Clinical Trial Data Use Agreement

prohibit the recipient from further using or disclosing the information, except to the extent permitted by the Agreement or otherwise permitted by law; In addition, affected companies such as Stanford must take all reasonable steps to remedy a recipient`s violation of the DUA. For example, if Stanford learns that the data it has provided to a recipient is being used in a way that is not authorized under the DUA, Stanford must work with the recipient to resolve that issue. If these efforts fail, Stanford would be required to stop any further disclosure of PHI to the recipient under the DUA and report the matter to the Federal Office of Public Health and Social Affairs for Civil Rights. Yes, you will need both a Data Use Agreement (DUA) and a Business Partnership Agreement (BAA), as the relevant entity (covered entity affiliated with Stanford University) provides the recipient with PSRs, which may contain direct or indirect identifiers. For this reason, a BAA may be required before we transmit the direct identifiers to the recipient outside of Stanford. The following page provides useful information about who internally manages different types of DUAs and other agreements at Stanford: ico.sites.stanford.edu/who-will-handle-my-agreement A covered entity (such as Stanford) can be used by a member of its own staff to create the “limited data set”. On the other hand, the recipient can also create the “limited registration” as long as the natural or legal person acts as a business partner of the registered entity. A Data Use Agreement (DUA) is used in the transmission of Protected Health Information (PHI), including coded anonymized data, limited data sets (LDS), and personally identifiable human data from one party to another. A DUA defines the rights, responsibilities and obligations of the providing and receiving parties with respect to matters such as permitted use, ownership, publications, intellectual property and liability.

This means that all of the following direct identifiers related to the person or his or her relatives, employers or household members must be deleted for a record to be considered a limited record, all subsequent direct identifiers related to the person or their relatives, employers or household members must be deleted: a limited record is a record, that is exempt from certain direct identifiers specified in the privacy policy. A limited data set may only be shared with an external party without a patient`s permission if the purpose of the disclosure is for research, public health or healthcare operations purposes, and the person or organization receiving the information signs a Data Use Agreement (DUA) with the relevant company or its business partner. Data Use Agreements (DUAs) are agreements that may restrict the use or disclosure of data and/or impose data security measures, in addition to addressing other legal issues. A Data Use Agreement (DUA) is an agreement required under the confidentiality rule and must be entered into before a limited record (defined below) is used or disclosed to an external institution or party. A limited record is always protected by Health Information (PHI), and for this reason, covered companies like Stanford must enter into a data use agreement with each recipient of a limited Stanford record. Note that individuals are not authorized to negotiate or sign agreements on behalf of the university. If a person signs such an agreement on behalf of the university, they could be exposed to legal and financial risks. However, it is important for the person to read and understand the terms of a DUA to ensure that they are able to comply with its terms. This is a DUA that you received from another institution. The other institution requires the host institution to accept certain restrictions on the use of the data before authorizing the transfer of the data to Stony Brook University. This agreement requires the signature of a person authorized to legally bind Stony Brook University.

Require the recipient to take appropriate safeguards to prevent unauthorized use or disclosure that is not provided for in the Agreement; No, disclosure of “limited records” is not subject to HIPAA accounting requirements. DHHS has taken the position that the privacy of individuals with respect to PSR disclosed in a “limited record” can be adequately protected by a single DUA. A data use agreement specifies who can use and receive the LDCs, as well as the authorized use and disclosure of that information by the recipient, and provides that the recipient: Limited records may only contain the following identifiers: A DUA must be entered before a limited record is used or disclosed to an institution or external party. From 1. In May 2017, investigators are required to provide important compliance information to the Office of Sponsored Programs when a federal lower price is issued. When a subcontracting activity involves the sharing of human data, the Sponsored Programs Office works with the examiner to assess whether a data use agreement is required. Guidance on when a DUA, glossary and templates are available can be found in sites.nationalacademies.org/cs/groups/pgasite/documents/webpage/pga_180635.pdf Determining Permitted Uses and Disclosures of the Limited Dataset; A DUA must be signed by a person authorized to sign on behalf of Stony Brook University. With the exception of Stony Brook Medicine, once a researcher receives a DUA from a data provider or plans to send a DUA, they must send the application, the DUA, along with a description of the proposed research or other activity, to one of the authorized administrative bodies listed below.

If a Stanford researcher is the recipient of a limited dataset from a source other than Stanford, the Stanford researcher may be asked to sign the other party`s DUA. In such a case, the Stanford researcher should contact the appropriate contracts office to determine if it is substantially equivalent to the Stanford DUA. .