Do I need to go to the IRB before sharing data? 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. Defining authorized uses and disclosing the limited set of data; OSP is the campus signatory for research-based data use agreements. DUAs must be forwarded to PSO through Kuali Research in order to obtain the final judgment and authorization. The PSO has the right to enter into contractual agreements on behalf of umBC, including THE AADs, to ensure compliance with the relevant guidelines and regulations. Researchers are not authorized to negotiate or sign these agreements and cannot sign DUAS on behalf of UMBC. DUAs should not be signed by university faculties or staff if the PSO does not obtain institutional authorization. A covered business (for example. B Stanford) can use a member of its own staff to create a “limited dataset.” On the other hand, the recipient can also establish a “limited data set” as long as the person or entity acts as a counterparty to the company concerned. A Data Use Agreement (ACA) is a contractual document used for the transfer of data developed by non-profit, public or private companies when the data is not public or subject to other usage restrictions. Often, this data is a necessary component of a research project and can be data from human subjects from a clinical trial or data set limited to the meaning of HIPAA. Universities will want to ensure that the terms of the AAU protect confidentiality if necessary, but allow for adequate publication and sharing of research results, in accordance with academic guidelines, applicable laws and regulations, and federal requirements. Confidentiality agreements are similar in that they limit the use and disclosure of the data set and, in some cases, a CDA format can serve as a starting point for creating an ASA suitable for data transmission.
Whenever limited data is transmitted to or by a Rutgers University researcher, a data use agreement and/or matching agreement must be established between the parties involved.