| Clinical Research Feasibility Funds (CReFF) Program |
Download
Application Instructions  |
Deadline: May 30, 2007
Funding Available: July 1, 2007 |
Download
GCRC Application Form |
CReFF award applications are requested to support
broadly defined clinical pilot studies subject to the review
and approval of the GCRC Advisory Committee. Eligibility is limited
to: a) professional, graduate, or postgraduate students, b) faculty
at the Assistant Professorial or Instructor ranks, and c) senior
faculty only if they are changing their research direction. Two
$10,000 awards are anticipated, although budget requests up to
$20,000 will be considered.
|
|
REQUIREMENTS FOR APPLICANTS: |
| Applicants should be a) professional, graduate,
or postgraduate students, b) faculty at the Assistant Professorial
or Instructor ranks, and c) senior faculty only if they are changing
their research direction.
Applicants must have written approval from their mentor or
immediate supervisor and Department Head to apply for funding
and guaranteeing protected time sufficient to complete the
project.
|
PRIORITIES FOR FUNDING: |
| The main objective for these funds
is to enhance opportunities for quality clinical research for
new clinical investigators. Specifically, priority will be given
to:
Applicants at the Assistant Professor or Instructor level;
Investigators without prior R01 support (as principal investigator);
Applicants with demonstrated commitment to a career in clinical
research;
Investigator-initiated projects that are independent of industry
funding;
Projects with a reasonable probability of being completed
with the award provided. |
Under special circumstances, senior
investigators undertaking a significant shift in focus and who
can demonstrate the need for funds to initiate this new research
effort may be considered. However, the eligibilities for such
investigators must be determined by the GCRC Advisory Committee
(GAC). Such investigators are urged to seek approval from this
committee prior to preparing an application (contact information
is provided at the conclusion of this RFA).
|
USE OF FUNDS: |
| Funds should be used for the conduct
of the project, including research assistant support, supplies,
subject payments, assays, etc.
Funds cannot be used to support salary of the Principal Investigator
or other investigators with faculty appointments.
|
SCOPE: |
| Within the general guidelines outlined
above, the types of projects that might be considered within
this mechanism include:
Pilot or feasibility studies
Secondary analysis of existing data
Small, self-contained research projects
Development of relevant research methodology
Development of relevant new research technology
|
CReFF PROTOCOL SUBMISSION PROCESS: |
| Applicants are urged to review the
instructions provided below carefully and to contact Abby Cosentino-Boehm
(323-7939, alcose0@email.uky.edu) with questions. Incomplete
or incorrectly prepared applications may be returned without
review.
Follow the steps below to apply for GCRC support.
|
| 1. Call or email Linda Rice (323-6481)
or Abby Cosentino-Boehm (323-7939) to schedule a meeting with
our staff. We will assist you by explaining how the unit operates
and what services we can offer you.
2. We also suggest that you consult with Dick Kryscio, PhD,
Analysis Director (257-4064, kryscio@uky.edu) for biostatistical
analysis and with Steven Shedlofsky, MD, Research Subject Advocate
(281-4957, shedlof@uky.edu) for help with your Data Safety
Monitoring Plan during protocol development, if needed.
3. Complete the GCRC Application (Application
Form )
4. Prepare the CReFF application (see instructions below)
5. After you have your documents ready, submit your application
online using the Protocol Submission System. You will need a
user ID and a password to log into the system. If you don't have
one, you can click on "new user registration" to apply
for one. After you submit your registration, we will verify your
information. You will receive an email notifying you when your
account is activated. After your account is activated, you can
log into Protocol Submission system. Follow the instructions
to submit your protocol. Please read Online Submission for more
information. Note: IRB materials are not required at
the time of CReFF protocol submission. |
CReFF APPLICATION INSTRUCTIONS: |
| The CReFF Program is seen primarily
as a means of enhancing the clinical research development in
young/new investigators. To facilitate the effectiveness of this
mechanism, new investigators must provide a letter of endorsement
and collaboration from a senior clinical investigator who is
willing to serve as a mentor for the applicant over the course
of the one-year project. This person may be either a M.D. or
Ph.D., but should have sufficient research expertise to serve
as a mentor to the applicant. The letter should reflect the amount
of time that the mentor is willing/able to direct to this role
as well as the specific types of activities that will be involved.
These activities might include reviewing progress on the project,
reviewing initial data, discussing relevant research articles
or related activities. It is NOT expected that the mentor commit
more than approximately 5% time to this role. This letter should
be included in the appendix material of the application.
Margins must be no smaller than .5” at all points. Font
size must be no smaller than 12 and font type should be Arial
or Helvetica. [Note that the font and margin requirements are
consistent with NIH expectations.] EACH page should provide
the applicant’s name in the upper right hand corner.
The application should be numbered consecutively in the center
bottom.
|
Page 1: Cover Page
Title of the Project: Total Amount Requested
Name, Degree(s) and Rank of the Applicant
Applicant’s Campus Address
Department Affiliation (Primary Appointment Only) and Address
College Affiliation/ Dean & Campus Address
Page 2: Budget:
Requests and their justification should be restricted to one
page
Allowable requests include:
Equipment essential for the conduct of the study
Data analysis costs
Participant reimbursement costs
Research assistant salary support
Project specific specimen collection/analysis or testing
Travel for relevant training or to present study results at
a national meeting
NON-ALLOWABLE COSTS
Faculty salary support
Travel unrelated to the study
Office materials not specific for project use
Applicants must account for fringe benefit costs when considering
assistant salary levels. NO INDIRECT COSTS ARE ASSIGNABLE THROUGH
THIS MECHANISM.
Page 3: Page 3 should provide a brief (not more than 250 word)
abstract. Beneath the abstract, each of the key personnel and
their departmental affiliation should be noted. The key personnel
should minimally include the PI and the designated mentor (one
of the endorsers). Data analysis consultants (if included),
collaborating investigators and others may be listed, if they
will play a significant, active role in the conduct of the
proposed work. Key personnel listed should provide a letter
confirming their role (INCLUDE THESE LETTERS IN THE APPENDIX).
NIH-FORMAT BIOSKETCH FOR APPLICANT AND KEY PERSONNEL: The
biosketch should follow NIH format and should include other
support.
BODY OF THE PROPOSAL: DO NOT EXCEED 8 PAGES The body of the
proposal should have the following sections in the designated
order: a) Specific Aims; b) Background and Significance; c)
Research Design, Methods, and Analysis; d) Limitations and
Future Directions. Note that in contrast to NIH applications
no preliminary studies/progress section is required. Relevant
work is expected to be succinctly integrated in other relevant
sections.
LETTER FROM SUPERVISOR/DEPARTMENT CHAIR: A letter signed by
the immediate supervisor (e.g. Division Chief) and/or Department
Chair that includes acknowledgement of their support for the
project and providing assurance that sufficient time to complete
the research will be available. No specific amount of protected
time is required, but the review committee will consider the
distribution of effort and other activities of the applicant.
REFERENCES: Authors, year, title and journal information is
expected for each citation. Given the length of the application,
investigators should not strive to provide an exhaustive relevant
review. (Not more than 2-3 pages).
APPENDIX: The required endorsement letter from the primary
mentor for new investigators, as well as the letters from key
personnel must be included. Relevant assessment materials may
be included provided they are of reasonable length and significantly
enhance the review of the application. DO NOT submit published
manuals, materials in the public domain or similar materials.
|
REVIEW PROCESS & CRITERIA: |
Your submission will be administratively reviewed. You will be
notified if portions are missing or incomplete. The Chair of
the Scientific Review Committee will assign members of the
committee for an in-depth review. They will be given two full
weeks to provide this review before the committee meets. You
will be notified of the outcome and possibly asked to provide
a response if the committee has any concerns. Depending on
the type of concerns, your response may be administratively
reviewed for approval or reviewed by the committee at their
next regular meeting. All applications must receive final approval
and priority score by the GCRC Advisory Committee (GAC).
The general criteria for review include:
Eligibility of the Applicant
Significance of the topic to health
Quality of the application, both in terms of the proposed
methods and in terms of the quality of the application construction/writing,
etc.
Commitment of the applicant to an academic research career
Feasibility of the project
|
IF FUNDED: |
| Once your protocol is fully approved,
you should contact Linda Rice, Director of Operations (323-6481,
lsrice0@email.uky.edu) and Abby Cosentino-Boehm, Administrative
Director (323-7939, alcose0@uky.edu) to schedule a working meeting
with the GCRC staff who will be involved with your protocol.
Successful applicants will be required to provide quarterly
progress reports and a final written report upon project completion.
|
| |
| For more information on this program, call the
UK GCRC at (859) 323-6623 or Tom Kelly at thkelly@uky.edu. |
| |
The UK GCRC is funded by National Center for Research Resources