Conflict of interest (COI) means a competing interest may compromise or bias, or have the appearance of compromising or biasing, a researcher’s professional judgment in designing, conducting or reporting results of research.
At HMH, both institutional and individual conflict of interest (COI) and research policies provide safeguards from actual and perceived bias due to a financial conflict of interest or associational relationship.
Policy Requirements
All individuals engaged in research under the auspices of Hackensack Meridian Health (HMH) must have both:
1. Up-to-date annual disclosure filed via HMH’s electronic disclosure system. New financial interests and relationships must be disclosed within 30 days of receipt.
2. Completed COI training via CITI every four (4) years with one of the following:
a. Biomedical researcher module
b. COI basic module
c. COI refresher module, only if COI basic module was completed four (4) years prior
Review Process
All research studies, regardless of funding, are reviewed by the COI Office to ensure compliance with COI policies and any identified COIs are mitigated.
Any identified significant financial interest (SFI) is referred to the COI Committee for review. The COI Committee makes the final decision if a disclosed SFI constitutes a financial conflict of interest (FCOI) and how best to mitigate the FCOI, which may include the following:
- Elimination/reduction of the conflict
- Removal from the study if conflict cannot be mitigated
- Management, if compelling circumstances are identified
Studies that are funded in part or whole by a public health service (PHS) funding agency have additional review and reporting requirements. All HMH COI policies are compliant with 42 C.F.R. Part 50, Subpart F.
Noncompliance
Noncompliance with HMH COI policies can result in:
- Study delays
- Removal from studies/study pause
- Sanctions or termination
In addition, noncompliance may be reported to relevant sponsors and regulatory agencies as required by policy, contract and regulations.
Public Disclosure
Information on financial conflicts of interest (FCOI) related to PHS-funded research shall be made available to the public as specified. Requests can be submitted to:
Research Compliance at Hackensack Meridian Health
343 Thornall Street, Edison, NJ 08837
Phone: 1-848-888-4400
Email: COI@hmhn.org
The information shall include the following:
- Investigators name
- Investigator's title and role in the research project
- Outside entity in which the significant financial interest (SFI) is held; and
- Nature and approximate value of the SFI