All Academic Research Organization (ARO) agreements will only be negotiated through the Financial Administration of Clinical Trials Services (FACTS) Office.
Academic Research Organization Agreements Guidelines Relating to Conflicts of Interest
The Icahn School of Medicine at Mount Sinai (ISMMS) is committed to maintaining the highest standards of integrity and transparency in scientific inquiry, advancement, and discovery. Consistent with this commitment, these guidelines ensure that all ARO agreements are aligned with institutional policies and practices relating to conflicts of interest.
ARO agreements are formal, written contracts between the Icahn School of Medicine at Mount Sinai and commercial or other biomedical entities. These agreements encourage scientific inquiry and collaboration, and enable faculty, as part of their employment by the School, to provide research-related expertise as defined below, and to assume leadership roles in industry-funded studies or research entities.
Mount Sinai’s participation in an ARO agreement creates a financial relationship that requires appropriate oversight and management essential to protect the scientific integrity of research and the integrity of associated patient care.
These guidelines contribute to the management and mitigation of potential institutional conflicts and to transparency by articulating disclosure requirements, restrictions, limitations, accountability and oversight.
Types of Academic Research Organization Agreements
There are two types of ARO Agreements into which ISMMS might enter:
Comprehensive ARO Agreement – The more common ARO agreement is a comprehensive agreement in which an ISMMS Designated Clinical Research Center (an institutionally recognized clinical research unit) provides a package of research-related support services to an outside commercial or research entity. This may include multiple line-item services such as faculty research roles (global PI, Data Safety Monitoring Board member, event-adjudication committee member), data management, clinical trials management, statistical analyses, and medical monitoring.
For an ISMMS clinical research unit to qualify as a Designated Clinical Research Centers (DCRC) it must have recognized expertise as either a clinical coordinating center or a data coordinating center, as well as the necessary infrastructure to carry out its work. In some cases, the infrastructure may be supported by a collaborative agreement with the ISMMS Institute for Transformative Clinical Trials. In all cases, creation of a DCRC requires presentation to the Business Conflict Working Group for review and approval by the Dean.
The School may not enter into an ARO agreement if either of the following conditions applies:
- The School has equity ownership in the proposed partnering entity;
- The School has financial incentives linked to the success of a clinical trial that would be conducted under the auspices of the ARO.
Limited ARO Agreement – Occasionally, an ARO agreement may be more limited in scope, involving only the participation of a faculty-investigator as a global PI or in another research support role. In such cases, the faculty-investigator must be a member of an ISMMS Designated Clinical Research Center.
If an individual faculty member who is not part of an institutionally recognized research unit requests an ARO agreement, the approval process includes presentation of this proposal to the Business Conflicts Working Group for review and approval by the Dean.
The ARO agreement will reflect that the individual is contributing services as part of his/her role as an ISMMS faculty member.
Arrangements That Would Not Qualify for ARO Agreements
Some types of arrangements with industry or other biomedical entities would not meet the requirements for an ARO agreement. The most common are:
- Consulting and Other Individual Agreements – Paid personal agreements between a faculty member and an outside entity, such as consulting or participation in scientific advisory board meetings or other investigator meetings, are independent of ISMMS and would not be covered by ARO agreements.
- Sponsored Research Agreement (SRA) – These are contracts between the School and a sponsor for funding and conducting a specific research project at ISMMS. The sponsoring entity may be for profit, e.g., industry, or not-for-profit, e.g., a foundation or government agency.
Academic Research Organization Agreement Requirements
Every ARO agreement, regardless of whether it is comprehensive or limited in scope, must be negotiated through the ISMMS Financial Administration of Clinical Trials Services (FACTS) Office.
Faculty cannot participate in an ARO agreement if they have personal financial interests with the proposed entity, e.g., personal consulting agreements, licensed IP, equity interest in a non-publicly traded company. Such interests would pose an unmanageable conflict of interest for the individual in relationship to the ARO.
In order to address, manage, or otherwise mitigate institutional conflicts of interest that arise from ARO participation, all ARO agreements must include the following:
- Identification of a specific ISMMS Designated Clinical Research Center for participation;
- Fee structure for ISMMS faculty that reflects fair market value for any and all services that they provide through the agreement;
- Promotion of responsibility and accountability through proper disclosures and reporting of ARO.
For purposes of the COI review and management, faculty members serving as investigators or otherwise participating in ARO agreements must:
- Track their time and effort on ARO activities consistent with ISMMS requirements;
- Follow ISMMS document retention policies to preserve all relevant research-related documents, including email correspondence;
- Use only the ISMMS email system for study-related communications. No communication between faculty members and entities sponsoring ARO agreements can use personal email;
- Disclose the institutional financial interests in the relevant ARO agreements as well as their own study-specific roles to research collaborators and on all related publications/presentations; and,
- Disclose these institutional financial interests in the relevant ARO agreements as well as their own study-specific roles in informed consent documents if Mount Sinai is participating as a clinical trials site.
Adherence to the above guidelines and requirements for faculty members engaging in ARO agreements will be monitored by the Compliance Department on a regular basis and shall be reported to the Business Conflicts of Interest Working Group within the Office of Industry Engagement and Conflicts of Interest. Faculty who fail to adhere to documentation, disclosure and/or other requirements may be subject to audits. Repeated failure may result in termination of participation in ARO agreements, and possible disciplinary action.
ISMMS will promote transparency through public disclosure on the School website of the institution’s participation in ARO agreements.
A proposed ARO agreement between ISMMS and the Acme Pharmaceutical Company would have to be negotiated with the FACTS Office. In order to participate in the ARO, faculty must be part of an ISMMS Designated Clinical Research Center (DCRC), and cannot have any personal conflicts of interest with the Acme Company. Qualifying faculty can provide services as defined in the ARO agreement, such as taking on leadership roles as part of the Data Safety Monitoring Board (DSMB) for Acme’s clinical trial.