The making of RECs as health research regulators

Abstract

Member States' national regulations. This next-generation health research regulatory reform is designed to be 'streamlined'-attuned and proportionate, calibrated to the 'scale and complexity of the research proposed'. 2 The tone of the current regulatory era is reflected in the HRA's RES, which, as noted in the previous chapter, states on its website: 'We have a duty to provide an efficient and robust ethics review service that maximises UK competitiveness for health research and maximises the return from investment in the UK, while protecting participants and researchers.' 3 This appeal to efficiency and a 'duty' to maximize UK competitiveness for health research and maximize the return from investment in the UK reflects an increasingly neoliberal discourse in government policy grounded in regulatory speed and considers economic optimization the central aim of governance. The research community largely seems satisfied with the most recent reforms. The number of academic articles lamenting the state of ethics review in the UK has dwindled and transformed into praise; many look at the UK's ethics review system today with envy, viewing it as comparatively highly coordinated, efficient, and robust. 4 But what do these regulatory reforms tell us about the nature of next-generation health research regulation and what its impact might be on RECs, to say nothing of its impact on research participants and publics? With the creation of the HRA in late 2011, the statutory rules promulgated under the Care Act 2014, and ensuing changes in regulatory instruments governing RECs, a key question arises: does instantiation of research promotion in law and at the governmental level of health research regulatory bodies have a trickle-down effect that impacts the day-today practices of individual, 'independent' RECs? Or, is law now merely reflecting a long-standing everyday practice of RECs? More broadly, has anything really changed in how ethics 'is done' by RECs, or have the changes only been at a higher, more overtly political level of legal and regulatory architecture? 2 GAfREC para 3.2.4.