Abstract
In the first issue of Volume 8, we are excited to offer readers insight into emerging debates in research ethics and to facilitate advancement of the discipline. Here, we present new and stimulating arguments relating to ways in which information is framed and presented to subjects of research at consent. The first article, written by Sapfo Lignou, presents the case for the ethical manipulation of information researchers present to potential research subjects (but not often, if ever, in an attempt to increase recruitment to their studies). The concept of manipulation has become topical (although still under-researched from a philosophical point of view) in the area of public health policy following publication of the book, Nudge: Improving Decisions about Health, Wealth, and Happiness, written by Richard Thaler and Cass Sunstein in 2008. Current thinking in research ethics has tended to categorise the choices potential subjects make rather crudely as either valid or invalid according to whether they are autonomous or coerced, respectively. Some forms of manipulation might sit somewhere in between these two conceptual extremes, involving the subtle use of psychological pressure which escapes traditional analysis of complete freedom and of strict coercion. The concept of the nudge is also highly relevant in research ethics, although the results of a rigourous analysis of it might emerge rather differently than it might in the case of health promotion. This article therefore opens up a whole new area of discussion and debate.
Again on the topic of presenting information in research, Isabelle Budin-Ljøsne reviews the ethical frameworks for disclosing personal results of genetic tests to the subjects of research in population studies. The practice of routinely disclosing personal results is generally thought unnecessary or even undesirable, so this review is a useful exercise in testing our intuitions and thinking critically about accepted policy.
The third article, by Zisis Kozladkidis and colleagues, examines the unintended consequences of strict and demanding policies on consent to donate tissue for biobanks. These consequences relate to how representative are subsequent clinical trials and on our ability to readdress existing health inequalities through scientific progress. By always requiring opt in and narrow consent specific to each project no matter how similar in scientific objectives they might be, a programme of research will tend to become artificially restricted along lines of ethnic minorities. This lack of representation will feed into later clinical trials, as they will be based on samples taken from these restricted biobanks. The minorities in question also tend to suffer more ill health than others, so that underlying health inequalities are likely to be exacerbated by scientific advance. This is especially true in the age of pharmaco-genetics, where treatments are tailored to be effective in certain genetic subgroups. The authors suggest that such strict policies should be reconsidered and that a better balance could be struck by ethics committees which review biobank applications. They could approve opt-out or even presumed consent in some cases where the existing health inequality is a serious problem.
The last original article by Stephen Humphreys picks up the problem of regulating new medical devices and assessing their safety before they become widely available on the market. This problem is especially topical in the wake of cases reported in the media. These cases include manufacturing difficulties with breast implants which used non-medical grade silicon and safety concerns with metal on metal hip replacements.
For our piece under Topics, Susan Kerrison examines the existing rules associated with compensating research subjects for injuries they have incurred during the course of a clinical trial. She suggests that there are too many barriers to claiming what is arguably due to them. As well as a report on a recent workshop, there are two analyses of cases, and a new study for readers to think about.
As always, we would encourage you to respond to the articles and their arguments by writing in. In the next issue, we have some commentaries on articles published in the special issue last year on ethics review of social science. Enjoy.