Clinical research under the usual regulatory constraints may be difficult or even impossible in a public health emergency. Regulators must seek to strike a good balance in granting as wide therapeutic access to new drugs as possible at the same time as gathering sound evidence of safety and effectiveness. To inform current policy, I reexamine the philosophical rationale for restricting new medicines to clinical trials, at any stage and for any population of patients (which resides in the precautionary principle), to (...) show that its objective to protect public health, now or in the future, could soon be defeated in a pandemic. Providing wider therapeutic access and coordinating observations and natural experiments, including service delivery by cluster (wedged cluster trials), may provide such a balance. However, there are important questions of fairness to resolve before any such research can proceed. (shrink)
Jansen and Wall suggest a new way of defending hard paternalism in clinical research. They argue that non-therapeutic research exposing people to more than minimal risk should be banned on egalitarian grounds: in preventing poor decision-makers from making bad decisions, we will promote equality of welfare. We argue that their proposal is flawed for four reasons.First, the idea of poor decision-makers is much more problematic than Jansen and Wall allow. Second, pace Jansen and Wall, it may be practicable for regulators (...) to uncover the values that a potential research participant holds when agreeing to enter a research project, so their claim that we must ban such research projects for all if we are to ban them for poor decision-makers looks to be unmotivated. Third, there seem to be cases where the liberty to enter the sort of research project Jansen and Wall discuss is morally weighty, and arguably should outweigh concerns of egalitarian distribution. Fourth, banning certain types of research, which seem on the face of it to offer an unfavourable risk-benefit ratio, would have unwelcome consequences for all clinical research, which Jansen and Wall do not recognize. (shrink)
The aim of this article is to examine whether informational manipulation, used intentionally by the researcher to increase recruitment in the research study, can be morally acceptable. We argue that this question is better answered by following a non-normative account, according to which the ethical justifiability of informational manipulation should not be relevant to its definition. The most appropriate criterion by which informational manipulation should be considered as morally acceptable or not is the researcher’s special moral duties towards their subjects. (...) We also propose that a broader definition of manipulation of information should be adopted (than that already existing in the literature) since informational manipulation can affect not only a person’s beliefs but also their desires in decision-making. We conclude that manipulation of information can either be used to protect the potential subject and facilitate the informed consent process or be used to exploit and merely use a person for scientific goals. (shrink)
Health-related Quality of Life measures have recently been attacked from two directions, both of which criticize the preference-based method of evaluating health states they typically incorporate. One attack, based on work by Daniel Kahneman and others, argues that ‘experience’ is a better basis for evaluation. The other, inspired by Amartya Sen, argues that ‘capability’ should be the guiding concept. In addition, opinion differs as to whether health evaluation measures are best derived from consultations with the general public, with patients, or (...) with health professionals. And there is disagreement about whether these opinions should be solicited individually and aggregated, or derived instead from a process of collective deliberation. These distinctions yield a wide variety of possible approaches, with potentially differing policy implications. We consider some areas of disagreement between some of these approaches. We show that many of the perspectives seem to capture something important, such that it may be a mistake to reject any of them. Instead we suggest that some of the existing ‘instruments’ designed to measure HR QoLs may in fact successfully already combine these attributes, and with further refinement such instruments may be able to provide a reasonable reconciliation between the perspectives. (shrink)
Cluster randomized controlled trials (cluster RCTs) randomize whole clusters of individuals in testing two or more competing interventions. Here we will present the ethical problems raised by cluster RCTs concerning their effect on inequality. We argue that some inequalities generated by cluster RCTs are larger in scope than those generated from individual RCTs. We also argue that any cluster RCT-generated inequalities, which divide groups rather than individuals, are more problematic in type than the inequalities created in individual RCTs. These concerns (...) should be taken into consideration when designing research at the cluster level, and those conducting the research should consider modified research design strategies in cases where they believe the risk of generating inequalities is large. (shrink)
Current orthodoxy in research ethics assumes that subjects of clinical trials reserve rights to withdraw at any time and without giving any reason. This view sees the right to withdraw as a simple extension of the right to refuse to participate all together. In this paper, however, I suggest that subjects should assume some responsibilities for the internal validity of the trial at consent and that these responsibilities should be captured by contract. This would allow the researcher to impose a (...) penalty on the subject if he were to withdraw without good reason and on a whim. This proposal still leaves open the possibility of withdrawing without penalty when it is in the subject's best interests to do so. Giving researchers recourse to legal remedy may now be necessary to protect the science, as existing methods used to increase retention are inadequate for one reason or another. (shrink)
Part 5, the concluding essay in the series describing and discussing the role, remit and function of research ethics committees, bases an enquiry into the nature of decision-making by research ethics committees on the processes followed by the committees in their deliberations leading to the final outcome.