Frequently asked questions about the School of Medicine's conflict-of-interest policy

1. What are the highlights of the Stanford School of Medicine’s conflict-of-interest disclosure policy?
2. Why is it important for a research institution like the School of Medicine to have policies that address conflict-of-interest issues?
3. Once a conflict of interest is disclosed, how is it handled? What determines whether a conflict is approved, denied or managed?
4. When was the university’s policy established?
5. Where do faculty members disclose this information? Is it available to the public?
6. Have you made any specific changes to the policy over the years?
7. What training on COI issues do faculty receive and how are revisions communicated?
8. Who sets and enforces the school’s policy?
9. Is self-reporting effective?
10. How do you ensure faculty compliance?
11. What penalties are available should a member of the faculty not comply with the COI policy?
12. How many faculty members have been subject to these penalties?
13. How does the school handle a situation involving allegations of biased research due to COI?
14. Why not simply ban conflicts outright?
15. How does Stanford’s policy compare to those of other academic medical centers?

1. What are the highlights of the Stanford School of Medicine’s conflict-of-interest disclosure policy?

Our policy differs from that of many other academic medical centers in several ways. We require disclosure of any relationship or financial interest that relates to a faculty member's research program, regardless of dollar amount. Our policy applies to anyone involved in the design, conduct or reporting of the research project, not just the principal investigator. And it applies to the broadest range of research acstivities — regardless of funding source — including sponsored research, gifts, human-subjects research, licensing arrangements, material transfer agreements, collaboration agreements and procurement.

Related Link: Overview of the Bayh-Dole Act

2. Why is it important for a research institution like the School of Medicine to have policies that address conflict-of-interest issues?

Opportunities for 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-subjects research, these opportunities to profit have the potential or may appear to affect a researcher’s judgments about which human subjects to enroll, clinical care provided to subjects, proper use of subjects’ confidential health information, delivery of informed consent, study design, data collection and analysis, adverse-event reporting, or the presentation and publication of research findings. Regardless of whether human subjects are involved, it is essential for us to actively oversee situations in which a faculty member has a financial relationship with an outside entity that overlaps with his/her academic research program in order to assure that early or exclusive access to research results, commonly called “pipelining,” does not occur.

3. Once a conflict of interest is disclosed, how is it handled? What determines whether a conflict is approved, denied or managed?

Within the School of Medicine, disclosures of financial interests are reviewed by a specifically designated, full-time COI administrator supervised by the Senior Associate Dean of Research to determine if the financial interests or relationships are significant enough to:

• Create the perception of, or actual potential for, bias
• Compromise the objectivity of the research
• Potentially harm a subject in the study
• Provide the company early or exclusive access to research results
• Constitute an inappropriate use of university resources and facilities
• Restrict the freedom to publish or publicly disseminate research results
• Compromise academic freedom of students, trainees or colleagues
• Create the circumstances under which students, trainees or faculty who work within their divisions, or others supervised by the conflicted investigator, might be exploited or coerced
• Inhibit the fair licensing of intellectual property

Financial interests or relationships that could potentially have any of these negative impacts would be deemed to have a direct and significant affect on the research. Such conflicts of interest would generally be reviewed with the relevant faculty member in order to manage, mitigate or eliminate them. If the review did not resolve the issues they would then be referred to the Conflict of Interest Committee to determine what steps might be needed to eliminate, mitigate or manage the conflict.

The Conflict of Interest Committee, which is made up of faculty from different departments and disciplines, reviews these disclosures to determine whether there are compelling reasons justifying the participation of someone with such a conflict; whether there is a plan in place for removing the conflicted individual(s) from points where he/she could direct the research or research results, such as selecting subjects in a study; examine the procedures for the objective review of the data, such as inclusion of a non-conflicted biostatistician or removal of the conflicted individual(s) from analysis of the data; and whether such strategies can effectively manage the conflict or it needs to be eliminated. If further review is appropriate, the case is examined by the university’s Associate Dean of Research, who reports to the Vice Provost and Dean of Research.

Possible strategies for managing a conflict include:

• Require disclosure of the financial interest in publications and public discussions of the research
• Modify the research plan
• Disqualify a principal investigator or member of the research team from all or a portion of the project
• Require severance of a relationship with a company or for-profit entity
• Require divestiture of a financial interest
• Exclude intellectual property from being licensed to a company in which there is a financial interest
• Manage the conflict through an oversight committee
• Other strategies, as deemed appropriate

4. When was the university’s policy established?

Stanford University established its current Faculty Policy on Conflicts of Interest and Commitment in 1994. This policy required annual disclosure of all outside professional activities and how these activities overlapped with Stanford activities. It also required disclosure of any new interests as they arose and addressed the specific requirements of human-subjects research. The School of Medicine established its zero-dollar disclosure policy for human-subjects research in 2001, and broadened its application to all research activities in 2003. As new situations arise, we continue to modify the COI policy and its implementation.

5. Where do faculty members disclose this information? Is it available to the public?

Faculty members at the School of Medicine disclose the presence of a conflict at the point of entering into a new activity, such as submitting a human-subject research protocol or grant application, or entering into a contract, material transfer agreement or procurement agreement. Specific information about the nature of the conflict is given to the Conflict of Interest Review Program. In addition, all faculty members complete an annual COI disclosure.

6. Have you made any specific changes to the policy over the years?

There have been several changes in the policy and in its implementation over the years. The 1999 death of Jessie Gelsinger in the gene-therapy trial at the University of Pennsylvania focused both public attention on conflicts of interest as well as increased scrutiny by academic institutions of the higher risks associated with human research. A detailed review by the AAMC Task Force on Financial Conflicts of Interest in Clinical Research (which generated the report, “Protecting Subjects, Preserving Trust, Promoting Progress: Policy and Guidelines for the Oversight of Individual Interests in Research”) was also instrumental in the development of our current policy. However, the Stanford School of Medicine policy has a more inclusive and rigorous approach to disclosure than either the AAMC guidelines or federal regulations. While we adopted the AAMC guidelines when they were published, our Conflict of Interest Committee, had, in fact, been using a similar rationale in its review of human-subjects research prior to this. We added material transfer agreements and collaboration agreements to the list of activities requiring disclosure in 2002. We eliminated the dollar threshold for such disclosures in 2003. In February 2005 we published "Tips for Avoiding Conflicts of Commitment and Interest" on the school’s Web site to provide guidance to our faculty members. On an institutional level, the university decided to divest itself of equity in companies started by faculty members whenever clinical trials involving these companies were anticipated to take place at Stanford. The university also decided to review any human-subjects research in which Stanford has equity and to dispose of such equity, which might constitute an institutional conflict of interest, regardless of whether the faculty investigator had a conflict of interest.

In October 2006, the school joined a handful of other academic medical centers in adopting a policy prohibiting faculty members from accepting industry gifts of any size, including drug samples. The policy also banned pharmaceutical industry representatives and other vendors from unscheduled visits to patient care areas and medical school facilities. In addition, it allowed for industry support of educational activities only under specified circumstances.

The school took further steps in 2008, when it announced it would no longer accept support from pharmaceutical or device companies for specific programs in continuing medical education. The school was one of the first to enact these restrictions, which went into effect Sept. 1, 2008. Under the policy, the school said it would only accept commercial support for CME programs if provided for broad areas, such as medical, pediatric and surgical specialties; diagnostic and imaging technologies; and health policy and disease prevention. Funding may not be linked to a specific course, topic or program. In addition, commercial exhibits would be banned at Stanford-sponsored CME events.

Under its most recent policy, announced in April 2009, the school will make available on its Web site information on the faculty’s medical- and research-related consulting activities. The policy will make widely available to the public information that clinicians and researchers already disclose annually as part of the school’s procedures to manage conflicts of interest. The information is expected to be posted later in 2009.

As new issues arise here and at other institutions, the medical school’s COI policies will continue to evolve.

7. What training on COI issues do faculty receive and how are revisions communicated?

All faculty members will be required to complete a conflict-of-interest training course. In addition, we offer a variety of training through the Stanford/Packard Center for Translational Research in Medicine, the Junior Faculty Mentoring program and other programs.

Faculty members are notified annually via e-mail of the need to file their yearly disclosure. The Dean’s Newsletter also carries a reminder notice. The faculty members are referred to the section of the school’s Web site that details all policies and procedures relating to COI. The Web site also links to related academic policies.

8. Who sets and enforces the school’s policy?

Our conflict-of-interest policy follows the university guidelines but is specifically adapted for the School of Medicine. The Senior Associate Dean for Research, who reports directly to the Dean of the School of Medicine, is charged with overseeing the disclosure processes and managing conflicts of interest for the school. He also serves as the chair of the Conflict of Interest Committee, a group of nine faculty members who evaluate disclosures and make recommendations to approve, deny or manage conflicts. The COIC serves in an advisory capacity to the dean. In addition, the school has a professional staff that manages the Conflict of Interest Review Program, including all annual disclosures, transactional disclosures related to sponsored research, licensing activities, human research protocols, gifts, material transfer agreements, collaboration agreements and procurement activities.

9. Is self-reporting effective?

Conflict-of-interest policies at all institutions require self-disclosure. However, the School of Medicine takes it a step further. First, we conduct training sessions on conflicts of interest and conflicts of commitment with all personnel working for the faculty member with a significant COI at which the nature of the conflict is fully disclosed to other faculty, staff, students and trainees. The training outlines the risks, how these risks can manifest and how they can compromise essential academic values. Thus, the consciousness of the entire lab is raised and the likelihood for accurate self-reporting is increased. We then require annual reports from the investigator outlining all activities in the lab and who is participating in these activities; copies of publications emanating from the lab during the reporting period; a listing of all intellectual property disclosed during this period and subsequent licensing information, if any; an update on the company; and analysis by the investigator as to where the conflicts of interest intersect with the research in the lab. We believe this type of self-reporting is instrumental in maintaining the investigator’s awareness of the conflicts and the negative effects they can have on the objectivity of the research and accepted academic values. That, coupled with the awareness of the conflict by everyone in the lab, raises the awareness of all parties. The use of oversight alone shifts the responsibility off the conflicted investigator and onto the overseers. We believe the best approach is to drive everything above ground and to expect our faculty to uphold the highest standards. In addition, over the past year we have begun to hold departmental COI meetings where the purpose of managing COI and the complexities of various types of relationships are carefully discussed with faculty. These meetings provide a venue where questions can be asked about individual situations and clarified in a prospective and open manner.

10. How do you ensure faculty compliance?

The School of Medicine operates on the honor system as do the state and federal income tax systems, for example. We require disclosure of conflicts of interest that may arise as a result of outside professional relationships. University policy allows faculty members to engage in outside consulting activities up to 13 days per quarter. These are private activities and do not require approval from the school. However, we do require that they disclose these interests if there is overlap with their Stanford activities.

11. What penalties are available should a member of the faculty not comply with the COI policy?

Faculty members who do not complete their annual COI disclosures in a timely fashion will have their research privileges revoked until they comply with the requirement. Other infractions of the COI policy are handled on a case-by-case basis by the Senior Associate Dean for Academic Affairs.

12. How many School of Medicine faculty members have been subject to these penalties?

We have approximately five or six faculty members a year who do not complete their disclosures in compliance with our policy, and their research privileges are revoked until they comply. Notably, virtually all faculty members comply rapidly after this sanction is invoked. With more than 800 faculty members, this is a tiny fraction of our faculty.

13. How does the school handle a situation involving allegations of biased research due to COI?

Allegations of bias in research would be subject to an inquiry into potential scientific misconduct to determine whether there was any merit to the charge; if so, the inquiry would proceed to the investigation phase, according to federal requirements. Scientific misconduct is not the same thing as conflict of interest. Allegations of scientific misconduct are investigated by the Senior Associate Dean for Academic Affairs in accordance with university policies.

14. Why not simply ban conflicts outright?

A major source of new ideas and intellectual stimulation comes from the dialogue between academics and their counterparts in industry. A core mission of the university is to foster the transfer of knowledge to the private sector in order for it to be translated into useful products. Two important means of accomplishing this include consulting and the commercialization of technologies derived from faculty research. Companies licensing those technologies need the guidance of the inventor(s) to learn how best to use and develop the technology. Faculty members accomplish this through consulting activities. Thus, conflicts of interest are common and practically unavoidable in a modern research university if we want to have the highest level of research dialogue and the most efficient transfer of basic discoveries into practical improvements for the population.

15. How does Stanford’s policy compare to those of other academic medical centers?

Disclosures of financial interests are mandated under federal regulations when Public Health Service or National Science Foundation research funds are involved, and many states have laws requiring disclosures as well. While institutions may differ in their disclosure policies—thresholds, types of activities requiring disclosure—there is probably not an academic research institution in the country that doesn’t have such a policy. At Stanford we have a creative and inventive faculty who have successfully moved many discoveries from the lab to the commercial sector, in order to benefit the public good. Because of this we have developed a broad and rigorous conflict-of-interest disclosure policy.