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

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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