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Data licenses/data agreements wh

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Data licenses/data agreements where Purdue is paying for the data are reviewed by Office of Legal Counsel. Researchers MUST develop a data sharing agreement or include these items as part of a master research agreement when they are conducting: A copy of the risk assessment and data sharing agreement (or research agreement which spells out the data sharing agreement) is to accompany the ethics application. Under Kentucky law, no state agency, including the University of Kentucky, can agree to laws, venue, and/or jurisdiction of another government. 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. Please report concerns to your supervisor, the appropriate University administrator to investigate the matter, or submit a report to U Report. 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. katie uwm edu directory staff Each Agreement is individually reviewed by the Office of Technology Commercialization to ensure fair and reasonable terms. The principal investigator is the lead researcher in charge of the research study and all research conduct for that study. Guideline on Research Participants Data Security. One of the exemptions for this is if you The Office of Technology Transfer will review all MTAs to clarify Eastern Michigan Universitys rights for copyright, patent, or commercialization. For questions on individual policies, see the contacts section in specific policy or use the feedback form at the bottom of the policy. Requests for Student Data are reviewed by Office of Enrollment Management. Refer to the guideline produced by the University of Toronto which provides a comprehensive overview of the benefits associated with data sharing and the context within which data sharing and data management challenges and obligations typically occur. Data is made available after harmonization. All MTAs must be sent to the Office of Graduate Studies and Research for processing. If you have trouble accessing this page because of a disability, please contact Sponsored Program Services at spsweb@purdue.edu. Agreement established between organisations that governs the transfer

have appropriate consent. MTAs will be processed first by the Research Compliance Officer to ensure that all compliance requirements are met. Once the terms of the MTA are agreed upon, signatures are collected from each party. 44106, 10900 Euclid Ave. -If Purdue is providing data to an outside entity: Complete the Data Transfer and Use Request Form and return it to spscontr@purdue.edu. The Director of the Office of Research Development and Administration will sign all approved MTAs and return them to the Research Compliance Officer. Can I submit one request to cover multiple materials? Data Transfer Agreement guidance for the transfer or use of human subject data. For DUAs, IRB approval or a non-human subject determination may be required. To request contracting services from Sponsored Program Services, please complete the Data Transfer and Use Request Form. Web page addresses and email addresses turn into links automatically. the Associate Vice President for Sponsored Projects Administration if the research data were generated as part of a sponsored project, unless the research data are part of a sponsored project that is being transferred and the transfer agreement already addresses the transfer of research data. original consent should be checked to see whether the proposed use by The Research Compliance Officer will retain a copy of the executed MTA. A non-Disclosure Agreement (NDA) is sometimes referred to as a Confidential Disclosure Agreement. 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. contains identifiers? If you are in need of an NDA, please complete theNDA Request form(pdf)and email it to the OTC's Senior Contracts Coordinator, Natalie Damron McCormick. The application and DUA will be reviewed by the Data Laboratory Director. the Associate Vice President for Sponsored Projects Administration if the research data are part of a sponsored project that is transferred to the University of Minnesota, unless the transfer agreement of the sponsored project already addresses the transfer of research data. https://www.purdue.edu/enrollmentmanagement/data-reports/student-data-reports.php. If the Privacy and Security Assessment suggests that this proposed data exchange or sharing requires a data sharing agreement, the Office of Research can assist you in developing and negotiating a data management or data sharing agreement or incorporating these elements into your master research agreement. 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. This guidance sets out the Clinical School necessary. ensured that any duty of confidence is not be breached. clear in your participant information sheet and consent form that data When the MTA is fully signed by both parties (i.e. The Office of Information Technology will review all DUAs for electronic data that have specialized data security or protection requirements to ensure that all requirements can be met. Every MTA is required to be signed by an authorized signatory for the university; this can only be done by the TTO. HIPAA and Protected Health Information Guidelines and Resources, https://www.purdue.edu/legalcounsel/HIPAA/index.html, Family Educational Rights and Privacy Act (FERPA) Resources, https://www.purdue.edu/registrar/FERPA/index.html, Purdue University, 610 Purdue Mall, West Lafayette, IN 47907, (765) 494-4600, 2014 Purdue University | An equal access/equal opportunity university | Copyright Complaints | Maintained by Sponsored Program Services. Office BEFORE the data is transferred as terms need to be checked turkcell channels tr notification Telephone: 01223 769291and 01223 335745, Undertaking Health Research in the United Kingdom, Undertaking International Health Research, Incident Management and Reporting Procedures, Register a Study using Sensitive Personal Data, Secure Data Hosting Service Introduction and FAQ, Copy of the consent form, PIS and ethics approval letter for the study under which the data was collected, Description of the data to be transferred, Funding details for the research which originally generated the data, including the RG number of the grant if available, If any identifiable data is involved, details about the safe haven arrangements at the institution receiving the data, Transferring institution, name and address, Funding details for the research requiring the data, including the RG number of the grant if available, If you are receiving identifiable data, detailed information about the secure data storage arrangements. This procedure provides the details on how to request a transfer. They can be sent via interoffice mail to 200 Boone or via email to. To assist with the completion of the form all of the questions, branching logic and additional guidance are provided in the. Please note that at Purdue University data agreements must be signed by an authorized institutional representative. 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. Are there times when is a data sharing agreement is absolutely required? Once the TTO receives the MTA Intake Form, we will contact the PI listed along with the person submitting the form, regarding their MTA. Signatory Authority:Signatory authority refers to individuals who, by virtue of their position at Eastern Michigan University, have the ability to sign on behalf of Eastern Michigan University. Associated reviews for regulatory compliance including, but not limited to, secure data storage and research uses are also required. We assist with the preparation and execution of these documents. They can be sent via interoffice mail to 200 Boone or via email to. If all materials have the same recipient, then yes, one request can be made. by Advancing Innovations That Make a Difference, OTC Intellectual Property Development Fellows Positions Open, August 2022 OTC Webinar: Everything You Need to Know About Agreements 2022. Data requests submitted without a draft agreement can lead to significant delays and lengthy negotiations. An MTA is a legally binding contract between two organizations (Provider and Recipient) for the transfer of tangible research materials. CIC - Committee on Institutional Cooperation, Central/Discovery(DP) Park Pre-Award Center, College of Agriculture/ College of Veterinary Medicine (Ag/Vet), College of Engineering Pre-Award Center (COE), College of Science/ College of Pharmacy/ College of Health and Human Sciences (COS/COP/CHHS), 5. microsoft mac autoupdate As you are completing the form, please provide as much detail as possible. University Policy Program A data agreement establishes the permitted disclosure of a unique data set, allowable uses, and any privacy or security requirements necessary for receiving and handling the data. Overview) requires that personal data must not be transferred outside The N3C Data Enclave does not yet include data from all of the institutions listed. It should be stressed that personal identifiable data Purdue will use the agreement provided by the outside entity to begin negotiations. Fully Executed), the final agreement is circulated and the material transfer may proceed. 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 When submitting an ethics application, include the portion of the research agreement which describes the data sharing arrangements which have been developed. Minneapolis, MN 55455. myRESEARCHpath is maintained in partnership by the Duke Office of Research Initiatives and participating research support offices across the institution. Every DUA is required to be signed by an authorized signatory for the university; this can only be done by the ORA.

An NDA can be implemented to protect confidential information that is leaving the University for a variety of reasons. Data agreements, including Data Transfer and Use Agreements (DTUA, DUA, or DTA) are contracts that govern the exchange of specific data between two parties. 2020 Challenge Details, Translational Science Education & Training, Translational Science Training at Partner Institutions, Translational Science Training and Education Resources, Drug Discovery, Development and Deployment Maps, Assay Development and Screening Technology (ADST), Bridging Interventional Development Gaps (BrIDGs), Discovering New Therapeutic Uses for Existing Molecules, Genetic and Rare Diseases Information Center (GARD), A Specialized Platform for Innovative Research Exploration (ASPIRE), A Translational Approach to Addressing COVID-19, Clinical Trial Readiness for Rare Diseases, Disorders and Syndromes, Multidisciplinary Machine-Assisted, Genomic Analysis and Clinical Approaches to Shortening the Rare Diseases Diagnostic Odyssey, The Accelerating Medicines Partnership Bespoke Gene Therapy Consortium (BGTC), Cures Acceleration Network (CAN) Review Board, National COVID Cohort Collaborative Forms and Resources, N3C Data Contribution Forms and Resources, About the National COVID Cohort Collaborative, National COVID Cohort Collaborative Funding, Board of Regents of the University of Oklahoma Health Sciences Center, Cincinnati Childrens Hospital Medical Center (CCHMC), Columbia University Irving Medical Center, Duke University, acting for and on behalf of its School of Medicine, George Washington University Hospital (GWU), Johns Hopkins University on behalf of its School of Medicine, Medical University of South Carolina (MUSC), Montefiore-Einstein Center for Health Data Innovations, NYU Grossman School of Medicine, an administrative unit of New York University, Oregon Health & Science University (OHSU), Research Foundation for SUNY obo University of Buffalo, University Medical Center Management Corporation d/b/a University Medical Center New Orleans, University of Arkansas acting for and on behalf of the University of Arkansas for Medical Sciences, University of Colorado School of Medicine, University of Massachusetts Med School Worchester, University of New Mexico Health Sciences Center, The University of North Carolina Health Care System, University of Texas Health Sciences Center at Houston, University of Texas Medical Branch at Galveston, d/b/a UTMB Health (UTMB), Weill Medical College of Cornell University, West Virginia University Research Corporation. formal recognition of University of Minnesota's continued ownership of the research data by the receiving organization. DUAs will be processed first by the Research Compliance Officer to ensure that all compliance requirements are met. 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. If a data provider requires signature of authorized signatory official, then SPS or Office of Legal Counsel can assist. katie uwm edu directory staff All ethics applications ask the researcher to describe how participant data will be secured and protected. The CWRU Technology Transfer Office (TTO) is responsible for the review and negotiation of material transfer agreements (MTAs), and the Office of Research Administration (ORA) is responsible for the review and negotiation of data use agreements (DUAs). Principal Investigator:The principal investigator is the researcher who initiates and/or manages a research study. Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re-identification. 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. OH Secondary use of information for research purposes: TCPS2, Securing information - Waterloo IST guidelines, Securing information for research - Waterloo IST guidelines, Personal Health Information Protection Act (PHIPA), The Office of Research is located on the third floor of East Campus 5. The Office of Research Development and Administration will review all DUAs for externally-funded research to ensure that the DUA is compliant with sponsor or contractual requirements. procedures that govern the transfer, both outgoing and incoming, of data Likewise, the University needs this opportunity as well. Importantly, the terms of these private industry MTAs may restrict university researchers from publishing research results. 2095 Martin Luther King Jr. Dr. Associated reviews will be conducted in parallel with contractual negotiations. Data agreements, depending on the type, are handled by various Purdue offices including Sponsored Program Services (SPS), Office of Enrollment Management, and Office of Legal Counsel. 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. The Laboratory Compliance Manager will review all MTAs to ensure that Eastern Michigan University will meet all safety and containment requirements for the materials to be transferred. 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. Frequently Requested Information & FAQ's, Faculty Resources - Executive Vice President for Research and Partnerships, Internal Controls, Roles and Responsibilities, Direct Costs and F&A, National Aeronautics and Space Administration (NASA), Agency for International Development (USAID), COVID-19 Sponsored Project Impact Application, https://www.purdue.edu/legalcounsel/working%20w%20us/Employees.html, An equal access/equal opportunity university. The Research Compliance Officer will send the MTA to additional offices for processing, if necessary. 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. Vehicle identifiers and serial numbers, including license plate numbers. For clinical trial NDAs, email Clinical Research Support Office's Operations Director,Jessica Heskel. This agreement must contain, at a minimum, the following items: Once the agreement with the receiving organization is obtained, the PI requests in writing the transfer of a copy of the research data to the receiving organization from the appropriate dean of the college or school or chancellor of the system campus. 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. Material Transfer Agreement (MTA): to be in place to cover the transfer of data sets between Can someone other than the PI create and submit an MTA Intake Form for that PI? If the research data are part of a sponsored project that is being transferred and the transfer agreement addresses the transfer of a copy of the research data, no further written agreements will be required. Some geographic information (City, county, state and more than 3-digit ZIP codes, including ZIP+4, are allowed in a Limited Data Set, but street address is not).

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which the data are to be transferred provides an adequate level of The University of Kentucky cannot agree to arbitration or to indemnification of any sort. The request must be initiated by the PI. If you are in need of a DUA, pleaseemail it to the OTC's Senior Contracts Coordinator, Ali Yankey. Contact Tyler Gray attjg47@case.eduor leave a message at 216.368.1401 for assistance with your MTA. 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. 140 McNamara Alumni Center Cleveland, In all other cases, a PI must contact the dean of the college or school or the chancellor of the system campus, wherever the administering unit for the project of the research data under consideration is located.

Institutions not on the list but interested in contributing data to the N3C Data Enclave should review the related forms and resources or contact NCATSPartnerships@mail.nih.gov. Any data agreement with an international entity is reviewed by Office of Legal Counsel. Cleveland, 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. If the data were acquired through a sponsored project and the administering unit of the project is different from the college where the PI resided, the administering unit is responsible for designating a person to preserve the data and destroy the data at the agreed-upon time. If written approval is required to send a copy of research data to a different organization, the PI must obtain in writing an agreement with the receiving organization prior to seeking approval from the University of Minnesota. third parties is covered and if not, then consent should be sought if Material Transfer Agreements are contracts that are developed, signed, and executed for the purpose of outlining procedures, expectations, requirements, and restrictions for sending and receiving physical materials or samples used for research purposes. 216.368.2000 carlson nathaniel Often, the University will agree to give the material provider an opportunity to review any research results or article that will be published prior to publication in order to redact any confidential information. Do I need to submit an MTA if I am transferring samples within CWRU?

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Data licenses/data agreements wh