Clinical and research ethics as moral strangers

Abstract

This article takes issue with those who defend a brand of clinical research ethics that tends to substitute the ethics of clinical care of patients being recruited as trial subjects. The distinction between therapeutic and non-therapeutic studies is being disregarded by arguing that research is concerned with the pursuit of knowledge rather than with the medical benefits for patients. Non-competent patients may therefore be recruited for studies that will offer them no medical benefits in spite of involving them in the inherent risks of any biomedical trial. Supported by the World Medical Association, clinicians tend to shun the use of placebos in randomized trials, because of the therapeutic void created in the control group. Nevertheless, investigators continue to consider that scientific purity demands the use of placebos as the most appropriate comparator, even if risks to patient-subjects are increased. Equipoise and clinical equipoise have been suggested as adequate criteria to evaluate the need for a clinical trial, when genuine uncertainty about the equivalence of medical measures requires clarification. If equipoise is understood as a balanced situation where alternatives are equivalent and exchangeable in the view of experienced and current medical thought, no comparison seems warranted until a substantiated doubt about their true equivalence appears. Whereas respecting equipoise is an important measure to curb redundant research, new trials become mandatory if equivalence is reliably questioned. In the best interests of patients being recruited for clinical trials, they should continue to be the full beneficiaries of clinical ethics, in addition to receiving the protection of research ethics. Placebos and sub-medication for control groups are to be used sparingly, and best existing therapy should be employed as control when new and promising agents are developed.

The Research‐Treatment Distinction: A Problematic Approach for Determining Which Activities Should Have Ethical Oversight

“…64 Steven Grunberg and William T. Cefalu state that in clinical research, "the selection of certain aspects of the treatment regimen is taken out of the hands of the treating physician," 65 and Michael Kottow argues that "when treatment decisions are made by protocol, the patient becomes 'a therapeutic orphan.'" 66 Some clinical research undeniably uses an algorithm to determine which intervention a patient-subject receives. In the classic randomized clinical trial, interventions are assigned to subjects randomly.…”

Exploring the Obligation to Inform: Disclosing the Purpose and Benefits of Research in an Increasingly Commercial Research Environment

“…While many institutions still retain their own IRBs, new models such as independent IRBs (Macklin 2008), community hospital IRBs (Hall et al 2009), and community-based IRBs now perform oversight functions (Jansen 2005). Many clinical studies that are approved by independent IRBs are conducted in multiple sites and in multiple states (Christensen and Orlowski 2005); many of these studies are designed to secure patents and develop marketable products (Kottow 2009). Thus, local IRBs can now spend a significant amount of time reviewing industry-funded and multisite research protocols (Christensen and Orlowski 2005).…”

“…Important functions of commercial research include securing patents, developing marketable products, and gaining a market share (Kottow 2009). This for-profit science stimulates much redundant research, such as the development of "me too drugs," drugs that are structurally very similar to already known drugs with only minor differences (Whitney 2006).…”

The Protectors and the Protected: What Regulators and Researchers Can Learn from IRB Members and Subjects

“…Federal funding for research has decreased and industry funding has steadily escalated; by 1991, industry funding outpaced federal funding, and by 2000, 70% of clinical trials were funded by industry (Bodenheimer, 2000). Some industry research is focused on the development of new or novel drugs, but considerable industry effort is directed toward commercial interests such as extending patents, fi nding new uses for existing drugs, developing "me-too" drugs to secure a market share, and assessing prescription practices (Kottow, 2009). The change in the research venue is also notable; most clinical research has migrated to nonacademic environments.…”

“…Although a robust literature base explores the ethical, legal, and regulatory challenges associated with the protection of human subjects, there is a growing sense that, as Michael Kottow (2009) cautions, "the agility of biomedical research far outstrips the pace of research ethics." He is not alone in his concerns.…”