Frequently Asked Questions (FAQs)
Clinical and Translational Research – Infrastructure Network (CTR-IN) Pilot Grants
- What is the purpose of the CTR-IN Pilot Grants Program?
- What type of research activity will the CTR-IN Pilot Grants Program support?
- Are animal or cell culture studies supported by the CTR-IN Pilot Grants Program?
- Who is eligible to apply for a CTR-IN Pilot Grant?
- Does the Pilot Grants Program accept multiple Principal Investigator applications?
- What are the responsibilities of a Pilot Grant recipient?
- What are the permitted expenses for a CTR-IN Pilot Grant?
- Does the Pilot Grants Program allow large equipment purchases (i.e., > $5,000)?
- How much should I budget for the CTR-IN Annual Scientific Meeting in my pilot grant application?
- What approvals are required for conducting human research?
- How will pilot grant applications be reviewed?
- How are funding award decisions made?
- What are the program priorities that help to guide funding decisions?
- What are the reporting requirements for pilot grantees?
- Will there be opportunities to meet with other grantees and network with potential research partners?
- What other resources are available through the CTR-IN?
- What is the CRDEB?
- How much time will the CTR biostatistician have toward my pilot project?
- Will the biostatistician help with my pilot application?
- What if I use a biostatistician that is not supported through the CRDEB?
- What is the CREMCaD?
What is the purpose of the CTR-IN Pilot Grants Program?
The CTR-IN Pilot Grant Program is a Limited Competition Mentored Career Development funding opportunity. The mission of the CTR-IN is to build clinical and translational research capacity and facilitate extramural funding success among investigators with faculty appointments at the 13 universities in the Mountain West Research Consortium. The program provides research funding, and a mentored pathway of milestones leading to publication, expansion of research skills, and career development to achieve independent investigator status as reflected in the submission of a National Institutes of Health R-level grant proposal (or equivalent) in clinical or translational research.Pilot funding support can be transformative in the Mountain West by helping existing programs reach national competitiveness, addressing regional health disparities, and providing opportunities for new investigators to become successful in clinical or translational research, and for established basic scientists to transition into these areas.
What type of research activity will the CTR-IN Pilot Grants Program support?
Eligible clinical or translational research embraces a spectrum of scientific disciplines (e.g., epidemiology, biostatistics, pharmacology, social and behavioral sciences, nutrition, nursing, health economics, biomedical engineering, community-based participatory research, dental health, and medicine), methodologies (e.g., observational and experimental), health professions (e.g., nursing, public health, pharmacy, clinical psychology, sports physiology, physical therapy), and medical specialties and subspecialties. Any application proposing clinical translational research meeting the NIH definition will be eligible.
Clinical research includes (1) patient-oriented research; (2) epidemiologic and behavioral studies; and (3) outcomes research and health services research. Further detail of this definition can be found in the Human Subjects Research Definitions and Terms of the PHS 398 (Part III-25): click here … Supportable projects must have measurable outcome(s) that will lead to publications, and that, ultimately, have a strong likelihood of leading to a sustainable research program for the Principal Investigator.
Translational research (T1-T4) includes:
- T1, Translation to Humans: Testing basic science discoveries in humans for clinical effect and/or applicability;
- T2, Translation to Patients: Testing new interventions in human subjects under controlled environments to form the basis for clinical applications and evidence‐based guidelines
- T3, Translation to Practice: Research on the application of new interventions or therapies in general practice; research that yields knowledge on best ways to implement new medical interventions in the clinic; and
- T4, Translation to Population: Investigations of factors and/or interventions that influence the health of populations; ultimately results in improved health of the public.
Are animal or cell culture studies supported by the CTR-IN Pilot Grants Program?
We appreciate the fact that pre-clinical (i.e., animal and cell culture) studies provide important information that are essential before translation to human studies is possible. However, the NIH program that funds the CTR-INrequires us to follow a strict definition of translational type 1 (T1) research that excludes most pre-clinical animal and cell culture studies. This policy supports the CTR program goal of developing new clinical and translational research programs in the region, following NIH guidelines for this type of work. These guidelines also serve to complement (rather than duplicate) support provided by other INBRE and COBRE mechanisms at IDeA institutions that emphasize support for pre-clinical programs.
Who is eligible to apply for a CTR-IN Pilot Grant?
Applicants must have a faculty-level appointment with a minimum of 0.5 FTE support at a participating CTR-IN Institution, and they must be eligible to submit extramural grant applications from their institution as a Principal Investigator (PI).While the Principal Investigator of a pilot project application must be a faculty member (or hold a letter of academic title) from one of the partner institutions, other collaborators will be encouraged to participate as co-investigators to foster new clinical collaborations. Early or New Stage Investigators (click here … ) are encouraged to apply. Established researchers wanting to move from basic science into translational or clinical research also are eligible to apply.Per IDeA program policy, an awardee may not concurrently receive research funding through other IDeA mechanisms (e.g., COBRE or INBRE).
Does the Pilot Grants Program accept multiple Principal Investigator applications?
No, while the CTR-IN encourages multidisciplinary and multi-institutional collaborations, CTR-IN pilot grants are career development awards intended to assist a single Principal Investigator obtain the requisite experience and skills to achieve success as an independent extramurally funded investigator. The inclusion of co-investigators and consultants on pilot projects is strongly encouraged.
What are the responsibilities of a Pilot Grant Recipient?
Pilot Grant recipients are expected to interact with the Clinical Research Education, Mentoring, and Career Development (CREMCaD) Core, formalizing a mentorship relationship through an Individual Development Plan. Pilot Grant recipients also are expected to utilize the Clinical Research Design, Epidemiology, and Biostatistics (CRDEB) Core. Pilot Grant recipients are expected to use the knowledge and data obtained through CTR-IN support to develop and submit R-level grant proposals to NIH Institutes (or similar extramural sponsors, e.g., AHA, ACS, ADA, PCORI, NSF, DOD) to continue their research. Pilot Grant recipients are also expected to report on their activities and research progress both during and after the period of their Pilot award. Research progress updates should be provided on a continuous basis via the CTR-IN web portal for the duration of the CTR-IN program. During their year of research support, pilot grant investigators are expected to attend, and participate in, the CTR-IN Annual Scientific Meeting held in Las Vegas each June.At the Annual Meeting pilot grant PIs will: 1) give an oral presentation summarizing their work to-date; 2) present a poster summarizing their work to-date; 3) meet with the External Advisory Committee to discuss their activities and their plans for achieving independent extramural support. Participation of pilot grant mentors in the Annual Meeting alongside the pilot grant PI is highly encouraged and support for that is available as a separate allocation in addition to the direct costs of the pilot grant itself.
What are the permitted expenses for a CTR-IN Pilot Grant?
Permitted expenses include support for half of the salary and benefits associated with the PI’s effort, salaries for research personnel, research supplies, and participant expenses. The PI must devote a minimum of 20% effort to the pilot grant, but please see ‘Special requirements regarding PI support’ below. All expenses must be allowable under NIH guidelines. The following are not allowable: Equipment costs over $5,000, computers/laptops, significant foreign participation, tuition and fees for graduate students, and subcontracts to institutions located in non-IDeA states. Services provided in non-IDeA states can be purchased on a fee-for-service basis. Publication costs (i.e., page charges) are also not allowable, however support for those costs is available upon request throughthe CTR-IN Administrative KCA both during, and after, the period of pilot grant support.
Budgets must also include travel expenses to the CTR-IN Annual Scientific Meeting where pilot grant recipients are expected to give a presentation on their research. Other travel expenses are permitted if necessary for conducting field work as part of the pilot project, or for domestic travel if justified for establishing a mentorship relationship, accessing experts or other resources, or presentation of peer-reviewed findings from the project at up to one national meeting per year.
Applicants may request up to $5,000 in addition to the $60,000 project limit, to support expenses for their Mentor. Allowable expenses for this budget include travel and consultant fees. If more than $2,500 is requested the Mentor must commit to attending the CTR-IN Annual Meeting in support of the Pilot Grant PI.
Budgets may not support office supplies, phone costs, or other costs considered to be indirect expenses under NIH guidelines, unless justified as directly related to research data collection. Facilities and Administration rates (i.e., indirect costs) will be held to 10% according to the agreement endorsed by the responsible official at each of the partner institutions. Budget items not well-justified may be reduced or removed upon the recommendation of scientific reviewers, and/or the Internal Advisory Committee.
Special requirements regarding PI support: Pilot Grant PI’s must devote at least 20% effort to the proposed research, and up to 50% effort may be proposed. While the budget narrative must reference the full amount of effort required to accomplish the proposed scope of work, the budget may request CTR-IN funds for not more than half of the PI effort. The balance of PI effort is to be covered by institutional support in the form of release from teaching, direct salary support, assignment of time provided to pursue scholarly activity, or other mechanism appropriate to the institution. This support is not a formal cost share, and no recording/reporting requirements exist. Budgets should list the full PI effort proposed as appropriate for their appointment in calendar months, or academic and summer months. Support requested may not exceed half of that value.
Does the Pilot Grants Program allow large equipment purchases (i.e., > $5,000)?
The CTR-IN is particularly focused on building Clinical and Translational Research capacity at partner institutions by focusing on researchers and the provision of support expertise and training. Large equipment purchases (i.e., > $5,000) are not allowable expenses for Pilot Grant projects.
How much should I budget for the CTR-IN Annual Scientific Meeting in my pilot grant application?
The pilot grant applicant should plan on a 3-4 day meeting in Las Vegas, NV with expenses to include hotel, airfare and local travel. There will be no registration fee. Budgeting $1,500 for the pilot grant PI to attend the meeting should be sufficient.
What approvals are required for conducting human research?
As with any NIH-funded research, projects must adhere to all requirements regarding protection of human subjects, including approval by the grantee’s Institutional Review Board (IRB) when relevant. Funds related to collection of human subjects’ data will not be released to the investigator until necessary IRB approvals are in place. Awardees must also provide documentation of human subjects training for key personnel (e.g., CITI). Other regulatory requirements such as the use of biohazard materials will be monitored per the procedures and guidelines of the investigator’s institution.
How will pilot grant applications be reviewed?
Pilot grant applications will be assigned to experienced grant application reviewers using standard NIH scoring criteria. In addition to the standard NIH review components (i.e., overall impact, significance, innovation, investigator, approach and environment) reviewers will be asked to qualitatively respond to the following questions: (1) Are plans for future extramural grant application(s) clear?; (2) If the proposed pilot project is successful, will the findings yield sufficient preliminary data to support a future NIH grant application?; and (3) Is the planned research concordant with the CTR-IN mission of supporting research that can address health issues in the Mountain West? (4) Will the proposed project help the PI to achieve independent status in clinical or translational research in a manner that would be much less likely absent this support. Reviewers will be asked to adhere to standard NIH conflict of interest guidelines.
How are funding award decisions made?
Funding decisions involve a 5 step process:
1) Scientific review using a rubric based on NIH guidance to Study Section members and supplemented by CTR-IN specific considerations as described just above. Each application is typically reviewed by 3 independent reviewers.
2) Results of the scientific reviews are tabulated and ranked. Those results are provided to the CTR-IN Internal AdvisoryCommittee (IAC), acting in a role similar to an NIH Council, for recommendations accounting for both scientific merit and concordance with CTR-IN policy considerations.
3) The recommendations of the IAC are provided to the External Advisory Committee (EAC) for further review with regard to scientific merit and concordance with the CTR-IN mission to increase independent extramurally-supported research.
4) The EAC recommendations are provided to the CTR-IN Principal Investigator who makes final decisions on awards selected for Intent to Fund based on scientific review, IAC and EAC recommendations, and program priorities.
5) Packets for applications selected for Intent to Fund, with all required documents, including but not limited to, updated IRB approvals, CITI certifications, and the like which may have been requested under the ‘Just-In-Time’ process, are forwarded to the NIGMS Program Office for agency approval. Sub-awards are then offered for applications approved by the NIGMS.
What are the program priorities that help guide funding decisions?
The primary program priorities are 1) to develop new clinical and translational research programs in the region; 2) to foster the development of investigators in the region who can conduct clinical and translational research; 3) to foster collaborations that can help achieve those goals;4) support health research relevant to rural and vulnerable populations; and 5) to provide distribution of program resources across the partner institutions concordant with the guidance of scientific peer review.
What are the reporting requirements for pilot grantees?
Research progress updates should be provided on a continuous basis via the CTR-IN web portal for the duration of the CTR-IN program. Reporting elements include a summary of progress towards completion of specific aims, completion of current enrollment tables, recording of related publications, presentation or other dissemination activities and listing of related research grant applications and status. At minimum, pilot grantees will be required to provide these progress report updates on a quarterly basis during their funding period, and annually in the early spring following the end of their CTR-IN support.
Will there be opportunities to meet with other grantees and network with potential research partners?
Pilot Grant investigators will present interim findings and progress at the CTR-IN Annual Scientific Meeting that will be attended by Network members, experts from the External Advisory Committee, and invited outside scientists.This venue serves as an opportunity for pilot investigators to highlight research progress, pose emerging questions, receive expert feedback, and develop external collaborations.
What other resources are available through the CTR-IN?
Pilot Grant recipients will have access to, and be expected to participate in, the educational and career development activities provided by the CRDEB andCREMCaDKey Component Activities. They will also have access to editorial assistance for abstracts and manuscripts and other documents related to their supported work. Awardees are encouraged to access all elements of the “CTR-IN Grants Pipeline” such as Grant Writing Workshops, Grants Clubs, Visiting Scholar Awards, and Mini-Sabbatical Awards.
What is the CRDEB?
The Clinical Research Design, Epidemiology, and Biostatistics(CRDEB) is a Core resource within the CTR-IN. The CRDEB provides education in the fundamentals of clinical and translational research. It supports CTR-IN investigators through assistance with study design, biostatistics, and basic data management.The CRDEB has identified a biostatistician at each partner institution who is funded by the CTR-IN and available to investigators for local support. Additional resources are available to CTR-IN investigators through the CRDEB Core, located at the University of New Mexico Clinical Translational Science Center.For more information on CRDEB please click here … .
How much time will the CTR-IN biostatistician provide to assist with my pilot project?
Investigators who request biostatistical support on their project are expected to meet with the CRDEB biostatistician at their institution during the planning stage of the pilot grant proposal. Free biostatistical support on funded pilot projects will be provided through the CRDEB, exclusive of time spent preparing the proposal.
Can I include a biostatistician who is not supported through the CRDEB on my pilot project?
No, theCTR-IN and CRDEB will only support the designated biostatistician(s) at your institution.Another biostatistician from one of the eligible institutions could be the Principal Investigator or collaborator on a pilot grant application, but this biostatistician’s effort on the pilot grant would not be financed by the CRDEB.
What is the CREMCaD?
The Clinical Research Education, Mentoring, and Career Development (CREMCaD)is a Core resource within the CTR-IN that will work with each individual Pilot Grant recipient to facilitate their development towards independent clinical or translational research. Investigators will receive access to coursework developed for training in all aspects of clinical and translational research. This will be provided via multiple modalities to facilitate access by investigators with diverse backgrounds and locations. For more information on CREMCaD please click here … .