Requester and Approved User Responsibilities The Requester agrees through the submission of the DAR that the PI named has reviewed and understands the principles for responsible research use and data management of the genomic datasets as defined in the NIH Security Best Practices for Controlled-Access Data Subject to the GDS Policy. The Requester and Approved Users further acknowledge that they are responsible for ensuring that all uses of the data are consistent with national, tribal, and state laws and regulations, as appropriate, as well as relevant institutional policies and procedures for managing sensitive genomic and phenotypic data. The Requester certifies that the PI is in good standing (i.e., no known sanctions) with the institution, relevant funding agencies, and regulatory agencies and is eligible to conduct independent research (i.e., is not a postdoctoral fellow, student, or trainee). The Requester and any Approved Users may use the dataset(s) only in accordance with the parameters described on the study page and in the 1 If contractor services are to be utilized, PI requesting the data must provide a brief description of the services that the contractor will perform for the PI (e.g., data cleaning services) in the research use statement of the DAR. Additionally, the Key Personnel section of the DAR must include the name of the contractor’s employee(s) who will conduct the work. These requirements apply whether the contractor carries out the work at the PI’s facility or at the contractor’s facility. In addition, the PI is expected to include in any contract agreement requirements to ensure that any of the contractor’s employees who have access to the data adhere to the NIH GDS Policy, this Data Use Certification Agreement, and the NIH Security Best Practices for Controlled-Access Data Subject to the GDS Policy. Note that any scientific collaborators, including contractors, who are not at the Requester must submit their own DAR. Addendum to this Agreement for the appropriate research use, as well as any limitations on such use, of the dataset(s), as described in the DAR, and as required by law. Through the submission of this DAR, the Requester and Approved Users acknowledge receiving and reviewing a copy of the Addendum which includes Data Use Limitation(s) for each dataset requested. The Requester and Approved Users agree to comply with the terms listed in the Addendum. Through submission of the DAR, the PI and Requester agree to submit a Project Renewal or Project Close-out prior to the expiration date of the one (1) year data access period. The PI also agrees to submit an annual Progress Update prior to the one (1) year anniversary2 of the project, as described under Research Use Reporting (Term 10) below. By approving and submitting the attached DAR, the Institutional Signing Official provides assurance that relevant institutional policies and applicable local, state, tribal, and federal laws and regulations, as applicable, have been followed, including IRB approval, if required. Approved Users may be required to have IRB approval if they have access to personal identifying information for research participants in the original study at their institution, or through their collaborators. The Institutional Signing Official also assures, through the approval of the DAR, that other institutional departments with relevant authorities (e.g., those overseeing human subjects research, information technology, technology transfer) have reviewed the relevant sections of the NIH GDS Policy and the associated procedures and are in agreement with the principles defined. The Requester acknowledges that controlled-access datasets subject to the NIH GDS Policy may be updated to exclude or include additional information. Unless otherwise indicated, all statements herein are presumed to be true and applicable to the access and use of all versions of these datasets.
