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Novel Methods Development Pilot Program (NMD Pilot Program)​​

Novel Methods Development RFA: How to Apply


Key Dates
 
​Posted Date ​October 2, 2017
Letter of Intent Due (mandatory)​ December 18, 2017​
NMD Application Submission Date ​ January 15, 2018​
​Grant Review Date​ February 2018​
Award Notification Date​ April 2018​
Project Funding Period ​​ ​May 2018 through April 2019​

PDF version​

Eligibility

  • Proposed methods development must represent the development of a novel (non-existing) assay, device, software, statistical method, protocol or technology. 
  • Investigators from non-affiliate institutions are ineligible to be Principal Investigators on NMD Pilot Awards, but are encouraged to collaborate with an investigator from a CCTSI affiliate who would be eligible to serve as PI on an application.  CCTSI affiliate institutions include: University of Colorado Denver, University of Colorado Anschutz Medical Campus, University of Colorado Boulder, Colorado State University, National Jewish Health, Denver Veterans Administration Medical Center, University of Colorado Hospital, Children’s Hospital Colorado, Denver Health, and Kaiser Permanente of Colorado. 
  • Underrepresented and minority researchers are particularly urged to apply, as the CCTSI intends to contribute to the creation of a research workforce that is representative of the U.S. population. Groups that have historically been underrepresented in biomedical research include, but are not limited to, African Americans, Hispanic Americans, Native Americans (including Alaska Natives), natives of the U.S. Pacific Islands, individuals with disabilities and individuals from socially, culturally, economically or educationally disadvantaged backgrounds that have inhibited their ability to pursue research careers.
  • ​Principal and Co-Investigators must be CCTSI members at the time of application.  There are no exceptions and membership is free. Membership may be verified by clicking the button “Check your Member Status” at http://www.ucdenver.edu/research/CCTSI/about/Pages/Become-a-Member.aspx. Individuals may become CCTSI Members from the same webpage by clicking the appropriate membership type button and completing the online form.

Application Requirements

  • Novel Methods Development (NMD) Pilot Awards are federally funded through the CTSA grant from NIH National Center for Advancing Translational Sciences (NCATS), but do not require official pre-award review (routing) through the CU Denver Office of Grants and Contracts prior to submission.
  • However, affiliate home organizations may require applicants to complete an internal review process prior to submission.  Please check with your institutional grants or sponsored projects office to ascertain if your institution has pre-submission requirements for applications to programs such as this.  Any awarded projects that have not met these requirements prior to submission will not be activated until all such affiliate institutional requirements are met. 
  • If a Novel Methods Pilot Award is made to an investigator at an affiliated institution, F&A costs may be included. Please contact the CCTSI for specific discussions [insert Dr Serkova email here] on how this may impact your overall budget prior to development and submission of your project.
  • NCATS has instituted a new policy requiring the review and approval of all CCTSI pilot grants involving human subjects research prior to CCTSI NIH funds being utilized.
    Therefore​, if your proposal is funded and involves research with human subjects (an approved IRB protocol), CCTSI will require additional documentation to send to NCATS. NCATS expects to complete their review in less than 30-60 days, The NCATS review can occur concurrently with the IRB review; however, final NCATS approval is contingent upon IRB approval. Please indicate clearly in your Letter of Intent (LOI) if your study involves human subjects/ IRB approval so we can start working with you in advance.
    All applicants are reminded to avoid public disclosure of results, in either text or verbal form, without first determining if intellectual property exists, as this may result in a lost opportunity to protect and commercialize your invention. Please call the CU Innovations Office (303-724-0221) before presenting or publishing results.

Application Process: Mandatory Letter of Intent

Submit by December 18th, 2017 using the standard Cover page with project title and PI name(s) as your Letter of Intent. Submit your information to Stephanie Vetter by email.


Application Process: Novel Method Development Plan

All application materials should be submitted together and emailed to Stephanie Vetter on or before January 15th, 2018. Please note page limitations.​​​​​​
 
Section One Cover page
Title of the application
PI name(s)
PI(s) affiliation
Utilized Technology or BERD Cores (if any)​
Section Two
(half page)
Specific Aims
Provide a scientific question/ rational followed by a clear, concise summary of the novel methodology to be developed. ​
Section Three
(one page)
Background and Significance
Provide a clear evidence that the methodology or technology to-be-developed is innovative and does not exist at the CU and the affiliate institutions
Preliminary data, which show PI expertise in developing the proposed methodology, are encouraged
What clinical or translational research areas will this novel methodology apply to, what questions will it answer, and their clinical impact?​
Section Four​
(two pages)
Novel methodology to be developed (suggested 1-2 pages) 
Clearly describe the overall plan and approach for methods development.
Describe proposed tests, procedures, subject population and ages in sufficient detail to allow adequate evaluation of your approach.
Include a projected time-line.​
Section Five
(half page)
Educational mission (suggested ¼ - ½ page) Describe how this proposal relates to the educational mission of the institution. Are there K12 awardees, residents, post-Docs or students involved in the project?​
Section Six​ Budget (maximum $20,000. No indirect costs are allowed)
a. Justification:  Justify items by categories. The use of CCTSI Technology Cores or BERD is encouraged.
b. Other support (see below).  Budgets should be specific with a maximum budget of $20,000. No indirect costs are allowed.  Please provide information as to other sources of funding that are involved in this project; how this proposal differs from those proposals, and any other sources of funding that may have been sought.​
Section Seven​ ​Include all IRB, IACUC, Biosafety, Radiation Safety approval numbers​
Section Eight​ ​Include an NIH biosketch for each key personnel on the project.​
Note: Consistent with NIH policies, IRB or IACUC approval or exempt, as well as conflict of interest review will be required prior to transmission of funds and project implementation. As noted above, all human subject research proposals need to be reviewed and approved by NCATS following the issuing of an award. Because of the short time line we strongly encourage preparation of regulatory documents as soon as possible. 

Review Criteria

Peer review panels, chaired by Dr. Natalie Serkova, will be responsible for award decisions. Reviewers with appropriate expertise will evaluate eligible applications with a specific emphasis on research that furthers the CCTSI mission. All decisions will be final, and a brief summary statement will be supplied to applicants. NIH scoring criteria will be apply in the review process related to:
  • Novelty and innovation in developing a new method or technology
  • Translational impact and significance: Can the new method or technology be generalized to other scientific settings/ applications?
  • PI(s) and collaborative teams: is all necessary expertise present?
  • Soundness of the proposed approach: Will the proposed study design achieve the aims of developing a new method or technology?
  • Responsiveness to the CCTSI educational mission and the use of existing Technology and BERD Cores.
Administrative questions about the grant submission process should be addressed to Stephanie Vetter. Scientific and budgetary questions should be addressed to Natalie Serkova, Novel Methods Development (NMD) Pilot Program Chair.

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