Optogenetics is being optimistically presented in contemporary media for its unprecedented capacity to control cell behavior through the application of light to genetically modified target cells. As such, optogenetics holds obvious potential for application in a new generation of invasive medical devices by which to potentially provide treatment for neurological and psychiatric conditions such as Parkinson's disease, addiction, schizophrenia, autism and depression. Design of a first-in-human optogenetics experimental trial has already begun for the treatment of blindness. Optogenetics trials involve a (...) combination of highly invasive genetic and electronic interventions that results in irreversible and permanent modifications of an individual's nervous system. Given its novelty, its uncertain benefit to patients, and its unique risk profile of irreversible physiological alteration, optogenetics requires a reassessment of the ethical challenges for protecting human participants in clinical trials, particularly at formative stages of clinical evaluation. This study explores the evolving ethical issues surrounding optogenetics’ potential harm to participants within trial design, especially focusing on whether Phase 1 trials should incorporate efficacy as well as safety endpoints in ways that are fair and respectful to research trial participants. (shrink)

In her article, Pascale Hess raises the issue of whether her proposed model may be extrapolated and applied to clinical research fields other than stem cell-based interventions in the brain (SCBI-B) (Hess 2012). Broadly summarized, Hess’s model suggests prioritizing efficacy over safety in phase 1 trials involving irreversible interventions in the brain, when clinical criteria meet the appropriate population suffering from “degenerative brain diseases” (Hess 2012). Although there is a need to reconsider the traditional phase 1 model, especially with respect (...) to first-in-human clinical trials involving novel technologies, the question arises as to whether it is appropriate to advocate for a new model that prioritizes efficacy over safety across all phase 1 clinical research trials involving irreversible interventions in the brain. -/- . (shrink)

In this paper we discuss an objection to human cloning which appeals to the welfare of the child. This objection varies according to the sort of harm it is expected the clone will suffer. The three formulations of it that we will consider are: 1. Clones will be harmed by the fearful or prejudicial attitudes people may have about or towards them (H1); 2. Clones will be harmed by the demands and expectations of parents or genotype donors (H2); 3. Clones (...) will be harmed by their own awareness of their origins, for example the knowledge that the genetic donor is a stranger (H3). We will show why these three versions of the child welfare objection do not necessarily supply compelling reasons to ban human reproductive cloning. The claim that we will develop and defend in the course of our discussion is that even if it is the case that a cloned child will suffer harms of the type H1-H3, it is none the less permissible to conceive by cloning so long as these cloning-induced welfare deficits are not such as to blight the existence of the resultant child, whoever this may be. (shrink)

Many doctors these days are aware of powerful disincentives to the giving of specific prognoses. The mentioning of an estimated time, even if heavily qualified, is likely to be heard by both patients and their loved ones as “the doctor gave me two months to live”. The result? Patients and relatives feeling cheated if the prognosis turns out to be an overestimate, anxious or worse if an underestimate, and colleagues critical of the doctor for having had the arrogance to predict, (...) no matter what the actual outcome. It is not surprising therefore that doctors wishing to avoid these results …. (shrink)

Has the time come to put to bed the concept of a harm threshold when discussing the ethics of reproductive decision making and the legal limits that should be placed upon it? In this commentary, we defend the claim that there exist good moral reasons, despite the conclusions of the non-identity problem, based on the interests of those we might create, to refrain from bringing to birth individuals whose lives are often described in the philosophical literature as ‘less than worth (...) living’. (shrink)

Studies of reasoning have often invoked a distinction between a natural or ordinary consideration of the premises, in which they are interpreted, and even distorted, in the light of empirical knowledge, and an analytic or logical consideration of the premises, in which they are analysed in a literal fashion for their logical implications. Two or three years of schooling have been seen as critical for the spontaneous use of analytic reasoning. In two experiments, however, 4-year-olds who were given brief instructions (...) that prompted use of an analytic approach continued to adopt this approach one week later. Thus, when given syllogistic problems in which the major premise was incongruent with their empirical knowledge (e.g. "All snow is black"), instructed children reasoned more accurately from that premise both immediately and a week later as compared to children given only a basic introduction. A third experiment showed that instructions also improved 4-year-olds' performance on hard-to-imagine, abstract material (e.g."All mib is white"). Similarities between the effects of brief instruction and of schooling are discussed. (shrink)

The report from the Organ Donation Taskforce looking at the potential impact of an opt-out system for deceased donor organ donation in the UK, published in November 2008, is probably the most comprehensive and systematic inquiry to date into the issues and considerations which might affect the availability of deceased donor organs for clinical transplantation. By the end of a thorough and transparent process, a clear consensus was reached. The taskforce rejected the idea of an opt-out system. In this article (...) we acknowledge the life saving potential of organ transplants and seek to highlight the difficulties that arise when the issue of organ shortage competes with concerns over choice and authorisation in the context of deceased donor organ donation. (shrink)