Emanuel (Emanuel E, et al., 2009, Ch 65) assesses the “reasonable availability” ethic that has come to the fore since the 1990s. He relates the generally-accepted principle that, in addition to providing a social good by developing drugs and procedures that improve community health, principles of ethical research require an equalization of risks and benefits not only for individual research participants, but also for the communities in which research is conducted. This is is especially important for vulnerable communities at high risk for exploitation. “In order to avoid or minimize the possibility of exploitation, those who assume the risks of burdens of research should be assured of receiving fair benefits from the research” (p. 720). In addition to his fair critique of the “reasonable availability” ethic, Emanuel assesses two other claims: the “fair benefits framework” and the “human development approach.”
Emanuel notes nine criticisms of “reasonable availability” (p. 722-24). While I won’t note all of them here, I will point out that one valid criticism could be added to his list. While this criticism could be subsumed under “narrow conception of benefits,” criticism number two in Emanuel’s schema, I believe the additional criticism that I propose stands on its own merits and requires further consideration. Essentially, Emanuel’s second criticism of the “reasonable availability” approach focuses on drug or intervention accessibility while ignoring other ancillary concerns required for accessibility such as “training, infrastructure, or health services” (p. 723). While valid in its own right, Emanuel’s second criticism, and indeed his remaining eight criticisms, fail to consider group harms caused by the accessibility of the drug or intervention, thus comprising a “narrow conception of detriments.”
Here, an example is in order. Say that a population that is generally vulnerable to exploitation agrees to a clinical trail involving an antibacterial agent following standard Western ethical principles and protocols, including the “reasonable availability” requirement. Results of the trial are conclusive in favor of the drug. However, six months after the trail a significant portion of the study population develops an acute fungal infection that requires treatment with topical and oral medication. None of Emanuel’s nine criticisms, including criticism two, provides for this contingency. Thus, a tenth critique would be “narrow conception of detriments,” which would find that the “reasonable availability” ethic also does not account for additional community burdens borne by the community that cannot be equalized through access to a drug or intervention used in a clinical trial. To be sure, there may be some way to account for medical conditions that arise due to a clinical trail, but the “reasonable availability” ethic does not. In and of themselves, drugs, interventions, and ancillary benefits, such as those mentioned in critique two, cannot account for this criticism.
Emanuel EJ. Benefits to Host Countries. Emanuel EJ, Grady C, Crouch RA, et al., eds. The Oxford Textbook of Clinical Research Ethics. New York: Oxford University Press. 2008;719-728.
Tags: Health Care Ethics
