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Data Use Agreement Clinical Research

27 September 2021 No Comment

A data use agreement specifies who may use and receive the LDS, as well as the authorized uses and disclosures of such information by the recipient, and provides that the recipient: requests the recipient to put in place appropriate safeguards to prevent unauthorized use or disclosure not provided for in the agreement; Limited datasets may contain only the following identifiers: It is important that researchers read the terms and conditions of a DUA before forwarding the draft contract to the UMBC Sponsored Programs Office (PSO) for review. It is the responsibility of the researcher to understand and monitor the conditions of the DUA and to use the data only for the purposes indicated. OSP assumes that a researcher submitting a DUA to OSP has read these Terms and agrees to comply with these Terms, whether or not the researcher`s signature on the DUA itself is required. If a researcher signs such an agreement, he could face legal and financial risks. A researcher should not sign a DUA before the OSP approval of the DUA. 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 compliant with the Stanford DUA. OSP acts as a signatory on campus of research-based data use agreements. DUAs must be forwarded to OSP through Kuali Research for final approval and approval.

OSP may enter into contractual agreements, including DUAs, on behalf of UMBC to ensure compliance with appropriate policies and regulations. Researchers are not allowed to negotiate or sign these agreements and cannot sign a DUA on behalf of UMBC. DUAs do not have to be signed by university faculty or staff unless there is institutional approval from the PSO. A DUA must be completed before a limited file is used or disclosed to an institution or external party. If Stanford is the provider of a limited dataset, Stanford requires a DUA to be signed to ensure that the appropriate provisions to protect the limited dataset are in place. Here are the contacts for different types of research: DUAs deal with important topics such as restrictions on the use of data, liability for damages resulting from the use of data, publication and data protection rights associated with the transmission of confidential or protected data. The DUA also guarantees that data users will use the data in accordance with applicable law (e.B. HIPAA, FERPA) and prevents the inappropriate use of proprietary or confidential data that could cause harm to the investigator, university or individuals whose data is part of the file. Please follow the following link for the training guide on the delivery of DUAs to UMBC: research.umbc.edu/kuali-training/. A link to the guide also appears on the PSO website under “Forms”: research.umbc.edu/forms-for-grants-contracts/. These step-by-step instructions provide instructions on how to transmit the DUA to Kuali and complete the DUA questionnaire to Kuali as well.

A Data Use Agreement (DUA) is a contractual document used for the transfer of data developed by non-profit organizations, the government or the private sector when the data is not public or otherwise subject to certain restrictions on its use. Often, this data is a necessary part of a research project and may or may not be data from human subjects from a clinical trial or a limited dataset in the hipAA sense. Universities will want to ensure that the terms of the DUA protect confidentiality as necessary, but allow for the appropriate publication and dissemination of research results in accordance with university guidelines, applicable laws and regulations, and federal requirements. DUAs are similar to confidentiality agreements in that they restrict the use and disclosure of the record and, in some cases, a CDA format can be used as a starting point to create an appropriate DUA for data transfer. 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. A DATA Use Agreement (DUA) is a contractual document between a “data user” (usually the UMBC investigator requesting access to the information) and the “record source” (the organization or institution providing the data) that describes the provisions for the transmission of confidential, protected or restricted data. Examples include datasets from government agencies or companies, information on student records, existing data on human research objects, and limited datasets.

determine the permitted uses and disclosures of the limited data set; Require recipients to ensure that all agents (including all subcontractors) to whom information is shared agree to the same restrictions set out in the Agreement; and this means that for a record to be considered a limited record, all of the following direct identifiers relating to the person or their relatives, employers or household members must be deleted: A Data Use Agreement (DUA) is a contractual document used for the transmission of non-public or restricted use data. Examples include records from government agencies, institutions, or companies, information about student records, and data from existing human research subjects. .

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Kathy Becker (19 Posts)

Kathy is the CEO/President of the Company of Experts, Inc. and oversees this Small Woman Owned Business serving schools, colleges and universities, businesses, corporations and non-profits moving them from deficit models of planning and thinking to engagement, empowerment and collaboration.

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