Conflict: a catalyst for institutional change.

Introduction

Conflict, simply defined, is a state of disharmony between incompatible or opposing persons, ideas, or interests. When asked to close their eyes and envision a recent conflict, most people will experience a disheartening feeling. They may notice physical or emotional signs of distress (e.g., palpitations, rapid breathing, sweaty palms, shaking, tearing, etc.). Therefore they tend to assign a negative connotation to conflict as a general concept. They view conflict as something to be avoided at all costs. But conflict is natural, and even when one acquires the skills to deal with it more effectively it continues to exist (ESR, 1998). It surrounds us on a daily basis, and while it might make us feel stressed, frustrated, angry, scared, or confused, it can offer new and positive opportunities for change, learning, and growth.

The same holds true for conflicts of interest and/or commitment within an organization. Again, by simple definition, a conflict of interest and/or commitment exists when there is a state of disharmony between one's responsibilities as an employee/member of a specific institution/ organization and an outside entity. Both the American Association of Medical Colleges (AAMC) and the American Association of Universities (AAU) have adopted this definition: "The term individual conflict of interest in science refers to situations in which financial considerations may compromise, or have the appearance of compromising, an investigator's professional judgment in conducting or reporting research" (Broccolo & Klanica, 2006). Yet, dealing effectively with the conflict of interest situation can also lead to positive opportunities for change, learning, and growth.

In essence, a potential conflict of interest or commitment is not inherently a bad thing. Often it means there is good work happening that will contribute to generalizable knowledge and benefit society. External or extramural financial interests often drive the research in ways that internal funding alone cannot by providing a direction to research that will result in the largest possible positive impact on society. Kalichman and Macrina (2001) state that conflicts encountered through the scientific profession are to be expected, it is how they are handled that can lead to untoward, inappropriate, or bad outcomes. Therefore, there is no shame in having external financial relationships, whether as an individual or an institution as a whole. The shame is in allowing those relationships to potentially bias the work, create false presumptions and distort decision-making, or in hiding the fact that they exist in the first place.

Maintaining even minimal standards of research integrity is dependent upon protecting and preserving not only the integrity of the science, but that of the researcher and the institution. There is also a fundamental obligation to preserve and sustain the public trust. The public trust is a fragile thing and once shattered it is almost impossible to repair (Schaller-Demers, 2006). Bradley (2005) says there is a concern that an escalating climate of secrecy and economic competition is contributing to the public's loss of confidence in the integrity of science and scientists, if not an actual deterioration in the quality of the science. If one accepts that public trust is what drives public funding, it may be logical to assume that once public trust is eroded, public funding will erode as well (Cohen, 2002).

Broccolo and Klanica (2006) state that instances of research misconduct can be motivated by the types of financial and associational (non-financial) interests that give rise to potential conflicts of interest and that the media and the public cannot distinguish the difference between actual conflict and perceptions of conflict. That is why perception and appearances are so important. Hiding is never the answer, because upon close examination, it may be determined that an actual conflict of interest doesn't even exist. When conflicts are revealed after-the-fact, especially in cases where misconduct is alleged or unanticipated adverse events occur, the perceptions can be more damaging than the reality.

An elemental question is to what extent financial incentives affect professional judgment. Barnes and Florencio (2002) state that financial incentives can and do exert significant influence over human behavior. Sadly, when individuals' reputations and/or livelihoods are at stake, good judgment can succumb to avarice. Institutional judgment can become clouded when reputations and/or finances hang in the balance. Bradley (2005) says that universities have a strong sense of self-preservation when confronted with these types of situations. Therefore, they may be reluctant to cancel lucrative contracts or prohibit or restrict certain studies even though a faculty member may have a potentially serious conflict of interest. The University of Oklahoma and the University of Toronto are two examples of institutions where professional judgment was overpowered by financial considerations to the detriment of reputation and research (Barnes & Florencio, 2002). At St. John Medical Center in Tulsa, Oklahoma, there was a study that investigated an experimental vaccine for malignant melanoma. Both the Institutional Review Board (IRB) chair and the dean allegedly concealed from both the IRB and the Food and Drug Administration (FDA) a report from an outside consulting firm that found severe deficiencies with the melanoma vaccine study. They eventually halted the study, but not because of these negative findings, and stated in an annual report that there were no significant safety issues related to the melanoma vaccine.

At the University of Toronto, the former university president urged the Canadian Prime Minister and four other cabinet ministers to withdraw proposed drug patent regulations or Apotex, a pharmaceutical giant, would rescind its multi-million dollar donation earmarked for the University and its affiliated teaching hospitals.

Barnes and Florencio (2002) point out that even high-level officials like an IRB chair, a dean of medicine, or a university president can be distracted from their primary responsibilities due to the influence of financial interests. One would automatically assume that safeguarding human research subjects and preserving the integrity of research, researchers, and the institution would be paramount. Yet even those held in the highest esteem may misstep while chasing ever-shrinking research dollars.

Objectivity through self-reflection can be difficult to achieve and/or maintain. Doctors, researchers, and other academic professionals might question whether "gifts" from a pharmaceutical company or consulting agreements could influence them to prescribe that company's drugs, use a particular device, or contract for a certain service (Gilbert, 2006). As professionals, people do not want to believe that they can be subconsciously bribed. It is almost impossible to judge one's own behaviors or motivations accurately and without bias. Gilbert (2006) says that the brain cannot see itself fooling itself. Therefore, he thinks that the only reliable method for avoiding bias is to avoid the situations that produce it in the first place.

Avoidance and elimination are ways to handle conflict of interest situations. However, in the scope of scientific research that is not always what is in the best interest of the science (see rebuttable presumption). As is the case with most learned professionals, scientists are generally strong in their beliefs and will stand long by a hypothesis. Understandably this mindset might tempt them to hold tight to a particular research plan, especially when it has become their life's work. However, as we have now seen by the misjudgments of others, strong beliefs can sometimes lead to disaster--as proven by more than one now-infamous example.

In 2005, researcher James Wilson and the University of Pennsylvania (UPENN) were found complicit in the case of Jesse Gelsinger, a teenage volunteer who died in a gene therapy trial. In addition to numerous research misconduct violations, it was discovered after-the-fact that Wilson, the principal investigator (PI), held a 30% equity interest and UPENN a 3.2% equity interest in the sponsor of the trial. When another corporation acquired the sponsor, the PI reportedly made a return of $13.5 million and the university reportedly earned $1.4 million (Lemonick & Goldstein, 2002).

Paul Gelsinger (2001), Jesse's father, says that when he met with the head researcher for the first time after his son's death he asked him about his financial position in the trial. The researcher's response was that he was an unpaid consultant to the biotech company behind the research effort. Gelsinger accepted his word and continued to support him and his work. He now contends that the over-enthusiasm of the clinical investigators painted an unrealistic picture of the study's safety and efficacy. That enthusiasm blinded them to the ill effects that they were witnessing. Therefore, Gelsinger says "... I still support our need for clinical trials, but with this caution: Informed consent is only possible if all facets of the research endeavor are ethical and in the open." The death of Jesse Gelsinger stands as a tragic reminder that transparency and full disclosure serve to protect us all--the public-at-large (all potential subjects), the researchers, the sponsors, and the institutions.

Today's media, fortified by intensified government review, focus an easily influenced public's attention on misconduct. In this atmosphere, potential biomedical research conflicts receive heightened scrutiny--especially when human subjects are involved. Broccolo and Klanica (2006) say that the current challenge to institutions is to establish and maintain a conflicts of interest infrastructure that achieves the right balance between promoting and supporting a spirit of innovation (as supported by Bayh-Dole) on the one hand and adapting to the best practice standards that are emerging through society's call for reform on the other. Cohen (2002) reminds us that it is critical for relationships between academic medicine and industry to remain principled, protective of subjects, respectful of scientific integrity, and capable of withstanding public scrutiny. In other words, it is not sufficient to know your heart is pure, your science is impeccable, and your motives are completely altruistic--you must be able to prove it on the front page of The New York Times.

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