Meet your Research Compliance Team

Michelle Benson, Ph.D. - Director of Research Compliance
Martin Kleber - Research Compliance Auditor
Jordan Phillips - Conflicts of Interest Analyst
Amanda Ortiz - Conflicts of Interest Analyst

Clinical Research Billing Compliance

Research billing compliance ensures the medical billing of clinical services provided to study subjects is in accordance with CMS Federal Guidelines and National Institutes of Health (NIH).

All HMH research studies with billable services are required to use HMH’s clinical trial management system (OnCore).

A Medicare Coverage Analysis (MCA) is required for research studies which may bill protocol required routine care services to patients or third-party payors (medical insurance companies).

HMHRI’s Director of Clinical Research Business oversees the administration of OnCore and ensures that the terms of clinical trial agreements align with the IRB approved protocols including the informed consent and study budget.

Routine medical audits and for-cause audits are conducted to ensure compliance with HMH policies and federal regulations.

HMH Contact Information

Sergio Garcia
Director, Clinical Research Business

Related policies

OnCore Utilization for Clinical Trials
Medicare Coverage Analysis

Conflicts of Interest and Research

A Conflict of Interest (COI) is a circumstance in which a competing interest may compromise or bias, or have the appearance of compromising or biasing, a researcher’s professional judgement in conducting research, interpreting, and/or reporting of research results. Both Institutional and Individual Conflict of Interest (ICOI) and Research Policies provide safeguards from actual and/or perceived introduction of bias due to a financial conflict of interest and/or associational relationship.

Policy Requirements

All individuals who are engaged in research under the auspices of HMH must have:

1. Up-to-date annual disclosure filed via HMH’s electronic disclosure system
1. New financial interests and relationships must be disclosed within 30 days of receipt
2. Completed COI training via CITI (every 4 years)
1. Biomedical Researcher Module, OR
2. COI Basic Module, OR
3. COI Refresher Module (only if COI Basic was completed 4 years prior)

All research studies, regardless of funding, are reviewed to ensure compliance with COI policies and any identified COIs are mitigated. 

HMH’s COI and Research Committee determines if a conflict is a financial conflict of interest (FCOI) and the appropriate mitigation strategy, which can include any of the following:

• Elimination/reduce 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 PHS funding agencies have additional review and reporting requirements. HMH’s COI policies are compliant with 42 C.F.R. Part 50, Subpart F.

Non-compliance with HMH’s COI policies can result in:

• study delays
• removal from studies/study pause
• sanctions or termination
• In addition, non-compliance may be reported to relevant sponsors and regulatory agencies as required by policy, contract, and regulations.

Relevant Policies and Resources

• Individual Policy
• ICOI policy
• What Happens to my Disclosure?
• Measures to Mitigate Bias in Research
• Disclosure requirements for HMH and NIH - Other Support
• HMH COI Resources

Information related to Financial Conflicts of Interest 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 (1-848-888-4400) or COI@hmhn.org. The information shall include the following:

the Investigators name;
the Investigator's title and role in the Research project;
the Outside Entity in which the SFI is held; and
the nature and approximate value of the SFI