| Goals: To test
novel therapeutic agents in individuals with Huntington's disease (HD) and
to cultivate new investigator leadership for future Huntington Study Group
clinical trials. 1. Award
The Huntington Study Group and the Huntington Society of Canada (Laura’s
Hope Fund) both have specific funds available totaling $100,000 to support
a 1-2 year pilot clinical trial of a potential pharmacotherapeutic agent
in Huntington's disease. Individuals without prior experience as the Principal
Investigator of a clinical research project of the HSG are eligible to
apply but are required to do so in collaboration with a mentor. Either
the mentor or the candidate (or both) must be a current member of the
HSG.
2. Optional Letter of Intent (due May 1,
2005)
Individuals interested in obtaining feedback prior to the submission of
a formal application may submit a letter of intent by May 1, 2005. The
letter, not to exceed two pages, should contain an adequate description
of the planned research (see below), including information about the proposed
experimental treatment, source(s) for its procurement, and the suggested
mentor(s). An NIH biosketch of the investigator and the mentor should
be attached, as well as a single page to include a brief budget with justification,
key references, and any additional relevant information. Application letters
should be sent as a Microsoft Word attachment to an E-mail to aileen.shinaman@ctcc.rochester.edu
that includes the candidate’s name, address, professional title,
institution and the title of the study. Those submitting letters of intent
will be sent a written response by May 15, 2005, including a brief analysis
of strengths and weaknesses and recommendations for the full proposal.
3. Full proposals (Deadline June 15, 2005)
Full proposals will require the following information:
a. Candidates should propose
a one-year clinical research plan that is designed to assess an experimental
pharmacotherapeutic agent for HD.
b. NIH biographical sketch
for all investigators.
c. A budget for the proposed
study which is to include the cost of study drug and the support for the
investigator, not to exceed 10% of the total budget request (mentor support,
if requested, is not to exceed 5% of the total budget request). The total
budget request should not exceed $100,000. No overhead or institutional
support will be provided.
d. Research Plan including
specific aims, background and significance, preliminary studies, research
design and methods, and statistical analysis, not to exceed 4 pages.
e. Literature cited.
f. A copy of the proposed
consent form. IRB approval is not required at the time of the application.
An optional one-page letter to address concerns pertaining to protection
of human subjects and safety may also be appended.
g. A description of the
source and estimate of availability of proposed experimental pharmacotherapeutic
agent.
h. A letter of support from
the mentor describing his or her role in the project and a copy of the
mentor's NIH biographical sketch.
i. An electronic copy of
the proposal in Microsoft Word must be received on or before June 15,
2005. Applications and supporting materials should be sent by email to
HSGGrant@ctcc.rochester.edu.
Materials that cannot be sent electronically may be forwarded by mail
to: Aileen Shinaman, HSG Executive Director, 1351 Mt. Hope Avenue, Suite
223, Rochester, NY 14620
4. Review Process
Full proposals and letters of intent will be reviewed by an ad-hoc HSG/HSC
RFP subcommittee appointed by the chair and approved by the HSG Executive
Committee. Members of the subcommittee who are applying for the award
or who have a professional relationship with applicants that would represent
a conflict of interest will be excused from the review process. Criteria
for review will be the quality of the proposal and how well it meets the
goal "… to test novel therapeutic agents in individuals with
Huntington's disease (HD) and to cultivate new investigator leadership
for future HSG clinical trials." The RFP subcommittee will make recommendations
to the HSG Executive Committee, whose decisions will be final.
5. Timelines
Optional letters of intent should be received electronically by May 1,
2005. Those received by this deadline will be reviewed and a formal response
will be provided by May 15, 2005. All full proposals are due by June 15,
2005. Award notification will be made by July 1, 2005. Travel costs will
be provided so that recipients can present the results of their research
at an HSG meeting.
6. Questions
Questions regarding the Request for Proposals or any of the above information
should be directed to the Chair of the HSG-RFP Subcommittee, Francis Walker,
MD, at fwalker@wfubmc.edu or to
Aileen Shinaman, HSG Executive Director, at aileen.shinaman@ctcc.rochester.edu.
|