Jan 31, 2018 | Glossary
Whenever research material is exchanged between Mount Sinai and other institutions or companies, a Material Transfer Agreement (MTA) is required. An MTA is a legal contract documenting the rights and responsibilities governing the use and exploitation of tangible research materials. These can cover an incoming or outgoing transfer of specialized laboratory animals, chemical compounds, human tissue, and other biological materials for research purposes.
MTAs protect both the researcher’s and Mount Sinai’s interests and the ability to conduct future research related to the material. Where a researcher is receiving material, MSIP will negotiate the MTA to ensure that the provider does not include terms that may restrict the researcher’s academic freedom, assert undue rights of ownership of discoveries, or use indemnification language that may put Mount Sinai at risk.
Jan 31, 2018 | Glossary
A License Agreement is a legal contract between Mount Sinai and a third party describing the rights and responsibilities related to the use and exploitation of intellectual property. The License may be exclusive, non-exclusive, or a time-limited option, for the defined use, development and/or sale of the patented (pending or issued) and licensed intellectual property. Mount Sinai’s main goal in any License Agreement is to ensure that the technology will be developed by the licensee for the benefit of the public, and if successful, provide a reasonable return to the institution and the inventor(s), while simultaneously ensuring that the agreement complies with both federal and institutional policies. Licensing negotiations are negotiated directly between MSIP and a non-inventor representative of the company in order to avoid potential conflicts of interest.
Jan 31, 2018 | Glossary
Also known as an IP Management Agreement, an Inter-Institutional Agreement (IIA) is a legal contract to provide for joint management of jointly owned intellectual property. IIAs delineate which party will take the lead on patenting and commercializing the resultant intellectual property as well as how the legal expenses and license revenue will be shared among the institutions that assert the ownership rights to the joint invention(s).
Jan 31, 2018 | Glossary
A Data Use Agreement (DUA) refers to a legal contract concerning the transfer of human subject data which includes PHI (typically but not exclusively in the form of a Limited Data Set). It is required to obtain satisfactory assurances that the recipient of the Limited Data Set will use or disclose the PHI in the data set only for specified purposes. DUAs are subject to HIPAA regulations and usually require IRB approval.
A Data Transfer Agreement (DTA) is a legal contract governing the transfer of non-human subject data or completely de-identified human subject data. It sets out the related protections, rights, and obligations of both parties and delineates the specific purpose(s) for which the data may be used.
Jan 31, 2018 | Glossary
A Collaborative Research Agreement (CRA) is a legal contract between Mount Sinai and one or more organizations, where the parties agree to contribute resources, such as materials, equipment, or specialized expertise, and work together collaboratively to find an answer to a particular research inquiry. A CRA describes the actions that each organization has agreed to undertake, and defines the obligations each party has to the other(s) participating in the collaborative research effort. CRAs are typically unfunded.
Jan 31, 2018 | Glossary
An agreement governing negotiating an agreement with a third party who is not the Sponsor, i.e. CRO whereby the CRO is executing the agreement on behalf of the Sponsor.
Jan 31, 2018 | Glossary
An agreement governing the loan or lease of equipment to be used in conjunction with a specific Clinical Trial Agreement and at no cost to ISSMS. The agreement cannot be a prerequisite nor imply any future leasing or purchasing of the equipment between ISMMS and the company. Furthermore, loaned/leased products cannot be utilized simultaneously for clinical and research purposes.
Jan 31, 2018 | Glossary
An agreement used when a for-profit entity or clinical research organization (CRO) wants to assist the Investigator and his/her research team by providing startup funding while the clinical trial agreement is being negotiated.
Jan 31, 2018 | Glossary
An agreement governing responsibilities for the overall data management, monitoring, communication, and general oversight for a Multi-Center clinical trial. The agreement may be designated either by a for profit entity or by mutual agreement of the participating sites.
Jan 31, 2018 | Glossary
An agreement governing standard terms, pre-negotiated between parties that reduces the need to renegotiate common language and allows focus to be placed on specific individual study work orders, protocols, and budgets.
