Tufts Clinical and Translational Science Institute (CTSI) is pleased to announce the application period for the 2015 Pilot Studies Program is now open. Selected projects will be funded for one year, beginning May 1, 2015 and ending April 30, 2016.
This Request for Applications seeks to fund innovative, high impact, translational science projects.
Tufts Clinical and Translational Science Institute (CTSI)
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 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. Clinical and Translational Science Awards (CTSAs) 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). Tufts CTSI cultivates collaboration and innovation by offering education and training, research expertise, and financial support to investigators.
Tufts CTSI is committed to support 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:
- Stakeholder and Community Engagement
- Comparative Effectiveness Research
- One Health
Funding for the 2015 Pilot Studies Program will prioritize Methods Development and the Signature Program research areas.
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 Pilot Studies Program
Tufts CTSI's 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 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
Tufts CTSI Pilot Studies Program awards will be made to individuals or teams from Tufts CTSI’s 39 partner institutions for up to $30,000 per award and include direct costs only. 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 a budget allocation up to $30,000/site (e.g., a three-site pilot could request a total budget of up to $90,000) and include direct costs only.
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 funds are exhausted.
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 for investigator salaries is discouraged and will be allowed only with written approval of both the appropriate department chair and administrator.
Cost sharing is the portion of pilot project costs that are not paid for by the pilot project budget. For example, investigators who include effort but do not request funding in the budget to cover that effort will need the approval of the department chair and /or their department administrator at time of application.
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, 2016 will be retained by Tufts CTSI. No extensions are allowed. An assignment account must be provided to cover any over-expenditure.
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, 3 academic partners outside of Tufts, 9 community organizations, and 5 industry and nonprofit organizations.
Proposals must designate a Primary PI with a primary appointment or position at a Tufts CTSI academic, medical, or non-profit research partner institution. These include:
12 Tufts University schools and centers
- Cummings School of Veterinary Medicine
- Fletcher School of Law and Diplomacy
- Friedman School of Nutrition Science and Policy
- Institute for Clinical Research and Health Policy Studies at Tufts Medical Center
- Jean Mayer USDA Human Nutrition Research Center on Aging
- Sackler School of Graduate Biomedical Sciences
- School of Arts and Sciences
- School of Dental Medicine
- School of Engineering
- School of Medicine
- Tisch College of Citizenship and Public Service
- Tufts Center for the Study of Drug Development
10 affiliated hospitals
- Baystate Medical Center
- Carney Hospital
- Lahey Hospital & Medical Center
- Maine Medical Center
- MetroWest Medical Center
- New England Baptist Hospital
- New England Sinai Hospital and Rehabilitation Center
- Newton-Wellesley Hospital
- St. Elizabeth’s Medical Center
- Tufts Medical Center
3 academic partners outside of Tufts
- Brandeis University
- Northeastern University
- RAND Corporation
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 2013 is not eligible to apply again until 2018.
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 (see list of eligible institutions above). 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. To confirm your proposal meets the multi-site eligibility criteria, please contact firstname.lastname@example.org.
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 February 20, 2015 to facilitate approval by the grant start date. Awards for successful applications may be withdrawn if 1) regulatory submissions are not made by February 20, 2015, or 2) final IRB and/or IACUC approval has not been granted by the project start date of May 1, 2015. 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 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. The deadline for online submission of a Letter of Intent is October 10, 2014 at 5:00PM.
- The Letter of Intent will be used to plan for application review. The Letter of Intent is available here: http://www.tuftsctsi.org/Registration/PilotLetterOfIntent.aspx
- An online application will be made available to applicants on October 17, 2014. On this date, general application instructions will also be available. The completed application and the signed face sheet are due to Tufts CTSI by November 21, 2014 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.
- Has a strong case been made in regard to translational research?
- Does the proposed project take an interdisciplinary approach to answering a question or solving a problem?
- Does the proposed project address a question or problem in a Tufts CTSI Signature Program research area or yield a new translational research method?
- 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.
- 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?
- 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.
- Does the project challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches, methodologies, instrumentation, or interventions?
- Will the proposed work have a broad application across disciplines?
- 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.
- Do the investigators/collaborators for the project have appropriate skills and training to complete the project?
- 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.
- 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 – clinical or methodological design plan will allow research team to meet proposed objectives and goals.
- Is the proposed project innovative, with a very high likelihood of being successfully developed during the award’s one-year time frame?
- 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?
Future Plans - clear articulation of next steps.
- Can the preliminary data that support the proposed project, including data from the literature, be used to develop hypotheses?
- If the development of new research methods is proposed, are the applications and plans for dissemination clearly outlined?
- 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)?
- 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 deduction to the 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:
The Scientific Training and Review Committee 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 Scientific Training and Review Committee at a meeting that will be open to the broader scientific community.
Award recipients will be required to submit a final report on the project, due to Tufts CTSI on July 29, 2016.
All publications resulting from pilot studies must comply with the NIH Public Access Policy (http://publicaccess.nih.gov/). Guidelines for citations are available at http://www.tuftsctsi.org/Library/How-to-Cite-Tufts-CTSI.aspx.
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.
Two online WebEx information sessions will be available:
- September 26, 2014, 8:30AM
- October 6, 2014, 4:00PM
To register for either session, please email email@example.com.
In addition, please send all questions to firstname.lastname@example.org or call 617-636-CTSI (2874).
Summary of Key Dates
|Online Information Session
||September 26, 2014, 8:30AM|
|Online Information Session
||October 6, 2014, 4:00PM|
|Letter of Intent Due
||October 10, 2014, 5:00PM|
||October 17, 2014|
|Final Application Due
||November 21, 2014, 5:00PM|
||February 6, 2015|
|Regulatory Submission Deadline
||February 20, 2015|
|Pilot Project Award Begins
||May 1, 2015|
|Award Period Ends
||April 30, 2016|
|Final Project Report Due
||July 29, 2016|
|Midcourse STRC Presentation
||Winter 2016 |
|Final Pilot Studies Symposium