Investing in Clinical Neurocritical Care Research (INCLINE)

INVESTING IN CLINICAL NEUROCRITICAL CARE RESEARCH (INCLINE) GRANT RFA

General Instructions:

Research Strategy
A sound research strategy to achieve the specific aims of the project must be provided. The research description should specifically address the impact, innovation, and approach of how the candidate intends to answer the scientific questions proposed in the specific aims. The research idea will be judged on impact and innovation. The approach will be judged primarily on feasibility and the ability to address the proposed specific aims within the 1-year funding time period.

The purpose of the INCLINE grant is allow investigators to develop pilot research strategies that enhance clinical care in the neuroscience intensive care unit. The scope of this RFA is to provide 1 year of funding to support pilot studies that will enable the awardee to successfully compete for federal funding such as from the NIH, Department of Defense, or PCORI.

Research Objectives
The INCLINE grant is designed to promote creative and collaborative research to improve clinical outcomes in neuroscience critical care. In 2016, the leaders of the Neurocritical Care Research Central (NCRC) and the Neurocritical Care Research Network (NCRN) identified important gaps in our research portfolio and envisioned an approach to begin to working constructively on these gaps. The mission-critical topic that has been embraced after much deliberation is “Curing Coma.” The goal is to develop an understanding of the mechanisms that underlie coma in critically ill patients and discover preventive and novel therapeutic measures. Moreover, this is a broad endeavor that should eventually lead to the intersections between scientific discovery, implementation, education and advocacy that are necessary to fundamentally change the care of patients with acute disorders of consciousness. To this end, the INCLINE grant will focus on facilitating collaborative research to address the mission of the “Curing Coma Campaign” and proposals enhancing this line of research will be viewed most favorably.

It should be noted that coma-related research is broad and includes conditions such as delirium, and encephalopathy which lie along the spectrum of disorders of consciousness, as well as a diverse group of etiologies of disordered consciousness. There are many areas of research within Neurocritical Care that are within the domain of the “Curing Coma” mission. For specific questions about the Curing Coma Campaign as it relates to this RFA, please contact Claude Hemphill (claude.hemphill@ucsf.edu), or Daiwai Olson (Daiwai.Olson@UTSouthwestern.edu).

The INCLINE RFA has a distinct clinical focus; however, translational science with direct application to clinical care is also broadly within the scope. NCS wishes to foster longitudinally meaningful scientific projects that will be competitive for future funding from NIH, DOD or similar; and which serve to create a pipeline of research and enhance one of more scientific lines of research. NCS desires to enhance collaborative research and team science, and enhance the rigor and visibility of neuroscience intensive care among existing and future team science collaborations.

Types of studies include, but are not limited to:
  1. Point prevalence studies, which describe a fundamental clinical care intervention and/or practice in the neuroscience intensive care unit
  2. Informatics/data analytics studies, which describe the fundamental aspects of data acquisition, monitoring, storage, analysis or processing in the neuroscience intensive care unit.
  3. Pilot clinical trials which foster novel treatment for common diseases seen in the neuroscience intensive care unit using translational approach, with emphasis on proof of concept in a targeted patient population, conducted in a small multicenter study.
  4. Pilot observational studies, which determine feasibility of conducting a future observational or interventional study in the neuroscience intensive care unit.
  5. Multidisciplinary process-oriented research, which directly impact patient-centered care and outcomes.
  6. Population health studies, which will directly enhance the care of neurocritically ill patients.

The following will not be considered:
  • Retrospective studies
  • Focused self-reported surveys
  • Mechanistic physiological studies in a laboratory setting
  • Computational Algorithm development in a laboratory setting using preexisting data
  • Infrastructure or registry development proposals

Collaboration Objectives that are desired for this application:
  1. Facilitate a future multicenter center approach to enhance scientific rigor and generalizability.
  2. Create data formats, which could be used as models for national networks.
  3. Enhance the opportunities for the NCRN to conduct early-phase studies.
  4. Studies conducted within NCRN will be viewed favorably. The expectation is that official NCRN endorsement, while not necessary for the application, will be sought for the successful application and before the study start.
Letters of Support from Collaborators and Consultants
Only applications which involve multicenter (≥ 3 sites) collaboration will be considered. Applications must contain signed letters on their letterhead from ALL individuals listed as collaborators or consultants confirming their participation in the project and describing their specific roles. Collaborators and consultants do not need to provide their biographical sketches, but information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration. To stay within the page limit, letters written and signed by 2 or more individuals are permitted.

Description of Institutional Environment
The institutional environment is extremely important in the success of a candidate. This section should outline the institutions commitment and success in fostering development and continued success of clinician-researchers, including specific information about the facilities and resources that will be brought to bear for the candidate in the award period.

There must be clear documentation that the sponsoring institution has a strong, well-established track record of a research candidate's area of interest, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate. The application must include a clear description of the resources and facilities that will be available and how the institutional research environment is particularly suited for the candidate's proposed research.

Budget Justification
The maximum award will be $100,000. A single award will be issued each year for a 1-year award period. The award must be spent within period of the award notice, with a no-cost extension permissible with appropriate justification.

Budget Constraints: The budget is constrained to the following:
  • $15,000 maximum salary support for the PI
  • Patient enrollment costs, including potential incentives for patients
  • Max. $10,000 for equipment or computer software
  • Max. $5,000 for travel to facilitate multi-center collaboration

No limits are set for research staff support. Travel expenses, institutional indirect/overhead costs, and office expenses will not be funded. No limits are set for research staff support. Travel expenses, institutional indirect/overhead costs, and office expenses will not be funded. 

Eligibility Criteria:
The study PI must be an active NCS member in good standing. Members in all career stages are eligible to apply if the study requirements of this RFA are met. For purposes of career development, early career investigators and trainees are encouraged to apply for the NCS Research Fellowship Training Award. All healthcare professionals providing neurocritical care in different roles, including physicians, advanced practitioners, nurses, pharmacists, and PhD-scientists are encouraged to apply. 

Applicants are required to submit a “Letter of Intent (LOI) to Submit an Application” by 2/28/2018. Letters of Intent will be reviewed by members of the NCS grants subcommittee in order to ensure that the proposed project fits appropriately within the INCLINE grant directive, and to plan for appropriate expertise in the peer review panel. Upon review of the LOI, qualified projects will be invited by 4/1/2018 to submit a full grant application, which will be due on 6/1/2018.

Letter of Intent (LOI) Instructions:
Please use the following formatting guidelines for LOI submission:

  1. The LOI must adhere to the following format:
    1. Font size must be at least 11-point Arial font.
    2. Margins must be at least one inch in all directions.
    3. Line spacing must not exceed six lines of text per vertical inch.
    4. Page size must be U.S. letter (i.e., 8.5" x 11").

  2. The LOI is limited to two (2) pages.

    On page 1, provide only the following information: proposal title, names, professional titles, departments, institutions, and e-mail addresses of the lead project investigator (PI), and all collaborating investigators (Co-Is).

    On Page 2 (one page only), include:
    i. A descriptive title
    ii. Rationale
    iii. Overall hypothesis or goal
    iv. Specific aims
    v. Approach
    vi. Potential impact and expected outcomes.

  3. Please also attach NIH-format biosketches of the PI(s) and Co-Is, using the most updated version from 3/2020 (https://grants.nih.gov/grants/forms/biosketch.htm), limited to four (4) pages per biosketch. 

  4. NCS will only accept LOI materials submitted in the portable document format (PDF). Please combine all data into one single PDF file. Send the PDF via e-mail to info@neurocriticalcare.org with “Letter of Intent, INCLINE Grant” in the subject heading.

Deadlines

Monday, June 15, 2020: Letter of Intent Deadline
Week of June 29, 2020: Invitations Sent to Submit Full Proposals
Monday, August 17, 2020: Full Proposals Due (By Invitation Only)
September 22-55, 2020: NCS Annual Meeting - Announcement of Grant Award

For all questions related to this RFA, please email:
info@neurocriticalcare.org
weziai@jhmi.edu
PVespa@mednet.ucla.edu
jp3b@virginia.edu