NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section II – Budget/Research Plan
Network Group Ops Center
Information on the policies for inclusion of children is available at:
http://grants.nih.gov/grants/funding/children/children.htm
http://www.nih.gov/grants/guide/notice-files/not98-024.html
NIH policy requires that children (i.e., individuals under 21 years of age) must be included in
all human subjects research, conducted or supported by the NIH, unless there are clear and
compelling reasons not to include them as described at:
http://grants.nih.gov/grants/funding/children/children.htm. For cancer clinical research,
Network Group Operations Centers conducting research in adult cancers can provide a
rationale for not including children because the majority of children with cancer in the
United States are already accessed by a Network Group devoted to pediatric cancer
research, so that requiring inclusion of children in the proposed adult study would be both
difficult and unnecessary (since the research question is already being addressed in children
by the pediatric network) as well as potentially counterproductive since fewer children
would be available for the pediatric Network study if other studies were required to recruit
and include children.
2.7 Resource Sharing Plans
Applicants are required to comply with the instructions for the Resource Sharing Plans (Data
Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as
provided in the PHS 398 Application Guide with the following modifications:
� Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms if
applicable, and Genome Wide Association Studies (GWAS) are expected in this
application.
� All applications, regardless of the amount of direct costs requested for any one year,
should address a Data Sharing Plan. An example of a Data Sharing Plan for Network
Group Operations Centers and associated Network Group Statistics and Data
Management Centers for the NCTN Program is provided in Part 4 – Appendices –
Section VII in these Guidelines.
The Data Sharing Plan and other resource plans (or rationale for not providing sharing
certain resources) should be provided in the research application; however, prior to funding
of an award, all resource sharing plans/policies will also need to be reviewed and approved
by NCI/DCTD program staff prior to funding any award in order to ensure that the
plans/policies are in compliance with NCI/NIH regulations and the Terms of the Award for
the applicable key component of the NCTN Program.
3. Appendix Material & Post Submission Materials
Information on the Appendix material that should be provided in the Network Group Operations
Center application, along with information on the timing of submission of this material and the
format in which it should be provided is described in Part 2 – Section I.D. of these Guidelines.
In addition to the information that can be included in the Appendix material described in that
section, copies of up to 3 protocol documents described or referenced in the narrative of Subsection
B (Clinical Trial Development Program) of the research plan for the proposed Network
Group Operations Center illustrating the Center's overall research directions may be submitted in
the Appendix. The applicant may not submit copies of all protocols being conducted or in
development by the applicant in the Appendix.
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