The purpose of this policy is to define the process for identifying, reporting, evaluating, and managing financial relationships that have or may have an impact on the objectivity and integrity of research conducted under the auspices of Memorial Health Services (“MemorialCare”) and its affiliated entities (“MemorialCare Entities”).
DEFINITION OF TERMS:
1. Conflict of Interest Official or COI Official means the institutional official designated by the MemorialCare Research Administration to oversee the implementation of, and compliance with, this policy.
2. Covered Individual means
3. Covered Family Member means an individual who is the spouse or dependent child of a Covered Individual.
4. Financial Conflict of Interest (FCOI) means a Significant Financial Interest (SFI) (as defined below) that could directly and significantly affect the design, conduct, or reporting of research.
5. Financial Conflicts of Interest in Research Committee (FCOI-R Committee) means the persons appointed by the Conflict of Interest Official to provide an appropriate review of disclosed SFI(s), make a determination of the SFI relationship of the Covered Individual and the funded research (reasonable belief of a FCOI) and devise an appropriate management plan for all instances in which a Conflict of Interest has been determined to exist. The FCOI-R Committee is a subcommittee of the MHS Compliance Committee
6. Financial Interest means anything of monetary value, whether or not the value is readily ascertainable.
7. Institutional Responsibilities means a Covered Individual’s professional responsibilities on behalf of a MemorialCare Entity including, but not limited to, activities such as research, research consultation, teaching, professional practice, institutional committee membership, and or service on panels such as the IRB or any other research related review committee or panel.
8. Investigator or Principal Investigator means an individual who is responsible for the design, conduct or reporting of research or proposals for research. This definition is not limited to those titled or budgeted as principal investigator or sub-investigator on a particular proposal.
9. Significant Financial Interest (SFI) means a financial interest consisting of one or more of the following interests of a Covered Individual or Covered Family Member that reasonably appears to be related to the Covered Individual’s Institutional Responsibilities:
Significant Financial Interest (SFI) does not include:
SCOPE AND RESPONSIBILITY:
This policy applies to Covered Individuals (as defined above). In cases where a MemorialCare Entity is the awardee Institution and carries out research through a sub-recipient (e.g., subcontractor or collaborator), the MemorialCare Entity will ensure that the written agreement with the sub-recipient establishes whether the sub-recipient will follow this policy or the sub-recipient’s own financial conflict of interest policy.
All research conducted at MemorialCare and all of its related entities shall be compliant with applicable laws, regulations and these policies and procedures, which includes the requirements that (a) all Covered Individuals disclose all significant financial interests in accordance with this policy, before research begins and immediately when a change in financial interest occurs, and (b) all Covered Individuals with conflicts address those conflicts as determined by the COI Official prior to beginning or resuming research activities.
A. Submission of Research Financial Disclosure Information by Covered Individuals
B. Review of Financial Disclosure Information and Assessment of Potential FCOI
C. Management of FCOIs
D. Reporting of Financial Conflicts of Interest to Sponsoring Agency
E. Monitoring and Compliance
Each Covered Individual conducting research under a management plan is responsible for fully and promptly complying with the plan. The management plan will specify who is responsible for monitoring ongoing compliance with the plan.
F. Corrective Action
H. Public Accessibility
This information is confidential and available only to pertinent MemorialCare personnel.
FDA: 21 CFR 54.1; 21 CFR 54.2; 21 CFR 54.4; 21 CFR 312.64(d); 21 CFR 812.110(d); HHS: 42 CFR 50, Subpart F; 45 CFR 94
1 42 CFR 50.605(a)(3); 45 CFR 94.5(a)(3).
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