NCI National Clinical Trials Network (NCTN) Program Guidelines

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PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Network Group Integrated Translational Science Centers should also have policies and procedures in place for potential onsite auditing of assay/test performance by NCI/DCTD, if requested. 3.2 Pilot Studies and Collaborative Projects The Principal Investigator(s) should be responsible for the design and analysis of pilot studies to collect preliminary data, if needed, to effectively incorporate specific translational science studies into late phase, definitive, NCTN trials. In addition, the Principal Investigator(s) are responsible for any collaborative projects with other NCTN Program components as well as other NCI-sponsored programs (e.g., SPOREs, NCI Cancer Centers) designed to facilitate hand-offs of translational science discoveries and/or early phase clinical trial results into later phase, NCTN trials. Principal Investigator(s) are also responsible for ensuring that any pilot data or results from collaborative projects are published in a timely manner as per the publication policy outlined for the Network Group Operations Center in Part 1: Section IV.B.1.1.5 (Publications). 3.3 Compliance with Federal Regulations for Clinical Research The Network Group Integrated Translational Science Center awardee(s) should have policies and procedures for ensuring that any work performed is in compliance with federal regulations regarding the protection of human subjects in clinical trials. In particular, policies and procedures related to confidentiality, integrity, and security of patient data should be in compliance with the Health Insurance Portability and Accountability Act (HIPAA). There should also be adequate safe-guards to ensure the technical integrity of assay/test performance in support of clinical trial research. Policies and guidelines to be addressed include the following: 3.3.1 IRB Review of the Network Group Integrated Translational Science Center Institutional Review Board (IRB) review of the Network Group Integrated Translational Science Center grant is required. The IRB should determine and document that the Group Integrated Translational Science Center has sufficient mechanisms in place to ensure appropriate data management and analysis of translational science data and pilot studies as well as mechanisms to ensure protection of the confidentiality of patient data, given the nature of the research involved. Information on this requirement for IRB review can be obtained on the OHRP website at: http://www.hhs.gov/ohrp/policy/aplrev.html. 3.3.2 Inclusion of Women, Minorities, and Children in Clinical Research NIH policy requires that women and members of minority groups and ethnic subgroups be included in all NIH-supported biomedical and behavioral clinical research projects involving human subjects at: http://grants.nih.gov/grants/funding/women_min/women_min.htm. Compliance with this policy requires appropriate study designs, targets for total protocol accrual with distribution by ethnic/racial categories and by sex/gender, as well as reporting of accrual by ethnic/racial categories and by sex/gender. Since Network Groups conduct multiple phase 3 clinical trials, the amended NIH Policy on inclusion of women and minorities in research also applies (see NIH Guide Notice on NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research – Amended October 2001 at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html, with a complete copy of the updated Guidelines available at: http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. A description of plans to conduct analyses, as appropriate, by sex/gender and/or ethnic/racial groups must be included in clinical trial protocols and the Network Group SDMC should ensure that it has appropriate procedures in place to address this requirement. Cumulative subject accrual and progress in conducting subset analyses must be reported to NIH in the annual Progress Reports. Final analyses of sex/gender and ethnic/racial differences must be reported in the required Final Progress Report or any future competitive renewal applications. The Network Group Integrated Translational Science Center should ensure that, when appropriate, translational science studies that it supports are incorporated into these reporting requirements Page 62 of 241
PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Network Group Integrated Translational Science Centers by its supporting Network Group Operations Center(s) and associated Network Group Statistics and Data Management Center(s) and have a policy in place to address this requirement. 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 Integrated Translational Science Centers supporting 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. 3.3.3 Resource Sharing Plans Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms if applicable, and GWAS Sharing Plan) are required for all key components of the NCTN Program. However, since it is expected that the Network Group Integrated Translational Science Center will follow the Resource Sharing Plans of the associated Network Group Operations Center(s) and the SDMC(s) supporting the Center, it is required to follow these policies for translational science studies (including pilot studies) its supports, if applicable. The Network Group Operations Center data sharing plans should comply with the NCTN Program Data Sharing Plan template as described in Part 4 - Appendices - Section VII for Network Group Operations Centers in these Guidelines. Biospecimen Sharing Policy: The Network Group Operations Center is required to follow the NCI/DCTD policy regarding review of requests for use of banked biospecimens collected in association with NCTN trials that it leads CTEP’s Protocol Review Committee or an NCI/DCTDapproved NCTN Correlative Science Committee. Network Group Operations Centers are also required to have a plan/policy in place to describe how information on its inventory of biospecimens will be made available to the public that is submitted to and approved by the Lead NCTN Program Director. The Network Group Integrated Translational Science Center is required to follow and support these policies for any pilot studies involving biospecimens that it conducts. Network Group Operations Centers should also have plans in place regarding the following types of resources, as appropriate for the clinical research it conducts: Sharing Model Organisms and Genome Wide Association Studies (GWAS). The Network Group Integrated Translational Science Center is required to follow and support these policies pilot studies performed for/with a supporting Network Group. 3.3.4 Education on the Protection of Human Subjects NIH policy requires education on the protection of human subject for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. This policy is available on the NIH website at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 3.3.5 Other Federal Regulations The NIH Public Access Policy ensures that the public has access to the published results of NIH funded research. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication. To help advance science and improve human health, the Policy requires that these papers are accessible to the public on PubMed Central no later than 12 months after publication. More Page 63 of 241
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NCI National Clinical Trials Network (NCTN) Program Guidelines

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