What is the Tufts CTSI Pilot Studies Program?
The Tufts CTSI Pilot Studies Program is a funding opportunity supported by the National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH). The program provides one-year awards to investigators and research teams at Tufts CTSI-affiliated partner and collaborator organizations. It aims to improve health by supporting new, innovative, interdisciplinary, high-impact, translational science projects rather than established projects or extensions of ongoing research. Applicants are expected to have a defined plan for the publication and dissemination of all research results and for seeking future extramural funding. They should also have an integrated strategy for engaging relevant stakeholders to support collective action for health improvement.
What is the National Center for Advancing Translational Sciences (NCATS)?
NCATS is the funding agency of Tufts Clinical and Translational Science Institute (Tufts CTSI). It is one of 27 institutes and centers at the National Institutes of Health (NIH). Its Clinical and Translational Science Awards (CTSA) Program supports a national network of medical research institutions, including Tufts CTSI, to help catalyze innovation in training, research tools and processes so that new treatments and cures for disease can be delivered to patients faster.
What awards are granted?
The Pilot Studies Program supports projects that provide generalizable insights to advance cutting-edge prevention practices, facilitate translation of new treatments and cures for disease into clinical care, and increase the overall effectiveness and quality of health care and public health interventions – thereby improving the health and well-being of the public. To help address existing translational roadblocks, the program supports research projects across the full translational spectrum. In addition, the program prioritizes actionable research that improves health outcomes of the community and advances health equity for traditionally marginalized, underserved, and underrepresented populations.
What is translational science?
NCATS defines translation as “the process of turning observations in the laboratory, clinic, and community into interventions that improve the health of individuals and populations – from diagnostics and therapeutics to medical procedures and behavioral interventions.” The translational science spectrum is generally divided into four interconnected stages, with each stage building upon and informing the others. The spectrum includes translation of basic biomedical research into demonstrated effects for patients or from bench to bedside (T1), from bedside to practice (T2), from clinical practice to widespread clinical practice and care delivery (T3), and from widespread clinical care delivery to new health policies aimed at improving public’s health (T4). Tufts CTSI also recognizes a critical phase which cycles between “basic” research and early clinical investigation (T1), which we call T.5 research. This bidirectional, nonlinear phase helps improve translational potential of basic biomedical discoveries and prototypes, bridging the pre-clinical development to initial human studies. To learn more about translational science and the translational spectrum for Tufts CTSI, please click here.
Does the program fund basic research?
No. Basic research (earlier than T.5), while a critically important foundation for translational research, is not part of the translational spectrum and focuses on gaining greater knowledge and understanding of the fundamental mechanisms of biology, disease, or behavior. Basic research identifies opportunities and potential approaches to health problems and includes a broad range of approaches employing animal models of human disease, research in tissue culture cell lines, computational models, human physiological studies, and non-interventional, correlational epidemiologic studies. Basic research yields knowledge about basic biological, social, and behavioral mechanisms and presentations of human disease.
Does the program fund clinical trials?
Yes. The Pilot Studies Program funds studies that involve human subjects, including those that meet the NIH definition of a clinical trial. However, it can only support clinical trial activity through the end of Phase IIB. As a general rule, Phase I clinical trial studies include those that involve testing of a drug or treatment in a small group of people (20-80) for the first time to learn about its safety and identify side effects. Phase II studies include those that involve giving the new drug or treatment to a larger group of people (100-300) to determine its effectiveness and to further study its safety. If you are unsure if your clinical trial study can be supported by the program or if your clinical trial activities involve treatment of a rare disease or condition, please contact the Pilot Studies Program team for assistance at email@example.com.
How do I know if my research meets the NIH definition of a clinical trial?
NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. To determine whether or not the study meets the definition of a clinical trial, answer the following four questions:
- Does the study involve human participants in research?
- Are participants prospectively assigned to an intervention?
- Is the study designed to evaluate the effect of the intervention on the participants?
- Is the effect being evaluated a health-related biomedical or behavioral outcome?
If the answers to all questions are yes, the study meets the NIH definition of a clinical trial, even if:
- The study involves only healthy participants;
- The study does not have a comparison group (e.g., placebo or control);
- The study is only designed to assess the pharmacokinetics, safety, and/or maximum tolerated dose of an investigational drug;
- The study is utilizing a behavioral intervention.
The study does NOT meet the NIH definition of a clinical trial if:
- It is intended solely to refine measures;
- It involves secondary research with biological specimens or health information.
Who is eligible to apply?
Principal Investigators (PIs) must have a primary appointment or position at a Tufts CTSI-affiliated academic, medical, industry, not-for-profit, or community partner organization and be eligible to receive NIH funding. Research teams may include collaborators who are not affiliated with Tufts CTSI. All PIs and Multiple PIs (Co-PIs) are required to have an Electronic Research Administration (eRA) Commons username. If the proposed project is funded, other budgeted key personnel will be required to have eRA Commons usernames as well. These usernames may be obtained from the research administration office of the investigator’s organization. To see a list of eligible partner organizations, please click here.
If I previously received a Tufts CTSI Pilot Studies Program grant, may I apply again?
Yes, you may apply again. However, your funding request must be for a new project; a follow-on project previously supported through the program will not be considered. If you have served as a PI or a Multiple PI (Co-PI) on two Tufts CTSI pilot awards, you will not be eligible to apply as key personnel for another award until five years from the end date of your last award. For example, a PI who received a second pilot award that ended in 2016 will not be eligible to re-apply as a PI or Multiple PI (Co-PI) until 2021. To be considered for new funding, you must comply with all prior award reporting requirements. Failure to report study outcomes may preclude you or your research team members from being eligible for new Tufts CTSI funding.
What is the expected duration of the 2021 Pilot Studies Program award?
Selected Tufts CTSI Pilot Studies Program projects will be supported for one year, beginning May 1, 2021 and ending April 30, 2022, pending official approval of our funding agency, NIH/NCATS. Please make sure to review all post-award procedures and requirements for details on the prior approval process and timeline.
What are the different types of funding levels?
Awards will be made to individual investigators and research teams from Tufts CTSI partner and collaborator organizations for up to $30,000 per award. To stimulate collaboration, Tufts CTSI will also consider funding multi-site research projects led by investigators from up to three Tufts CTSI-affiliated organizations with an incremental budget allocation up to $15,000 per additional organization. For example, research teams including collaborators from two Tufts CTSI-affiliated organizations could request a total budget of up to $45,000 and research teams including collaborators from three Tufts CTSI-affiliated organizations could request a total budget of up to a maximum award amount of $60,000. Funds for multi-site research projects may be allocated across sites in accordance with project needs. Please note that Tufts CTSI-affiliated for-profit organizations are eligible as sites, but they may not receive funding.
What qualifies as a “multi-site research project”?
Applicants seeking funding for a multi-site research project must include research team members with primary appointments or positions at two or three Tufts CTSI-affiliated organizations. Each site must designate a contact PI responsible for the scientific development and execution of a project. Research teams may include other personnel at each site including investigators from the basic, clinical, and/or applied science. Members of multi-site research teams must meet all Tufts CTSI Pilot Studies Program eligibility requirements. Please note that the schools and centers of Tufts University are considered one site for the purposes of this program. For example, if your project includes Tufts University School of Medicine and Tufts University School of Engineering, both schools count as one site, not two.
Can my research team include collaborators who are not affiliated with Tufts CTSI?
Yes, research teams may include collaborators from organizations not affiliated with Tufts CTSI and/or who do not have a primary appointment or position at Tufts CTSI-affiliated organization. However, their organization will not be considered as a funded site for a multi-site proposal.
Are there any budget restrictions or limitations?
Applicants may request funds for direct costs only. Such costs must be necessary and reasonable to complete the work described in their proposals. These may include key personnel and support staff (e.g., student or research assistant, technician) salaries and fringe benefits; consultant services (e.g., biostatistician, biomedical informatician, recruitment and retention specialist); clinical support; stipends or compensation for stakeholders involved in the project; participant incentives; and laboratory research supplies and consumables. 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.
Indirect costs are not allowed and will not be covered. Unallowable indirect 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
- Conference registration and attendance costs (including airfare, hotels, and ground transportation)
- Postage and mail (unless specifically required and justified)
- Budget over-expenditures
- Other items generally considered “facilities and administrative” or operating expenses
What are the application requirements and due dates for the Pilot Studies Program?
Unless otherwise announced, the Request for Applications is issued annually in the late summer/early fall of each calendar year.
The 2021 application is a two-step process. It involves submission of an initial Letter of Intent (LOI). Unlike in previous years, the LOI is meant to present an abbreviated description of the ultimate proposal – not just a high level overview limited to a 250 word summary.
The LOI should include a project narrative, a list of specific aims, a description of how the proposed research will translate into direct impact on human health, and a brief statement describing how the proposed research can be feasibly conducted during possible pandemic COVID-19-related closures and/or associated restrictions on research activities.
If determined that the research team is eligible to apply and proposed research is in line with the mission of Tufts CTSI and the objective of the Pilot Studies Program for 2021, the primary applicant will be invited to submit a full proposal.
The 2021 Pilot Studies Program key pre-award dates are:
- Letter of intent submission period: rolling basis through Wednesday, October 7, 2020 at 11:59 PM
- Proposal due: Wednesday, November 18, 2020 at 11:59 PM (by invitation only)
- Award announcement: January 2021
May I submit two or more pilot project ideas?
Yes. Provided that you meet the eligibility requirements, you may submit more than one research proposal; however, we encourage you and your research team to prioritize quality over quantity.
Does my study need to be IRB/IACUC-approved prior to proposal submission?
No. IRB and IACUC approvals are not required at the time of proposal submission, but applicable awarded projects will be required to obtain IRB/IACUC approval before seeking NIH/NCATS approval. Please note: projects involving human and animal subjects may not begin until all institutional and regulatory approvals, including NIH/NCATS, are received. To learn more about the project prior approval process and timeline, please click here.
How will my application be reviewed?
Applications will be reviewed for scientific merit following modified NIH guidelines for peer review. Each application will be assigned at least two peer reviewers with relevant expertise from the Tufts CTSI Pilot Studies Program Scientific Training and Review Committee (comprised of past pilot awardees and other investigators from Tufts CTSI partner and collaborator organizations). Key scientific review criteria include:
- Ability to advance translational interdisciplinary research, significance and scientific rigor of the proposed pilot project
- Potential to shift current research or clinical practice paradigms by using novel approaches
- Qualifications of the research team
- Likelihood of meeting proposed objectives and goals
- Clear articulation of next steps (e.g., plans and timeline for publishing research results and seeking extramural funding).
In addition, all stakeholder engagement plans will be reviewed by at least two members of the Tufts CTSI Stakeholder Expert Panel (comprised of community members with diverse professional and cultural backgrounds) and/or Tufts CTSI Stakeholder and Community Engagement Task Force (comprised of Tufts CTSI staff and faculty with expertise in early-stage translational research). Both reviewer groups will evaluate the applicants’ ability to identify relevant stakeholders, engage these stakeholders in the research project, and articulate relevance of project outcomes to the identified stakeholder groups and the public. To learn more about the review criteria, please click here.
May I apply simultaneously for a KL2 Career Development Award Program grant and a Pilot Studies Program grant?
Yes. A single PI or a Multiple PI (Co-PI) may submit both a KL2 and a pilot application. These two applications will be reviewed and scored independently by separate review committees. Please note, however, a PI or a Multiple PI (Co-PI) cannot be awarded a simultaneous KL2 and Pilot Studies Program award. If an investigator has a KL2 award, he or she may only serve as a Co-I of a Pilot Studies Program application. This pilot study must be a different research project than that proposed for the KL2 program.
Does Tufts CTSI offer any assistance with proposal development?
Tufts CTSI offers an array of pre-award research services at no cost to investigators with primary appointments or positions at Tufts CTSI partner organizations. We strongly encourage applicants to take advantage of these resources and services to help them prepare the most responsive and competitive grant application. Our research service include:
- Lead and Content Area Navigators and Research Collaboration Team – guidance about the inclusion, provision, and deployment of Tufts CTSI resources and services to enhance protocol development, speed study enrollment, and improve and accelerate the adoption of research results into practice; connections to mentors and collaborators; methodological consultations; facilitation of multi-institutional projects.
- Biostatistics, Epidemiology, and Research Design (BERD) Center – determination of specific aims and hypothesis; assistance with research grant and protocol development (e.g., study design, power and sample size calculations, analysis and randomization plans).
- Stakeholder and Community Engagement – assistance with stakeholder engagement plan development; guidance for and assistance with engaging stakeholders and community members in research; promotion and facilitation of stakeholder engagement; capacity-building for community partnerships.
- Informatics – cohort discovery to identify eligible populations for prospective research projects; assistance obtaining data for retrospective research projects; help with database development and collection and management of research data.
- Multi-Site Clinical Research Center (MCRC) – protocol review and development; site identification; multi-site study support and coordination; participant recruitment and retention; guidance on, and facilitated access to, central Institutional Review Boards (IRBs) and Data and Safety Monitoring Boards (DSMBs); access to industry trial opportunities.
- T.5 Capacity in Medical Devices – consultations on conducting pre-clinical, early-phase human research, and proof-of-concept studies; study planning and operationalization; regulatory consultations.
- Recruitment and Retention Support Unit (RRSU) in collaboration with the Integration of Underrepresented Population in Research (IUPR) Program – development of approaches to recruitment and retention, including of children, elderly, and medically and socially vulnerable populations; advice on best practices for integrating underrepresented populations; consultations on submission of recruitment materials and recruitment-related amendments to the IRB.
- Research Process Improvement – support services to improve project quality and efficiency; assistance identifying problems or research process barriers; hypothesizing and testing changes to resolve problems.
- Regulatory Support – regulatory consultations for projects involving human subjects; optimization of clinical trial processes; assistance with IRB submissions and single IRB requirement; advice on patient recruitment.
- Tufts CTSI Research Development Specialist – assistance with proposal development; grant editing and submission.
To request an in-person or virtual consultation with any of the service providers listed above, please submit a service request here.
Where can I find a list of pilot awardees from prior years?
I am an investigator conducting early-stage translational research. How does stakeholder engagement apply to my T.5-T1 project? Where can I learn more about stakeholder and community-engaged research?
View this conversation with Drs. Jonathan Garlick and Thomas Concannon about how T1/basic researchers can use Stakeholder and Community Engagement to strengthen their research teams and impact population health (full version and highlights):
Why is NCATS prior approval required?
Consistent with the US Department of Human and Health Services (HHS) regulations (§46.120) and NIH policies on human subjects protections and vertebrate animals, Tufts CTSI must seek prior approval from its funding agency, NIH/NCATS, to support all Pilot Studies Program projects that involve human and/or animal subjects. This requirement applies to all Tufts CTSI-supported project that receive any direct funding and/or voluntary committed cost share through the Tufts CTSI NCATS CTSA award.
My research study involves neither human nor animal subjects. Does the NCATS prior approval requirement apply to me?
No, research studies that do not involve human or animal subjects do not require NCATS prior approval.
How long does it take to get NCATS prior approval?
To reduce administrative burden, NCATS classifies research studies into the following categories:
- Category 1 (require both submission of NCATS-required documentation and receipt of NCATS’ formal prior approval, with the review process taking generally 30 days):
- Human subjects studies that involve greater than minimal risk;
- Human subjects studies that meet the NIH-definition of a clinical trial;
- Animal subjects studies that involve live vertebrate animals;
- Human or animal subject studies that involve a foreign component, as defined by NIH;
- Category 2 (require submission of NCATS-required documentation, but do not require NCATS’ formal prior approval)
- Human subjects studies that involve minimal risk or studies that are otherwise exempt, as determined by the IRB.
What would delay approval of my NCATS prior approval request?
The most common reasons for delays identified by NCATS include inconsistencies in submitted documents (e.g., titles of study differ on protocol and consent/assent documents; target enrollment number varies in protocol, consent, inclusion plan, and/or enrollment table/inclusion data records), failure to include the required documents/information or provide proper justifications (e.g., not providing sufficient detail to allow evaluation of the procedures; not following instructions outlined in Forms F guidance developed and maintained by NIH; not including a budget and/or budget description/explanation clarifying of what is being supported by NCATS), providing outdated documents or documents with tracked changes and typographic errors, and submitting a parent protocol for a sub-study or ancillary study instead of a specific study protocol for research to be supported by NCATS.
How do I know if I my research project requires Institutional Regulatory Board (IRB) and/or Institutional Animal Care and Use Committee (IACUC) approval?
Such determination can only be made by the IRB and IACUC offices federally-mandated to protect the rights and welfare of human and animal subjects. Therefore, it is the responsibility of the awardee to provide an overview of their proposed research and any relevant documentation to their respective IRB and/or IACUC offices to determine if the proposed research falls under their purview. If so, awardees will be required to request a formal review and approval of their research activities following the policies and procedures outlined by their respective ethical administrative bodies.
How long on average does it take to receive IRB approval?
The length of the IRB review and approval varies by different IRB offices, ranging usually from three to six weeks. It depends on the number of factors, such as the volume of IRB submissions at the time of the review request, complexity and nature of the proposed research, investigators’ ability to respond to the IRB’s requests for clarifications and modifications in a timely manner, review type (exempt, expedited, or full review), and frequency of the IRB full-board review meetings, when applicable. Many IRB offices provide their target and actual turnaround times as a general guide. Please contact your respective IRB for more information.
The IRB has approved my study in an expedited manner. What human subjects NCATS study category does my research fall into?
The FDA Code of Federal Regulations (21 §56.110) authorizes IRB offices to review and approve certain kinds of research through an expedited review procedure without the full IRB committee convening. The kinds of research that can be reviewed in an expedited manner are strictly limited those that involve no more than minimal risk or that require minor changes in previously approved research during the period covered by the original IRB approval. As such, the expedited review procedure alone cannot be used to determine the NCATS study category. For instance, research that meets the NIH definition of a clinical trial may be reviewed in an expedited manner.
Whom can I contact with additional questions?
If you have any questions related to the program, please contact the Pilot Studies Program team at firstname.lastname@example.org.
To request an in-person or virtual consultation, please submit a service request.