Abstract
Most discussions concerned with advancing the just and ethical treatment of research participants in developing countries have revolved around the moral principle of autonomy and the legal doctrine of informed consent (O’Neill 2002). However, if emerging ethical concerns are to be addressed effectively, the discussion needs to expand into the domain of business ethics where arguments addressing issues such as fair/appropriate compensation, entitlement, and corporate obligations to stakeholders are commonplace. The argument I present in this paper will conclude that emerging ethical considerations regarding the treatment of research participants in developing countries have evolved well beyond the scope of the principle of informed consent and that in order to resolve these concerns more appropriately and effectively, the new default or status quo should be to consider research participants as stakeholders of the sponsoring pharmaceutical company, even after the clinical trial is completed. This conclusion is significant because although it is fair to assume that, at some point in the timeline, most stakeholder theorists already do consider research participants stakeholders of the pharmaceutical company sponsoring the trial, the completion date of the clinical trial usually signifies and marks the termination of their stakeholder status and thus any consideration of what is owed further to the research participant.
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Notes
Clinical Trial in the Philippines involving the genetic mutation of cleft lip and palate.
Clinical Trial for Zidovudine and HIV in Africa.
Usually as a subset of the doctor/patient relationship.
This would be analogous to how customers and employees are stakeholders of the relevant corporation by default.
What type of stakeholder and what obligations are attached to that status are yet to be determined.
Though pragmatic in feel, my intention is to provide an analytic argument prescribing the next logical step to addressing the moral gap regarding treatment of research participants in developing countries. Of course, the prescription for which I argue rests on the assumption that scholars concerned with ethical corporate action actually do want to make progress on this subject.
In referencing the organization that sponsored the clinical trial, I will be using the following terms interchangeably: sponsoring company, pharmaceutical company, sponsoring pharmaceutical company, big pharma, drug company, sponsoring drug company, research sponsor, etc.
This questions falls within the domain of public health concerns which can be expanded from the benefit to family member to the benefit of the general population represented by the research participant (Glantz et al. 1998).
It seems to me that my position can be defended by either Freeman’s or Phillips’ stakeholder theory.
I have called this a charitable reading of Freeman, meaning that it allows for stakeholder theory to determine which specific parties count as stakeholders and when stakeholder status begins. Under this interpretation, a traceable path of effects due to the corporation’s operations onto another party and/or a traceable path of effect from a party onto the corporation serve as sufficient criteria for stakeholder status. The point of this criterion seems clear to me given Adam Smith’s inclusion of the moral sentiments of sympathy and compassion within the free market (Smith 2007/1759). Others have attempted to provide a normative foundation for Stakeholder Theory by grounding it in a moral principle. Phillips grounds stakeholder theory in the principle of fairness resulting in a theory of stakeholder fairness (Phillips 1997). My reading of these theories is that the latter compliments and further justifies the acceptance of the former as the right way to determine corporate obligations and when they are violated.
Although contracts (the informed consent form) are used to explicitly identify the existence of a stakeholder relationship between individual parties, the absence of one does not necessarily mean there is no longer a relationship.
It is actually not necessary, according to Freeman’s stakeholder theory, for there to exist effects in both directions. The significant point is that the more powerful of the two parties, that being the pharmaceutical company, continues to prosper from the contribution of research participants. This is sufficient, according to stakeholder theory, to grant research participants stakeholder status far beyond the date of the completion of the clinical trial.
While I have simplified the case study for the purposes of this paper, I believe this is an accurate representation of the case.
It is also when they begin to garner praise for their actions.
This is in anticipation to critics who want to make the claim that this type of obligation is not feasible in a market economy.
Helpful comments at the 2015 Pacific APA has made it clear that even if the clinical trial failed to produce a marketable drug, the information gathered from the failed clinical trial would still be relevant and considered a valuable contribution by the research participants, thus establishing a symbiotic relationship.
The task for this section is not to provide the actual solutions and answers to Barnbaum’s concerns. That is a task for an entirely independent paper. My task here is to determine whether stakeholder theory could justify rational solutions by explaining that Barnbaum’s issues fall right within the scope of stakeholder theory.
This is not to say that stakeholder theory is the only way to account for Barnbaum’s concerns that fall outside the scope of informed consent, but that it is at least one theory that is appropriate and effective in addressing them.
What level of access is not entirely clear; however, it is a considerable step to claim the requirement of providing access.
Within informed consent, all that needs to rectify this injustice is to make sure that the research participants have the knowledge and understanding that they will more than likely be exploited if the just drug proves to be profitable. But being informed in this way does not quite capture the injustice that Barnbaum is talking about.
It can be grounded by both the previously defined “narrow definition” and the “wide definition” of stakeholder theory. “‘Wide definition’ includes any group or individuals who can affect or is affected by the corporation” (Freeman 2004).
It is important to notice that even from the public health perspective, they have not questioned the status quo of appealing to the informed consent form to address their concerns about obligations. The requirement of agreeing to all conditions before the trial has even begun signifies their reliance on the informed consent form. There is no argument for this requirement and yet there is the mistaken assumption that no duties can be established post-clinical trial completion.
I fully agree that more than likely, a different theory of obligation having to do with public health concerns would need to be utilized to ground corporate duties to public health.
Using an approach like Goodpasters’s might be helpful in determining where research participants should be positioned on the stakeholder hierarchy. Perhaps their position on the drug company’s stakeholder hierarchy is different during the clinical trial versus after the clinical trial. Perhaps research participants from developing countries should be distinguished from those that are from developed countries given differing levels of access to drugs, social infrastructure, social corruption, urgency, etc.
I am almost certain that Big Pharma would not be happy about this.
I want to make clear that this is alongside and not in opposition to our moral sentiments of prudence and self-interest (Smith 2007/1759).
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Chang, P.L. The Abandoned Stakeholders: Pharmaceutical Companies and Research Participants. J Bus Ethics 143, 721–731 (2017). https://doi.org/10.1007/s10551-016-3070-5
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DOI: https://doi.org/10.1007/s10551-016-3070-5