900. Conflict of Interests in Human Subject Research
Updated Oct. 4, 2019
Institutional Requirements for COI Disclosure by University Faculty, Investigators, and Key Personnel
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. Researchers and research staff should understand the University’s financial conflict of interest policy in order to follow it. Researchers and research staff should understand how financial conflicts of interest could influence the protection of research participants.
Under its Conflict of Interests (COI) policy and the related extended COI 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.
When investigators from an external site rely on the University IRB for review and oversight of human subject 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.
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. Research Integrity (RI) staff confirm PIs and other research personnel are compliant with the University’s requirements for human research protection training. The basic training requirements for human research protection (including COI training) must be completed before a researcher becomes engaged in human research and at least once every five years thereafter. Neither exempt determinations nor IRB approvals are finalized until all researchers on a project have complied with the training requirements.
All University employees must submit a COI disclosure form shortly upon being hired, within 30 days of acquiring of a new interest, and at least annually at the first of each calendar year. When completing the disclosure form, employees must certify they read the Conflict of Interest Policy, including the extended COI policy, in the University Administrative Manual, policy 2,050.
Information about the University COI policy and disclosure requirements is presented at new faculty orientation.
Requiring employees to review the University COI policy at least annual generally suffices to communicate revisions. Should substantive changes occur, employees would be notified by email that changes to the COI policy require them to re-certify they read the policy and submit an updated disclosure form.
Additional training, to be renewed at least every four years, is required for researchers involved in the design, conduct, or reporting of research sponsored by the Public Health Service (see section 18.1, Training Requirements for Investigators and Key Personnel Engaged in PHS-funded Research in the extended COI policy available from the University Administrative Manual, policy 2,050).
Researcher Conflict of Interests
A researcher COI exists when a COI disclosed under the University’s COI policy is related to a research project; or the researcher has other financial, business, or personal interests that compete with her/his obligation to protect the rights and welfare of research participants, preserve the integrity of the research, or uphold the credibility of the University’s human research protection program.
Research Integrity Processes for Identifying Researcher COI
IRB application forms include questions for PI’s to identify research-related COI. The PI completes each form to provide the names of researchers who themselves or whose spouse or dependent child may have a COI related to the research. Under IRB policy, responsibilities for Researchers include informing the PI of potential or actual COI that may be related to the research.
All disclosed conflicts of interests and sponsor awards and funding for all researchers are maintained in InfoED software. RI staff make inquiries regarding a reported COI from the researcher to Michele Dondanville, Program Manager Research and Compliance.
Assessment and IRB Review and Documentation of Researcher Conflict of Interests
Review of Outside Activities and COI Disclosure Forms
Michele Dondanville, Program Manager Research and Compliance reviews completed Outside Activities and COI Disclosure forms when the determination is that a COI may exist. When an outside activity or COI may affect the health or welfare of research participants or the integrity of human subject research, the RI Director determines if the related research was approved by the IRB.
- For approved projects, the RI Director confirms the COI was reviewed by the IRB or requires a subsequent review specific to the COI.
- For projects not yet approved, the RI Director or designated senior staff documents COI for immediate consideration if the project/package is under review or for future reference if the research has not yet been submitted.
Review of Conflict of Interests
RI staff notify the RI Director of new projects, continuing reviews, and amendments with an identified COI. The Director assesses the COI for relatedness to the research. For COIs related to the research, the RI Director will determine if there is Management Plan by contacting Michele Dondanville, Program Manager Research and Compliance.
If the RI Director and Primary Reviewer for the project at the convened IRB meeting determines the COI does not affect the research, she/he documents the decision in IRBNet. If the project requires Full Committee 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. The completed Investigator COI supplemental form will be reviewed.
During the assessment process, the RI 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. If the project requires Full Committee Review, 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 Primary Reviewer for the project/package (or other designated IRB Member) also considers the possible effects of an identified COI on the rights and welfare of research subjects and the integrity of the research. Primary reviewers may ask to review the Management Plan.
The RI Director or staff attach the Management Plan as a Reviewer Document in IRBNet. Adding the Plan as a Reviewer Document limits access to the RI Director and staff and IRB members. 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 RI policy for retaining projects in IRBNet.
The IRB has the final authority to decide whether the Management Plan sufficiently reduces, manages, or eliminates financial COI or COI related to student involvement in faculty research such that the IRB can approve the research.
Situations may arise when a potential, perceived, or actual COI is not identified in the IRB application or exempt form but is known to Michele Dondanville, Program Manager Research and Compliance through the University’s COI disclosure processes because of her role as the COI Official. Notification to the RI staff who is coordinating the review of COI to be disclosed in the application/form and will proceed with the process for assessment and IRB review of COI as outlined above.
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.
Identifying Members or Consultants with a Conflict of Interest
Prior to assigning Primary, Secondary, or Expedited reviewers, RI 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 RI 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.
RI staff self-regulate and refer Administrative and Exempt 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 RI applies this prohibition of participation in initial or continuing review of a project in which an individual has a COI to
- RI Director, Research Compliance Officer, and IRB Chair assessment of researcher problem reports;
- IRB review of possible noncompliance and unanticipated problems; and
- RI staff review of human research determinations, exemptions, and requests to use an external IRB.
In addition to declining review of a protocol 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 subject 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 subject research in which the Member has or may have a COI.
When engaging consultants to supplement the review process, RI 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 extended COI policy available from the University Administrative Manual, policy 2,050.
An RO with a potential, perceived, or actual COI for non-exempt 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 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 extended 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.