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NCI National Clinical Trials Network (NCTN) Program Guidelines

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PART 1: Overview of <strong>NCTN</strong> <strong>Program</strong> Section IV – Terms/Conditions of Award – <strong>Network</strong> RT & Imaging<br />

Core Services Centers<br />

Genome Wide Association Studies (GWAS) as well as a biospecimen sharing policy. <strong>Network</strong><br />

Radiotherapy & Imaging Core Services Centers are required to follow and support these policies<br />

for the <strong>NCTN</strong> trials led by the supporting <strong>Network</strong> Group Operations Centers, if applicable.<br />

5.4.4 Education on the Protection of Human Subjects<br />

NIH policy requires education on the protection of human subject for all investigators submitting<br />

NIH applications for research involving human subjects and individuals designated as key<br />

personnel. This policy is available on the NIH website at:<br />

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.<br />

5.4.5 Other Federal Regulations<br />

The NIH Public Access Policy ensures that the public has access to the published results of NIH<br />

funded research. It requires scientists to submit final peer-reviewed journal manuscripts that<br />

arise from NIH funds to the digital archive PubMed Central upon acceptance for publication. To<br />

help advance science and improve human health, the Policy requires that these papers are<br />

accessible to the public on PubMed Central no later than 12 months after publication. More<br />

information about this policy or the submission process is available on the NIH Public Access<br />

Policy website at: http://publicaccess.nih.gov/.<br />

Information on other federal regulations (and their associated citations/URLs) that may be<br />

applicable to the <strong>Network</strong> Radiotherapy & Imaging Core Services Centers’ activities is provided in<br />

Part 4: Appendices – Section IV.B.<br />

5.5 Conflict of Interest Policy<br />

The <strong>Network</strong> Radiotherapy & Imaging Core Services Centers receiving NIH funding from a grant or<br />

cooperative agreement must be in compliance with all of the DHSS regulatory requirements for conflict<br />

of interest as outlined by NIH grants policy available at: http://grants.nih.gov/grants/policy/coi. The<br />

<strong>Network</strong> Radiotherapy & Imaging Core Services Centers policy should ensure that there is no<br />

reasonable expectation that any investigator of staff member at the Core Centers involved in the<br />

design, conduct, or reporting of research conducted by the <strong>Network</strong> Group Operations Centers and<br />

their associated <strong>Network</strong> Group SDMCs will be biased by any conflict of interest (using the definition of<br />

investigator provided in the NIH grants policy). The policy should also be in compliance with the<br />

<strong>NCI</strong>/DCTD/CTEP’s Conflict of Interest Policy for <strong>NCTN</strong> Phase 3 <strong>Clinical</strong> <strong>Trials</strong> found on the CTEP website<br />

at: http://ctep.cancer.gov/investigatorResources/default.htm#guidelines_policies.<br />

Page 74 of 241

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