Conflict of Interest Policy Instituted at CSSIFM
The Chan Soon-Shiong Institute for Medicine, Immuno-Oncology Network, Mariposa (CSSIFM) is a new cancer center that offers state-of-the-art molecular diagnosis and immuno-oncology treatments, and is dedicated to patient care and research to facilitate the efficient transfer of knowledge and technology to support the improvement of patient health. CSSIFM fully expects and requires that research Investigators and physicians, engaged in the design, conduct or reporting of clinical trials involving CSSIFM patients or facilities will conduct their relationships with CSSIFM with candor and integrity.
Clinical Investigators often have multiple obligations, various roles, and certain interests related to their professional goals, including relationships with pharmaceutical companies. Accordingly, CSSIFM allows clinical Investigators to engage in activities and relationships with outside interests that may financially benefit the Investigators, but only if it furthers and enhances the mission of CSSIFM, and such activities and relationships are disclosed. Disclosure and recognition of these multiple interests, roles, and obligations is a necessary first step in transparent acknowledgement of the concurrence of these interests, and prospectively managing the perceived risks posed by competing incentives and obligations.
It is important to note that Phase I (safety & proof of concept) clinical trials often require both medical, scientific, technical and clinical knowledge and skill, as well as familiarity with the novel technologies being tested in these trials, especially in the fields of cellular transplant. For this reason, it is expected that such Investigators in CSSIFM conducting Phase I clinical trials of breakthrough first in human immunotherapies will hold such multiple skills and interests. These various interests will be disclosed and managed before the Investigator is permitted to conduct trials at CSSIFM.
Multiple steps have been taken to ensure that outside activities do not negatively impact an investigator’s obligations or judgement with respect to their clinical care of patients or their conduct of clinical research. These include the appointment of an independent third party Clinical Research Organization (CRO) with no financial ties to CSSIFM, to provide clinical monitoring of the operations of trials at CSSIFM. In addition, an independent Data and Safety Review Board will assess the safety of the novel agents being tested. In all activities, Investigators will abide by the highest standards of research and ethical conduct.
CSSIFM acknowledges the importance of conflict of interest management which is why the Institute has proactively taken the appropriate steps and adopted a Conflict of Interest Policy (COI Policy) that requires comprehensive disclosure of the financial interests of Investigators conducting clinical research at the CSSIFM which has been implemented in full prior to opening of the institute.
The COI Policy requires detailed review of these interests including the following examples of actions already implemented to assure the highest standards are maintained:
- Required disclosure in the informed consent documents submitted to potential human clinical trial participants of the fact of the Investigators related financial interests,
- Review of data from the clinical trials performed at CSSIFM by a group of knowledgeable individuals who have no financial interests related to the clinical trials,
- Justification for the involvement of Investigators with financial interests in the conduct of clinical research,
- Plans for the management of perceived risks posed by the financial interests of investigators,
- Providing potential clinical trial participants with contact information of an independent third party that can
address any questions or concerns that trial participants might have about an Investigator’s personal
- In addition to this COI policy and procedures developed by CSSIFM, before any Investigator is permitted to
participate in the clinical trials, all Investigators are required by FDA regulations to provide information about
their financial interests to the sponsor of the clinical trials, and to the Investigational Review Board that will
review and approve the conduct of the clinical trial.