When should a d

When should a data sharing or transfer agreement be developed? If you are in need of a DUA, pleaseemail it to the OTC's Senior Contracts Coordinator, Ali Yankey. 2095 Martin Luther King Jr. Dr. 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. If all materials have the same recipient, then yes, one request can be made. 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. sets MUST be reviewed by a member of the contracts team in the Research

DUAs will be processed first by the Research Compliance Officer to ensure that all compliance requirements are met. Contact Tyler Gray attjg47@case.eduor leave a message at 216.368.1401 for assistance with your MTA. 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. 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. 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. Vehicle identifiers and serial numbers, including license plate numbers. If you have any questions concerning your proposed data management plan, the Privacy Officer should be contacted prior to submitting an ethics application or while you are developing a research agreement to ensure that the proposed data management plan is appropriate to manage these identified risks.

OH They can be sent via interoffice mail to 200 Boone or via email to. Some research protocols involving human participant data submitted for ethics review may require a data management plan. They can be sent via interoffice mail to 200 Boone or via email to. Overview) requires that personal data must not be transferred outside 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. The AVP-GSR will sign the approved DUA and return it to the Research Compliance Officer. An authorized official of the outside entity provider must make this determination. 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. An inter-institutional or intra-institutional agreement to share data according to certain terms and conditions. To request contracting services from Office of Legal Counsel, please complete the New Matter Intake Form. Any MTA that requires Biosafety Level 3 or 4 containment cannot be executed by Eastern Michigan University. Data Use Agreement (DUA):Data Use Agreements are contracts that are developed, signed, and executed for the purpose of outlining procedures, expectations, requirements, and restrictions for sharing research data. A Material Transfer Agreement (MTA) is an agreement that governs the transfer of tangible research materials between two organizations. University of Waterloo requirements concerning human participant data security and storage are outlined in the Guideline on Research Participants Data Security.

The Research Compliance Officer will send executed copies of the MTA via email to the principal investigator with the Dean and Department Head copied. These procedures apply to all Data Use Agreements and Material Transfer Agreements required for research purposes at Eastern Michigan University. Every DUA is required to be signed by an authorized signatory for the university; this can only be done by the ORA.

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. Minneapolis, MN 55455. -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. may be sent outside the UK or the EEA.

third parties is covered and if not, then consent should be sought if 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). These agreements govern the terms for exchanging confidential information between the University and an outside party and are negotiated, drafted, and signed by the Office of Technology Commercialization to ensure fair and reasonable terms. Do I need to submit an MTA if I am transferring samples within CWRU? Yes. establishments.

It is therefore important that you have made Elevating Communities, Inspiring Generations, EMU Research, 200 Boone Phone: 734.487.3090 [emailprotected], Eastern Michigan University, Education First, Non-Discrimination Statement | Report a Title IX incident | Accessibility 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. The PI must provide the reason for transferring the research data and include the written agreement from the sending organization when submitting the request.

The Research Compliance Officer will retain a copy of all signed and fully executed DUAs and MTAs in accordance with the Eastern Michigan University procedures. When submitting an ethics application, include the portion of the research agreement which describes the data sharing arrangements which have been developed.

Questions and concerns: 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. Any geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. The Intellectual Property Development (IPD) Team has Fellows positions open. 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 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. 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. 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. 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. 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 Research Administration (ORA) is responsible for the review and negotiation of data use agreements (DUAs). Cleveland, The application and DUA will be reviewed by the Data Laboratory Director. the European Economic Area (the European Union member states plus 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. In situations where the researcher has legal or ethical obligations, or where a real risk exists if the data is inappropriately accessed or used. 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. 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).

The University of Kentucky cannot agree to arbitration or to indemnification of any sort. A non-Disclosure Agreement (NDA) is sometimes referred to as a Confidential Disclosure Agreement. Under Kentucky law, no state agency, including the University of Kentucky, can agree to laws, venue, and/or jurisdiction of another government. of one or more data sets from the owner/provider to a third party. In the event that identifiable What things do I need to consider when developing a data sharing agreement? Full-face photographic images and any comparable images. For questions regarding policy development process at the University or to report a problem, please call: 612-625-2210 or email: [emailprotected]. 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 principal investigator will return the executed DUA to the original sender. These agreements are negotiated, drafted, and signed by the Office of Technology Commercialization for the usage of data from the University of Kentucky. The form has questions designed to help DUA staff determine the type of DUA needed and regulatory requirements. Likewise, the University needs this opportunity as well. It is important to have the OTC review every MTA as a recipient's ability to publish research results may be affected. We assist with the preparation and execution of these documents. 2018 Challenge Details, NCATS Rare Diseases Are Not Rare! sets between the Clinical School and a recipient organisation. 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. 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. 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.

ensured that any duty of confidence is not be breached. 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. procedures that govern the transfer, both outgoing and incoming, of data 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.

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. Every MTA is required to be signed by an authorized signatory for the university; this can only be done by the TTO. Biometric identifiers, including fingerprints and voiceprints.

The institutions listed below have executed a Data Transfer Agreement (DTA) with NCATS.

formal recognition of University of Minnesota's continued ownership of the research data by the receiving organization. The PI must also provide a contact at the receiving organization. As you are completing the form, please provide as much detail as possible. Certain terms may require review and approval from the Office of General Counsel. Contact the Office of Research Compliance at [emailprotected] or 734-487-3090. The dean of the college or school or the chancellor of the system campus must inform and seek consent from. 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 Director of Information Security can also be consulted should you require clarification on the categorization of the data contained in the proposed data set. The N3C Data Enclave does not yet include data from all of the institutions listed. To request contracting services from Sponsored Program Services, please complete the Data Transfer and Use Request Form.

The Research Compliance Officer will send the DUA to additional offices for processing, if necessary. What needs to be in a data sharing agreement? These agreements are negotiated, drafted, and signed by the Office of Technology Commercialization for all material coming in and out of the University of Kentucky.

Gathering anonymous information may require minimum safeguards.

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. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000.

coded or completely anonymised data. Consult the University of Waterloodata security and storage guidelines. 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 principal investigator is the lead researcher in charge of the research study and all research conduct for that study.

140 McNamara Alumni Center It should be stressed that personal identifiable data Please note Purdue will use its template DUA when providing Purdue owned Data to an outside entity. All MTAs must be sent to the Office of Graduate Studies and Research for processing. Once TTO receives an MTA Intake Form, a draft agreement is reviewed or generated, and the terms must be negotiated with the other party. Office BEFORE the data is transferred as terms need to be checked Publically available datasets do not require review. 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. is secure. Transferring Research Datarefers to the process of moving data to and from another organization in cases where a PI leaves or joins the University or the PI responsibility of a project is moved to or from another institution. 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. However, investigators must submit eligible datasets to the Purdue IRB/HRPP office prior to conducting research. myRESEARCHpath is maintained in partnership by the Duke Office of Research Initiatives and participating research support offices across the institution. 44106, 10900 Euclid Ave. Whenever possible data sharing agreement terms should be contained within a master research agreement (e.g., clinical trial agreement). Importantly, the terms of these private industry MTAs may restrict university researchers from publishing research results. This agreement should be developed prior to submitting the ethics application. Data Use and Transfer Agreements not related to a sponsored research project or proposal, are reviewed by Office of Legal Counsel (E.g. The November issue of the Innovation Insider Newsletter is available. Can someone other than the PI create and submit an MTA Intake Form for that PI? 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. 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. In order to initiate a Data Use Agreement or Data Access Agreement, aData Use/Access Request Formneeds to be submitted. This procedure provides the details on how to request a transfer. Data sharing agreements identify the parameters which govern the collection, transmission, storage, security, analysis, re-use, archiving, and destruction of data.

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. 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). should not be passed on unless consent is in place and the storage area Data agreements, including Data Transfer and Use Agreements (DTUA, DUA, or DTA) are contracts that govern the exchange of specific data between two parties. Cleveland,

To assist with the completion of the form all of the questions, branching logic and additional guidance are provided in the. Agreement established between organisations that governs the transfer The Office of Technology Transfer will review all MTAs to clarify Eastern Michigan Universitys rights for copyright, patent, or commercialization. We would normally expect only anonymised data to be Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re-identification. Data Transfer Agreement guidance for the transfer or use of human subject data. If you havequestions about Data Use/Access Agreements please emailcwru-dua@case.eduwith your questions and a DUA staff member will get back to you. 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. 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.

Principal investigators are not authorized institutional representatives. Purdue will use the agreement provided by the outside entity to begin negotiations. For DUAs, IRB approval or a non-human subject determination may be required. This agreement typically lays out the terms for exchanging the material and determines how this material can be used by the receiving party. Employees in different positions may have signatory authority for different types of agreements. Fully Executed), the final agreement is circulated and the material transfer may proceed. These procedures may be superseded by contractual, sponsor, or regulatory requirements. An MTA provides protection (to both provider and recipient) on ownership rights, intellectual property, academic publication, permitted use and liability. Once the terms of the MTA are agreed upon, signatures are collected from each party.

When I should NOT share data even if the situation suggests that a data sharing agreement may be required? These procedures provide guidance on routing and obtaining appropriate signatures for Data Use Agreements and Material Transfer Agreements. 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. Please note that at Purdue University data agreements must be signed by an authorized institutional representative. 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. No, only transfers between institutions require MTAs.

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