Research involving human subjects is much more stringently regulated than many other nonresearch activities that appear to be at least as risky. A number of prominent figures now argue that research is overregulated. We argue that the reasons typically offered to justify the present system of research regulation fail to show that research should be subject to more stringent regulation than other equally risky activities. However, there are three often overlooked reasons for thinking that research should be treated as a (...) special case. First, research typically involves the imposition of risk on people who do not benefit from this risk imposition. Second, research depends on public trust. Third, the complexity of the moral decision making required favors ethics committees as a regulative solution for research. (shrink)

A probabilistic explication is offered of equipoise and uncertainty in clinical trials. In order to be useful in the justification of clinical trials, equipoise has to be interpreted in terms of overlapping probability distributions of possible treatment outcomes, rather than point estimates representing expectation values. Uncertainty about treatment outcomes is shown to be a necessary but insufficient condition for the ethical defensibility of clinical trials. Additional requirements are proposed for the nature of that uncertainty. The indecisiveness of our criteria for (...) cautious decision-making under uncertainty creates the leeway that makes clinical trials defensible. (shrink)

It is widely maintained that a clinical trial is ethical only if some form of equipoise between the treatments being compared obtains. To be in equipoise between two treatments A and B is to be cognitively indifferent between the statement ‘A is strictly more effective than B’ and its negation. It is natural to claim that equipoise regarding A and B is necessary for randomised assignment to treatments A and B to be beneficent and non‐maleficent and is sufficient for such (...) an assignment to be fair. Cashing this out precisely is difficult, and various forms of equipoise have been discussed which consider whose equipoise is relevant to the decision. This is to make judgement of equipoise something to be managed socially, while its prima facie significance is supposedly cognitive. Recent reconstructions of equipoise‐like concepts in epistemology give clues about how to understand equipoise cognitively. In this paper I examine some of this work and discuss how successful it has been. I suggest that while this work is promising, it still has far to go, and that while equipoise remains the best theory we have of the cognitive justification for clinical trials, it is nonetheless incoherent. (shrink)

To examine the ethical issues involved in governmental decisions with potential health risks, we review the history of the decision to raise the interurban speed limit in Israel in light of its impact on road death and injury. In 1993, the Israeli Ministry of Transportation initiated an “experiment” to raise the interurban speed limit from 90 to 100 kph. The “experiment” did not include a protocol and did not specify cut-off points for early termination in the case of adverse results. (...) After the raise in the speed limit, the death toll on interurban roads rose as a result of a sudden increase in speeds and case fatality rates. The committee's decision is a case study in unfettered human experimentation and public health risks when the setting is non-medical and lacks a defined ethical framework. The case study states the case for extending Helsinki type safeguards to experimentation in non-medical settings. (shrink)

Research is subject to more stringent ethical requirements than most other human activities, and a procedure that is otherwise allowed may be forbidden in research. Hence, risk-taking is more restricted in scientific research than in most non-research contexts, and privacy is better protected in scientific questionnaires than in marketing surveys. Potential arguments for this difference are scrutinized. The case in its favour appears to be weak. A stronger case can be made in favour of a difference in the opposite direction: (...) If perilous or otherwise problematic activities have to be performed it is usually better to perform them in a research context where they are properly evaluated so that guidance is obtained for the future. However, retreating from current ethical demands on research is not a desirable direction to go. Instead, research ethics can serve to inspire the introduction of more stringent ethical principles in other social sectors. (shrink)