NINDS ADMINISTRATIVE SUPPLEMENT TO CLINICAL STUDIES FOR COLLECTION OF BLOOD 
SAMPLES AND DATA FOR REPOSITORY BANKING IN EPILEPSY, PARKINSON'S DISEASE AND 
STROKE
	
RELEASE DATE:  May 21, 2003

NOTICE:  NOT-NS-03-016

National Institute of Neurological Disorders and Stroke (NINDS)
 (http://www.ninds.nih.gov)

The National Institute of Neurological Disorders and Stroke (NINDS) 
announces an administrative supplement program for currently funded 
NINDS clinical research projects in order to encourage the collection 
and timely sharing of whole blood samples via the NINDS Human Genetics 
Repository ("the repository") (http://locus.umdnj.edu/ninds).  The 
NINDS repository allows receipt, storage, maintenance, standardization, 
quality control, and equitable, ethical distribution of DNA and other 
resources important in the genetic study of Neurological diseases. The 
sharing of data, biomaterials and other unique research resources is an 
essential element towards understanding the genetic basis of 
neurological disorders.  This supplement initiative is responsive to 
the NIH Grants Policy Statement requiring investigators to provide 
prompt and effective access to unique research resources generated by 
NIH funds (http://grants.nih.gov/grants/policy/nihgps_2001/part_iia_6.htm
#_Toc504811860).

These supplements are intended to assist researchers who have an 
ongoing NINDS clinical project to perform additional blood sample 
collection.  The supplement will do this by defraying some of the added 
costs of collecting and characterizing samples for submission to the 
Repository.  Costs associated with the actual clinical research project 
are not part of this supplement program.  Those eligible to apply are 
NINDS Principal Investigators (PIs) with Clinical Trials, 
epidemiological projects, and other clinical studies under any of the 
following mechanisms: Research Project (R01), Phase II SBIR (R44), 
Program Project (P01), Specialized Center (P50 or U54), or Cooperative 
Agreement (U01) grants.  To be eligible, projects must be ongoing 
during the time of the supplement period (studies that have been 
awarded a no cost extension may also be eligible).  There will be a 
maximum award per year (direct costs) of $100,000 for any of the above 
mechanisms.  

Supplemental funds can be used for personnel to facilitate sample 
collection as well as for sample collection itself.  Goals may include, 
but are not limited to, the following:

o Resources (such as personnel time) required by project personnel for 
working with their local institution, including the local Institutional 
Review Board, in development of the consent form and project logistics.   
Note that a sample consent form is available at 
http://locus.umdnj.edu/ninds/comm/submit/icmodel.pdf.
 to facilitate these efforts.
o Resources needed to ensure that clinical data collection and samples 
meet repository requirements for submission.  See 
http://locus.umdnj.edu/ninds for sample submission standards and 
clinical data guidelines.  

o Recruitment and ascertainment of subjects.  NOTE THAT SUBJECTS 
SCREENED FOR BUT EXCLUDED FROM THE PARENT CLINICAL TRIAL MIGHT STILL BE 
APPROPRIATE FOR SAMPLE COLLECTION UNDER THIS SUPPLEMENT, AND THAT SOME 
SUBJECTS APPROPRIATE FOR CLINICAL TRIAL INCLUSION MIGHT NOT BE 
APPROPRIATE FOR SUBMISSION.  

o Sample collection including phlebotomy costs.

The amount of award will be based on number of blood samples and sample 
type submitted and accepted into the repository.  Award will occur 
after at least one minimal sample set is submitted successfully as 
specified below.  There are two types of possible sample submissions:  

o Affected siblings (a.k.a. a "sib pair").  Two affected siblings from 
the same family with the same diagnosis constitute a sib pair in this 
context.  This type of sample will be reimbursed at $400 per collected 
affected (concordant) sib pair.  A minimum of 10 sib pairs is required 
for a complete sib pair sample set.  

o Cases and control series sets (minimum of 25 samples from cases and 
25 samples from controls).  Each sample of this type will be reimbursed 
at a rate of $150 each sample following submission to the repository of 
a complete case control series sample set.

The following types of sample submissions will NOT be accepted:

o Existing sample collections (e.g., blood, DNA or cell lines 
previously collected and stored)

o Samples other than whole blood (such as brain tissue, cerebrospinal 
fluid)

o Samples without accompanying clinical data according to repository 
guidelines

All samples submitted must be accompanied by required clinical data 
(Clinical data elements or CDEs) strictly according to the repository 
guidelines (see http://locus.umdnj.edu/ninds).  A minimum of 10 sib 
pairs per grantee (a complete sib pair set), or a complete case control 
series (25 in each group) must be collected in order to be reimbursed 
under this award.  Samples submitted in addition to the required 
minimum number are encouraged.  Collections from a single investigator 
may include one or more sets of each type.  

We realize that it is not feasible for all samples from a set to be 
submitted to the repository at a single time; therefore single sample 
submissions will be accepted to the repository and tracked until the 
minimum number is met prior to reimbursement.  Note that all samples 
collected under this supplement will be made available immediately to 
the research community as a sample resource.  As a benefit of 
contributing, investigators submitting samples to the repository will 
be able to withdraw cell lines or DNA samples created from the blood 
samples they have submitted as well as access an equal number of the 
other samples available via the repository, for a nominal fee. 

All samples must be collected according to NIH policy and under an IRB 
approved protocol.  IRB approval must be documented and a copy of the 
(unsigned) IRB approved consent form that will be used must be 
submitted prior to sample acceptance.  The guidelines of ethical 
standards protecting subject confidentiality and rights as described at 
http://grants.nih.gov/grants/funding/SBIRConf2000/Scharke/ apply and 
must be followed in regard to these and all other NINDS repository 
activities.  Applicants should consider applying for a certificate of 
confidentiality for subject characterization and sample collection done 
under this supplement (see 
http://www.ninds.nih.gov/funding/certificates_of_confidentiality.htm).  The 
NINDS Repository is HIPAA compliant (http://www.hhs.gov/ocr/hipaa/).
 
HOW TO APPLY

Applicants should submit an original and five copies of a complete 
written application, signed by an authorized business official at their 
institution, to Dr. Katrina Gwinn-Hardy at the address listed at the 
end of this notice. The following sections should be included:

1) A cover page citing this NOTICE and requesting an administrative 
supplement, including the PI name, grant number and title, name and 
title of the institutional business official, and phone, email, and 
address information for the PI and institutional official.  For P01s 
and P50s and U54s, the named PI must submit the request for a 
supplement.

2) A letter (5-page limit) describing the project, including:

o An abstract
o The timeframe and numbers of samples anticipated
o Anticipated budget

3) Documentation of IRB approval or agreement to obtain IRB approval 
within timeline projected prior to sample submission.

4) Agreement to submit required clinical data elements to the repository 
with each sample.

5) Agreement to allow immediate release of all submitted samples and 
non-personally identifiable data to the research community via the 
repository.

BUDGET INFORMATION  

These supplements will be awarded as DIRECT COSTS.   Requests will be 
limited to a maximum of $100,000 for R01, R44, P01, P50, U01, or U54 
grants.  For awards anticipated to be beyond these amounts, please 
contact Program staff. The NINDS will commit $3 million over FY04, 05, 
and 06 to fund applications for supplements submitted in response to 
this Notice.

REVIEW CRITERIA  

Applications for submission will be reviewed administratively by the 
NINDS Project officer and NINDS Repository Committee.  All funding 
decisions are final and are not subject to appeal.  Applicants should 
provide the following information for consideration in review: 

o The sample collection strategy;
o How the collection strategy will be incorporated into the parent 
project;
o Justification for the anticipated number of samples;
o Types of samples (sib pair sets, case control sets, or both types);
o Track record of previous sample collection and repository 
submissions, if any.

RECEIPT DATES (starting October 2003, ending June 2006):

October 1
February 1
June 1

The supplemental award will take place approximately two months after 
favorable review and approval by NINDS staff.

INQUIRIES 

Direct your inquiries about scientific /research issues to:

Dr. Katrina Gwinn-Hardy
Program Director, Neurogenetics
NSC Rm 2142   
6001 Executive Blvd
Bethesda, MD  20892 (Regular Mail)
Rockville, MD  20852 (Express Mail)  
Tel: (301) 496-5745
Fax: (301) 402-1501
Email: gwinnk@ninds.nih.gov

Direct inquiries regarding fiscal and business administration matters 
to: 

Kathleen A. Howe
Grants Management Branch
National Institute of Neurological Disorders and Stroke 
NSC Rm. 3290-MSC 3597
6001 Executive Blvd., Bethesda, Maryland 20892 
Tel: (301) 496-3291
Fax: (301) 402-0219 
Email:  howek@ninds.nih.gov


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.