Conflict of Interest (COI)

Effective Dec 5, 2022, please use Cayuse to submit all research-based disclosures. Please see this guidance document for step by step instructions.

Research Conflict of Interest

CHA is committed to the conduct of ethical research. A component of ethical research involves conflict of interest (COI) oversight and management.

A COI exists when it can be reasonably determined that a researcher’s personal financial concerns could directly and significantly influence the design, conduct, or reporting of research activities. The concept of a COI refers both to actual COI and the appearance or perception of a conflict. As a result, CHA has policies and procedures that all CHA personnel must abide by when conducting human subject research.

  • COI Reporting for Industry or Unfunded Research

    CHA has established policies, including reporting requirements, which must be abided by when research is conducted, regardless of funding source.

    The COI in Research, A-COM-0009 (StaffNet access required) policy establishes the definition of COI involving research conducted at CHA or by CHA workforce. It is intended to serve as a guide for research staff in structuring their relationships with industry and other outside ventures in view of their responsibilities for research and patient care. The policy applies to any CHA workforce who is responsible for the design, conduct, or reporting of research activities.

    The Pharmaceutical/Medical Device Industry Relations, A-PHA-0001 (StaffNet access required) policy specifies requirements regarding COIs that may arise from relationships with pharmaceutical and medical device companies.

    Furthermore, investigators conducting research funded by the Public Health Service (for example, National Institutes of Health (NIH) and Department of Health and Human Services) and National Science Foundation, as well as those conducting studies regulated by the US Food and Drug Administration, are subject to agency specific regulations. Those regulations set forth the obligations of investigators, sponsors, and institutions for research involving significant financial interests (SFI) or other COIs. Affected parties are advised to review the relevant regulations prior to submissions of a research proposal or application. Financial Conflict of Interest training (FCOI) can be done via CITI or NIH.

  • COI Reporting for PHS-Funded Research

    In August 2012 new regulations went into effect regarding research funded by the US Public Health Service (PHS).

    The regulations require specific information to be reported at specific time points; summaries are below, but all affected parties are strongly advised to read the CHA policy on COI in PHS-Funded Research, A-COM-0015.

    The regulations require disclosure of significant financial interests by investigators who participate in PHS-funded research either directly or via sub-award. Links will list all PHS institutions.

    All CHA employees, collaborators, or contractors, regardless of title or position, who are responsible for the design, conduct, or reporting of research activities that are funded by the PHS, and any of its components.

    The CHA Summary Guidance on PHS COI regulations may assist researchers.

    Please also reference the CHA COI Reporting Requirement Reminders for PHS-Funded Grants for a quick summary about the "who, what, and when" of PHS COI reporting.

    The CHA Office of Sponsored Research will determine if a financial conflict of interest exists and develop a proposed resolution. The CHA COI Committee will make final determinations on the resolution of financial COIs. The CHA IRB retains authority to make final determinations to disapprove research involving human subjects based on the existence of financial COIs.

    This is a summary of Investigator significant financial interest (SFI) disclosure and Institutional FCOI reporting requirements for PHS-funded research:

    When Investigators, including sub-recipients, are to disclose a known SFI to CHA When CHA designated official reviews SFI disclosure and reports identified FCOIs to the PHS Awarding Component
    At the time of application Prior to fund expenditure
    Within 30 days of acquiring or discovering SFI Within 60 days of identification
    Annually at the time period prescribed by the Institution during the award period Annually: At the same time as when the grantee is required to submit the annual progress report, including multi-year progress report, or at the time of extension. Annual FCOI reports are submitted through the eRA Commons FCOI module.

    This is a summary of types of reports, information to be included in each report and the reporting time points:

    Type of Report Information in Report When Required
    Initial FCOI report Grant number, PD/PI name or contact PD/PI if a multiple PD/PI model is used, name of the Investigator with the FCOI, name of the entity with which the Investigator has a FCOI, nature of the FCOI, value of the financial interests, description how the financial interest related to the PHS-funded research and the basis of CHA’s determination that the financial interest conflicts with the research, and key elements of the Institution’s management plan.
    1. Prior to fund expenditure.
    2. Within 60 days of any subsequently identified FCOI.
    Annual FCOI report Status of the FCOI and any change(s) to the management plan. Due at the same time as when the grantee is required to submit the annual progress report, a multi-year progress report, or at the time of award extension.
    Revised FCOI report If applicable, update a previously submitted FCOI report to describe actions that will be taken to manage a FCOI going forward. After completion of a retrospective review, if needed.
    Mitigation report Project number, project title, PD/PI or contact PD/PI if a multiple PD/PI model is used, name of Investigator with the FCOI, name of the entity with which the Investigator has a FCOI, reason(s) for the retrospective review, detailed methodology used for the retrospective review, findings of the review, conclusions of the review, description of the impact of the bias on the research project, and the plan of action(s) to eliminate or mitigate the effect of the bias. When bias is found after a retrospective review.
  • ALL COI Disclosure Forms and Tracking Documents
    Industry or Foundation Sponsored and Unfunded Research

    Please login to Cayuse to submit an annual or research-based disclosures.

    Once you login, please follow the steps outlined in this guidance document.

  • Additional Resources and Information

    With respect to PHS-funded research, there are numerous resources about the regulations that went into effect regarding COI, including the Final Rule on the FCOI regulations - Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding is Sought and Responsible Prospective Contractors. In addition, Frequently Asked Questions may help answer questions researchers have on the topic.

    CHA Office of Sponsored Research personnel are also available to assist researchers with COI-related questions.

Contact Us

Ida Rego
Office Contact
P: 617-806-8702
F: 617-806-8710
IRB office mailing address
Cambridge Health Alliance
Institutional Review Board Office
1493 Cambridge Street
Cambridge, MA 02139
J. Glover Taylor
Institutional Official
Chief Compliance Officer

Sarah E. Nelson, PhD
IRB Chair
Erica Dwyer, MD, PhD
IRB Vice-Chair
Michelle Ewahi
Manager, Human Subject Protection and Research Integration
Mercedes Hasan
IRB Analyst

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