An individual involved with the PI in the scientific development or execution of a project. The investigator may be employed by, or be affiliated with, Mount Sinai or another organization participating in the project under a subaward agreement. A investigator typically devotes a specified percentage of time to the project and is considered senior/key personnel.
Other Terms: Investigator, Collaborator (NIH)
Individuals who do not contribute to the scientific development or execution of a project in a substantive, measurable way. This is regardless of whether or not they receive salaries or compensation from the sponsored project. Typically research assistants and technicians are considered non-key personnel.
The PI and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way. This is regardless of whether or not they receive salaries or compensation from the project. Typically these individuals have doctoral or other professional degrees, although individuals at the masters or baccalaureate level may be considered key personnel if their involvement meets this definition. Consultants and those with a postdoctoral role also may be considered key personnel if they meet this definition. “Zero percent” effort or “as needed” is not an acceptable level of involvement for key personnel.
Other Term: Senior/Key Personnel
A Sponsored Research Agreement (SRA) is a legal contract between Mount Sinai and a third party (often a for-profit company) for the purposes of funding and conducting research at Mount Sinai according to the investigator’s design. Proposals inclusive of a statement of work and project budget must be submitted to MSIP Business Development prior to providing to the sponsor.
Note: It is expected that Mount Sinai’s full Facilities and Administrative rate (F&A) (currently, 69.5%) is fully reflected in the budget. F&A costs are neither a profit nor a tax. Acceptance of an SRA without full compensation of Mount Sinai’s F&A costs places the institution at risk by providing research for amounts lower that the true costs incurred, which may be construed as subsidizing a commercial entity, a violation of IRS regulations. In addition, use of an F&A rate lower than that which is charged to the federal government may be seen as benefiting private companies at the government’s expense. For these reasons, reductions or waivers of F&A costs are rarely granted and must receive prior written approval from Stephen Harvey, Senior Vice President, Chief Financial Officer. Mount Sinai Health System. If a waiver has been issued, a copy should be forwarded to MSIP for formal inclusion in the file prior to signature.
This is to be distinguished from:
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.
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.
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).
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.
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.
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.