Jan 31, 2018 | Glossary
An individual who provides professional advice or services for a fee. On NIH and other Federal grants, consultants are typically “Key Personnel.” A Mount Sinai employee cannot be a paid consultant on a sponsored project conducted at Mount Sinai. Example: Dr. Smith in Pediatrics has an NIH grant and would like to pay Dr. Howell in Neurology as a consultant. This is not allowed. For the policy on faculty as consultants for an external entity (e.g., consultant on a NIH grant that is not conducted at Mount Sinai), please click on link below and go to Section E.
http://icahn.mssm.edu/about-us/services-and-resources/faculty-resources/handbooks-and-policies/faculty-handbook/faculty/full-time-faculty
A Mount Sinai employee can be an unpaid consultant on a sponsored project conducted at Mount Sinai. Example: Dr. Smith in Pediatrics is applying to the American Cancer Society and would like to include Dr. Kim in Oncological Sciences as an unpaid consultant. Assuming that the time commitment is minimal (i.e., less than 1%), this is allowable.
Jan 31, 2018 | Glossary
The NIH uses the term “Collaborator” to mean “Investigator,” “Consultant,” or “Other significant contributor.” On NIH and other sponsored projects, it may also refer to an individual who provides technical advise or a necessary supply (e.g. reagents) but is not involved in the day to day execution of the project.
Jan 31, 2018 | Glossary
A term only used by the NIH and other funding agencies in which it is explicitly stated in their policy. Individuals who have committed to contribute to the scientific development or execution of the project, but are not committing any specified measurable effort (i.e., person months) to the project. These individuals are typically presented at “effort of zero person months” or “as needed.” Individuals with measurable effort may not be listed as Other Significant Contributors (OSCs). Consultants should be included if they meet this definition.
Other Terms: OSC, Collaborator, Consultant
Jan 31, 2018 | Glossary
Refer to this definition when determining which personnel complete the COI form each year for your InfoEd application. An individual responsible for the design, conduct or reporting of the study. Since Federal Conflict of Interest regulations require that all investigators complete Conflict of Interest Forms, the definition of who meets this criteria is of special importance. ISMMS’ policy is that the following personnel always meet this definition:
- PI
- Key Personnel
- Anyone with a role that includes the word Investigator (Example: Sub-Investigator)
- Primary Mentor on a Fellowship or Mentored Career Development Award
- Faculty Personnel, either key or non-key (with some very limited and well documented exceptions where the non-key faculty is not engaged in the research)
Other ISMMS personnel may meet the Investigator definition. ISMMS leaves the following to the discretion of the PI:
- Other Significant Contributor
- Consultant
- Non-faculty, non-key personnel
Please consider the role, rather than the title, of those involved in research and the degree of independence with which those individuals work. When the definition of investigator is limited to titles or designations (e.g., to principal investigators, key personnel, faculty), the risk increases of an unidentified FCOI that may compromise the research enterprise.
Jan 31, 2018 | Glossary
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)
Jan 31, 2018 | Glossary
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.
Jan 31, 2018 | Glossary
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
Jan 31, 2018 | Glossary
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:
- A Research Service Agreement, whereby a for-profit company provides funding for the performance of research designed by the company; and
- Clinical Trial Agreements specific to evaluating products in human subjects trials following a protocol developed by the sponsor (as well as CDAs made in anticipation or otherwise regarding a clinical trial), which are negotiated through Financial Administration of Clinical Trials Services (FACTS) instead of through MSIP.
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.
