Further insights on institutional conflicts of interest in research settings

Defining the problem

A conflict of interest (COI) is understood to be a situation where a primary interest tends to be unduly influenced by a secondary interest, ¹ in which the latter may interfere with objectivity of action pertaining to the former. In the research setting, COIs will potentially threaten the integrity of scientific investigations, objectivity of professional education, and overall delivery of care to patients. COIs can be easy to comprehend using personal gain as a point of conflict (personal COI), but are less apparent in institutions focused on academic medicine, when they may emerge as a result of secondary interests that are seen to compromise an institution’s primary goals (institutional COI). In reality, personal COI may be difficult to distinguish from institutional COI, as many senior officials holding several appointments within an academic institution may inadvertently encounter personal COIs. ² Often, it may be onerous to identify a responsible individual or apportion COIs between persons involved with a research project when decisions on institutional COIs are made.

It is essential to anticipate, recognize, and reflect on COIs responsibly. Many public institutions mandate regular formal declarations of personal COIs, but mandates become less clear with institutional COIs. Hence, better management of institutional COIs should start by earnestly acknowledging their existence within the entire research community.

Delving deeper

Although numerous research activities with COIs hinge ultimately on financial ties, the current discussion endeavors to broaden its scope by outlining possible scenarios in which monetary interest is not a starting point.

Academic medical centers have a primary mission in healthcare delivery, but research and education are of equal interest. Very often, they contribute to the prestige of an institution, which ultimately benefits funding and revenue generation. Failure to manage these priorities adequately may, unfortunately, result in institutional COIs.

A possible situation could arise whereby an esteemed researcher of a particular institution has obtained local funding to conduct a study deemed of high value by that institution. Regulatory bodies, including institutional review boards (IRB), may indirectly feel compelled to expedite the review and approval process for the study over other applications. This poses additional risks pertaining to ethical oversight, safety, and compliance, as the professional decisions made under the relevant circumstances can be subversively influenced. Furthermore, diversion of valuable resources to this project may generate a conflict with the primary intentions of healthcare delivery, or even compromise fair recruitment and conduct of other studies within the same institution.

In the current climate of data security breaches, healthcare institutions may be vulnerable targets. ³ Medical information held in research databases is extremely sensitive, particularly if the databases are not anonymized. In the event of a data breach, be it the result of lost storage drives or large-scale server hacks, the institution might be caught in a dilemma over whether to disclose the incident to subjects at the expense of affecting its reputation. Internally, senior management, research administration, and even IRBs will have specific responsibilities, but institutional secondary interests may interfere with the overall objectivity of making unconflicted final decisions.

The publication of research findings serves several aims. It is often perceived as prestigious for work to be featured in journals with high impact factors, both for the individual and for the institution. To achieve this goal, publication bias might emerge, such that negative trials, which are less likely to be accepted, are not reported. Indeed, there is evidence to show an overwhelming excess of published positive trials over negative ones. ⁴ However, there exists a fundamental responsibility for publicly funded studies to report negative results, which may also contribute to better understanding of a clinical problem and point to new directions for future research. ⁵

Indeed, the pressure to publish can be overwhelming, and can lead to data falsification, unethical research practices, and breach of publication ethics. ⁶ Emergence of such incidents would once again put the institution in a delicate position of balancing competing interests of facilitating research output versus admitting erosion of integrity, with resultant loss of public trust, especially among funding agencies, donors, and participating subjects.

On an expanded scope, it is recognized that many IRBs receive state funding over and above institutional support for their operations. Would that lead to COIs for IRBs then, when deliberating over state-funded studies deemed to be of national interest? There is not likely to be a straightforward answer, but coming to terms with its existence attests to a need to recognize this most poignant issue.

The way forward

Moving ahead, the most immediate task is to focus on developing a positive attitude toward recognition, declaration, and action on COIs. Having a COI statement should not be viewed as being unethical or corrupt. Senior officials and researchers will then be more forthcoming with COIs, especially if they are viewed as part of a conventional administrative process. The entire institution can be educated so as to be able to point out potential COIs, be it in healthcare delivery, education, or research settings, even regarding non-financial issues. This should not amount to a full whistleblower exercise, but more toward mutually respectful guidance. In this way, fear, suspicion, and even hostility toward handling COIs will gradually be diminished.

There are no gold standards when dealing with institutional COIs. Few institutions involved in research have existing policies in place. However, the policies may be strengthened to include elements of proportionality, accountability, and transparency. Some institutions appoint special committees or specific boards designated to focus on institutional COIs, which ideally can work in unison with IRBs. These governing committees should provide recommendations on addressing disclosure and on managing conflict. Ideally, they should not retain members who themselves have COIs relevant to the activities of the institution. A minimum of one member who is not a direct employee of the institution and yet has the relevant expertise would effectively form a more balanced and impartial committee.

A similar argument would be that while the IRB has a certain indirect role to play, appointing a totally neutral board may prove challenging. This is because IRB composition must be carefully balanced between internal members, who possess the familiarity, expertise, and duty to advise, and completely external members, who may lack such qualities but are viewed as fully unconflicted. Within an IRB, internal members should proactively admit to any individual COIs and, in extreme circumstances, enlist the help of other IRBs within its network should it be deemed to be too conflicted to manage.

As IRBs do not have a direct mandate to handle COIs outside of those that encroach on ethical issues that disadvantage subjects, it is worthwhile to explore the creation of a high-level composite entity with broader capabilities to deliberate, audit, or even enforce compliance on identified COI matters. This entity may also help by advising on seminal research issues arising from hospital contracts with large sponsors that, for example, compromise the primary healthcare delivery mission of an institution such that the recruitment process may be disadvantageous to internally treated patients. To date, however, such a structure remains untested.

Ultimately, regardless of the quality and quantity of appointed committees, the bottom line pertains to their autonomy in making decisions. Hence, it is crucial that a committee’s reporting line be sufficiently independent, such as directly to the institution’s board of trustees, and not to research administration, as often is the case. ⁷

When deliberating on matters of COI, a high level of confidentiality will certainly help instill faith in the process and promote fruitful discussion of views expressed. Paradoxically, rather than generate secrecy, a climate of transparency will be realized in the longer term.

Finally, the views expressed pertain exclusively to the author, who sincerely welcomes relevant responses. It is hoped that such insights will contribute to a more transparent and legitimate research environment beneficial for all.