GUIDELINES FOR APPLICATIONS INVOLVING CLINICAL RESEARCH WITH YEARLY DIRECT COSTS
OVER $1,000,000
Release Date: June 25, 2001 (see correction NOT-NS-03-025)
NOTICE: NOT-NS-01-012
National Institute of Neurological Disorders and Stroke
PURPOSE
Current NIH-wide policy states that programmatic acceptance is required
for all unsolicited grant applications requesting $500,000 or more in
direct costs for any year, including new (Type 1), competing
continuation (Type 2), competing supplement and any amended/revised
version of the preceding grant application types ( Acceptance For
Review Of Unsolicited Applications That Request More Than $500,000
Direct Costs
http://grants.nih.gov/grants/guide/notice-files/not98-030.html).
The guidelines and procedures for programmatic acceptance
of unsolicited clinical research grant applications requesting direct
costs of $1,000,000 or more in any year by the National Institute of
Neurological Disorders and Stroke (NINDS) are outlined in the present
document. For purposes of this policy clinical research is as
defined in the 1997 Report of the NIH Director’s panel on Clinical
Research http://www.nih.gov/news/crp/97report/execsum.htm). According
to this definition, clinical research includes (a) Patient-oriented
research (including research on the mechanisms of human disease,
therapeutic interventions, clinical trials, and the development of new
technologies), (b) Epidemiologic and behavioral studies, and (c)
Outcomes research and health services research. Excluded from this
definition are in vitro research studies that utilize human tissue that
cannot be linked to a living individual or research that does not
involve human participants.
The current policy is intended to meet NINDS commitment toward
developing its clinical research program (as identified in the NINDS
strategic planning process
http://www.ninds.nih.gov/about_ninds/plans/strategic_plan.htm) by
standardizing the process of accepting an investigator’s request to
submit an unsolicited clinical grant application requesting direct
costs of $1,000,000 or more in any year. It also ensures that the
NINDS staff has sufficient information and time necessary to make an
informed decision to accept an application for review. Obtaining NINDS
agreement to accept an application does not guarantee funding. As
with all grant applications, the decision to make an award depends upon
the results of independent peer review for technical/scientific merit,
a subsequent recommendation of approval by the National Advisory
Neurological Disorders and Stroke (NANDS) Council, and availability of
funds. It is in everyone’s best interest that potential applicants
planning an application that requests unusually high direct costs
contact the NINDS program staff as early as possible. Potential
applicant(s) may also request a meeting between the NINDS and the
investigator(s) to discuss the proposed project.
POLICY
An applicant planning to submit an investigator-initiated new (type 1),
competing continuation (type 2), competing supplement, or an
amended/revised version of the preceding grant application types for a
clinical research project requesting $1,000,000 or more in direct costs
for any year is advised that he or she must contact the NINDS (see
INQURIES) a minimum of 3 months prior to the next submission deadline for
new grant applications (Feb 1, June 1, or Oct 1). Furthermore, the
applicant must obtain agreement from the NINDS staff that the Institute
will accept the application for consideration for award. Any application
subject to this policy that does not receive permission to submit will be
returned to the applicant without review.
These guidelines apply to unsolicited grant applications (e.g., R01, U01,
U54, P01, P50), including applications submitted in response to NINDS
Program Announcements (PAs).
They do not, however, apply to grant applications that are submitted in
response to NINDS Requests For Applications (RFAs). Solicitations for
SBIR or STTR applications are also excluded from this policy. Approval
for submission of these applications is sought directly from the
appropriate NINDS Program Director.
PROCEDURES
An applicant planning to submit a grant application to which this
policy applies is required to contact Dr. Scott Janis (see INQUIRES) no
later than 90 days before the application receipt date (November 1 for
the February 1 receipt date, March 1 for the June 1 receipt date, or
July 1 for the October 1 receipt date). Prospective applicants are
asked to submit a letter of intent that should include a descriptive
title of the proposed research, name, address, and telephone number of
the Principal Investigator, and identities of other key personnel and
participating institutions.
Although a letter of intent is not binding and does not enter into the
review of subsequent applications, the information allows NINDS staff
sufficient time necessary to make an informed decision to accept an
application for review.
A response will be sent to the potential applicant no later than 6
weeks prior to the requested submission deadline. If the NINDS is
willing to accept assignment of the application for consideration of
funding, the staff will notify the Center for Scientific Review before
the application is submitted.
EFFECTIVE DATE: June 1, 2001
INQUIRIES
Submit all requests for applications subject to this policy to:
Scott Janis, Ph.D.
National Institute of Neurological Disorders & Stroke
National Institutes of Health
6001 Executive Boulevard, Rm. 2209, MSC 9525
Bethesda, MD 20892-9525
(301) 594-0211
(301) 480-1080 Fax
email: sj151t@nih.gov
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