DATA USE REVIEW BOARD

The NIH ACD Working Group of Participant and Data Protection (PDP) for GAIN will serve as the Data Use Review Board (DURB) described in GAIN policies. The DURB will provide ongoing, independent oversight of the data use policies and participant protection mechanisms for GAIN in order to ensure that all uses of GAIN-generated data are consistent with limitations on research use specified by Contributing Studies (e.g., restrictions stemming from participant consent documents) and adhere to the highest standards for protecting the privacy and confidentiality of participants. 

The DURB will meet as needed, but at least semi-annually, with at least one face-to-face meeting per year. DURB meetings will include the review of summary reports and other materials assembled by GAIN staff and relevant GAIN committees. These materials will address topics such as, but not limited to:

• GAIN data distribution procedures; 
• names and affiliations of Requestors for each GAIN Project Dataset;
• investigator-provided information on the use of GAIN data;
• GAIN oversight activities to monitor compliance with the GAIN data access and publication policies; and
• any untoward effects of access of GAIN data that were identified.

The DURB will make recommendations to the NIH ACD with respect to:

• issues related to human research ethics and participant protection policies, including topics such as informed consent, privacy and confidentiality, and dissemination of potentially significant findings by approved data users to contributing study investigators and the public;
• the performance of the Data Access Committee in the review and processing of requests for GAIN data access;
• issues related to the publication of GAIN data analyses by approved data users, including the assessment of any new information learned relevant to participant protection issues; and
• impact of any identified intellectual property concerns relevant to ensuring broad research access and use of GAIN project data by approved users.

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