UTHSC iRISE (Institute for Research Innovation, Synergy and Health Equity)

Pilot Projects Grants

Announcement of solicitation for Pilot Project applications for iRISE, the UTHSC Clinical and Translational Science Institute, for Funding Start Date July 1, 2015

We are pleased to announce a call for applications for grants from theiRISE Pilot Projects Program. This programwill fund awards from $10,000 to $100,000 each for one year starting July 1, 2015. The total number and quality of the applications will determine the final number funded.

Program Vision

The iRISE Pilot Projects Program provides funding to develop innovative patient-oriented, clinical and translational research projects, both Type 1 (“bench to bedside”) and Type 2 (“bedside to community”). We are particularly interested in applications that include multidisciplinary teams, potentially sustainable research programs, advance the careers of young scientists, and that will impact health disparities in our regional communities.

Clinical Researchinvolves human participants and includes epidemiological and behavioral studies; outcome and health services research; and patient-oriented research, such as the study of disease pathology and mechanisms, development and testing of therapeutic interventions or technologies, and clinical trials.

Translational Research includes two broad areas: the translation of basic science and preclinical discoveries into human subject research (bench to bedside), and the subsequent translation of clinical trial results, research findings, and knowledge into practice in clinical and community settings (bedside to community). However, this linear model is a simplification of a more complex process that is circular and interdependent across research phases, and iRISE favors a “learning healthcare system” model that involvescontinuous data generation, analysis, dissemination, and interaction across research phases.Research should ideally involve continuous feedback from communities to researchers to ensure that results are relevant to patient and community health needs(Ethical Oversight of Learning Health Care Systems, Hastings Center Report Special Report 43, no. 1 (2013): S16-S27).

Patient-oriented research is defined as research conducted with human subjects (or material of human origin, such as tissues, specimens and cognitive phenomena) for which investigators directly interact with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) studies on mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies for these types of research.

This funding initiative is proactive, responsive, and supportive in providing new research programs with needed funds. An added value of the program is to facilitate project development and execution, as new projects enter iRISE andmature. The ultimate goal is to achieve extramural funding for projects, including federal, private foundation and industry sources.

Eligibility and Selection Criteria

All full-time and part-time faculty at UTHSC or its affiliated institutions and partners are eligible to apply for iRISE pilot funding. Eligible applicants include physicians, PhDs, PharmDs, nurses, and other faculty with an interest in translational research. Projects from applicants whoassemble an interdisciplinary team with expertise that crosses departments, divisions and disciplines, and that involves both clinicians and basic scientists will be reviewed more favorably.Although all eligible applicants are encouragedto apply, we are particularly interested in receiving applications from young investigators (less than 5 years after completion of professional training, such as subspecialty fellowship or postdoctoral fellowship). These less experienced applicants must have in place a strong mentoring plan prior to submission of the application. The program also encourages more senior applicants to include trainees and junior faculty who will benefit from involvement with the project.

Whenever possible, proposed projects should address important clinical and translational research challengeswith innovative and novel technologies and approachesor that will develop these over the course of the project. Applicants should carefully define the role of each team member.

Projects should have high potential for rapidly achieving extramural funding from federal and/or industry sources.We also encourage practicing physicians and other health professionals in the community to become involved. To encourage widespread participation, the Pilot Projects Program is soliciting projects from all UTHSC colleges. Each PI may submit only one proposal.

Note: Applicants may not simultaneously apply for both an iRISE grant and a Le Bonheur Children’s Hospital Grant.

Selection Criteria

The iRISE Scientific Advisory Board (SAB) will review all grant applications as described below.

Application Process and Deadlines

Applicants are encouraged to discuss their intent to submit an application with Dr. Dennis Black ( or 901-287-5355) prior to submission.

Please submit a letter of intent to Dr. Dennis Black, () by April 30, 2015 containing the applicant’s contact information, proposal title and summary (250 word limit) to facilitate recruitment of reviewers. Please include names and contact information for up to three reviewers. Suggested reviewers should be within the institution whenever possible. Outside reviewers should be suggested only when non-conflicted internal reviewers are not available. For revised proposals, every effort will be made to utilize the same reviewers of the previous submission.

The deadline for submission of full applications for this round of iRISE Pilot Projects funding will be noon, May 15, 2015 for a funding date of July 1, 2015.

An abbreviated PHS398 format will be used and must contain the following. Please note the detailed instructions and page limits at the end of this document:

1. A well-defined hypothesis that can be tested or goals that can be reached in the amount of time projected by the investigators (usually approximately one year).

2. Experimental plan that specifically addresses the clinical and translational impact of the study and how the research may lead to federal, private or industry extramural funding. Preliminary data canbe included but are not required.

3. Biosketches of the applicant and all key personnel (four-page NIH format).

4. A summary of other support, including all current and pending sources of funds with amounts and dates for each for all sources (external and internal, including any start-up funds). The team leader and other faculty participants should list their other research support, highlighting any support that is available for the proposed project.

5. Resources and environment.

6. Budget and justification.

7. Mentoring plan for junior investigators, including list of members of mentoring team members and a description of how the Pilot Project funding will advance the applicant’s career plans as a clinical/translational investigator.

Before funding is awarded, all projects must have IRB, IACUC, or IBC (if applicable) approvals, and appropriate data and safety monitoring plans/boards must be in place.

Review of Applications

A subcommittee consisting of SAB members and iRISE staff members will initially review the proposal and consider all relevant issues and may return the applicationto the investigator for revision, as needed. Proposalsare then sent to twoiRISE SAB reviewers, as well as any needed ad hoc reviewers with relevant expertise. Applications will be formally discussed and scored along the lines of an NIH Study Section. Criteria for selection include innovation, recognition of clinical opportunities, scientific approach, and potential for translation to the community. Additional merit will be given applications that facilitate the development of sustainable interdisciplinary research programs, advance the careers of young scientists and have potential to impact health disparities. Projects that engage community feedback in a learning healthcare system model will also receive extra consideration.

Important elements in the review process will be:

1. Scientific merit: Is the research proposed important and innovative? Does it significantly move the field forward? Certain projects may have significant merit for moving a field forward, although they may not be highly innovative. Does the research have the potential to contribute to our understanding or directly impact health disparities? Extra merit will be given to such projects.

2. Interdisciplinary nature: Project team members should possess expertise in all aspects of the proposed research. Projects that cross departments, divisions and disciplines, and involve clinicians and basic scientists will be reviewed more favorably.Applicants should not simply provide lists of names and affiliations of team members, but should carefully define the role of each team member within the context of the project.Those projects involving trainees and junior faculty will receive additional merit.

3. Funding: Is the research likely to establish the basis and rationale for a larger project and to result in a successful application for extramural funding for this larger project?

4. Could the research be accomplished without funds from this program?

5. If the applicant is a junior investigator, has a strong mentoring plan been formulated with a clear pathway for career development to achieve independence and extramural funding? A letter is required from the mentor as part of the application.

Funding Period and Renewal of Pilot Grants

Funding is allocated for a one-year. The progress of awards will be monitored on a quarterly basis to ensure that proper regulations are being met and the study makes sufficient progress. Should studies lag behind in subject recruitment, data analysis, etc., a member of the SAB or iRISE staff will meet with the investigator to determine the best strategy for completing the study in a timely manner.

Projects are funded for one-year with the possibility of additional funding or no-cost extension, if justified and approved by the SAB. We anticipate that the pilot funds will allow for feasibility determination and data collection that will lead to external peer-reviewed funding in about one to two years. Budgets and internal accounts are developed for each pilot study and will beoverseen by the iRISE financial office to ensure all expenditures are appropriate, justified, and within the guidelines of the project.

Additional Requirements

All investigators must acknowledge support fromiRISE and UTHSC in any publications resulting from the funded studies.

Application Details and Format

The iRISE Pilot Projects Program Director, Dr. Dennis Black (287-5355, ), and iRISE staff will be happy to answer questions and assist applicants with application preparation.

Application formsare available on request from Terrie Swearingen at . Applications must include the following sections:

1. Face Page listing the name, title, address, telephone number, e-mail address of the candidate; and title of the project. Also, space is provided to list suggestions for up to three possible non-conflicted reviewers. Suggested reviewers should be within the institution whenever possible. Outside reviewers should be suggested only when non-conflicted internal reviewers are not available. For revised proposals, every effort will be made to utilize the same reviewers of the previous submission.

2. Summary of proposal (250 word limit)

3. Body of grant (a through fare limited to 10 pages), must include:

Note: If this is a revised proposal, a one-page Introduction is allowed to address how the revised proposal addresses the previous reviews and will not be counted in the 10-page limit.

a. Hypothesis and aims

b. Background

c. Preliminary data (not required but may be included)

d. Experimental plan (must specifically address the clinical and translational impact of the study and how the data collected will lead to federal, private or industry extramural funding, as well as statistical considerations, such as power analysis and plan for data analysis)

e. Mentoring plan for junior investigators. The applicant should includea briefoutline of his/her research career development plans and how the funding will facilitate these plans. These applicants should identify a faculty mentor who should supply a letter of support, as well as a NIH-style biosketch.

f. Justification and protections for use of human subjects and animals

g. References (limited to 2 pages)

4. List of key personnel and biosketches (NIH format).

Note: This application is not using the new NIH biosketch format. Use the format included in the application packet.

5. Full description of other support, including all current and pending sources of funds with amounts and dates for each for all sources (external and internal, including any start-up funds). The team leader and other faculty participants should list their other research support, highlighting any support that is available for the proposed project.

6. Resources and environment (one page).

7. Budget and justification (NIH format). No PI or faculty salary support will be allowed.

8. Appendix that may include reprints (no more than 3), letters or other supporting documents in the PDF format.

Font
  • UseArial typeface, a black font color, and a font size of 11 points or larger. A symbol font may be used to insert Greek letters or special characters; the font size requirement still applies.
  • Type density, including characters and spaces, must be no more than 15 characters per inch.
  • Type may be no more than six lines per inch.
  • Print must be clear and legible.
Page Size and Page Margins
  • Usestandard size (8 ½" x 11") pages.
  • Use at least one-half inch margins (top, bottom, left, and right) for all pages, including continuation pages.
Page Formatting
  • Since several reviewers will be reviewing applications as an electronic document and not a paper version, applicants are strongly encouraged to use only a standard, single-column format for the text. Avoid using a two-column format since it can cause difficulties when reviewing the document electronically.
  • The application must be single-sided and single-spaced.
  • Consecutively number pages throughout the application. Do not use suffixes (e.g., 5a, 5b).
  • Do not include unnumbered pages.
Figures, Graphs, Diagrams, Charts, Tables, Figure Legends, and Footnotes
  • A smaller type size is acceptable, but it must be in black, readily legible, and follow the font typeface requirement.
Grantsmanship
  • Use English and avoid jargon.
  • If terms are not universally known, spell out the term the first time it is used and note the appropriate abbreviation in parentheses. The abbreviation may be used thereafter.
Photographs and Images
  • Do not include photographs or other materials that are not embedded directly into an application page in the body of the application. Color images may be used.

Page Limitations and Content Requirements

The Hypothesis and Aims, Background, Preliminary Data (not required but may be included), Experimental Plan, Mentoring Planand Justification and protections for use of human subjects and animals must not exceed 10 pages excluding references that are limited to 2 pages. NIH format biosketches are limited to 4 pages per person. The resources and environment description is limited to one page.

Submission

The iRISE website will be open for electronic submission. You may also submit the application electronically to Terrie Swearingen , and she will confirm receipt.Also send one hard copy with all of the necessary institutional signatures to:

Dennis D. Black, M.D.

iRISE Operations Manager

Children’s Foundation Research Institute

Le Bonheur Children’s Hospital

Room 471R, Children’s Foundation Research Tower

50 North Dunlap

Memphis, TN 38103

1