An agreement wherein an academic and/or nonprofit institution performs certain functions in the conduct of clinical trials. The research services that an ARO provides can range from academic leadership to full-service clinical trial management capabilities, including site monitoring, data management, statistical analysis, safety monitoring, and clinical events classification, in addition to clinical expertise.
Research consortium owned by several New York metropolitan area institutions, including the Icahn School of Medicine.
BRANY offers a variety of services, including:
- IRB review
- Budget negotiation and contracting for multisite studies
- Monitoring services for investigator initiated studies
- Medicare Coverage Analysis (MCA)
The interval of time, generally 12 months, into which a project period is divided for budgetary and funding purposes. Many times a budget period may also correspond with an IRB or IACUC approval period. Since they are not interchangeable, a PI must track different periods for reporting purposes.
Other Terms: Increment
A Clinical Trial is defined by the FACTS Office as a research study where the objective is either the testing of drugs, devices, diagnostics, treatments, interventions or preventive measure. This includes testing for an unapproved indication or Data collection to increase knowledge that would lead to enhanced safety and efficacy of a drug or device. The study must involve contact with humans, inclusive of medical record reviews. The source of funding or support must be a for-profit entity.
The OnCore Clinical Trials Management System (CTMS), a product of Forte Research Systems, is a centralized web-based technology solution for the management of clinical trials for the Mount Sinai Health System.
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)
A term only used by the NSF and other funding agencies in which it is explicitly stated in their policy. NIH does not allow use of this term or recognize this status. The NSF definition is as follows: “… the individual(s) designated by the proposer, and approved by NSF, who will be responsible for the scientific or technical direction of the project. NSF does not infer any distinction in scientific stature among multiple PIs, whether referred to as PI or co-PI. If more than one, the first one listed will serve as the contact PI, with whom all communications between NSF program officials and the project relating to the scientific, technical, and budgetary aspects of the project should take place. The PI and any identified co-PIs, however, will be jointly responsible for submission of the requisite project reports.
Other Term: Co-PI
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.
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.
Applications that compete with other applications for funding. These include New, Competitive Renewal, Re-submission, and New Supplement Applications.
An application requesting additional funding for a period subsequent to that provided by a current award. A renewal application competes with all other applications and must be developed as fully as though the applicant is applying for the first time.
Example: Your award, which was funded for 5 years is coming to an end. You are applying for 5 additional years to continue the research.
Other Terms: Renewal (NIH), Competing Continuation
Also referred to as a non-disclosure agreement (CDA or NDA), is an agreement governing the exchange of confidential information. It is designed to protect the confidential information that may be released between a for-profit entity and the faculty and staff of the Icahn School of Medicine (ISMMS) so that they may determine whether or not to enter into a subsequent agreement for a clinical trial.
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.
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.
A mechanism for procurement of a product or service with specific obligations for both Mount Sinai and the extramural funding agency and recipient. Typically, there are greater performance expectations associated with contracts, including project milestones and detailed deliverables (e.g., reports). The arrangement is usually designed to benefit the extramural funding agency by achieving an expected outcome or product.
Other Terms: Acquisition Mechanism
A type of grant award in which there is substantial scientific or programmatic involvement from the extramural funding agency. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.
Other Terms: U-series (NIH)
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.
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.
EH&S supports the research community by providing guidance on a variety of topics, including safe handling, use and storage of chemicals, proper disposal of hazardous waste, hazard identification and spill response and remediation. Together, EH&S and the research community work to develop and maintain a culture of safety in all laboratories.
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.
External entity that provides funding for a project or activity.
Other Terms: Sponsor, External Funding Agency
An application closing out the project.
Example: Your grant is over and it’s now time to submit the close out documents.
Other Terms: Close Out
A type of financial assistance mechanism providing money, property, or both to Mount Sinai to carry out research or other approved project or activity.
Other Terms: Assistance Mechanism
Is the number assigned by PPHS when an IRB application is submitted.
An IF number is generated when an Investigator Form is completed in Sinai Central. The IF number is required for an Ideate IRB application with the exception of studies requesting to rely on BRANY. The IF number is GCO submissions.
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).
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:
- 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
- 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.
According to PPHS guidelines, when completing the Investigator Form for Human Subject Research you are required to list:
- Everyone who meets the Federal definition of an Investigator, that is anyone responsible for the design, conduct or reporting of the project. Please link this to the GCO definition of “investigator”
- All employees involved in the design, conduct and reporting of the human research study. This includes all those listed on the HRP 211 form.
An agreement governing the conduct of a study based upon a protocol authored by an ISMMS Investigator/Sponsor Investigator. A for profit entity provides funding and/or drug or device.
A project in which Mount Sinai is not receiving external sponsored program funding to carryout the associated activities. However, in certain circumstances, the project may be externally funded and those funds are associated with an already registered GCO project. Please contact GCO with any questions.
Other Terms: In House Study, Mount Sinai Sponsored Study, Unfunded Study
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
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.
A letter issued by a for-profit entity which promises by written confirmation to act as a 3rd-party on behalf of the first party in a transaction or contract. This 3rd-party covers loss or damage to the 2nd-party in the agreement caused by the first party.
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.
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.
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.
An individual who guides, advises, and provides feedback on the applicant’s research and professional development. The NIH sometimes refers to mentors as sponsors.
Other Term: Sponsor
A single submission with multiple, interrelated components (i.e., cores/projects) with defined work, personnel, sites and budgets that share a common focus or objective.
Other Terms: Program Project Grant, NIH PSeries
A term only used by the NIH and other funding agencies in which it is explicitly stated in their policy. Multiple PI/PD awards are an opportunity for multidisciplinary efforts and collaboration through a team of scientists under a single grant award. All PI/PDs share equally the authority and responsibility for leading and directing the project, intellectually and logistically. Each PI/PD is responsible and accountable to the applicant organization, or as appropriate to a collaborating organization, for the proper conduct of the project or program, including the submission of all required reports. The presence of more than one PI/PD on an application or award diminishes neither the responsibility nor the accountability of any individual PI/PD.
Other Terms: MPI, MPD
An application that is being submitted to an agency, or if unfunded, to the GCO for the first time.
Example: You are submitting a brand new project to the NIH or other funding agency.
An application requesting the extension of the award end date without additional funds from the extramural funding agency.
Example: Your grant end date is approaching, you are not done with your research, you would like to continue, and are not requesting any additional funds from the agency to do so.
A type of InfoEd submission in which Mount Sinai uses InfoEd internally at ISMMS only and not to submit an application to an extramural funding agency.
Other Term: non-S2S
An application that is not competing with other applications receives additional funding for a budget period within a previously approved project period. Mount Sinai also treats unfunded projects and yearly renewals of clinical trials paid on a per patient basis in this category.
Example: Your grant is for 5 years of funding and you are submitting the required yearly progress report to the agency before the 2nd year begins.
Other Terms: Yearly Renewal, RPPR (NIH), Continuation, Progress Report
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.
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
The individual designated by ISMMS to have the appropriate level of authority and responsibility to direct the project. All full-time, part-time, emeritus, and voluntary faculty of ISMMS and its affiliates are eligible to serve as PIs. Other professional staff, who hold titles typically associated with independent work, and whose appointments are subject to a rigorous review of credentials, may also serve as a PI. All PIs must have the approval of their departments indicated by the Chair’s and/or Departmental Administrator’s electronic signature via InfoEd.
Other Terms: PI, PD
The total time interval for which an extramural funding agency has approved the project. For NIH sponsored projects, it includes the initial competitive segment, any subsequent competitive segments, and extensions.
The Proposal Development (PD) # is a unique number assigned by InfoEd each year of the project.
An agreement governing the conduct of a study that is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes.
An industry funded agreement by entities with an economic interest in the sale of a product where the study looks at the use and or outcomes of use of their product subsequent to selling to MSH at the full commercial price.
For purposes of application and registration with the GCO, research is defined as systematic investigation designed to develop or contribute to generalizable knowledge. Activities meet this definition, even when the overall purpose is not primarily research, but may include training, demonstration, or service programs.
An application that has been previously submitted, but was not funded, and is being resubmitted for new consideration.
Example: Your grant was not funded the first time around and you are applying again.
An agreement governing an external site’s participation in an Investigator Initiated clinical trial as provided above.
A term that has a range of meanings that are used in different research contexts. It can mean extramural funding agency in sponsored project administration, IND or IDE holder in FDA regulated research, as well as mentor of a fellowship.
Externally-funded activities in which a formal written agreement, i.e., a grant, contract, or cooperative agreement, is entered into by Mount Sinai and the extramural funding agency generally after a competitive peer review process.
Other Terms: Grant, Contract, Cooperative Agreement
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.
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.
An agreement governing financial support from a for-profit entity/prime awardee or pass-through entity (i.e., ISMMS) for the performance of a substantive portion of the effort under the prime award. It does not include procurement of goods and services purchased under an award, as the providers of these goods and services have no programmatic responsibility.
A legal instrument by which a recipient (i.e., the prime institution) provides funds (or property in lieu of funds) to an eligible sub-awardee (or a lower-tier transaction) to perform a substantive portion of an externally sponsored program or project. The term includes such financial assistance when provided by any legal agreement (even if the agreement is called a contract).
Other Terms: Consortium Agreement, Subcontract
An application that is requesting additional funding from funding agency beyond what is already approved.
Example: You are requesting funds to replace a piece of equipment that broke or add an additional post-doc.
Other Terms: Revision (NIH)
A type of InfoEd submission in which Mount Sinai submits competitive NIH and other federal grants electronically to these agencies.
Other Term: S2S
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