FAQ-OLD

Frequently Asked Questions (FAQs)
Clinical and Translational Research – Infrastructure Network (CTR-IN) Pilot Grants
  1. What is the purpose of the CTR-IN Pilot Grants Program?
  2. What type of research activity will the CTR-IN Pilot Grants Program support?
  3. Are animal or cell culture studies supported by the CTR-IN Pilot Grants Program?
  4. Who is eligible to apply for a CTR-IN Pilot Grant?
  5. Does the Pilot Grants Program accept multiple Principal Investigator applications?
  6. What are the responsibilities of a Pilot Grant recipient?
  7. What are the permitted expenses for a CTR-IN Pilot Grant?
  8. Does the Pilot Grants Program allow large equipment purchases (i.e., > $5,000)?
  9. How much should I budget for the CTR-IN Annual Scientific Meeting in my pilot grant application?
  10. What approvals are required for conducting human research?
  11. How will pilot grant applications be reviewed?
  12. How are funding award decisions made?
  13. What are the program priorities that help to guide funding decisions?
  14. What are the reporting requirements for pilot grantees?
  15. Will there be opportunities to meet with other grantees and network with potential research partners?
  16. What other resources are available through the CTR-IN?
  17. What is the CRDEB?
  18. How much time will the CTR biostatistician have toward my pilot project?
  19. Will the biostatistician help with my pilot application?
  20. What if I use a biostatistician that is not supported through the CRDEB?
  21. What is the CREMCaD?

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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 an NIH R-type 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.

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What type of research activity will the CTR-IN Pilot Grants Program support?
Eligible clinical ortranslational research embraces a spectrum of scientific disciplines (e.g., epidemiology, statistics, pharmacology, social and behavioral sciences, nutrition, nursing, 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 …

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.

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Are animal or cell culture studies supported by the CTR-IN Pilot Grants Program?
We appreciate the fact that many pre-clinical (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 serves to complement (rather than duplicate) support provided by other INBRE and CoBRE mechanisms at IDeA institutions that emphasize support for pre-clinical programs.

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Who is eligible to apply for a CTR-IN Pilot Grant?
Applicants must have a faculty-level appointment at a participating CTR-IN Institution. 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 researcherswanting 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).

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Does the Pilot Grants Program accept multiple Principal Investigator applications?
The CTR-IN encourages multi-disciplinary and multi-institutional collaborations, but the CTR-IN pilot grants are designed to fund a single Principal Investigator. The inclusion of co-investigators and consultants on pilot projects is strongly encouraged.

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What are the responsibilities of a Pilot Grant Recipient?
Pilot Grant recipients are expected to interact with the CREMCaD, work with a mentor, utilize educational and statistical resources provided by the CRDEB, provide brief quarterly reports and a final report, and attend the CTR-IN Annual Scientific Meeting.In addition, 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 to continue their research, and to report on those activities both during and after the period of their Pilot award.

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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, significant foreign participation, and subcontracts to institutions located in non-IDeA states. Services provided in non-IDeA states can be purchased on a fee-for-service basis.

Budgets must also include expenses to travel to, and present at, the CTR-IN Annual Scientific Meeting. 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.

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 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.

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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.

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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 $1500 for the pilot grant PI to attend the meeting should be sufficient.

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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 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.

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How will pilot grant applications be reviewed?
Pilot grant application will be assigned to experienced grant application reviewers. In addition to the projects significance, innovation and approach, 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) Does the pilot project include, or have the potential for leading to, multi-disciplinary and/or multi-institutional collaboration? Reviewers will be asked to adhere to standard conflict of interest guidelines.

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How are funding award decisions made?
Following the meeting of the scientific review committee, the external peer reviews and fundingrecommendations will be forwarded to the CTR-IN Internal AdvisoryCommittee (IAC) and the External Advisory Committee (EAC) for review. The EAC will make funding recommendations to the CTR-IN Principal Investigator. The CTR-IN PI will make final decisions on the awards based on peer-review, IAC and EAC recommendations and program priorities.

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What are the program priorities that help to 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.

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What are the reporting requirements for pilot grantees?
Brief quarterly progress reports and a final report will be required of all pilot grantees. Quarterly reports will include a brief summary of research progress and milestones, expenditure of project funds, unanticipated barriers or problems, meetings with mentor(s), publications and abstracts submitted or accepted, presentations made at professional meetings, grant applications submitted or accepted, and goals for the next quarter. The first quarterly report will also identify support linkages that have been established to include, at minimum, a mentor and a biostatistician.

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Will there be opportunities to meet with other grantees and network with potential research partners?
Pilot Grant investigators will present interim findings and progress in a poster 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 will serve as an opportunity for pilot investigators to highlightresearch progress and pose emerging questions, receive expert feedback, and develop external collaborations.

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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 CRDEBand the CREMCaD. They will also have access to editorial assistance for abstracts and manuscripts based on their supported work, and to editorial assistance with human subjects applications.

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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 … .

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How much time will the CTR-IN biostatistician provideto 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. Up to 50 hours of free biostatistical support on funded pilot projects will be provided through the CRDEB, exclusive of time spent preparing the proposal.

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Can I include biostatistician whois 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.

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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 translationalresearch. This will be provided via multiple modalities to facilitate access by investigators with diversebackgrounds and locations. For more information on CREMCaD please click here … .