Centralised, compliance-focused approaches to research ethics have been normalised in practice. In this paper, we argue that the dominance of such systems has been driven by neoliberal approaches to governance, where the focus on controlling and individualising risk has led to an overemphasis of decontextualised ethical principles and the conflation of ethical requirements with the documentation of ‘informed consent’. Using a UK-based case study, involving a point-of-care-genetic test as an illustration, we argue that rather than ensuring ethical practice such compliance-focused (...) approaches may obstruct valuable research. We call for an approach that encourages researchers and research communities—including regulators, ethics committees, funders and publishers of academic research—to acquire skills to make morally appropriate decisions, and not base decision-making solely on compliance with prescriptive regulations. We call this ‘ethical preparedness’ and outline how a research ethics system might make space for this approach. (shrink)

We thank Parker and Wright for engaging in this roundtable debate in such a spirited way. The ‘Pharmacogenetic [test] to Avoid Loss of Hearing’ Trial is the first time a genetic point of care test has been applied in the acute neonatal setting; therefore, it is not surprising that questions have been raised which require debate, discussion and clarification. Parker and Wright misattribute several assumptions to the roundtable authors, which we would like to clarify here. Since they raise wider questions (...) about the PALOH trial itself, several of the roundtable discussants have made a joint response. (shrink)

Epidemics, the medical historian Charles Rosenberg argued, typically have four Acts, as in a play. In Act I, which he termed ‘Progressive revelation’, ‘merchants’, ‘municipal authorities’ and ‘the complacency of ordinary men and women’, alike are reluctant to acknowledge an epidemic because of its threat to their ‘economic and institutional interests’ and to ‘their accustomed way of doing things’: gradually however, ‘inexorably accumulating deaths and sicknesses’ bring ‘ultimate, if unwilling, recognition’. In Act II, ‘Managing randomness’, ‘collective agreement’ is sought on (...) an ‘explanatory framework’ to manage the epidemic’s ‘dismaying arbitrariness’. Such frameworks, in previous centuries mainly religious, are now more ‘secular and mechanistic’, but again also moral and social: explanation for example of the ‘differential susceptibility of particular individuals’ is sought in terms of ‘risk-enhancing behaviour’ and ‘style of life’, but also of environmental and social factors, such as ‘residence and occupation’, providing ‘a vehicle for social criticism as well as a rationale for social control’. In Act III, ‘Negotiating public response’, pressure is generated for ‘decisive and visible community response’, often taking the form of ‘collective rites integrating cognitive and emotional elements’. Such rites, including not only ‘the imposition of a quarantine’ and ‘procedures to cleanse and disinfect’, but also religious, or now more often moral or social rituals, afford ‘the reassurance of familiar frames of explanation and logically consequent policies that provide both meaning and the promise of efficacy’. Finally, In Act IV, ‘Subsidence and retrospection’, ‘incidence of the disease gradually declines’, and questions are raised ‘for retrospective moral judgement’ about ‘what “lasting impact” particular incidents have had and what “lessons” have been learnt. Have the dead died in vain? Has a heedless society reverted to its accustomed ways of doing things as soon as denial became once more a …. (shrink)