Offering Lottery Entry as an Incentive for Research Participation Compromises Informed Consent.

This paper argues that offering entry into a lottery as an incentive to those who participate in research studies represents a challenge to the principle of informed, coercion-free consent that is considered an essential ingredient of permissible recruitment to studies. This is, first, because information about the chances of winning in this context is normally unavailable to potential participants and, without this, they cannot accurately weigh up the risks and potential benefits of participation. Second, even when this information is available, such an incentive capitalizes, I contend, on the difficulty of weighing up small probabilities, exploiting the fact that people tend to be beset by cognitive biases that make it challenging to make decisions rationally. The resulting conclusion is that we should not view lotteries as more ethical than simply paying participants, when the latter is feasible.

Potential research participants' use of information during the consent process: A qualitative pilot study of patients enrolled in a clinical trial.

There is increasing evidence that clinical trial participants are uninformed about the trials in which they participate, raising ethical concerns regarding informed consent. The aim of this pilot study was to explore clinical trial participants' use of consent discussions and information sheets when considering participating in clinical trials research. A qualitative, interview-based pilot study was designed in order to elicit, through dialogue, details of the reasons for participants' use of, and preferences regarding, different modes of information provision. Semi-structured interviews were undertaken with two different groups of patients who were participants in the Reinforcement of Closure of Stoma Site trial. The first group comprised newly-consented trial participants, who had been recruited up to 72 hours before our interview; the second group comprised patients attending a follow-up clinic 12 months after joining the trial. Thirteen participants were recruited in total: three newly-consented patients, and ten follow-up patients. The study found that participants' use of consent discussions to gain information about clinical trials was varied, and that they only minimally used information sheets after providing initial consent for the trial. Participants demonstrated varying degrees of knowledge about the trial, with some having forgotten that they were still involved in the trial. Participants reported a high level of trust in medical staff as a reason for not seeking more information about the trial. Some participants reported dissatisfaction with the timing of information provision. Some were amenable to novel ways of receiving trial information, such as web-based methods. The pilot study demonstrated the feasibility of a larger study into the provision of information to prospective clinical trial participants. The results suggest that considering alternative ways of providing information and the appropriateness of existing information provision may be acceptable to and useful for potential trial participants.

Is the four quadrant approach to military medical ethics a cargo cult? A call for more unity between philosophers and practitioners.

Moral theory should be practically useful, but without oversight from the philosophical community, the practical application of ethics by other institutions such as the military may drift into forms that are not theoretically robust. Ethical approaches that drift in this way run the risk of becoming 'cargo cults': simulations that will never properly fulfil their intended purpose. The four quadrant approach, a systematic method of ethical analysis that applies moral principles to clinical cases, has gained popularity in the last 10 years in a variety of medical contexts, especially the military. This paper considers whether the four quadrant approach is a cargo cult or whether it has theoretical value, with particular reference to the more popular four principles approach. This analysis concludes that the four quadrant approach has theoretical advantages over the four principles approach, if used in the right way (namely, with all four quadrants being used). The principal advantage is that the four quadrant approach leaves more room for clinical judgement, and thus avoids the charge of being too algorithmic, which has been levelled at the four principles approach. I suggest that it is the fourth quadrant, which invites the user to consider wider, contextual features of the case, which gives the approach this key advantage. Finally, I make a more general proposal that theoretical ethicists should work closely with those practitioners who apply ethics in the world, and I call for a symbiotic relationship between these two camps.