Release Date:  August 30, 2000

NOTICE:  CA-00-025

National Cancer Institute

The National Cancer Institute announces the availability of administrative 
supplements to encourage investigators collecting human specimens and 
associated clinical data as part of large studies to make them more available 
to research. The NCI has invested significantly in specimen and data 
collection for large studies.  This investment could be leveraged considerably 
if those specimens could be made available to other researchers once the major 
goals of the original studies had been met. Institutions with an NCI supported 
study that has accrued at least 2000 cases (individuals); is funded at a 
direct cost of $1M or more over the life of the grant; and plans to retain 
specimens for 5 years or more, are eligible to apply. In addition, studies 
with significant numbers of cases of rare or unique tumor types or specimens 
and data from unique populations likely to be of long term interest to the 
scientific community are eligible for supplements.  The resource must have 
both specimens and relevant associated clinical and demographic information.  
Investigators collecting specimens and data in the NCI Clinical Trials 
Cooperative Groups and other large clinical studies are examples of the type 
of resource we are interested in supplementing.

The proposed resource should fill a need; it should not duplicate publicly 
accessible procurement or banking efforts currently supported by the NCI.  In 
addition, the specimen collection and data should already exist; supplements 
will not be provided to support the creation of specimen resources or to  
support research activities.

Administrative supplements may be requested by any investigator holding an 
existing NCI-funded research project (R01) grant, program project (P01) grant, 
cooperative agreement (U01 or U10), Center (P30) grant or SPORE (P50) grant. 
The grant must have at least 2 years of support remaining at the time the 
supplement is requested.  Holders of recently reviewed competing applications 
that have been selected for competitive funding are also invited to apply.  
Applicants may request up to 10% of the annual direct cost of the parent grant 
or $200,000 direct cost annual funding, whichever is lower.  Typically funds 
would be used to provide staffing necessary to take requests for specimens, 
access specimens and data, prepare specimens (eg. cut sections), package and 
ship specimens to researchers; cover shipping costs; and for other costs 
directly related to providing the existing specimens and data.

Submit the request for supplement support as a letter that addresses the 
following points:

The number of cases in the collection and the extent, quality and 
accessibility of associated clinical and outcome data. 

Process for assuring quality of the specimens

Plans to address informed consent and to maintain the confidentiality of 
individually identifiable information.

The feasibility of making specimens and data available.  Applicants should 
specifically address competition within the funded project for access to 
specimens, whether local research needs are likely to use all of the specimens 
and whether researchers outside the applicant institution will have access to 
the specimens.

An equitable decision process to prioritize requests for specimens and data.  
This should include a timeline, address conflicts of interest, and indicate 
whether or not formal collaborations will be required for access to specimens. 
Examples of equitable prioritization processes include using a review 
committee of outside scientists to determine the scientific priority of 
requests; having an oversight committee with both outside and internal members 
that reviews operating policies and ensures the equity of access to the 
resource, or having a policy of open access in which all reasonable requests 
are filled in accordance with clearly defined equitable guidelines.

Plans for marketing or broadcasting of the availability of the specimen 
resource and whether the investigators will require NCI assistance.

Budget and justification

Letters must be submitted directly to the NCI program director listed on the 
most recent Notice of Grant Award.  Grantees are strongly encouraged to 
discuss their request with the program director before submitting.

Requests in response to this announcement must be submitted on or before 
November 5,2000. The program director will evaluate the request to assure that 
it meets the eligibility requirements of this announcement and addresses an 
important resource need.  Following this evaluation, an NCI committee of 
extramural program staff with expertise in relevant scientific areas will 
review and prioritize the requests.

Direct general inquires relating to this notice to: 

Roger L. Aamodt, Ph.D.
Division of Cancer Treatment and Diagnosis
National Cancer Institute
6130 Executive Boulevard, Room 6035A
Bethesda, MD  20892
Telephone:  (301) 496-7147
FAX:  (301) 402-7819

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