900. Conflict of Interests in Human Research

Updated September 28, 2023

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 his or her 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 his or her 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

The entire study team must answer COI questions in IRBNet. The COI questions in IRBNet include:

• Do you (or your spouse, registered domestic partner and/or dependent children) have financial interests related to this study, including:
  • Ownership Interest, stock options or other financial interest in one year before now and until one year after the completion of the study.
  • Income or compensation related to the research (e.g., lectures, seminars, teaching) paid to you or your institution during the study and for the prior year and following one year exclusive of the costs of conducting the study.
  • Proprietary Interest including but not limited to a patent, trademark, copyright or licensing agreement.
  • Membership on the Board, director or officer or other executive position, regardless of compensation, for any company with whom there are financial interests.
  • Any travel for industry, a non-profit or a professional society (excluding any travel paid by your employer, federal or state government agencies, any institution of higher education or academic teaching hospital).

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.

COI Financial Interest Disclosed Does Not Require Management

If the Primary Reviewer or Research Integrity Staff member determines a possible or perception of any financial interest which could affect the research, additional information may be requested. The request may be informal with a conversation with the PI/study team member to clarify response or a formal request in IRBNet for more information and/or completion of the Conflict of Interest Disclosure form. Also, Research Integrity Staff assigned to the project with a financial interest which could affect or be affected by the research- may request any documentation from the UNR University's COI Designated Official or as appropriate leadership at the affiliation’s research office specific to the financial COI.

Research Integrity staff should communicate to Research Integrity Director the status of COI inquiry. In consultation, Research Integrity Director/Staff and Primary Reviewer for the project determine the COI does not affect the research, she/he documents the decision in IRBNet.

COI Financial Interest Disclosed Requires Management

The Research Integrity Director, IRB Chairs, Primary Reviewer, or Institutional official (for Affiliates) determines whether the suggested management of the conflict is appropriate and whether additional action is required to protect human participants under advisement of the assigned RI staff member. 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 Research Integrity Director, IRB Chairs, Primary Reviewer, or Institutional Leadership for Affiliates determines 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 Conflict of Interests-Expedited Minimal Risk Studies

In consultation with Research Integrity assigned staff member, Research Integrity Director, IRB Chairs, Primary Reviewer, or Institutional Leadership for Affiliates determines a course of action to manage or reduce the conflict of interest for expedited research.  The determined course of action will be reflected in IRBNet and IRB correspondence to the Principal Investigator. If the Research Integrity Director/Staff and Primary Reviewer for the expedited research project determines the COI does not affect the research, she/he documents the decision in IRBNet.

IRB Review of Conflict of Interests-Full Board Above Minimal Risk Studies

In consultation with Research Integrity assigned staff member, the Research Integrity Director and Primary Reviewer for above minimal risk full board study determines the COI does not affect the research, she/he documents the decision in IRBNet.

If the project requires Full Board Review (e.g., has research-related conflict or a Management Plan), the Director and Primary Reviewer for the project at the convened IRB meeting presents her/his conclusions for discussion at the convened IRB meeting. Completed COI forms will be reviewed, which may include a proposed Management Plan, the Conflict of Interest Disclosure form, and the IRBNet Cover Sheet. The management plan is a key component of this process. It is a document that outlines and implements measures to actively reduce, mitigate or eliminate an actual, potential or perceived conflict of interest. The Management Plan articulates the steps that will be taken to mitigate the risk of impaired objectivity. The University's COI Designated Official should be engaged on possible text for the management plan. Unmanaged financial conflicts of interest can call into question the professional objectivity and ethics of the individual and reflect negatively on the University. It is important to note that conflicts of interests do not imply wrongdoing; they are practically inevitable at a research university. Activities can usually continue with proper oversight and safeguards. The most effective way to ensure transparency and oversight of conflicts of interest is through disclosure, review, and management. During the assessment process, the Research Integrity Director and Primary Reviewer for the project at the convened IRB meeting also evaluates the consent procedures and materials to determine if the interest should be disclosed to participants and documents the findings in IRBNet. The Director and Primary Reviewer for the project at the convened IRB meeting presents her/his conclusions about the adequacy of the consent process for discussion by the convened IRB.

The Research Integrity Director or 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 Director and 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 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. Notation in IRBNet should reflect the date that the Investigator shall file a report annually with the IRB that documents the actions taken to implement the terms and conditions outlined in the management plan.

Relationship between COI Committee and the IRB

When there is a conflict of interest situation related to research that involves human participants, the COI Designated Official, the COI Committee (COIC), Research Integrity, and the Institutional Review Board (IRB) will work together to identify, mitigate, manage, or eliminate the risks inherent in the situation.

The COI Designated Official will draft a COI management plan based on the recommendations of the COIC and IRB.  Standard COI management plan terms include requirements that 1) the researcher must disclose conflicts of interest on IRB protocol submissions, 2) human subjects research cannot commence without an approved IRB protocol or determination of exempt research by Research Integrity and 3) the researcher must abide by all COI-related conditions set by the IRB.

The IRB may proceed with protocol review while the COI Committee 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.

Therefore, a COI management plan can be finalized before the IRB determination and it will include the above requirements. However, if the IRB determination is finalized before the COI management plan is completed, the IRB approval will be conditional upon a signed COI management plan. Human subjects 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 to document that the condition has been met.

The COI Designated Official will send a copy of the fully signed COI management plan to Research Integrity. The annual COI management plan status report will include a question to Research Integrity 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 will receive a copy of the fully signed modified management plan.

Review of Conflict of Interests for Veteran Affairs Employees

A general conflict of interest is defined as a convergence of an individual’s private interests with his or her research interests, such that an independent observer might reasonably question whether their professional actions or decisions are improperly influenced by considerations of personal gain, financial, or otherwise. A COI can also be defined as a direct or indirect participation in the research (e.g., protocol development, principal, sub-investigator, key personnel, committee members, consultants) and their immediate family members (e.g., spouse, dependent children, and/or those living under the same household), or any significant financial interest in the sponsoring company, product or service being tested. Following ORD guidance, Research Financial Conflict of Interest (COI) Statement OGE Form 450 Alternate-VA will be completed by an investigator (i.e., principal investigator, co-principal investigator, investigator [including a collaborator who has a VA appointment], study chair or site principal investigator). The COI form must be provided for each investigator at the time of a new study submission for initial review or when a new investigator is added to an ongoing study.

Review of Conflict of Interests for Affiliate Researchers and Study Staff

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 her/himself, and Key Personnel, and immediate family members of the PI/Key Personnel. Researchers will answer COI questions in IRBNet these include:

• Do you (or your spouse, registered domestic partner and/or dependent children) have financial interests related to this study, including:
  • Ownership Interest, stock options or other financial interest in one year before now and until one year after the completion of the study.
  • Income or compensation related to the research (e.g., lectures, seminars, teaching) paid to you or your institution during the study and for the prior year and following one year exclusive of the costs of conducting the study.
  • Proprietary Interest including but not limited to a patent, trademark, copyright or licensing agreement.
  • Membership on the Board, director or officer or other executive position, regardless of compensation, for any company with whom there are financial interests.
  • Any travel for industry, a non-profit or a professional society (excluding any travel paid by your employer, federal or state government agencies, any institution of higher education or academic teaching hospital).

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 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 staff may ask for additional information regarding a Conflict of Interest disclosure.

Monitor and Enforce Management Plans

Annual review will be conducted by Research Integrity Director or delegate of the approved Management Plan. Investigators shall file a report annually with the IRB 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. 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 his or her 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 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 projects supported by the Public Health Service (PHS), agencies adopting PHS policies, or the Department of Energy, researchers must complete the CITI Conflicts of Interest (COI) training at least once every four years.

COI Training is required immediately when:

• Financial conflict of interest policies is 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

An IRB member or consultant is determined to have a COI when the member/consultant or her/his 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 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 RI Staff determines an IRB Member has or may have a COI that is relevant to the project under review, she/he assigns 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 her/his ability to conduct an objective review, the conflicted member must inform Research Integrity 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 staff self-regulate and refer reviews for which she/he has a COI to a colleague.

Restrictions for Participation in IRB 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.

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.

University Research Integrity applies this prohibition of participation in initial or continuing review of a project in which an individual has a COI to:

• Research Integrity Director, Research Compliance Officer, and IRB Chair assessment of researcher problem reports;
• IRB review of possible noncompliance and unanticipated problems; and
• Research Integrity staff review of research determinations, exemptions, and requests to use an external IRB.

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 staff will ask the prospective consultant is she/he has 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 her/his discussion to providing information requested by the IRB.

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.

Organizational 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 his or her authority on behalf of the University may affect or reasonably appear to affect institutional processes for the review or oversight of research.

According to University Administrative Manual Policy 2,051: Policy on Institutional Conflict of Interest in Research Involving Human Subjects (Revised: June 2021), the following significant financial interests of the University warrant review for potential Institutional COI with respect to non-exempt human research:

1. Royalties: Agreements to receive milestone payments and/or royalties from commercialization of a product or technology that is the subject of the research.
2. Non-publicly traded equity: Equity interest or entitlement to equity of any value (including options or warrants) in a non-publicly traded company that: i) is the sponsor of the research; ii) owns or controls products being studied, tested or evaluated; or iii) could materially benefit from the research.
3. Publicly traded equity: Equity interest or an entitlement to equity (including options and warrants) in a publicly traded company, the value of which meets or exceeds the threshold set by the Institutional Conflict of Interest Committee, that: i) is the sponsor of the research; ii) owns or controls products being studied, tested or evaluated; or iii) could materially benefit from the research.
4. Gifts: Gifts (including restricted, unrestricted and gifts in kind) that meet or exceed the threshold set by the Institutional Conflict of Interest Committee, from i) a sponsor of the research; ii) a company that owns or controls products being studied, tested or evaluated; iii) a company that could materially benefit from the research; or iv) an individual affiliated with such a company.
5. Other: Other financial interests of the University or its Institutional Officials, as determined by the President.

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. 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.