Conflicts of Interest in Research

ECU is committed to being an incubator of innovation, expanding our research enterprise, and advancing scientific discovery through both the individual and combined efforts of our faculty, students, and staff.  By developing collaborations with industry and other outside entities, we can expedite the transfer and application of newly discovered knowledge and technologies that drive economic growth and transform lives.  While such collaborations are impactful and serve the public good, the intersection of such collaborations can result in real, perceived, or potential individual and institutional conflicts of interest that must be managed appropriately.

Financial Interests and Human Subject Research

All investigators involved in human subject research conducted under the auspices of ECU must have a current financial interest disclosure on file prior to the submission of an UMCIRB application. If a financial conflict of interest is identified related to a specific project, it must be reviewed by ORIC staff and an appropriate management mechanism put in place prior to IRB approval.

This requirement also applies to investigators from other institutions or organizations named on an UMCIRB application.

Requirement for Compelling Justification

Financial conflicts of interests in human subject research may present real or perceived risks to the rights and welfare of research participants. As a result, the University applies a greater level of scrutiny with respect to these conflicts and their management. In a report prepared by the Association of American Medical Colleges (AAMC) and the Association of American Universities (AAU) it notes:

“With the welfare of research subjects always of foremost concern, an institution should regard all significant financial interests in human subject research as potentially problematic and, therefore, as requiring close scrutiny. Institutional policies should establish the rebuttable presumption that an individual who holds a significant financial interest in research involving human subjects may not conduct such research.”

Using this report as a framework, the University will not generally allow an investigator who has a significant financial conflict of interest with a study sponsor to conduct human research designed to answer questions about the effects or impact of particular drugs, medical devices, treatments, or diagnostic procedures — unless there are compelling circumstances for the investigator’s participation in the research. Standard conflict management strategies may not be adequate in such scenarios and adequate monitoring plans could be difficult or impossible to implement. This restriction applies not only to the principal investigator, but to anyone who is responsible for the design, conduct, or reporting of the research.

In order for the Conflict of Interest Committee (COIC) to determine whether the circumstances surrounding the investigator’s involvement are compelling, the investigator must provide additional information to ORIC and the IRB. The COIC will not review the COI until the investigator provides the following required additional information:

  1. Nature of the research, including related research conducted by the investigator; goals of the project; phase of the research (early-stage vs. closer to commercialization such as Phase III)
  2. Risk to human subjects
  3. Description of investigator’s role in the following activities:
    • subject recruitment
    • determination of subject eligibility
    • consenting subjects for the study
    • data collection
    • conducting study procedures (i.e. administration of study drug; implantation of study device; performance of diagnostic tests/procedures; etc.)
    • assessment of side effects of the study product (adverse events); safety monitoring
    • data analysis
    • publication of study results
  4. The degree to which the investigator’s financial interest is related to the project and the extent to which the financial interest could be directly and substantially affected by the outcome of the research
  5. Relevant to the determination of compelling justification, the following information must also be provided:
    • why the investigator believes that he/she is uniquely qualified by virtue of expertise and experience to conduct the research
    • why the investigator believes the research cannot otherwise be conducted safely or effectively without his/her involvement
    • why the research must be conducted at ECU as opposed to another institution
    • why the investigator’s participation is necessary in the activities listed in question #3 above

If the COIC determines that the investigator’s involvement is justified by compelling circumstances, the COIC will follow the usual COI management process and the Human Research Protection Office will be informed of the decision by ORIC staff.

Disclosure of Research Related Conflicts of Interest

“The public trust in what we do is just essential, and we cannot afford to take any chances with the integrity of the research process.”

— Dr. Francis Collins, Director, NIH

The federal definition of a research conflict of interest includes situations in which Significant Financial Interests may compromise, or have the appearance of compromising, an investigator’s professional judgment in the design, conduct or reporting of research.

As much as the University values and encourages entrepreneurship, the University also values and encourages transparency.  Transparency begins with full disclosure of industry relationships. AAMC President and CEO, Dr. Darrell Kirch, emphasizes the importance of such disclosures in his recent article “The integrity of our research depends on the full disclosure of industry relationships.”

To ensure the integrity of the research process, it is of paramount importance that research be conducted in compliance with applicable regulations and free from any reasonable expectation that the research results are biased by the financial self-interest of those engaged in research.

In recent years, federal sponsors have placed a renewed emphasis on transparency and the disclosure of significant financial interests related to industry collaborations.  As such, research personnel must complete a project specific, self-initiated disclosure through the COI Risk Manager system when a significant financial interest exists in relation to a sponsored project. ORIC refers such cases to the COIC Committee for review and determination of whether the significant financial interest creates a conflict of interest and if so, recommends appropriate management strategies.

Research Related Disclosures: Federally funded research projects require special financial disclosures by investigators. Any individual defined as an investigator (i.e., any person responsible for the design, conduct or reporting of a proposed or federally funded research project) must disclose financial interests as they relate to that specific project. Project specific, self-initiated, disclosures must be completed in the COI Risk Manager system by all project personnel prior to proposal submission.

The American Medical Association’s Statement on Conflicts of Interest in Research

Code of Medical Ethics Opinion 7.1.4:

Increasing numbers of physicians, both within and outside academic health centers, are becoming
involved in partnerships with industry to conduct biomedical and health research. As they do so,
physicians must be mindful of the conflicts such engagement poses to the integrity of the research and the welfare of human participants. In addition to financial conflicts of interest created by incentives to conduct trials and recruit subjects, physicians must be sensitive to the differing roles of clinician and investigator, which may require them to balance dual commitments to participants and science. This conflict of commitment is particularly acute when a physician-investigator has treated or continues to treat a patient who is eligible to enroll as a participant in a clinical trial the physician is conducting.

Minimizing and mitigating conflicts of interest in clinical research is imperative if the medical community is to justify and maintain trust in the medical research community.

Physicians who engage in research should:

  • Decline financial compensation that awards in excess of the physician’s research efforts and does not reflect fair market value. Physicians should not accept payment solely for referring patients to research studies.
  • Ensure that the research protocol includes provision for funding participants’ medical care in the event of complications associated with the research. A physician should not double-bill a third-party payer for additional expenses related to conducting the trial if he or she has already received funds from a sponsor for those expenses.
  • As part of the informed consent process, disclose to prospective participants the nature and source of funding and financial incentives offered to the investigators. This disclosure should be included in any written consent materials.
  • Avoid engaging in any research where there is an understanding that limitations can be placed on the presentation or publication of results by the research sponsor.
  • Refrain from knowingly participating in a financial relationship with a commercial entity with whom they have a research relationship until the research relationship ends and the research results have been published or otherwise disseminated to the public.
  • Disclose material ties to companies whose products they are investigating or other ties that create real or perceived conflicts of interest to:
    • institutions where the research will be carried out;
    • organizations that are funding the research;
    • any journal or publication where the research results are being submitted.
  • Physicians who have leadership roles in institutions that conduct biomedical and health research as well as the entities that fund research with human participants should promote the development of guidelines on conflicts of interest that clarify physician-investigators responsibilities.

External Institutions/Investigators Receiving a Federal Sub-award from ECU

Certification of Institutional Compliance with Public Health Service Financial Conflict of Interest Requirements

External investigators at institutions that are the recipients of a federal sub-award from ECU must comply with SFI disclosure requirements.  The FDP FCOI Institutional Clearinghouse may be used to document and verify that an educational institution or other entity is in compliance with the PHS Financial Conflict of Interest (FCOI) rules and regulations. The site is to be used by PHS recipients to verify the compliance of their potential subrecipients with PHS requirements. The links below may be used for determining the compliance status of a specific institution or entity.

Agencies using PHS FCOI regulations

Compliance institutions and entities

In those instances where a subrecipient institution or contractor does not have a FCOI Policy, an FCOI disclosure must be completed prior to the submission of a proposal for funding. The latest disclosure template is available on our guidance page. 

Significant Financial Interest Defined

A significant financial interest is anything of monetary value received or held by an investigator or family member (spouse, domestic partner, parents, siblings or children), whether or not the value is readily ascertainable, that reasonably appears to be related to the investigator’s institutional responsibilities. SFI includes:

  • Salary or other payments for services (e.g., consulting fees, honoraria, or paid authorships for other than scholarly works) when the aggregated value received from a publicly traded entity during the 12-month period preceding the disclosure, and the value of any equity interest during the 12-month period preceding or as of the date of disclosure, exceeds $5,000;
  • Salary or other payments for services, when the aggregated value received from a non-publicly traded entity during the 12-month period preceding the disclosure exceeds $5,000;
  • Equity interests (e.g., stocks, stock options, or other ownership interests) in a non-publicly-traded company of any value during the 12-month period preceding or as of the date of disclosure;
  • Income related to intellectual property rights and interests (e.g., patents, trademarks, service marks, and copyrights) not reimbursed through ECU; and
  • Reimbursed or sponsored travel that is related to investigator’s institutional responsibilities. This includes travel that is paid on behalf of the investigator rather than reimbursed, even if the exact monetary value is not readily available. It excludes travel reimbursed or sponsored by U.S. Federal, state or local governmental agencies, U.S. institutions of higher education, research institutes affiliated with institutions of higher education, academic teaching hospitals, and medical centers.

Travel Disclosure Decision Tree

SFI does NOT include:

  • Salary, royalties, or other remuneration from ECU;
  • Income from the authorship of academic or scholarly works;
  • Income from seminars, lectures, or teaching engagements sponsored by or from advisory committees or review panels for U.S. Federal, state or local governmental agencies, U.S. institutions of higher education, U.S. research institutes affiliated with institutions of higher education, academic teaching hospitals, or medical centers; or
  • Equity interests or income from investment vehicles, such as mutual funds and retirement accounts, so long as the investigator does not directly control the investment decisions made in these vehicles.

Disclosure Thresholds Chart

Investigators governed by FDA regulations would also have a Significant Financial Interest if one or more of the following apply:

  • Compensation made to the investigator in which the value of compensation could be affected by the outcome of the study/research project.
  • A proprietary interest in the tested product, including but not limited to, a patent, trademark, copyright or licensing agreement.
  • Significant payments of other sorts, which are payments that have a cumulative monetary value of $25,000 or more made by the sponsor of a covered study to the investigator or the investigators’ institution to support activities of the investigator exclusive of the costs of conducting the clinical study or other clinical studies, (e.g., a grant to fund ongoing research, compensation in the form of equipment or retainers for ongoing consultation or honoraria) during the time the clinical investigator is carrying out the study and for one year following completion of the study.

Retrospective Review

A retrospective review is required under specific agency regulations for non-compliance with disclosing a significant financial interest that is determined to constitute a financial conflict of interest. There may also be instances where the University determines that a retrospective review is warranted. If so, the Designated Institutional Official shall conduct a retrospective review to determine whether any funded research, or portion thereof, conducted during the time period of the non-compliance, was biased in the design, conduct, or reporting of the sponsored research. In all cases involving PHS-funded research, the University will conduct its review within 120 days of becoming aware of the non-compliance. Non-compliance occurs when:

  • An Investigator fails to disclose a Significant Financial Interest that is determined by the institution to constitute a Financial Conflict of Interest
  • The University fails to review or manage a Financial Conflict of Interest
  • An Investigator fails to comply with a Financial Conflict of Interest management plan, or
  • In some other manner, a Financial Conflict of Interest is not identified or managed in a timely manner

Management of Research Related Conflicts of Interest

There are numerous strategies for managing conflicts of interest in research and such strategies may include public disclosure, independent monitoring, modification of the research plan, disqualification of the researcher from participation, divestiture of any financial interest, or a combination of several strategies.