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The University of Kentucky is a signatory to this template, if the co-institution is also a signatory, the MTA process can be completed very quickly.

To help reduce confusion over what constitutes Protected Health Information (PHI)(health information that includes additional information that can be used to identify the subject of the data) under HIPAA, a researcher should understand that HIPAA definesidentifiersas any of the following: HIPAA defines a Limited Data Set of indirect identifiers (which are still PHI) which may be disclosed under a Data Use Agreement for research, public health or health care operations purposes without authorization, as the following: Please note that Duke researchers are not authorized to sign DTAs on behalf of Duke - the DTA must be submitted to ORC to obtain the proper signature.

-If Purdue is providing data to an outside entity: Complete the Data Transfer and Use Request Form and return it to spscontr@purdue.edu. Privacy Statement | Copyright 2022, Contact the Office of Research Compliance at, Undergraduate Research & Creative Activity, All DUAs must be sent to the Office of Graduate Studies and Research for processing.

University of Waterloo requirements concerning human participant data security and storage are outlined in the Guideline on Research Participants Data Security. We assist with the preparation and execution of these documents. In order to initiate a Data Use Agreement or Data Access Agreement, aData Use/Access Request Formneeds to be submitted. A researcher wanting to transfer or use data should be prepared to discuss with ORC, among other things: the purpose of the transfer; the identities of the transferor and transferee; the nature of the data to be transferred (human subject data? contains identifiers?

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They can be sent via interoffice mail to 200 Boone or via email to. Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re-identification.

may be sent outside the UK or the EEA.

the European Economic Area (the European Union member states plus Can I submit one request to cover multiple materials?

They can be sent via interoffice mail to 200 Boone or via email to. ensured that any duty of confidence is not be breached.

Data is made available after harmonization.

Every DUA is required to be signed by an authorized signatory for the university; this can only be done by the ORA.

The principal investigator will return the executed DUA to the original sender. Our main campus is situated on the Haldimand Tract, the land granted to the Six Nations that includes six miles on each side of the Grand River. An NDA will determine what is confidential information and what is not, how the information is disclosed, how long the information must be kept secret, who the information can be disclosed to, as well as a variety of other topics depending on the individual agreement. Importantly, the terms of these private industry MTAs may restrict university researchers from publishing research results. If you are in need of an MTA, please complete theMTA Request form(pdf)and email it to the OTC's Senior Contracts Coordinator, Ali Yankey.

If written approval is required to receive a copy of research data from a different organization, the PI must obtain in writing an agreement with the sending organization that clarifies the expectations of the University of Minnesota's custodial and other responsibilities with respect to the research data prior to seeking approval to transfer a copy of the research data from a different organization to the University of Minnesota.

Only approved signatories from the CWRU Technology Transfer Office may sign for the university, though often PIs are asked to sign that they have Read and Acknowledged the agreement. To reduce delays, please request a draft contract from the data provider before submitting a data request or submitting a protocol application to the IRB. The Office of Technology Transfer will review all DUAs that may involve intellectual property or that involve ideas, processes or products that may have the potential for patent, copyright, or commercialization. A Data Use Agreement (DUA) is a contractual document used for the transfer of non-public data that is subject to some restrictions on its use.

These procedures may be superseded by contractual, sponsor, or regulatory requirements.

Email:researchgovernance@medschl.cam.ac.uk

If you have problems viewing PDF files, download the latest version of Adobe Reader, For language access assistance, contact the NCATS Public Information Officer, National Center for Advancing Translational Sciences (NCATS), 6701 Democracy Boulevard, Bethesda MD 20892-4874 301-594-8966, U.S. Department of Health & Human Services, Clinical and Translational Science Awards (CTSA) Program, Rare Diseases Clinical Research Network (RDCRN), Therapeutics for Rare and Neglected Diseases (TRND), Additional Rare Diseases Research and Initiatives, Patient/Community Engagement & Health Information, Genetic and Rare Diseases Information Center, NCATS Toolkit for Patient-Focused Therapy Development, National COVID Cohort Collaborative (N3C), About NCATS Role in the NIH HEAL Initiative, Accelerating the Translation of Novel Compounds Toward INDs for Subsequent Clinical Testing, Fiscal Year 2019 Funded Projects and Prizes, NIH HEAL Initiative Funding & Collaboration Opportunities Led by NCATS, NCATS Program-Specific Funding Information, Prior NIH Approval of Human Subjects Research Frequently Asked Questions, NCATS Challenges and Prize Competitions Program, LitCoin Natural Language Processing (NLP) Challenge, NCATS Rare Diseases Are Not Rare!

To assist with the completion of the form all of the questions, branching logic and additional guidance are provided in the.

Office BEFORE the data is transferred as terms need to be checked In addition, it is the responsibility of the PI to obtain any other authorization that is required to transfer the research data, for instance, if the research data are owned by a consortium. Business Associate Agreements are reviewed by Office of Legal Counsel.

Certain non-academic research activities (e.g., institutional reporting, quality assurance, program evaluation) might also present the possibility of high risks of privacy or security breaches as indicated by the Privacy and Security Assessment.

Some research protocols involving human participant data submitted for ethics review may require a data management plan. Every MTA is required to be signed by an authorized signatory for the university; this can only be done by the TTO. A Material Transfer Agreement (MTA) is an agreement that governs the transfer of tangible research materials between two organizations.

A Limited Data Set may include a link field to allow the provider to re-identify the individual.

Biometric identifiers, including fingerprints and voiceprints.

Duke researchers wishing to transfer or use human subject data must contact ORC to initiate a discussion on the proposed data transfer or use. Associated reviews will be conducted in parallel with contractual negotiations. In the event that identifiable

Yes.

This guidance sets out the Clinical School

These procedures provide guidance on routing and obtaining appropriate signatures for Data Use Agreements and Material Transfer Agreements. Principal Investigator:The principal investigator is the researcher who initiates and/or manages a research study. Principal investigators are not authorized institutional representatives.

An NDA can be implemented to protect confidential information that is leaving the University for a variety of reasons. Data sharing agreements identify the parameters which govern the collection, transmission, storage, security, analysis, re-use, archiving, and destruction of data.

Once the TTO receives the MTA Intake Form, we will contact the PI listed along with the person submitting the form, regarding their MTA. Overview) requires that personal data must not be transferred outside The application and DUA will be reviewed by the Data Laboratory Director.

The Director of the Office of Research Development and Administration will sign all approved MTAs and return them to the Research Compliance Officer. The PI must also provide a contact at the sending organization. 44106-7015, Office of Research and Technology Management, About the Core Facilities Support Committee, Human Stem Cell Research Oversight Committee (HSCRO), Institutional Animal Care and Use Committee (IACUC), Quality Improvement Program (IRB Auditing), About the Technology Transfer Office (TTO), CWRU Portfolio of Selected Faculty Start-Up Companies. For questions regarding policy development process at the University or to report a problem, please call: 612-625-2210 or email: [emailprotected]. The Office of Research Development and Administration will review all MTAs for externally-funded research to ensure that the MTA is compliant with sponsor or contractual requirements.

carefully against any applicable funding terms, A DTA must be put in place by a member of the contracts team in the Research Office before data is transferred, To ensure that this is done as efficiently as possible researchers should supply the following information, Whenever possible it is good practice for research to be conducted on

In cases where a PI leaves or joins the University or a project is moved to or from another institution, the PI may request that a copy of the research data be transferred. The dean of the college or school or the chancellor of the system campus, or their designee, has the authority to decide whether a written approval is required. Research Data Management: Archiving, Ownership, Retention, Security, Storage, and Transfer, adoption by the receiving organization of all custodial responsibilities for the research data, including acceptance of all University of Minnesota and federal security requirements for restricted data that is transferred; and.

have appropriate consent. Unless prohibited by specific terms of the sponsorship, other agreements, or University policy, a PI may request transferring a copy of research data to or from a legal entity outside of the University of Minnesota. In the absence of an MTA, one can lose valuable intellectual property and other rights. The institutions listed below have executed a Data Transfer Agreement (DTA) with NCATS. other colleges, schools, or system campuses that were involved in the generation of the research data; the Vice President for Clinical Affairs if the research data are health related; and. katie uwm edu directory staff

The University will reserve the right to continued ownership of University-owned research data when a copy of the research data is sent to a different organization, and will acknowledge the right of an organization to ownership of research data when the University receives a copy of the research data from that organization. For a data set to be de-identified, the University of Waterloo requires that de-identification meet, as a minimum, either the US Safe Harbor standards or expert determination method.

thing don self yu right carlson nathaniel pm posted The Research Compliance Officer will maintain a copy of the executed DUA and send a copy via email to the principal investigator with the Dean and Department Head copied.

Unless specifically agreed upon by both the sending and the receiving organization, it is understood that the primary research data will be retained at the organization that transfers the research data, and only a copy of the research data will be transferred. A non-Disclosure Agreement (NDA) is sometimes referred to as a Confidential Disclosure Agreement.

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