Common use of Introduction and Statement of Policy Clause in Contracts

Introduction and Statement of Policy. The National Institutes of Health (NIH) has established the Rapid Acceleration of Diagnostics (RADxSM) Data Hub for securely storing and sharing human data submitted to NIH as part of the RADxSM program. Because the volume of human data maintained in this data repository is substantial and potentially sensitive (e.g., data related to the presence or risk of developing particular diseases or conditions and information regarding family relationships or ancestry), data must be shared in a manner consistent with the research participants’ informed consent, and the confidentiality of the data and the privacy of participants must be protected. Access to RADxSM data will be provided to research investigators who, along with their institutions, have certified their agreement with the expectations and terms of access detailed below. NIH expects that, through Data Access Request (DAR) process, approved users of open and controlled-access datasets recognize any restrictions on data use established by the Submitting Institutions through the Institutional Certification. Definitions of the underlined terminology in this document are found in section 13. The parties to this Agreement include: the Principal Investigator (PI) requesting access to the genomic study dataset (an “Approved User”), the PI’s home institution (the “Requester”) as represented by the Institutional Signing Official designated through the eRA Commons system, and the NIH. The effective date of this Agreement shall be the DAR Approval Date, as specified in the notification of approval of the Data Access Committee (DAC).