ICTS CALL FOR PROPOSALS

Washington University Institute of Clinical and Translational Sciences

 

Development of Novel Clinical and Translational Methodologies

Pilot and Collaborative Translational and Clinical Studies

 

                                                                                                          Issue Date: October 19, 2007

 Letters of Intent Due: November 19, 2007

Applications Due: December 17, 2007

Award Start Date: January 14, 2008

 

BACKGROUND

The NIH funded Institute of Clinical and Translational Sciences (ICTS) is currently in its first year of funding under the Clinical and Translational Science Awards program.  Several institutions in the St. Louis area are participating in this program including: Washington University; BJC HealthCare; Saint Louis University School of Public Health; Doisy College of Health Sciences and Center for Health Care Ethics; the University of Missouri-St. Louis College of Nursing; Southern Illinois University-Edwardsville School of Nursing; St. Louis College of Pharmacy and key industrial and community partners.

 

o   The purpose of this communication is to encourage applications to the Novel Methodologies and Pilot Studies program, one of the programs supported by the ICTS.

 

ELIGIBILITY

Applicants must hold a faculty level appointment at one of the participating institutions.  Fellows in the final year of training with a commitment by their Department for a faculty position in the following year are also eligible.  There is no specific citizenship requirement for the applicant.

 

 

ABOUT THE PROGRAM

 

A.  Investigator Categories

The Novel Methodologies and Pilot Studies program will support:

 

·         New investigators in either clinical or translational research who do not yet have their own peer-reviewed research support

 

·         Established investigators who are working in other fields, but are interested in exploring new directions in clinical and/or translational research

 

·         Established investigators already active in the field of clinical or translational research, but whose proposed project is different from their previous work

 

·         Developing or maintaining inter- or multidisciplinary groups working on novel methodologies or research teams working on a clinical problem of interest and importance.

 

B.  Program Categories

Awards will be made in three categories:

·         Planning Grants: Provide up to $25,000 for 1 year to facilitate the planning of a new clinical or translational research project.

·         Individual Research Grants: Provide up to $75,000 per year for 1-2 years to individual investigators to support a clinical or translational research project.

·         Collaborative Research Grants: Provide up to $100,000 per year for 1-2 years to multidisciplinary groups or research teams working on a common clinical or translational research project.  Multidisciplinary will be defined as more than one discipline and a group or team will be defined as consisting of at least 2 investigators generally from 2 or more departments or academic units.

 

In all cases the second year of funding is contingent upon a successful progress report due near the end of the previous year.  Continued funding for existing projects will compete with new projects.  We anticipate that up to $800,000 will be allocated on an annual basis to this program.

 

C.  Proposal Focus

This program is designed to support a broad range of clinical and translational studies including but not limited to the following:

·         New Methodologies and Technologies: Funds may be requested to develop new technologies with strong promise for being introduced into humans in the short term (< 5 years).  Funds may also be used to develop methods that could be applied in humans, e.g. methods to improve the phenotyping of human subjects (mass spectrometry in biomarker development, novel imaging approaches, stable isotope turnover methods).  Methodologies that are not technologically based are also eligible for funding (e.g. new methodological approaches to problems in biostatistics and clinical trial design, novel approaches to implementing community based research and outcomes studies).

·         First-in-Human Studies: These funds are specifically intended to support unique costs related to bringing new technologies (diagnostic or therapeutic) into humans for the first time.

·         Preliminary Data: This represents a more general category for support of new projects.  Funds can be used for generating sufficient preliminary data to justify a grant application for sustained funding from an external source (NIH, national foundation, etc.).

·         Process Improvement: Funds may be requested for pilot programs aimed at demonstrating the value of new processes to facilitate clinical research or for research related to process improvement.  Research intended to develop improvements in study design, statistical analytic approaches, research ethics, or harmonization of regulatory processes would all come under this category.

·         Development of Clinical Research Cores: The ICTS will consider underwriting a portion of the start-up costs for new cores that will materially improve the conduct of clinical research.  An example would be to improve subject recruitment programs.  Travel support and major equipment may be included in this type of proposal.

·         Collaborative Research Programs: A major theme for the ICTS is to support the development or expansion of highly productive teams that can have a significant impact on the likelihood of success for a given research project.  Funds targeted toward facilitating collaborative research projects may also be requested.

 

AWARD TERMS

Awardees are required to submit a progress report and report related publications and funding within 90 days of the award’s end date.  Acceptance of funds implies a firm commitment to provide these reports in a timely manner and to adhere to applicable institutional and agency funding guidelines.  All publications should acknowledge the source of funding.  It is expected that awardees will completely utilize the full amount of funding awarded during the one-year term of the award.  All unexpended funds at the end of the term will be returned to the ICTS Administrative Core.  Extensions or changes to the terms of the award (length of funding period and budget) will generally not be permitted.

 

REVIEW PROCESS

Prospective applicants must submit a letter of intent by 5 p.m. CST on Monday, November 19, 2007.  This letter will be used to review program eligibility and recruit qualified reviewers.  Full applications are due by 5 p.m. CST on Monday, December 17, 2007.

 

All proposals will be scored by a Funding Review Committee with the help of selected outside consultants who have expertise in the proposed area of investigation.

 

Priorities: The ICTS Funding Review Committee will give priority to proposals that meet one or more of the following criteria:

·         Proposals from new or junior investigators in one of the ICTS-supervised training programs within the Center for Clinical Research Training

·         Proposals that involve more than one ICTS investigator

 

Awardees will be notified by ICTS Director, Dr. Kenneth S. Polonsky by January 11, 2008.  Awards will start on January 14, 2008.

 

 

TO APPLY

 

LETTER OF INTENT

Submit the letter of intent as a single .pdf file via email to Rebecca Evans at ICTS@wustl.edu no later than 5 p.m. CST, Monday, November 19, 2007.  A Division or Department Chair signature is not required at this point. The letter should be a one page outline of the proposed research and should specify each of the following.

·         Investigator Category

o   New investigator in either clinical or translational research

o   Established investigator interested in exploring new directions in clinical and/or translational research

o   Established investigator whose proposed project is different from their previous work

o   Support for developing or maintaining inter- or multidisciplinary groups working on novel methodologies or research teams working on a clinical problem of interest and importance.

·         Proposal Category

o   Planning Grant

o   Individual Research Grant

o   Collaborative Research Grant

·         Proposal Focus: Provide a brief overview of the proposal you would plan to submit if invited to do so.

o   New Methodologies and Technologies

o   First-in-Human Studies

o   Preliminary Data

o   Process Improvement

o   Development of Clinical Research Core (Core Development)

o   Collaborative Research Programs

 

Applicants must be registered members of the ICTS.  Membership is open to investigators from any of the ICTS partners who conduct or participate in clinical and/or translational research.  Within 5 working days of submitting the Letter of Intent applicants will be notified whether they will be asked to submit a full application.  Instructions for ICTS member registration and for submitting a complete research proposal will be sent to the applicant at that time.  Investigators who submit the letter of intent early will have more time to prepare the full applications.