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Tufts CTSI Pilot Studies Program

Request for Applications

Tufts Clinical and Translational Science Institute (CTSI) is pleased to announce the application period for the 2016 Pilot Studies Program is now open. Selected projects will be funded for one year, beginning May 1, 2016 and ending April 30, 2017.

This Request for Applications seeks to fund innovative, high impact, translational science projects.


Summary of Key Dates: Pre-Award

Online Information Session Monday, August 24, 2015, 8:30AM 
Online Information Session  Wednesday, September 16, 2015, 4:00PM 
Letter of Intent Due  Friday, September 25, 2015, 5:00PM 
Application Available  Wednesday, October 7, 2015 
Final Application Due  Friday, November 6, 2015, 5:00PM 
Awards Announcement  Friday, January 15, 2016    
Regulatory Submission Deadline Friday, February 19, 2016, 5:00PM

Summary of Key Dates: Post-Award

Pilot Project Award Begins  May 1, 2016 
Award Period Ends  April 30, 2017 
Final Project Reports Due  July 28, 2017 
Midcourse STRC Presentation  Winter 2017 
Final Pilot Studies Symposium Fall 2017


Tufts Clinical and Translational Science Institute (CTSI)

The mission of Tufts CTSI is to identify, stimulate, and facilitate innovative clinical and translational research, with the goal of improving the public’s health. To reach this goal, we link researchers 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. Supported by NIH at 62 institutions across the country, Clinical and Translational Science Awards (CTSAs) impact health by promoting research that translates basic biomedical research from bench to bedside (the first translational step, T1), from bedside to practice (T2), and into widespread practice and impact on the public and on policy (T3 and T4). Tufts CTSI cultivates collaboration and innovation by offering education and training, research expertise, and financial support to investigators. Translation, as defined by the National Center for Advancing Translational Sciences (NCATS), is the process of turning observations in the laboratory, clinic, and community into interventions that improve the health of individuals and populations, including, for example, diagnostics, therapeutics, medical procedures, and behavioral interventions. To learn more about translational science, please click here.  

Tufts CTSI is committed to supporting researchers in the development of new translational research methods. In addition, Tufts CTSI leverages its strengths and 39 partner institutions to support translational research in its Signature Program research areas including:

Funding for the 2016 Pilot Studies Program will prioritize Methods Development in addition to the Signature Program research areas. Applicants may propose projects outside of these areas as well.

For more information about Tufts CTSI Signature Programs or to request a consultation, please visit: http://www.tuftsctsi.org/Services-and-Consultation/Request-Services-or-Ask-a-Question.aspx.  


The Tufts CTSI Pilot Studies Program

Tufts CTSI Pilot Studies Program seeks proposals for innovative, high impact, translational science projects with a focus on building interdisciplinary, multi-institutional research teams including investigators from the basic, clinical, and/or applied sciences. Applicants are strongly encouraged to focus on one of Tufts CTSI’s Signature Program areas and/or the development of new translational research methods across the T1-T4 spectrum. The Tufts CTSI Pilot Studies Program funds seed projects that will allow applicants to generate sufficient preliminary data to secure future extramural funding, or to develop new methods that will significantly advance translational science. All applicants should 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) or a defined plan for the application and dissemination of new research methods (i.e., extramural funding, publications, conferences, etc.). Junior investigators are encouraged to apply and to collaborate with senior researchers.

Budget and Funding Requirements

Budget

Tufts CTSI Pilot Studies Program awards will be made to individuals or teams from Tufts CTSI’s 39 partner institutions for $5,000 up to $30,000 per award. In order to stimulate collaboration, Tufts CTSI will also consider multi-site applications including Principal Investigators (PIs) from up to three Tufts CTSI partner institutions with an incremental budget allocation up to $5,000 to $15,000 per additional site (e.g., a two-site pilot could request a total budget of up to $45,000 and three-site pilot could request a total budget of up to $60,000). Pilots may request direct costs only.

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 benefits; 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 pilot is completed.

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 is the portion of pilot project costs that are not paid for by the pilot project budget.

Cost sharing for investigator salaries is discouraged and will be allowed only with written approval of both the appropriate department chair and administrator.

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 April 30, 2017 will revert toTufts CTSI. Related to the NIH rules for CTSAs, extensions cannot be allowed. An assignment account must be provided to cover any over-expenditure.


Eligibility

Principal Investigators and Research Team Members

Eligible applicants include members of Tufts CTSI’s 39 partner institutions, which span 12 Tufts University schools and centers, 10 affiliated hospitals, nine community organizations, five industry and nonprofit organizations, and three academic partners outside of Tufts. Please refer to the Tufts CTSI website for a complete list of partners.

Proposals must designate a Principal Investigator (PI) with a primary appointment or position at a Tufts CTSI academic, medical, or nonprofit research partner institution.

Secondary PIs and other team members included in a proposal must hold positions at a Tufts CTSI partner institution. Each budgeted key personnel member of the research team must have an eRA Commons Username at the time of award to meet federal reporting guidelines.

For assistance in finding appropriate Tufts CTSI affiliated collaborators, please contact a Tufts CTSI Navigator.

Investigators who previously received a Tufts CTSI pilot award may apply to the program again to obtain funding only for a new research project and will not be considered for additional funding for a project previously supported through the program. Investigators who have received two Tufts CTSI pilot awards are not eligible to apply for another award until five years from the end date of their last award. For example, an investigator who received a second pilot award ending in 2015 is not eligible to apply again until 2020.

Multi-Site Research Teams

Applicants seeking funding for multi-site research projects must include PIs with primary appointments or positions from at least two, but no more than three, Tufts CTSI academic, medical, or non-profit research partner institutions. Partners are listed below and can be found on the Tufts CTSI website.

Each site included in the proposal must designate a Primary PI responsible for managing communication of the overall project and may also include secondary PIs or other team members at each site. Members of multi-site research teams must meet all Tufts CTSI Pilot Award eligibility requirements.
Multi-Site projects can include:

  • Action for Boston Community Development (ABCD)
  • Asian Community Development Corporation
  • Asian Task Force Against Domestic Violence
  • Asian Women for Health
  • Baystate Medical Center
  • Blue Cross Blue Shield of Massachusetts
  • Boston Chinatown Neighborhood Center
  • Brandeis University
  • Carney Hospital
  • Greater Boston Chinese Golden Age Center
  • Health Resources in Action
  • Institute for Systems Biology and P4 Medicine Institute
  • Lahey Hospital & Medical Center
  • Maine Medical Center
  • MetroWest Medical Center
  • Minuteman Health Network
  • Museum of Science, Boston
  • New England Baptist Hospital
  • New England Quality Care Alliance
  • New England Sinai Hospital and Rehabilitation Center
  • Newton-Wellesley Hospital
  • Northeastern University
  • Pfizer, Inc.
  • RAND Corporation
  • St. Elizabeth’s Medical Center
  • Tufts Health Plan
  • Tufts Medical Center
  • Tufts University

To confirm your proposal meets the multi-site eligibility criteria, please schedule a consultation with the Tufts CTSI Research Collaboration Team.

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 10 business days to submit their regulatory paperwork. All IRB/IACUC submissions are due by February 19, 2016 at 5:00PM to facilitate approval by the grant start date. Awards for successful applications may be withdrawn if 1) regulatory submissions are not made by February 19, 2016 at 5:00PM, or 2) final IRB and/or IACUC approval has not been granted by the project start date of May 1, 2016. All applicants are strongly encouraged to contact their IRB/IACUC office as well as any participating IRB/IACUC offices to discuss any potential issues. 
 

How to Apply

There are two phases in the application period: a Letter of Intent (LOI) and a final application. The LOI period is designed to begin the collaborative planning for project development, required protocol development, and budget discussions.

The LOI submission is open on a rolling basis until September 25, 2015 at 5:00PM. All applicants who submit their LOI before September 1, 2015 will be contacted by a member of the Tufts CTSI Research Collaboration Team. Applicants are encouraged, but not required, to work with the Research Collaboration Team in order to catalyze proposal development efforts by advancing projects, fostering collaboration, and facilitating infrastructure. The Tufts CTSI Research Collaboration Team can provide methodological and technical support, identify additional project team members as required, and assist teams to develop proposals. In addition, the Tufts CTSI Research Collaboration Team will ensure applicants meet all eligibility and funding requirements which includes submission as a new method, signature program, or multi-site proposal as well as meeting all primary PI and multi-site requirements. If you would like to speak to a member of the Research Collaboration Team prior to submitting a LOI, please request a service.

Two online WebEx information sessions will be available on August 24, 2015 at 8:30AM and September 16, 2015 at 4:00PM. 

The deadline for online submission of a Letter of Intent is September 25, 2015 at 5:00PM.

  1. The LOI will be used to plan for application review. The LOI is available here: http://www.tuftsctsi.org/Registration/PilotLetterOfIntent.aspx
  2. An online application will be made available to applicants on October 7, 2015. On this date, general application instructions will also be available. The completed application and the signed face sheet are due to Tufts CTSI by Friday, November 6, 2015 by 5:00PM.

Scientific Review Criteria

Each application will be reviewed according to the following criteria:

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

  1. Has a strong case been made in regard to translational research?
  2. Does the proposed project take an interdisciplinary approach to answering a question or solving a problem?
  3. Does the proposed project address a question or problem in a Tufts CTSI Signature Program research area or yield a new translational research method?
  4. If a multi-site project is proposed, is it clear how the research is linked across sites?

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?
  4. If the development of new methods is proposed, do the methods enable an approach to research that is new, otherwise was not possible, or was less effective with current methods?

Innovation – high-reward proposals are encouraged.

  1. Does the project challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches, methodologies, instrumentation, or interventions?
  2. Will the proposed work have a broad application across disciplines?
  3. Is the project a development of a novel method or a new application of an existing method?

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

  1. Do the investigators/collaborators for the project have appropriate skills and training to complete the project?
  2. Is there complementary, cross-disciplinary representation of expertise at multiple 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 – clinical or methodological design plan will allow research team to meet proposed objectives and goals.

  1. Is the proposed project innovative, with a very high likelihood of being successfully developed during the award’s one-year time frame?
  2. Are the overall strategy, methodology and analyses well-reasoned and appropriate to accomplish the specific aims of the project?
  3. Are potential problems, alternative strategies, and benchmarks for success presented?
  4. If the project is in the early stages of development, will the strategy establish feasibility, and will particularly risky aspects be managed?
  5. 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?

Future Plans - clear articulation of next steps.

  1. Can the preliminary data that support the proposed project, including data from the literature, be used to develop hypotheses?
  2. If the development of new research methods is proposed, are the applications and plans for dissemination clearly outlined?
  3. Are plans for subsequent funding clearly outlined? Is the proposed project feasible as a basis for future R01- or P01-type applications (not a requirement of methods development proposals)?
  4. For multi-site projects, how will the entire project team plan to seek extramural funding across all sites?

Scoring: Tufts CTSI follows NIH guidelines for peer review for significance, innovation, approach and overall impact. Reviewers are selected from the Tufts CTSI Pilot Studies Program Scientific Training and Review Committee pool. Proposals that successfully incorporate a Tufts CTSI signature program or focus on the development of a new research method will receive a one point improvement in their overall impact score. 

Grant and Funding Review

The funding recommendation is made independently from the scientific review. Funding recommendations will be made by the review committee based upon available funds, the funding level required for study implementation, and distribution by translational spectrum. 
 

Investigator Agreements upon Funding

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

Progress Tracking

The STRC provides 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 STRC at a meeting that will be open to the broader scientific community.

Reporting

Award recipients will be required to submit a final report on the project, due to Tufts CTSI on July 28, 2017.

Publication Requirements

All publications resulting from pilot studies must comply with the NIH Public Access Policy.
Guidelines for citations are available here.

The Tufts CTSI award number is UL1TR001064 (verbatim).


Future Pilot Review Commitment

Pilot awardees are expected to serve as reviewers for future Tufts CTSI Pilot Studies Program Applications.

Long-term Outcomes Tracking

Pilot awardees are required to report subsequent outcomes (such as any publications, extramural funding, and conference presentations) resulting from the work completed from the Tufts CTSI Pilot Studies Program.

Questions?

Two online WebEx information sessions will be available:

  • Monday, August 24, 2015, 8:30AM
  • Wednesday, September 16, 2015, 4:00PM

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).