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Policy Because the volume of human genomic and phenotypic data maintained in these repositories is substantial and, in some instances, 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 human genomic 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 controlled-access datasets recognize any restrictions on data use established by the Submitting Institutions through the Institutional Certification, and as stated on the dbGaP study page. 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).
