Letter of Intent (LOI) Instructions: Clinical and Non Clinical Studies

The objective of this Letter of Intent is to solicit ideas for Proposals for the best overall clinical trial and non-clinical trial research with high value to the MSRC.

A clinical trial is defined as a prospective accrual of human subjects where an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention, or other) is tested on a human subject for a measurable outcome with respect to exploratory information, safety, effectiveness, and/or efficacy.

The MSRC is interested in the following research areas:

  • Help-seeking behavior
  • Improving intimate relationships
  • Creation and use of web-based and/or application enhanced interventions
  • Interventions in peer-based, community, and/or primary care settings, and brief interventions appropriate for military inpatient settings
  • Upstream suicide prevention efforts that include suicide behavior outcomes
  • Community and peer-based interventions, specifically identifying at-risk individuals and what do to when an individual is in crisis
  • Suicide bereavement
  • Messaging about interventions to increase effectiveness in dissemination and implementation
  • Effectiveness of suicide risk assessment and management training in primary care settings

Funding

  • The maximum period of performance is three years.
  • The anticipated total budget for the entire period of performance should not exceed $1.5M. Indirect costs are to be budgeted in accordance with the organization’s negotiated rate.
  • All direct and indirect costs of any subaward must be included in the total direct costs of the primary award.

Submission Guidelines and Requirements

  1. Only qualified individuals with prior experience as Principal Investigators (PIs) for military and/or suicide-related research should submit a letter of intent (LOI).
  2. The Letter of Intent (LOI) should be submitted no later than 11:59 pm EST on Friday, February 17, 2017. LOI submissions are to be made through our website: https://msrc.fsu.edu/loi.
  3. Proposals will be by invitation only and include a Narrative/Research Strategy (limit 12 pages), Abstract (1 page), Statement of Work (limit 5 pages), and a detailed budget. Full details on proposal requirements will be distributed with invitations.
  4. The LOI must be clear and legible.

Documents must conform to the following guidelines:

  1. Type Font: 11 point or greater (Times New Roman is strongly recommended).
  2. Margins: Minimum of 1 inch on all sides.
  3. Length: No more than three double spaced pages.
  4. Acronyms: Spell out all acronyms the first time they are used.
  5. References: List the references according to current APA or AMA format. Do not send or attach copies of articles in print. This does not count toward page limit.
  6. LOIs must be submitted as a PDF using the following file name format:
    LOI_Research_PI Last Name_PI First Initital.PDF.

Elements of the Letter of Intent

In order to determine fit of the proposed project with MSRC priorities please address the following points in no more than three double spaced pages to be uploaded on our website.

  1. Background. Provide a brief statement of ideas and reasoning behind the proposed study. State the relevance of the proposed project to at least one of the topic areas listed above and explain the applicability of the anticipated findings. Cite relevant literature and pilot or preliminary data.
  2. Personnel. Briefly state the qualifications of the PI(s) and key personnel to perform the described research or clinical trial. Briefly describe their roles on the project.
  3. Military Significance. State how the proposed study is responsive to improving scientific knowledge about suicidal behavior in the military that improves mental health outcomes of Service members. Proposals should focus on military populations (Active Duty, National Guard, Reserve), or, if veterans (OEF/OIF/OND). If a veteran or non-military population will be used for the proposed research project, explain how the population simulates Service members. If a non-military population will be used, a phased approach building to the inclusion of Active duty, National Guard or Reserves within the overall research design is required. Proposals which do not include an active duty sample at some point will not be considered.
    The MSRC can provide contacts to help identify military sites. Please contact us early in the proposal process for assistance.
  4. Aims and Hypotheses. State the aims and hypotheses to be tested and the expected results.
  5. Methods. Provide an overview of the experimental design and methodology.
  6. Budget. Provide an estimate of the total direct and indirect costs of conducting the study. A budget justification is unnecessary for the LOI.
  7. Length of Study. Please indicate the proposed length of study, not to exceed three years.

In addition to the three page double spaced letter of intent, PIs will be prompted to answer the following with the online submission:

  1. Institution/Organization name and job title.
  2. Research information including project title, total budget, which staff are MSRC members.
  3. Three to five sentences on your success and challenges in clinical trial and/or clinical research.

Submit an LOI