Scandals, Ethics, and Regulatory Change in Biomedical Research

Abstract

This paper explores how a particular form of regulation--prior ethical review of research--developed over time in a specific context, testing the claims of standard explanations for such change (which center on the role of exogenous shocks in the form of research scandals) against more recent theoretical approaches to institutional changes, which emphasize the role of gradual change. To makes its case, the paper draws on archival and interview material focusing on the research ethics review system in the UK National Health Service. Key insights center on the minimal role scandals play in shaping changes in this regulatory setting and how these depend upon the absence of a single coherent profession (and accompanying social contract) associated with biomedical research.

From “a Fair Game” to “a Form of Covert Research”: Research Ethics Committee Members’ Differing Notions of Consent and Potential Risk to Participants Within Social Media Research

“…However, different views on the publicly available nature of SM platforms and the perceived privacy of SM users present an ethically gray area for research ethics committees (RECs) charged with ensuring that research using SM data is conducted responsibly and ethically. 1 Ordinarily, researchers’ responsibilities to their research participants are outlined in a range of disciplinary codes of conduct (BERA: British Psychological Society [BPS], 2010; Jones, 2011), and in the off-line context, these responsibilities have clear boundaries that are familiar to researchers and RECs alike (Hedgecoe, 2016). However, in the context of SM research, new challenges that obscure the “fundamental rights of human dignity, autonomy, protection, safety, maximization of benefits and minimization of harms” (Markham & Buchanan, 2012, p. 4) are presented that render familiar ethical principles considerably less so.…”

The making of RECs as health research regulators

“…In this chapter, I have argued that while the value and REC role (or responsibility) of research promotion has emerged as a recent statutory phenomenon in health research regulation, perhaps as a kind of beacon to encourage a more proportionate or streamlined approach to regulating health research, it has nevertheless existed throughout the history of RECs, appearing in various disguises alongside the role of participant protection. I have also argued that, having become entrenched in the regulation of health research for more than half a century, and through 'steady, incremental institutional change', 162 RECs are now governed by the government and by central regulatory agencies, administrative staff and offices, standardized forms and communications, lengthy governance arrangements, 163 and SOPs-the latest version of which stands at a daunting 302 pages. 164 As advisory but fundamentally research gatekeeping bodies, RECs are a key node situated in the health research regulatory space.…”

‘Becoming-with’ a repeat healthy volunteer: Managing and negotiating trust among repeat healthy volunteers in commercial clinical drug trials

“…This signifies a key moment in the history of clinical trials, highlighting the impact of abuse and need for humans rights in medical research (GAWMA, 2014). Whilst there have been numerous failings (Hedgecoe, 2017), a thrust of the declaration was the need to end paternalistic practices in clinical trials, encourage agency and restore public trust by ensuring voluntary involvement and informed consent. Today, these processes are established emblems of good research and a basis for public trust.…”