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DATA Use Agreements (DEAs) are agreements that may limit the use or publication of data and/or impose data security measures, in addition to other legal issues. Protected health information is data “that goes beyond what would qualify as an LDS” – Sharing PHI data will require a business association agreement if participants have not signed a HIPC authorization for data sharing. Developed and operated and archived by the National Center for Biotechnology Information (NCBI) of the National Library of Medicine, DbGaP distributes data from studies that have investigated the link between phenotype and genotype, such as.B genome-wide association studies (GWAS). Data Use Agreements (DUAs) are unfunded contracts that set out the conditions applicable to non-public data subject to restricted use. A DUA is normally used to help parties wishing to share data to better understand important information about the data exchanged, for example. B confidentiality rights related to the transfer of confidential or protected data, data protection obligations, limitations on data use and all obligations related to the use of data. The additional authorizations required depend on the circumstances. When materials leave the United States, an export control audit is required. If the transmission concerns human subjects, an IRB authorisation may be required. In the case of data, you may be asked to find that personal health information (PHI) has been identified anonymously in accordance with HIPAA.

Ask your negotiator for advice. Please read both Starting Point to Applying for dbGaP Data and dbGaP Individual Level Individual Data Access Request Procedures for the detailed instructions provided by NCBI to request access to data. ATMs and AEDs are legally binding agreements and can only be signed by authorized university officials. The database offers two levels of access: open (available to everyone without restriction) and controlled (pre-authorizing). Controlled access to the database allows genotype and phenotype data to be downloaded at the individual level that has been anonymized (i.e. no personal identifiers such as name, etc.). If the submitted agreement is a research cooperation agreement or an agreement for a department-funded project, in which the sponsor requires the agreement to cover expanded terms, please submit an editable version of the agreement to OSP with an additional UAB support checklist and an original/new RPL checklist. Note that individuals are not allowed to negotiate or sign agreements on behalf of the university.

If a person signs such an agreement on behalf of the university, the person could be exposed to legal and financial risks. However, it is important for the individual to read and understand the terms of a DUA in order to ensure that the individual is able to meet their conditions. A DUA should not be used if there is a funding agreement between the UAB and the other entity for the same project. The financing agreement for the project should address the exchange of data. This is a DUA that you received from another institution. The other institution requires the receiving institution to accept certain restrictions in the use of the data before authorizing the transfer of the data to Stony Brook University. . . .

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