Nih Data Use Certification Agreement
Applicants who wish to use as secondary users specific human genome data from data called NIH (z.B dbGaP) to achieve the specific objectives of the research proposed in the grant application must comment briefly on their data access plans and indicate their intention to comply with the NIH Data Code of Conduct Code of Conduct code of conduct in the Enforcement Genomics Plan. Data with controlled access to NIH-designated data repositories is only made available to secondary research when examiners have obtained niH approval for the use of the requested data for a given project. Data in repositories with unlimited access is accessible to the public by everyone. Once the application is made, the Senior Auditor (IP) should contact the Human Protection Authority (OPHS) to discuss next steps to ensure that it has an approved protocol including the submitted data sharing plan and that informed consent documents allow for the sharing of the resulting data. , as described in the plan presented. If PI does not have an existing protocol covering the proposed work, it should cooperate with OPHS staff to have a new protocol or amendment in the works to allow for the rapid development, submission and approval of the CPHS if the institution and IP are informed that the proposal is in the due process (JIT). Respect and protection of the interests of researchers is essential for niH management of human genome data. Before IP data is transmitted to a data repository, IP and an authorized institutional official (OPS) must sign and submit an institutional certification indicating that the data transmitted is in line with the expectations of the MSD Directive. Institutional certification should also describe restrictions on the use of data and whether the data provided at the aggregate level are suitable for the overall use of research. NIH offers multi-center and single-site institutional certification forms. Access to TCGA and TARGET data is governed by guidelines established by the National Institutes of Health (NIH), the National Cancer Institute (NCI) and the National Center for Biotechnology Information (NCBI) Database of Genotypes and Phenotypes (dbGaP).
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