COI: Conflicts of Interest Overview

Introduction

The overview contains a brief review of the policies and procedures associated with the disclosure and management of conflicts of commitment and interest at Stanford University. This page also includes information to help identify and mitigate potential conflicts. In addition, this overview contains summaries of policies specific to the School of Medicine.

Defining Conflicts

Conflict of Commitment

Stanford faculty members owe their primary professional allegiance to the University, and their primary commitment of time and intellectual energies should be to the education, research, and scholarship programs of the institution. The specific responsibilities and professional activities that constitute an appropriate and primary commitment will differ across schools and departments, but they should be based on a general understanding between the faculty member and his or her department chair and school dean. Even with such understandings in place, however, attempts of faculty to balance University responsibilities with external activities--such as consulting, public service, or pro bono work--can result in conflicts regarding allocation of time and energies. Conflicts of commitment usually involve issues of time allocation. Whenever an individual's outside professional activities (as defined in the RPH: Stanford’s Policy on Consulting and Other Outside Professional Activities) exceed the permitted limits (normally thirteen days per quarter), or whenever a full-time faculty member's primary professional loyalty is not to Stanford, a conflict of commitment exists. Due to conflict of commitment concerns Stanford prohibits direction of a program of research or scholarship at another institution that could be conducted appropriately at Stanford (i.e. outside PI-ship).

If a situation that raises questions about a possible conflict of commitment arises, faculty should discuss the situation with their department chair or school dean, or with the Dean of Research.

Conflict of Interest

Stanford University is an institution of public trust; faculty must respect that status and conduct their affairs in ways that will not compromise the integrity of the University or that trust. A conflict of interest occurs 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 are determined by considerations of personal financial gain. Such situations do NOT necessarily imply wrong-doing or inappropriate activities. However, in a research university setting, they can compromise, or be perceived as compromising, important academic values, research integrity, or the university mission. At Stanford, it is essential for all faculty, staff, and students to understand how these divergent interests can become a problem and how they should be disclosed and managed. Conflicts of interest often arise at the intersection of two fundamental missions: to push the boundaries of knowledge and to transfer that knowledge to the private sector for the benefit of the public. There may be, for example, significant personal financial incentives related to outside consulting, patenting and licensing an invention, or being involved with a ‘start up’ company. Considerations of personal financial gain, however, must not influence the decisions or actions of individuals in carrying out their University responsibilities. The perception that such incentives might harm research objectivity, the protection of human subjects, or adversely affect other institutional responsibilities in the areas of education, clinical care, or administrative activities is enough to mandate that such conflicts be identified and then eliminated, mitigated, or managed.

Policies

Consulting Policies

Stanford policies concerning the outside professional activities of Stanford personnel include: Consulting and Other Outside Professional Activities By Members of the Academic Council and University Medical Line Faculty, which applies to faculty; the Conflict of Commitment and Interest for Academic Staff policy; and the Staff Policy on Conflict of Commitment and Interest for all other staff. The staff policies only permit consulting with the written permission of the department/program chairman, by the principal investigator, or by the director of the appropriate library, relative to the specific appointment of the staff person.

In addition to the limit set on the time that a full-time faculty member may spend on outside consulting, Stanford's policy also prohibits:

• Management roles (activities or titles that constitute or imply managerial or supervisory responsibility); titles such as CEO, Director, Scientific Officer, or Vice President, etc. are designations generally assigned to people with line management responsibilities
• Ghost writing or publishing articles or other forms of scholarly communication under a faculty member’s own name in the course of an outside professional activity that are written in whole or material part by employees of the outside entity

Conflicts of Interest in Research

Conflicts of interest are common and practically unavoidable in a modern research university. Conflicts of interest can call into question the professional objectivity and ethics of the individual, and reflect negatively on the University. Opportunities to profit from research may influence or appear to influence the choice of the direction of the research, the design and conduct of the research, objectivity of the data, or interpretation of research results. Moreover, in human research, these opportunities to profit may influence or appear to influence a researcher's judgments about which human subjects to enroll, the clinical care provided to subjects, and the proper use of subjects' confidential health information, and such influences may create biases in study design, data collection and analysis, adverse event reporting, or the presentation and publication of research findings. On the other hand, there may be special circumstances that create compelling reasons for an individual to engage in research involving human subjects despite having a financial conflict of interest. Stanford seeks to help faculty, staff, and students in translating their discoveries and developments as part of its mission to benefit the public. The university also seeks to minimize the adverse affects of conflicts of interest and to advise faculty and staff on how to avoid, mitigate, or, if warranted, manage those conflicts. The purpose of Stanford’s Faculty Policy on Conflicts of Commitment and Interest and policies on consulting and other professional activities is to describe the risks, explain the requirements for how faculty, staff, and trainees must address these risks through disclosure, and provide information about the standards and processes that Stanford uses to review and assess personal financial interests related to University responsibilities.

While most disclosures of financial interests will probably be deemed de minimus or not significant conflicts of interest, financial interests above certain thresholds will automatically be deemed significant conflicts of interest and will require closer scrutiny and possible elimination, mitigation, and/or management. The thresholds are as follows:

• Payments for services over $10,000/a year or the ownership or promise of stock or stock options in a publicly traded company valued at over $10,000 or 0.5% of the total value of the company 
• The ownership or promise of stock or stock options of any amount in a privately held or start-up company

In addition, research funded by the Public Health Service (PHS) and National Science Foundation have specific requirements that are covered in PHS and NSF Requirements Regarding Financial Disclosures and Agency Notifications.

Special Policy for Conflicts of Interest in Human Subjects Research

Financial interests or compensated relationships above these thresholds if the research involves human subjects will require that all conflicted investigators provide compelling reasons justifying their involvement in the research despite their conflict, if their financial interests are above the thresholds described in this document. A simple statement of an investigator's importance or expertise will not suffice. An investigator with a significant financial stake in the outcome of the research would need to provide a sufficient reason detailing his/her unique contribution to the study, explain how the investigator’s conflict of interest serves the subjects’ interests, present a reasonable plan that will protect the human subjects, the data, and the university, and describe their plan for transferring expertise to other non-conflicted investigators. Without compelling reasons and a plan that isolates the investigator from direct interaction with the human subjects or identified specimens, the Conflict of Interest Committee may require that the investigator either divest his/her financial interest or not perform the work at Stanford.  

Disclosure of Personal Financial Interests

All faculty investigators, and any other non-faculty participants in the research, who have responsibility for the design, conduct, or reporting of the research must disclose any personal financial interests that reasonably appear to be related to the project. Personal financial interests in a company may reasonably appear to be related to the research/scholarship if that company/organization:

• Sponsors research at Stanford in which the investigator is directly involved
• Has financial interests that could reasonably be considered to have a potential influence on the design, conduct, or reporting of the investigator’s research/scholarship
• Has a reasonable possibility of being financially affected by the investigator’s research/scholarship
• Makes gifts to Stanford that benefit the investigator’s research/scholarship (including equipment gifts or loans)
• Makes a product that is under study in research in which the investigator is involved
• licenses Stanford intellectual property in which the investigator has a financial interest
• Has a Materials Transfer Agreement or Human Tissue Agreement (MTA/HTA) to provide materials used in the investigator’s research or for materials provided by the investigator to the company/organization
• Sponsors or makes a product that is under study in human subjects in which the investigator is directly or indirectly involved
• Has interests that are related to the investigator’s general scientific or scholarly expertise

The financial interest thresholds defined as significant financial interests (SFI) by the Public Health Service (PHS) (see here for further information) are as follows:

• Payments for services over $5,000/year or the ownership or promise of stock or stock options valued at $5,000 in a publicly traded company
• The ownership or promise of stock or stock options of any amount in a privately-held or start-up company
• Royalties over $5,000/year not paid through Stanford University

While most disclosures of financial interests will be deemed de minimus or not significant in terms of potential effects on the individual’s ability to perform his or her duties without risk of bias, financial interests above thresholds will automatically be deemed significant conflicts of interest and will require closer scrutiny and possible elimination, mitigation, and/or management.

Prior Approval 

Effective September 1^st, 2023, Stanford faculty and research personnel will be able to request prior approval for outside activities through our Outside Professional Activities Certification System (OPACS). This module aims to enhance, streamline and document the process of obtaining prior approval for certain Outside Professional Activities in accordance with Stanford's updated Research Policy Handbook, Section 4.1 on Conflict of Interest and Conflict of Commitment (COIC).

Please see this document for more details and information.  It is important to note that all activities that have been disclosed and received approval before September 1, 2023, do not necessitate resubmission for prior approval.

The implementation of this online module will further strengthen our commitment to managing COIC effectively and transparently.

Assessing Conflicts of Interest in Research

Financial interests above thresholds that are disclosed and deemed to be related to a faculty member’s research responsibilities will be further reviewed to determine if the financial interest or relationship could have a direct and significant effect on the faculty member’s performance of his or her research. In addition, we need to ensure that:

• An open academic environment is maintained
• There are not restrictions on publication or dissemination of research results
• Intellectual property is licensed fairly
• The use of University resources, including personnel, students, and facilities, is appropriate
• The academic activities of students and postdoctoral scholars are free from the personal financial interests of the faculty member
• The work of students, staff, postdoctoral scholars, and collaborators is not exploited in the course of a faculty member’s outside obligations

Eliminating, Mitigating, or Managing Conflicts of Interest in Research

If it is determined that a significant financial interest could have a direct and significant effect on the research, and/or the research on the financial interest, the conflict will need to be eliminated or managed according to a plan provided to the faculty member by the Cognizant dean for COI. Other administrative actions, such as disclosure in publications and public talks, may be required when the financial interest is not considered likely to directly and significantly affect performance of research. Some common strategies for eliminating, mitigating, or managing conflicts include:

• Public disclosure of significant financial interests
• Training on conflicts of interest and commitment for all involved students and personnel
• Independent monitoring and oversight of the activity
• Modification of the Stanford research activity to remove the conflicted faculty member from participation in all or a portion of the research
• Divestiture of significant financial interests
• Other mitigating strategies

Other Requirements for PHS-Funded Research

Additional requirements under regulations for PHS-funded research include the following.

• Agency notification of any identified financial conflicts of interest (FCOIs) both when a Stanford investigator is directly involved with PHS funded research as well as when an investigator at an institution receiving a sub-contract through Stanford has an FCOI prior to the expenditure of funds.
• Response to any requests that the University receives for information on Financial Conflicts of Interests (FCOIs) on PHS-funded research within five days of such requests.
• The inclusion of any sponsored or reimbursed travel paid by any entity except a federal, state, or local government agency; an institution of higher education or an academic teaching hospital; a medical center or a research institute affiliated with an institution of higher education; or as a personal financial interest requiring disclosure.  Disclose your travel that may be related to PHS-funded research at opacs.stanford.edu and click on Travel in the left-hand column.  Follow the instructions on the travel disclosure form. Note that your initial disclosure must include reimbursed or sponsored travel received in the preceding twelve months.
• Faculty investigators must complete training on conflicts of interest prior to engaging in PHS-sponsored research and again every four years.

Types of Conflicts of Interest

Conflicts of Interest in Teaching and Educational Activities

Education and guidance given to students by faculty, including the nature and direction of research or other studies, should be governed by what is in the academic interest of the student. In addition, personal financial interests should not influence the content of any educational activity or presentation at Stanford or elsewhere when given to students or the public, and any personal financial interests related to the educational activity should be disclosed. A financial interest in a company/organization could create a conflict of interest related to institutional responsibilities for education if that company/organization:

• Provides financial support for the faculty member’s trainees (students, graduate students, postdocs)
• Has products (excluding textbooks) or devices that are used in faculty member’s teaching
• Produces or markets distance learning services or materials in which the faculty member has an interest
• Supports faculty member’s participation as a lecturer/speaker in educational activities or on-line education programs

Such conflicts need to be disclosed and reviewed by the Dean, Cognizant dean, or COI Program administrator to ensure that such interests do not negatively affect students and trainees. In addition, the School of Medicine has several specific policies addressing educational conflicts of interest. The policy on Commercial Support of Continuing Medical Education has prohibited the direct support of topic specific Continuing Medical Education (CME) by the commercial sector. See a link to the policy below in Related Items. Support from industry for CME will be considered only in the following general categories:

• medical, pediatric, and surgical specialties
• diagnostic and imaging technologies and disciplines
• health policy and disease prevention
• other broadly defined topic areas

The School of Medicine’s Stanford Industry Interactions Policy (SIIP) requires that non-CME educational activities supported by industry be designated for broadly defined areas only, not involve promotion or marketing, and that industry not influence the curriculum, among other things. Conflicts of interest must be disclosed to the learners. Industry support for educational activities involving medical and graduate students and postdoctoral fellows and trainees must be approved by the Senior Associate Dean for Education. SIIP also prohibits industry-sponsored "speakers bureaus” (i.e., contractual relationships to give talks in which the topic(s) and/or content are provided by the company) and dedicated marketing and training programs designed solely or predominantly for sales or marketing purposes.

Conflicts of Interest in Administrative Responsibilities

Stanford policy on conflicts of interest applies to administrative duties carried out on behalf of the institution. A financial interest in a company/organization could create a conflict of interest if:

• The faculty member is directly involved or in a position to influence decisions or requests to purchase goods or services from this entity or provide goods or services to the entity
• Another faculty member who reports to this faculty member is engaged in human subjects research related to the interests of this entity (e.g., testing a drug, device, or diagnostic)

These conflicts of interest need to be reported and reviewed by the Dean, Cognizant dean for COI, COI program administrator, or if human subjects research is involved, by the Institutional Conflict of Interest Committee (ICOIC).

Conflicts of Interest in Clinical Care

Stanford School of Medicine has a policy on Conflicts of Interest in Clinical Care which recognizes that physicians have a unique opportunity to improve patient care through collaboration with industry. However, these interactions must take place in an atmosphere of high integrity and transparency so that collaborations with industry can optimally benefit patients and improve human health and well-being. Accordingly, Stanford physicians are expected to fully disclose financial relationships with companies that produce, manufacture, or provide medical devices, implants, pharmaceuticals, biologics, diagnostics, or other medical care related products that may be used in the care of their patients. A financial interest in a company could create a conflict of interest if:

• The physician prescribes pharmaceuticals made or supplied by this entity for FDA-approved or non-FDA-approved indications
• The physician uses a medical device or implant made or supplied by this entity
• The physician refers patients to a health care facility with which he/she has a financial relationship
• The physician is involved in evaluating products made or supplied by this entity

Clinical care conflicts need to be reviewed by the Senior Associate Deans for Clinical Affairs.