formal recognition of University of Minnesota's continued ownership of the research data by the receiving organization. DUAs serve to outline the terms and conditions of the transfer. An MTA should be put in place any time tangible research materials are transferred from one institution to another for non-commercial research use. The form has questions designed to help DUA staff determine the type of DUA needed and regulatory requirements. 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. OH This agreement should be developed prior to submitting the ethics application. MTAs will be processed first by the Research Compliance Officer to ensure that all compliance requirements are met. In the event that identifiable Complete the Data Transfer and Use Request Form, Submit the Data Transfer and Use Request Form and draft agreement obtained from the data provider to. Data Use and Transfer Agreements not related to a sponsored research project or proposal, are reviewed by Office of Legal Counsel (E.g. No, only transfers between institutions require MTAs. MTAs with private companies tend to have more complex terms that need to be negotiated, including related to commercial and other use of the material and resulting research results and inventions. Minneapolis, MN 55455. Purdue will use the agreement provided by the outside entity to begin negotiations. The Research Compliance Officer will send executed copies of the MTA via email to the principal investigator with the Dean and Department Head copied. 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. Data requests submitted without a draft agreement can lead to significant delays and lengthy negotiations. sets MUST be reviewed by a member of the contracts team in the Research 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. Data licenses/data agreements where Purdue is paying for the data are reviewed by Office of Legal Counsel. 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. 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. Please report concerns to your supervisor, the appropriate University administrator to investigate the matter, or submit a report to U Report. 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. data licenses and other access agreements for data, data agreements for student projects or degree requirements, data agreements for new faculty and students bringing (human subjects or sensitive) data from their previous institution, and data agreements for faculty leaving the University). An authorized official of the outside entity provider must make this determination. As a summary only and not intended to be complete guidance on the transfer or use of data, generally the transfer and use of data is governed by various important considerations including those related to Duke IRB rules, the Health Insurance Portability and Accountability Act of 1996, as amended (HIPAA), ethical considerations, whether or not the transfer and/or use of the data is subject to contractual constraints, and issues related to intellectual property. Cleveland, 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. For clinical trial NDAs, email Clinical Research Support Office's Operations Director,Jessica Heskel. All ethics applications ask the researcher to describe how participant data will be secured and protected. University of Waterloo requirements concerning human participant data security and storage are outlined in the Guideline on Research Participants Data Security. It should be stressed that personal identifiable data Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re-identification. It is important to have the OTC review every MTA as a recipient's ability to publish research results may be affected. Yes. What needs to be in a data sharing agreement? Resources from Purdue Libraries (http://guides.lib.purdue.edu/DataStorage) and Secure Purdue (https://www.purdue.edu/securepurdue/) may be useful to assist researchers with proper data protections. third parties is covered and if not, then consent should be sought if establishments. To request contracting services from Office of Legal Counsel, please complete the New Matter Intake Form. Any material transfer agreement for human-related data or human-derived samples must be approved by an IRB or receive a non-human subject determination from the CWRU IRB before the MTA can be finalized. 2095 Martin Luther King Jr. Dr. Likewise, the University needs this opportunity as well. What is a data sharing or transfer agreement? 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). 140 McNamara Alumni Center The University of Kentucky's Intellectual Property Policy can be found. 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. An MTA provides protection (to both provider and recipient) on ownership rights, intellectual property, academic publication, permitted use and liability. Have a good faith belief there has been a violation of University policy? The form has branchinglogic andcontains questions regarding funding, type of data to be accessed or transferred, data storage, data security, and human subjects information. 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? necessary. Employees in different positions may have signatory authority for different types of agreements. may be sent outside the UK or the EEA. The dean of the college or school or the chancellor of the system campus must inform and seek consent from. If the DUA specifies security measures that can only be met by the Data Laboratory, then the principal investigator must also submit an application for Data Laboratory use. Associated reviews for regulatory compliance including, but not limited to, secure data storage and research uses are also required. 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. Office BEFORE the data is transferred as terms need to be checked US Safe Harbor standards or expert determination method. If the University selects to continue ownership of the data after the PI left the University, the college where the PI resided must designate a person responsible for preserving the data and destroying the data at the agreed-upon time. 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. A Material Transfer Agreement (MTA) is an agreement that governs the transfer of tangible research materials between two organizations. Every DUA is required to be signed by an authorized signatory for the university; this can only be done by the ORA. This guidance sets out the Clinical School 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. protection for personal data. If a data provider requires signature of authorized signatory official, then SPS or Office of Legal Counsel can assist. transferred. The application and DUA will be reviewed by the Data Laboratory Director. 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. 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. Legal Notice | Privacy Policy, Nord Hall, Suite 615 The transfer and use of human subject data is a complicated issue that cannot be adequately addressed on this website. Certain terms may require review and approval from the Office of General Counsel. To comply with information governance a Data Transfer Agreement needs The AVP-GSR will sign the approved DUA and return it to the Research Compliance Officer. 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. A data agreement also assigns appropriate responsibilities to the researcher(s) and recipient(s) using the data. In the absence of an MTA, one can lose valuable intellectual property and other rights. does not hold intellectual property rights, Secondary use of information for research purposes, section 16, requirement for research plans, Multi-site clinical trials where compliance obligations require that the data management plan and agreements be explicitly detailed, Any data sharing involving multiple institutions which have been assessed using the, Participants have expressed a preference to not have their data used or shared for other activities or other research, The data is embargoed or otherwise restricted under pre-existing agreements. The PI must also provide a contact at the receiving 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. myRESEARCHpath is maintained in partnership by the Duke Office of Research Initiatives and participating research support offices across the institution. 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 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. The January issue of the Innovation Insider Newsletter is available. The dean of the college or school or the chancellor of the system campus, or their designee, must then inform and seek consent from: The PI must provide the reason for transferring the research data and include the written agreement from the receiving organization when submitting the request. An MTA is a legally binding contract between two organizations (Provider and Recipient) for the transfer of tangible research materials. -If Purdue is receiving data from an outside entity: Please note if Purdue is receiving data, SPS is not responsible for determining the data type or if an agreement is required. Data agreements, including Data Transfer and Use Agreements (DTUA, DUA, or DTA) are contracts that govern the exchange of specific data between two parties. Contact the Office of Research Compliance at [emailprotected] or 734-487-3090. Data sharing agreements identify the parameters which govern the collection, transmission, storage, security, analysis, re-use, archiving, and destruction of data. They can be sent via interoffice mail to 200 Boone or via email to. Vehicle identifiers and serial numbers, including license plate numbers. We would normally expect only anonymised data to be To request contracting services from Sponsored Program Services, please complete the Data Transfer and Use Request Form. The principal investigator will return the executed MTA to the original sender. Lines and paragraphs break automatically. Full-face photographic images and any comparable images. Each Agreement is individually reviewed by the Office of Technology Commercialization to ensure fair and reasonable terms. The Director of Information Security can also be consulted should you require clarification on the categorization of the data contained in the proposed data set. 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. 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. One of the exemptions for this is if you Once the agreement with the sending organization is obtained, the PI requests the transfer of a copy of research data from the sending organization in writing from the dean of the college or school or the chancellor of the system campus where the administering unit for the project of the data under consideration will be. 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! 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. Ownership rights are not transferred in an MTA. Material Transfer Agreement (MTA): The National Institutes of Health has developed a template MTA for universities and non-profit institutions to utilize, known as the Uniform Biological Material Transfer Agreement (UBMTA). DTAs received by researchers from external parties for incoming data Can someone other than the PI create and submit an MTA Intake Form for that PI? However, investigators must submit eligible datasets to the Purdue IRB/HRPP office prior to conducting research. The University of Kentucky cannot agree to arbitration or to indemnification of any sort. The PI must also provide a contact at the sending organization. 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. 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. They can be sent via interoffice mail to 200 Boone or via email to. The November issue of the Innovation Insider Newsletter is available. As you are completing the form, please provide as much detail as possible. 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. information is requested by third parties or collaborators it should be All MTAs must be sent to the Office of Graduate Studies and Research for processing. Consult the University of Waterloodata security and storage guidelines. When should a data sharing or transfer agreement be developed?
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