Ethical fundamentals in human subjects research : On equipoise and human dignity

Abstract

In her PhD thesis Rieke van der Graaf has studied how we can ethically justify human subjects research. In particular she has studied two ethical fundamentals that play a key role in the justification process, that of equipoise and human dignity. Equipoise is often taken to mean that physician-researchers must be genuinely uncertain as to which treatment arm is better before they randomize participants. She has also studied human dignity, usually meaning that people must not be used merely as a means. The fundamentals have been related to concrete controversial issues in human subjects research, like the standard of care for control groups and biobank research. The findings of this thesis demonstrate that two extreme views on the ethics of human subjects research have to be rejected. According to the first view enrolling human beings in clinical research is never ethically problematic since we have Institutional Review Boards (IRBs) and international ethical guidelines, like the World Medical Association’s Declaration of Helsinki and the CIOMS guidelines, which can protect participants. Guidelines do not protect people sufficiently, amongst others because guidelines are often contradictory in detail, and because they are not exhaustive. Furthermore, even if physician-researchers follow guidelines they are confronted with a dual role dilemma. Equipoise is often considered as a means to reconcile the dual roles of physicians in the research context, that is acting as caregivers for individual patients and as scientists who consider what is best for patients as a group. In the thesis it has been argued that appeals to equipoise cannot prevent that physicians do things that are not in the best interest of participants. In the other view medical research involving human beings is ethically problematic from the start because there are tensions in human subjects research that cannot be solved, like the dual role dilemma. The analysis and discussion of equipoise and human dignity in this thesis could counterbalance this view. According to an improved understanding of equipoise it appears to be a useful requirement for trials where medical procedures are being compared. In these cases it provides a warrant that participants are not provided with less than the medical professional standard. Moreover, in most medical studies, at least those conduct in societies with well-functioning IRBs, human beings are not used merely as a means for gains in health knowledge because ethical conditions of possible consent and end sharing can often be met. In the thesis it has also been set out that even if researchers use participants merely as a means, this does not necessarily imply that they are also used wrongly. Furthermore, there are indications that the second view is changing due to a paradigm change in research ethics. In the new paradigm human subjects research is no longer regarded as an extraordinary but as an ordinary practice in our society. These findings may improve the willingness of people to participate in medical research.