Overview
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Background
A conflict of interest arises when an individual's private interests (such as outside professional or financial relationships) might interfere with his or her professional obligations to Stanford. 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, academic staff, staff, and students to understand how these divergent interests can become a problem.
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 patenting and licensing an invention, or to outside consulting or other interests. 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, or the protection of human subjects, students or others whose work depends on the direction of the individual is enough to mandate that such conflicts be identified, and then managed, mitigated or eliminated.
Stated another way, Stanford University must protect itself and its faculty, staff and students from any of the following allegations:
- exploitation of students for private gain
- compromise of appropriate controls in the conduct of research such that research subjects could be harmed
- undue personal gain from public funds
- compromise of university priorities due to financial considerations
- unfair access by a company to information or technology
- compromise of scientific objectivity in the conduct of research
- use of university resources for private gain
- adverse effect by those in leadership roles on the professional or academic advancement of colleagues, staff or students as a result of outside interests.
To protect against such dangers, all Stanford faculty members must certify annually to their school deans their compliance with Stanford's policies related to conflict of interest and commitment, and must disclose their outside professional activities and any financial interests in outside entities that they, and their immediate family members, have. In addition, faculty, staff, postdocs and students must disclose on an ad hoc basis any current or prospective situations which may raise questions of conflict of interest, such as those involving sponsored research, gifts, human subject protocols, licensing of intellectual property, procurement or other relationships with outside companies. Ad hoc disclosures are to be made to the appropriate school dean's office as soon as the individual becomes aware of such situations.
Potential conflicts of interest will be assessed against the concerns listed above. Where there is a risk that the outside interest may have, or be perceived to have, a harmful affect on academic values, Stanford will take steps to eliminate, mitigate or manage the conflict.
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Conflicts of Interest Policy Overview
Conflicts of interest are common and practically unavoidable in a modern research university. At Stanford, conflicts of interest can arise out of the fact that a mission of the University is to promote public good by fostering the transfer of knowledge gained through University research and scholarship to the private sector.
Two important means of accomplishing this mission include consulting and the commercialization of technologies derived from faculty research. The opportunity for researchers to receive financial rewards from these endeavors is not intrinsically unacceptable. However the potential for financial gain creates risks for the individual investigator and for the institution. Financial interests in human subjects research are of special concern. Financial conflicts are distinct from other interests that might impart bias because financial interests are discretionary. Such conflicts are not usually necessary for the conduct of the research. Finally, conflicts of interest can call into question the professional objectivity and ethics of the individual, and also reflects negatively on the University.
Opportunities to profit from research may affect - or appear to affect the direction of the research, objectivity of the data, or interpretation of research results. Moreover, in human research, these opportunities to profit may affect, or appear to affect, a researcher's judgments about which human subjects to enroll, the clinical care provided to subjects, the proper use of subjects' confidential health information, and create biases in study design, data collection and analysis, adverse event reporting, or the presentation and publication of research findings. On the other hand, while human subject research is the highest risk, there may be special and rare circumstances which require an individual to engage in research on human subjects despite having a financial conflict of interest.
We seek to assist Stanford personnel in translating their discoveries and developments so that we can fulfill our mission to benefit the public. We also seek to minimize the adverse affects of conflicts of interest, and to advise faculty and staff on how to avoid, mitigate, or, if necessary, how to manage those conflicts. The purposes of this policy are to educate faculty about disclosure requirements, and to provide information about how conflicts of interest are assessed.
Financial Interests or Relationships that pose Conflicts of Interest
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:
- The ownership or promise of stock or stock options over $10,000 or 0.5% of the total value of the company, 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.
- An individual serves in a consulting or other fiduciary role for a financially interested company, whether or not remuneration is received.
Research involving 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, and a reasonable plan that will protect the human subjects, the data, and the university. Without compelling reasons and a plan that isolates the investigator from direct interaction with the human subjects or identified specimens, the Stanford University may require that the investigator either divest his/her financial interest or not perform the work at Stanford.
Assessing Conflicts of Interest
One way to personally assess your own conflict of interest is to ask yourself 'how would this look on the 6:00 news'. We often call that the 'smell test'. While you might not consider your relationship with, or financial interest in, a company to pose a risk to the objectivity of the design, conduct or reporting of your research, it can create that perception. Perception of bias, or the perception that harm came to a human subject in research as a result of bias, can be just as damaging as actual bias or harm. Thus, we must, and you should, ask the following questions:
Are basic academic values upheld?
- an open academic environment is maintained.
- there are no restrictions on publications or dissemination of research results.
- fair licensing practices are ensured.
- the use of University resources and facilities is appropriate.
- students are not exploited for the private gain of their mentors, and they are free to choose and pursue research
- the research is appropriate to the mission of the University.
What is the scientific direction of the University research and what is the scientific or business direction of the company? Is it the same? Where does it overlap?
Could these personal financial interests have a direct and significant affect on the research?
- how much income or equity is involved?
- from how many sources does it derive?
- could these financial interests be a significant incentive for the individual with the conflict?
- could this financial interest pose a direct conflict with the research?
- could this conflict compromise the objectivity of the research results or their evaluation and presentation?
Could human subjects involved in the research be harmed by the conflict?
Could potential incentives to show that products are effective affect future patients negatively if the products are actually not as effective as indicated in the clinical study?Eliminating, Mitigating, or Managing Conflicts of Interest
Conflicts that are deemed to have the potential or are likely to be perceived as having the potential to have a direct and significant affect on the research must be eliminated, mitigated, or managed. Such strategies for eliminating, mitigating, or managing conflicts can include:
- public disclosure of significant financial interests;
- training on conflicts of interest and commitment for all personnel involved in the research;
- monitoring of research by independent reviewers;
- modification of the research plan;
- disqualification from participation in all or a portion of the research;
- divestiture of significant financial interests; and/or
- severance of relationships that create actual or potential conflicts.
Conflicts of Commitment
These are conflicts relating to the allocation of time, attention and energy. When outside activities, including consulting, public service or pro bono work, interfere with a faculty member's primary commitment of time and intellectual energies to the education, research and scholarship endeavors of the University, a conflict of commitment can result.
Since requirements for field research and other reasons for absence from campus differ across the University, the definition of inappropriate, extended or frequent absences will vary by discipline. Any absences that would raise questions from fellow faculty, students or staff should be discussed within your department and may be appropriate to document on this annual form.
In addition to the limit set on the amount of outside consulting that a full-time faculty member may do, Stanford's policy also prohibits:
- direction of a program of research or scholarship at another institution that could be conducted appropriately at Stanford (i.e., outside PIship)
- significant management roles (those that involve supervision of the work of others and/or day-to-day responsibility for operating decisions) in a private business.
Discussion of Cases
Conflicts of interest are sometimes difficult to consider in the abstract. The following three hypothetical situations illustrate potential conflicts involving:
The analysis presented in these cases does not lead to simple answers. Rather, these cases are intended to point out the complexity involved in potential conflicts of interest, and to suggest questions to ask and possible approaches to consider.
School of Medicine Information
See also School of Medicine Information website