Data Use Agreement Decision Tree

For more information on research data, including the general principles of data exchange and other resources available at Stanford, visit DoResearch. Talk to an Office contract administrator from Industry Alliances to help you verify and execute a data or software agreement. The database offers two levels of access: open (available to all without restrictions) and controlled (pre-authorized). Controlled access to the database allows you to download data from individual genotypes and phenotypes that have been de-defined (i.e. no personal identifiers such as name, etc.). A limited set of data (LDS) is one that „has been removed from all HIPAA data, with the exception of age/date and city/state/Zip” – an LDS DUA is required if HIPAA authorization for data sharing has not been obtained from participants. If participants have signed a HIPAA authorization to share data, a DUA referring to an LDS is not appropriate. Question 2: Does it contain any of the 18 personal identifiers defined by HIPAA? No no. HIPAA and the corresponding requirements do not apply. Send the protocol directly to the IRB.

Yes, yes. This data is PHI and is protected by HIPAA. See question 3. IRB (for human subjections research data) for requesting data or software from other institutions or the Industrial Data Use Agreement („AEA”) is a contract that governs the exchange of specific data between two parties. DuAs establish who can use and receive a single data set, as well as authorized uses and disclosure of data by the recipient. An AAU also gives the researcher and recipient appropriate responsibility for the use of the data. There are usually three types of data that can be shared by UAB and other institutions. Research data use agreements govern the access and processing of data provided by an outside organization in Berkeley for use in Berkeley research. The data may be unstructured or structured, but is not accompanied by a licensing agreement.

Examples include: developed and operated by the National Center for Biotechnology Information (NCBI) of the National Library of Medicine, dbGaP archive and distributes data from studies that have studied the relationship between phenotype and genotype, as. B Genome-wide Association Studies (GWAS). Decision Support Tool for Contracts A decision-making structure to determine which UC Berkeley office has the right to develop and execute the agreement you need. The completed DUA application form provides the SSO manager with the necessary background information about the search. A summary of the projects, a list of data elements, funding sources, expectations for the exchange of results and authorisation for publication, as well as compliance with the rules between humans/animals/stem cells (if any) are essential to ensure that the conditions of the AEA are appropriate. The head of the OSR can contact you with additional questions based on the information provided and specific contractual terms. During our review of the AEA, we may also consult with other compliance and law offices at Stanford to ensure that adequate safeguards and authorizations are in place. Changes to the agreement may be necessary based on project/data specifications. Please read both the starting point of the dbGaP data request and the dbGaP procedures for accessing data at the individual level in order to obtain detailed instructions from the NCBI on requesting access to data. For incoming data, the data provider may request a modification of the DUA for changes to the existing agreement.

If you want to send your data to another party, the Office of Technology Licensing (OTL) can help you compile a data usage or software agreement.