900. Conflict of Interests in Human Research

Updated August 31, 2026

COI Disclosure Defined

In recent years, the issue of conflict of interest (COI) has become increasingly important. A conflict of interest may take various forms but exists when there is a divergence between an individual's private interests and their professional obligations to the University such that an independent observer might reasonably question whether the individual's professional actions or decisions might be influenced by considerations of gain, financial or otherwise, for the individual or their family members or for other parties. A conflict of interest depends on the situation, not on the character or the actions of the individual. The fact that an investigator has or appears to have a financial conflict of interest in research does not preclude conduct of that research, but the interest must be disclosed and the conflict managed in a way that ensures that the welfare of participants and the integrity of the data are not compromised by that interest.

University Requirements for COI Disclosures

All University-affiliated investigators, with the exception of undergraduate students must submit the University’s COI disclosure as a condition for serving on non-exempt human research projects. All disclosed conflicts of interest (as well as sponsor awards and funding) for all researchers are maintained in InfoED software. Under the University’s Conflict of Interest Policy (see policy 2,050 in the University Administrative Manual), the University specifies requirements for

• Disclosure by all University faculty, and Investigators and Key Personnel participating or planning to participate in PHS or NSF-funded research of Significant Financial Interests (SFI) * (as defined by the Public Health Service at 42 CFR 50.603 and 45 CFR 94.);
• Disclosure by all University faculty of potential, perceived, or actual COI related to student engagement in faculty research;
• Disclosure by all University faculty of business relationships that may constitute potential, perceived, or actual COI;
• Institutional assessment of disclosed SFI to determine if the SFI constitutes a Financial Conflict of Interests (FCOI) for PHS or NSF-funded research (per 42 CFR 50.604, item (f) and;
• Management, monitoring, enforcement, and reporting of FCOI for PHS and NSF-funded research (per 42 CFR 50.605 and 45 CFR 94.4);
• COI training for Investigators and Key Personnel involved in the design, conduct or reporting of PHS-funded research (required every four years) (per 45 CFR 94.4, item (b);
• Overview of IRB notification and responsibilities related to COIs; and
• Organizational COIs.

*For SFI, the University applies the more stringent PHS minimum of >$5,000 to all faculty, investigators, and key personnel regardless of funding and the inclusion of travel only to Investigators and Key Personnel involved in PHS-funded research.

The University requires subcontractors for PHS and NSF-funded research to comply with the University’s COI policy or provide documentation of compliance with regulatory requirements for PHS (at 42 CFR 50.601-607 and 45 CFR 94; or for NSF as codified in the NSF Grant Policy Manual, 510 Conflict of Interest Policies.

Review of Outside Activities and COI Disclosure Forms for University

The University’s COI Designated Official reviews completed Outside Activities and COI Disclosure forms when the determination is that a COI may exist.

Disclosure to IRB of COI Related to Human Research IRBNet Package

Under IRB policy, responsibilities for Researchers include informing the PI of potential or actual COI that may be related to the research. Reporting of financial interests should be completed at the initial submission and at any time there is a change, i.e. change in financial interest, adding study personnel.  At a minimum, the criteria must include:

• Whether the financial conflict of interest will adversely affect the protection of participants in terms of the criteria for IRB approval.
• Whether the financial conflict of interest will adversely affect the integrity of the research.

The PI must attest to COI questions in IRBNet on behalf of the study team. If any study team member indicates a potential COI, they must complete a conflict-of-interest disclosure form and upload it as part of the IRB submission.

COI Relatedness Review

If the Primary Reviewer or Research Integrity & Security Staff member determines a possible or perceived financial interest could affect the research, the IRB submission and COI disclosure form will be shared with the University’s COI Designated Official or designee to conduct a COI relatedness review. Note: The COI Designated Official may request additional information from the PI/study team member to complete their assessment. Following their review, the COI Designated Official or designee will attach their COI review worksheet within IRBNet to document the decision on whether or not a potential conflict is present and the appropriate next steps in management, if applicable.

Possible actions listed below should be appropriate to manage the real, possible or perceived financial conflict.

• Adding appropriate language regarding the conflict of interest in the informed consent statement.
• Requesting that the personnel with the conflict not obtain consent from participants.
• Requesting an independent PI conduct the study.
• Requiring independent safety monitoring.
• Conducting renewal or review at an interval less than one year.
• Any other audits/reviews or mitigating or restrictive actions deemed appropriate based on the nature of the conflict.

If elimination of the financial conflict of interest is not possible, the COI Designated Official, COI Committee, HRPP Manager, IRB Committee, and Institutional Leadership for Affiliates, as applicable, will work together to determine a course of action to manage or reduce the conflict of interest. Examples of conditions or restrictions that may be employed to manage, reduce, or eliminate such conflicts include:

• Public disclosure of significant financial interests;
• Monitoring of the research by independent reviewers;
• Modification of the research plan;
• Disqualification from participation in all or a portion of the research;
• Divestiture of the significant financial interest; or
• Severance of relationships that create the actual or potential conflict of interest.

IRB Review of Proposed Conflict of Interest Management Plans

If a COI management plan is required, The COI Designated Official will draft a COI management plan based on the recommendations of the COI Committee and IRB. If a COI management plan is created for a minimal risk study, the designated reviewer may review and approve the appropriateness of the management plan in relation to the study on behalf of the IRB or they may request review by the convened IRB. The designated reviewer is permitted to request additional mitigative actions be applied to the management plan to ensure human subjects are appropriately protected and informed.

If a COI management plan is created for a greater than minimal risk study, the convened IRB will review and approve the appropriateness of the management plan in relation to the study. Likewise, the IRB may request additional mitigative actions be applied to the management plan to ensure human subjects are appropriately protected and informed.

The COI Designated Official or Research Integrity & Security staff attach the proposed Management Plan as a Reviewer Document in IRBNet. Adding the Plan as a Reviewer Document limits access to the Research Integrity & Security staff and IRB members assigned to the convened IRB meeting. This protects the researcher’s privacy. Adding the Management Plan to the project in IRBNet ensures the document is available for at least three years from completion of the research because of Research Integrity & Security policy for retaining projects in IRBNet. The IRB has the final authority to decide whether the course of action to manage or reduce the conflict of interest (Management Plan) sufficiently reduces, manages, or eliminates financial COI. The decision of the IRB shall be communicated to researcher using IRBNet.

Relationship between COI Committee and the IRB

A COI management plan can be finalized by the COIC before the IRB determination. However, the IRB may proceed with protocol review while the final COIC review is pending. If the IRB review is complete before the COI management plan has been finalized, a condition of IRB approval will be that research cannot commence without a signed COI management plan. The COI Designated Official will send a copy of the fully signed COI management plan to Research Integrity & Security to document that the condition has been met. The annual COI management plan status report will then include a question to Research Integrity & Security regarding the researcher’s compliance with IRB requirements.

If research with human participants occurs after a COI management plan has been created, the COI Committee and IRB will work together on a modification to the management plan. Research Integrity & Security will receive a copy of the fully signed modified management plan.

Conflicts of Interest for VA Researchers

VA investigators should follow the Standards of Ethical Conduct for Employees of the Executive Branch codified at 5 CFR Part 2635. VA facilities are not required to follow PHS requirements, even when research is funded by a PHS agency (e.g., NIH).

The VASNHCS manages researcher conflicts of interest and notifies the IRB of conflicts that may be relevant to a research project. Affiliates that serve as IRBs of record for VA facilities must use the VA financial conflict of interest form, and may not create, re-draft, or change this form.

Review of Conflict of Interests for External Researchers

(For non-exempt research) When investigators from an external site rely on the University IRB for review and oversight of research, they (or their Institutional Official) must sign an Individual Investigator Agreement or IRB Authorization Agreement. The agreement templates specify that the external PI must disclose and confirm management of COI for themselves.

In addition, researchers upload into IRBNet a disclosure of conflicts of interest filed with their institution or complete the Conflict of Interest form as described in item #7 Individual Investigator Agreement or IRB Authorization Agreement.

Renown Health and Saint Mary’s Medical Center have a Memorandum of Understanding with the University Research Integrity & Security office. Researchers from these facilities may submit evidence of annual disclosure of conflicts of interest filed with the institution or complete the Conflict of Interest Disclosure form and upload into IRBNet. Research Integrity & Security staff may ask for additional information regarding a Conflict of Interest disclosure.

Monitor and Enforce Management Plans

Annual review will be conducted by The COI Designated Official or delegate of the approved Management Plan. Investigators shall file a report annually with the COI Designated Official that documents the actions taken to implement the terms and conditions outlined in the management plan. A final report shall also be submitted at the end of the project. The COI Designated Official or delegate has the authority to conduct a retrospective review and mitigation report in response to potential compliance concerns with the approved management plan. Any Investigator who fails to provide 1) requested information needed for an appropriate review of potential or actual conflict of interest situations or 2) fails to file the required annual Disclosure Statement within 60 days of the end of the designated reporting period, shall have their active research or other sponsored agreements suspended. No funds may be expended for any sponsored activity until the Disclosure Statement has been submitted and administratively reviewed.

Record Keeping

Research Integrity & Security staff will maintain records related to disclosures and management of financial conflicts of interest for at least three years from completion of the research in IRBNet.

Researcher COI Training and Education Requirements

The required training for University/Affiliate researchers involved in the design, conduct, or reporting of human research includes information about conflicts of interest in human research. Each member of the study team must complete the required training, including the Conflicts of Interest in Human Subjects Research module, at least once every four years.

In addition, for PHS or NSF supported projects, researchers must complete the CITI Conflicts of Interest (COI) Basic course training at least once every four years.

COI Training is required immediately when:

• Financial conflict of interest policies are revised in a manner that changes researcher requirements.
• A researcher is new to the organization.
• A researcher is non-compliant with financial conflict of interest policies and procedures.

IRB Member and Consultant Conflict of Interests

Defining IRB Member or Consultant Conflict of Interests

The University IRB complies with 45 CFR 46.107, item (e) that specifies “No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.” Agencies that accept the Common Rule include identical or similar language. The University Research Integrity & Security extends this prohibition of participation further to include reviews of researcher problem reports, reviews of noncompliance and unanticipated problems, administrative reviews, exemptions, reliance requests, and the like.

An IRB member or consultant is determined to have a COI when the member/consultant or their immediate family member (i.e. spouse, domestic partner and dependent children)

• was, is, or will be involved in the design, conduct, or reporting of the research;
• has a business or other relationship that may compete with the member’s/consultant’s obligation to protect research participants;
• has a business or other relationship that may compromise the integrity of the review process; or
• has a Significant Financial Interest (see Policy Manual Definitions) related to the research, sponsor, or product or service being tested; and/or
• having any other conflict that might be perceived to inhibit a fair and unbiased review of the research.

Identifying Members or Consultants with a Conflict of Interest

Prior to assigning reviewers, Research Integrity & Security staff consider IRB Member’s curriculum vitae, institutional and professional affiliations, and COI Management Plans (if any)

• to confirm their qualifications to review the research (per IRB policy 556); and
• to identify potential or actual COI that are or may be related to the research.

When Research Integrity & Security Staff determines an IRB Member has or may have a COI that is relevant to the project under review, they assign the review to another IRB member.

IRB members are asked about COI when given information about review assignments, including those involving possible noncompliance or an unanticipated problem. If an IRB member thinks a financial, personal, or professional interest may affect their ability to conduct an objective review, the conflicted member must inform Research Integrity & Security staff before accepting the review so the review can be assigned to another IRB member.

At the beginning of each convened IRB meeting, the Chair explicitly asks for disclosure of COI related to action items on the meeting agenda, and reminds conflicted members/consultants to leave during the discussion and vote of the new project or continuing review/amendment package to which the conflict applies. Members who are recused from voting on a specific study because of conflicting interests may not be counted toward the quorum. When appropriate, a conflicted member/consultant may provide information requested by the IRB before leaving the meeting.

Research Integrity & Security staff self-regulate and refer reviews for which they have a COI to a colleague.

In addition to declining review of a project in which one has a conflicting interest, the IRB Chair, Vice Chair, IRB members, and consultants employed by the University must comply with institutional prohibitions, and notification and disclosure requirements as specified in University Policy 2,050: Conflict of Interest Policy.

IRB Members representing University Affiliate sites must comply with both the standard COI disclosure requirements of their home institutions and the University requirement for immediate disclosure and declination of review for any human research in which the Affiliate member has or may have a COI.

Community IRB Members must comply with the University requirements for immediate disclosure and declination of review for any human research in which the Member has or may have a COI.

When engaging consultants to supplement the review process, Research Integrity & Security staff will ask the prospective consultant if they have a COI related to the specific research project. If a consultant has a COI and is allowed to review the protocol, the consultant will disclose the COI when the Chair asks for COI disclosures at the beginning of the meeting. In these circumstances, the consultant must limit their discussion to providing information requested by the IRB.

Restrictions in IRB Operations and Review

University and Affiliate employees who are responsible for business development at the University or one of the University’s Affiliate sites do not serve as members of a University IRB and are prohibited from engagement in the day-to-day operations of the review process.

Protocol-specific Conflict of Interests of Responsible Official

As University employees, Responsible Officials (RO) are subject to the disclosure requirements in the University’s COI policy available from the University Administrative Manual, policy 2,050.

An RO with a potential, perceived, or actual COI for a research project must inform the PI a conflict may exist and defer to another person with the requisite authority to assume the RO responsibilities for the project.

Prohibited Investigator Remuneration from Corporate Sponsors

University and affiliate investigators are prohibited from accepting recruitment bonuses, time-designated accrual incentives, or finders-fees from corporate sponsors.

Institutional Conflict of Interests

The University may have an institutional conflict of interest in research whenever the financial interests either of the University or of a University Official acting within their authority on behalf of the University may affect or reasonably appear to affect institutional processes for the review or oversight of research.

It is the policy of the University to ensure that its research programs are conducted with integrity and free from any real or perceived institutional conflict of interest. The review of institutional conflict of interest follows the same COI relatedness review process as described for individual conflict of interest. Each significant financial interest that represents a potential institutional conflict of interest, whether real or perceived, shall be fully disclosed to the Conflict of Interest Committee. Once disclosed, the conflict or perceived conflict shall be managed, or eliminated, before any sponsored or contractual agreement is executed, or any research activity is undertaken that may be influenced by or appear to be influenced by the conflict. The University shall be governed by a rebuttable presumption against conducting research when certain types of institutional conflict of interest exist. The University shall not ordinarily participate in any clinical trial of a therapeutic strategy, product or device if: (i) the University has entered into a license agreement or acquired equity in a company sponsoring such trial; or (ii) if the University or University Official, or both, hold equity in a sponsoring company. The presumption may be overcome if the University is also the preferred or only feasible site for the research, going forward is recommended by the Conflict of Interest Committee and the joint approval of the Vice President for Research and Innovation.

An organization or key organizational leaders sometimes have financial interests that conflict with the organization’s obligation to protect participants, preserve the integrity of the research, or maintain the credibility. The fact that a financial interest exists does not necessarily indicate that an organization will act contrary to the best interests of research participants. Financial conflicts of interest are identified, managed, and minimized or eliminated to maintain protection of research participants, ensure the integrity of the research, and ensure the credibility. The following Nevada State Laws describe requirements/prohibitions to avoid or minimize organizational conflict of interests for the University and its employees, including officials and presidents; and the Nevada System of Higher Education (NSHE) Board of Regents:

• Unlawful commissions, personal profit and compensation of public officers and employees; penalties; payment of commission, profit or compensation to public employer at NRS 281.230;
• Code of Ethical Standards at NRS 281A.400;
• Interest of member of governing body or evaluator in contract prohibited; exception; penalty at NRS 332.810; and
• Interest in certain contracts prohibited at NRS 396.122

NSHE Code (as specified in the Board of Regents Handbook and referenced in the University Conflict of Interest policy (see the Institutional COI section in the COI policy available from the University Administrative Manual, policy 2,050) describes requirements and processes for NSHE Institutions, which includes the University of Nevada, Reno) to avoid, limit, or manage organizational COI. (In the BOR Handbook see T4 Ch1, Sec 3 for requirements for Regents; T4 Ch3 Sec 8 for policy for Chancellor and Presidents; NSHE Purchasing Policy, T4 Ch10 Sec 1.7 for prohibitions).

Separation of Business Interests from Ethics Review Functions

Nevada State law (NRS 281A.420) requires Nevada public employees disclose and abstain from voting on any decision in which the employee has or may have a COI.