The purpose of the program is to support clinical research among junior faculty who have not yet established independent NIH or comparable funding. Senior faculty may also apply for this program if the research they propose represents a change for them in their research career path. The program will provide funding for research projects of up to $20,000 per year for one year with the potential to apply for a second year of funding of up to $20,000. This funding will be in addition to traditional General Clinical Research Center (GCRC) resources (i.e., inpatient days, outpatient visits, nutrition services, core laboratory services, informatics services, biostatistical consulting and support for ancillary tests) that the project may utilize. Preference will be given to projects which use traditional GCRC resources. The goal of this program is to develop clinical investigators who will successfully compete for NIH or comparable support and continue to pursue a clinical research based academic career.

Eligibility

Junior faculty at the rank of Assistant Professor or below at the University of Rochester are eligible to apply. Senior faculty are also eligible to apply if the research proposed represents a substantial change in research career path. Applicants must have an M.D., Ph.D., Pharm.D, or D.D.S. degree. If University of Rochester GCRC inpatient or outpatient facilities are to be utilized, non-M.D. applicants must have a physician co-investigator or collaborator who has clinical privileges at Strong Memorial Hospital. Applicants may not have NIH or comparable external funding for the project proposed, although recipients of K23 or other career development awards may supplement those funds with a CReFF award.

Selection Criteria

Applications will be judged on the potential for funding to help develop the research career of the principal investigator and on the potential of the project to generate data and scientific reports that could be used to secure subsequent peer reviewed funding. Criteria to be considered with respect to the principal investigator are:

• training in the performance of clinical investigation,
• availability of an appropriate mentor or collaborator,
• availability of adequate time to perform the proposed project.

Applicants must provide a letter of support from a senior faculty member who agrees to participate as a research mentor for the project.

Documentation that adequate time will be made available by the appropriate division director or department chairperson is encouraged.

Selection criteria with regard to the project are:

• A statement of a focused hypothesis which can be tested in the time and with the resources available.
• An appropriate consideration of study design, statistical analysis, subject safety plan, and inclusion of gender and ethnic balance.
• Scientific importance of the issue raised.
• Use of the University of Rochester GCRC resources to conduct the study.

Application and Review Process

All applicants must submit a Bio Sketch in the standard NIH format. To apply, use the University of Rochester GCRC protocol application form. It must include a hypothesis, background information, design and methods, biostatistical design, information regarding the inclusion of women children and minority groups in the study population, explanation of risks to which subjects will be exposed, a data and safety monitoring plan, and a 1-year budget (direct costs only) using standard NIH budget pages. All approved projects must have IRB approval prior to initiation of the protocol.

The Bio Sketch and budget pages are available on the NIH web site at http://www.grants.nih.gov/grants/forms.htm.

The GCRC protocol application form is available on the GCRC website at http://www.urmc.rochester.edu/medicine/gcrc/.

Applicants with currently approved projects need only submit a cover letter detailing the request for CReFF funds along with the NIH Budget page. A letter of support from a senior faculty member who agrees to participate as a research mentor for the project is also required.

Two expert reviewers will be assigned to each application submitted. The expert reviewers will report and make recommendations to the GCRC Advisory Committee which will rank the applications and select the awardee(s). Awardees may submit an application for a second year of funding which will be competitively reviewed by the GCRC Advisory Committee.

Evaluating Success

All recipients will be required to prepare a final report for each year of funding awarded. The report should include copies of any submitted manuscripts and scientific publications which have resulted from the CReFF award. The GCRC grant should be acknowledged in all publications.

To Apply

Submit GCRC application, budget and cover letter to the GCRC Program Director, 601 Elmwood Ave. Box MED/CRC, Rochester, NY 14642, by December 6, 2004. Applications will be reviewed and awards announced in late December with funds ready for immediate access by awardees.

This same information can be downloaded from this file:

 Clinical Research Feasibility Funds - Program Guidelines