent will be used to plan for application review.   The Letter of Intent is available here.
  2. An online application will be made available to applicants on Monday, October 31, 2011.  General application instructions will be available on this site prior to that time.  The application will be submitted online as PDF documents, with required signatures by the primary applicant’s department/division chief and administrator.  The online submission is due to Tufts CTSI by Friday, December 9, 2011 at 12:00 PM (Noon).


Scientific Review Criteria

Each application will be reviewed against the following criteria:

  • Significance – quality and merit of the proposed research project.
    • Does the project address an important problem or critical barrier to progress in the field?
    • If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?
    • 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.
    • Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches, methodologies, instrumentation, or interventions?
    • Are the above concepts novel to one field, or novel in a broader sense?
    • Is a refinement, improvement, or new application of the above concepts proposed?
  • Investigators – qualifications of the research team to carry out proposed research.
    • Are the investigators/collaborators and other researchers well suited to the project?
    • 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.
    • Will the scientific environment in which the work will be done contribute to the probability of success?
    • Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed?
    • 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.
    • Are the overall strategy, methodology, and analyses well reasoned and appropriate to accomplish the specific aims of the project?
    • Are potential problems, alternative strategies, and benchmarks for success presented?
    • If the project is in the early stages of development, will the strategy establish feasibility, and will particularly risky aspects be managed?
    • 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?

Planning Awards will have the following additional review criteria:

  • The potential of the proposed partnerships to create productive collaborations within the scope of translational research.
  • The feasibility of the initial idea, with hypotheses or study questions arising from the relevant literature.
  • Delineation of plans for future funding.

Catalyst Awards will have the following additional review criteria:

  • The potential feasibility of the proposed project as a basis for future R01- or P01-type applications.
  • Preliminary data supporting the proposed project, including data from the literature that may be used to develop hypotheses.
  • Delineation of plans for future funding.

Methods Awards will have the following additional review criteria:

  • The proposed method is novel and has a very high likelihood of being successfully developed during the one-year timeframe with the resources awarded.
  • Such methods must enable an approach to research that is new, otherwise was not possible, or was less effective with current methods.
  • Delineation of plans for future funding.

 

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 when they are funded:

Reporting

Award recipients will have several required reports:

  1. Interim quarterly reports will be due:
    1. Friday, August 3, 2012
    2. Friday, November 2, 2012
    3. Friday, February 1, 2013
  2. A final report on the project will be due to Tufts CTSI Friday, May 23, 2013.
  3. A brief presentation of project findings will be scheduled at a date to be determined in the spring of 2013.

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 RR025752.

Future Pilot Review Commitment

Pilot awardees are expected to serve as reviewers for the Tufts CTSI Pilot Studies Program for 2013.

 

Information Sessions and Proposal Development Assistance

Two information sessions have been scheduled to provide information about the Pilot Studies Program and award application process.  The sessions will include information on resources offered by the Tufts CTSI Central Office, Research Design Center (RDC ), Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC), and Institutional Biosafety Committee (IBC) and will be held on the following dates:

  • Thursday, October 13, 2011 1:00 PM to 2:00 PM Sackler Building, Room 114E
  • Tuesday, October 18, 2011 3:00 PM to 4:00 PM Sackler Building, Room 114E

 

Questions?

Please send all questions to pilots@tuftsctsi.org.   If your question is urgent, please contact Wilfred McCalla at 617.636.1122.

 

Summary of Key Dates


Pre-Application

Information Sessions Thursday, October 13, 2011 1:00PM – 2:00PM
  Tuesday, October 18, 2011 3:00PM – 4:00PM 
Letter of Intent due Friday, October 28, 2011 12:00 PM (Noon)
Proposal Development Assistance October 14 – November 18, 2011
Final application due Friday, December 9, 2011 12:00 PM (Noon)
Announcement of Awards Wednesday, February 15, 2012


Post-Application

Pilot project award begins Tuesday, May 1, 2012 
First quarterly report due Friday, August 3, 2012
Second quarterly report due Friday, November 2, 2012
Third quarterly report due Friday, February 1, 2013
Pilot project award ends Tuesday, April 30, 2013
Final project report due Friday, May 23, 2013
Brief presentation of project findings TBD