Report on standardized data use agreement

Task 23 Ethical and legal framework and governance for cloud based federated storage and synthesis of laboratory and field data from infectiousdisease related cohortsEquitable and acceptable governance that includes addressing ethical and legal issues at the cohort level is an essential precondition for sharing field and OMICS data With cohort and stakeholder input we will develop a data governance framework that is responsive to the barriers and enablers of data sharing The cloud based platform will allow for the development of cohort specific tiered permissions for different types of data in accordance to local and international standards for human subject research The platform will use existing user authentication and data protection systems to ensure the appropriate use and the integrity of data contributed to the platform Data transfer between cohorts and the cloud based platform will be conducted through secure data transfer protocol following encryption of field and OMICS data We will develop a standardized data use agreement that can be tailored for individual cohorts and a system that can be deployed across cohorts to keep track of the dates and scope of existing data use agreements ongoing and completed analyses and related publications Cohorts will always be able to access their own data and may be afforded priority access to crosscohort data In the federated system requests for data access from multiple sites will be reviewed by a data access committee that includes experts from different infectious disease fields who can assess the scientific statistical and ethical soundness of proposed research as further described in Task 51 Task 23 will provide a unifying framework for the functioning of the panel and the scientific analysis of requests whilst Task 51 will ensure the inclusion and organization of local stakeholders to expedite the process and prevent bottlenecks The data access committee will include representation from cohort staff and the open science community and will be informed by feedback from the participant advisory panel The data access committee will review research proposals in a timely fashion using established criteria that include a commitment to strong ethical principles and will maintain a publicly accessible list of ongoing research projects that includes their submission revision and approval dates to ensure transparency and accountability to both cohort studies and the larger scientific community Projects that use crosscohort field or OMICS data will be required to cite the repository and contributing cohort studies in any publication and will be encouraged to include cohort study staff or principal investigators in analyses interpretation of results and related publicationsThe governance model will draw from similar initiative for the HDL data in the COMPARE model In COMPARE data generators decide what data are uploaded to a data hub typically the HDL data with some CE metadata and can choose who can access the data and for which analyses Conditions for sharing in a data hub are codified through a consortium agreement that specifies code of conduct for data use including details on involvement of data providers and possible benefit sharing such as publications or other uses of the data and analyses New requests for data access are sent to the group of data hub owners Requests for access can also come from groups that analyze rather than provide data termed data consumers In the data hub model the expectation is that analyses outputs are shared in the data hubs and can be accessed and explored by all who have access Data hubs also are configured with some automated analysis workflows visualization software and query tools Hubs are provided with the understanding that the intent is to work towards release of deidentified data in as much as is possible Data will be made available upon request through a PortalA separate agreement