Regulation and governance of medical research is frequently criticised by researchers. In this paper, we draw on Everett Hughes’ concepts of professional licence and professional mandate, and on contemporary sociological theory on risk regulation, to explain the emergence of research governance and the kinds of criticism it receives. We offer explanations for researcher criticism of the rules and practices of research governance, suggesting that these are perceived as interference in their mandate. We argue that, in spite of their complaints, researchers (...) benefit from the institutions of governance and regulation, in particular by the ways in which regulation secures the social licence for research. While it is difficult to answer questions such as: “Is medical research over-regulated?” and “Does the regulation of medical research successfully protect patients or promote ethical conduct?”, a close analysis of the social functions of research governance and its relationship to risk, trust, and confidence permits us to pose these questions in a more illuminating way. (shrink)

We analysed research ethics committee (REC) letters. We found that RECs frequently identify process errors in applications from researchers that are not deemed “favourable” at first review. Errors include procedural violations (identified in 74% of all applications), missing information (68%), slip-ups (44%) and discrepancies (25%). Important questions arise about why the level of error identified by RECs is so high, and about how errors of different types should be handled.

New models of data governance for health data are a focus of growing interest in an era of challenge to the social licence. In this article, we reflect on what the data trust model, which is founded on principles of participatory governance, can learn from experiences of involving and engagement of members of the public and participants in the governance of large-scale biobanks. We distinguish between upstream and ongoing governance models, showing how they require careful design and operation if they (...) are to deliver on aspirations for deliberation and participation. Drawing on this learning, we identify a set of considerations important to future design for data trusts as they seek to ensure just, proportionate and fair governance. These considerations relate to the timing of involvement of participants, patterns of inclusion and exclusion, and responsiveness to stakeholder involvement and engagement. We emphasise that the evolution of governance models for data should be matched by a commitment to evaluation. (shrink)

There has been longstanding interest in the consistency of decisions made by research ethics committees in the UK, but most of the evidence has come from single studies submitted to multiple committees. A systematic comparison was carried out of the decisions made on 18 purposively selected applications, each of which was reviewed independently by three different RECs in a single strategic health authority. Decisions on 11 applications were consistent, but disparities were found among RECs on decisions on seven applications. An (...) analysis of the agreement between decisions of RECs yielded an overall measure of agreement of κ = 0.286 , indicating a level of agreement that, although probably better than chance, may be described as “slight”. The small sample size limits the robustness of these findings. Further research on reasons for inconsistencies in decision making between RECs, and on the importance of such inconsistencies for a range of arguments, is needed. (shrink)

Public health and service delivery programmes, interventions and policies (collectively, ‘programmes’) are typically developed and implemented for the primary purpose of effecting change rather than generating knowledge. Nonetheless, evaluations of these programmes may produce valuable learning that helps determine effectiveness and costs as well as informing design and implementation of future programmes. Such studies might be termed ‘opportunistic evaluations’, since they are responsive to emergent opportunities rather than being studies of interventions that are initiated or designed by researchers. However, current (...) ethical guidance and registration procedures make little allowance for scenarios where researchers have played no role in the development or implementation of a programme, but nevertheless plan to conduct a prospective evaluation. We explore the limitations of the guidance and procedures with respect to opportunistic evaluations, providing a number of examples. We propose that one key missing distinction in current guidance is moral responsibility: researchers can only be held accountable for those aspects of a study over which they have control. We argue that requiring researchers to justify an intervention, programme or policy that would occur regardless of their involvement prevents or hinders research in the public interest without providing any further protections to research participants. We recommend that trial consent and ethics procedures allow for a clear separation of responsibilities for the intervention and the evaluation. (shrink)

Research Ethics Committees (RECs) are frequently a focus of complaints from researchers, but evidence about the operation and decisions of RECs tends to be anecdotal. We conducted a systematic study to identify and compare the ethical issues raised in 54 letters to researchers about the same 18 applications submitted to three RECs over one year. The most common type of ethical trouble identified in REC letters related to informed consent, followed by scientific design and conduct, care and protection of research (...) participants, confidentiality, recruitment and documentation. Community considerations were least frequently raised. There was evidence of variability in the ethical troubles identified and the remedies recommended. This analysis suggests that some principles may be more institutionalized than others, and offers some evidence of inconsistency between RECs. Inconsistency is often treated as evidence of incompetence and caprice, but a more sophisticated understanding of the role of RECs and their functioning is required. (shrink)

Two separate regulatory regimes govern research with adults who lack capacity to consent in England and Wales: the Mental Capacity Act (MCA) 2005 and the Medicines for Human Use (Clinical Trials) Regulations 2004 (“the Regulations”). A service evaluation was conducted to investigate how research ethics committees (RECs) are interpreting the requirements. With the use of a coding scheme and qualitative software, a sample of REC decision letters where applicants indicated that their project involved adults who lacked mental capacity was analysed. (...) The analysis focuses on 45 letters about projects covered by the MCA and 12 letters about projects covered by the Regulations. The legal requirements for involving incapacitated adults in research were not consistently interpreted correctly. Letters often lacked explicitness and clarity. Neither consent nor assent from third parties is a legally valid concept for purposes of the MCA, yet they were suggested or endorsed in 10 post-MCA letters, and there was evidence of confusion about the consultee processes. The correct terms were also not consistently used in relation to clinical trials. Inappropriate use of terms such as “relative” had the potential to exclude people eligible to be consulted. Unless the correct terms and legal concepts are used in research projects, there is potential for confusion and for exclusion of people who are eligible to be consulted about involvement of adults who lack capacity. Improved clarity, explicitness and accuracy are needed when submitting and reviewing applications for ethical review of research in this area. (shrink)

Commentators frequently point to the involvement of biomedicine and bio-science in the objectification and commodification of human body parts, and the consequent potential for violation of personal, social and community meanings. Through a study of UK media coverage of controversies associated with the removal of body parts and human materials from children, we argue that an exclusive emphasis on the role of medicine and the bio-sciences in the commodification of human materials ignores the important role played by commercially motivated mass (...) media organizations. Analysis of the language of news reports covering the period of the organ retention controversies in the UK reveals the ways in which the mass media contribute to the commodification of body parts by recruiting them for use in the manufacture of a media scandal. This is achieved through use of horror language, the fetishization of certain body parts, emphasis on the fragmentation of the body, and the use of a variety of rhetorical devices to convey enormity and massive scale. Media participation in the commodification of children's body parts has profound implications for practices and policies in relation to use of body parts, and has significantly influenced the governmental regulation of science and medicine. The role of mass media deserves fuller recognition by theorists of body commodification. (shrink)

Objectives To conduct an independent evaluation of the first phase of the Health Foundation’s Safer Patients Initiative (SPI), and to identify the net additional effect of SPI and any differences in changes in participating and non-participating NHS hospitals. Design Mixed method evaluation involving five substudies, before and after design. Setting NHS hospitals in the United Kingdom. Participants Four hospitals (one in each country in the UK) participating in the first phase of the SPI (SPI1); 18 control hospitals. Intervention The SPI1 (...) was a compound (multi-component) organisational intervention delivered over 18 months that focused on improving the reliability of specific frontline care processes in designated clinical specialties and promoting organisational and cultural change. Results Senior staff members were knowledgeable and enthusiastic about SPI1. There was a small (0.08 points on a 5 point scale) but significant (P<0.01) effect in favour of the SPI1 hospitals in one of 11 dimensions of the staff questionnaire (organisational climate). Qualitative evidence showed only modest penetration of SPI1 at medical ward level. Although SPI1 was designed to engage staff from the bottom up, it did not usually feel like this to those working on the wards, and questions about legitimacy of some aspects of SPI1 were raised. Of the five components to identify patients at risk of deterioration—monitoring of vital signs (14 items); routine tests (three items); evidence based standards specific to certain diseases (three items); prescribing errors (multiple items from the British National Formulary); and medical history taking (11 items)—there was little net difference between control and SPI1 hospitals, except in relation to quality of monitoring of acute medical patients, which improved on average over time across all hospitals. Recording of respiratory rate increased to a greater degree in SPI1 than in control hospitals; in the second six hours after admission recording increased from 40% (93) to 69% (165) in control hospitals and from 37% (141) to 78% (296) in SPI1 hospitals (odds ratio for “difference in difference” 2.1, 99% confidence interval 1.0 to 4.3; P=0.008). Use of a formal scoring system for patients with pneumonia also increased over time (from 2% (102) to 23% (111) in control hospitals and from 2% (170) to 9% (189) in SPI1 hospitals), which favoured controls and was not significant (0.3, 0.02 to 3.4; P=0.173). There were no improvements in the proportion of prescription errors and no effects that could be attributed to SPI1 in non-targeted generic areas (such as enhanced safety culture). On some measures, the lack of effect could be because compliance was already high at baseline (such as use of steroids in over 85% of cases where indicated), but even when there was more room for improvement (such as in quality of medical history taking), there was no significant additional net effect of SPI1. There were no changes over time or between control and SPI1 hospitals in errors or rates of adverse events in patients in medical wards. Mortality increased from 11% (27) to 16% (39) among controls and decreased from 17% (63) to 13% (49) among SPI1 hospitals, but the risk adjusted difference was not significant (0.5, 0.2 to 1.4; P=0.085). Poor care was a contributing factor in four of the 178 deaths identified by review of case notes. The survey of patients showed no significant differences apart from an increase in perception of cleanliness in favour of SPI1 hospitals. Conclusions The introduction of SPI1 was associated with improvements in one of the types of clinical process studied (monitoring of vital signs) and one measure of staff perceptions of organisational climate. There was no additional effect of SPI1 on other targeted issues nor on other measures of generic organisational strengthening. (shrink)

Biomedical research increasingly relies on long-term studies involving use and re-use of biological samples and data stored in large repositories or “biobanks” over lengthy periods, often raising questions about whether and when a re-consenting process should be activated. We sought to investigate the views on re-consent of participants in a longitudinal biobank. We conducted a qualitative study involving interviews with 24 people who were participating in a longitudinal biobank. Their views were elicited using a semi-structured interview schedule and scenarios based (...) on a hypothetical biobank. Data analysis was based on the constant comparative method. What participants identified as requiring new consent was not a straightforward matter predictable by algorithms about the scope of the consent, but instead was contingent. They assessed whether proposed new research implied a fundamental alteration in the underlying character of the biobank and whether specific projects were within the scope of the original consent. What mattered most to them was that the cooperative bargain into which they had entered was maintained in good faith. They saw re-consent as one important safeguard in this bargain. In determining what required re-consent, they deployed two logics. First, they used a logic of boundaries, where they sought to detect any possible rupture with their existing framework of cooperation. Second, they used a logic of risk, where they assessed proposed research for any potential threats for them personally or the research endeavour. When they judged that a need for re-consent had been activated, participants saw the process as way of re-actualising and renewing the cooperative bargain. Participants’ perceptions of research as a process of mutual co-operation between volunteer and researcher were fundamental to their views on consent. Consenting arrangements for biobanks should respect the cooperative values that are important to participants, recognise the two logics used by research volunteers, and avoid rigidity. Agility may be favoured by tiered consent combined with strong oversight mechanisms; this approach requires evaluation. (shrink)

Although there has been critical analysis of how the informed consent process functions in relation to participation in research and particular ethical 'dilemmas', there has been little examination of consenting to more routine medical procedures. We report a qualitative study of 25 women who consented to surgery. Of these, nine were ambivalent or opposed to having an operation. When faced with a consent form, women's accounts suggest that they rarely do anything other than obey professionals' requests for a signature. An (...) interactionist analysis suggests that women's capacity to act is reduced by the hospital structure of tacit, socially-imposed rules of conduct. Bourdieu's concepts of habitus, capital and symbolic power/violence show how the practical logic that women apply confers a 'sense of place' relative to professionals. Women experience deficits in capital that constrain their ability to exercise choice. This work demonstrates the weakness of the consent process as a safeguard of autonomy. (shrink)

Disquiet about the research ethics review process has, historically, been anecdotal and often takes the form of ‘atrocity stories’ from researchers about the bureaucratic nature of the application process or inconsistency and capriciousness in decision-making. However, systematic evidence has often been lacking. We analysed 100 decision letters written by NHS research ethics committees (RECs). We found evidence of poor communication in the way in which REC decisions were conveyed to applicants. Typos and grammatical mistakes were found in almost 30% of (...) letters; sometimes wording was impolite and demonstrated a lack of respect towards applicants; and there was often lack of clarity about the nature of a revision and whether the revision was compulsory or optional. The analysis provides messages for RECs about how they can improve their practices to establish a more cooperative relationship between researcher and committee through the careful use of language and attention to detail in decision letters. (shrink)

Bioethics, Volume 36, Issue 4, Page 434-444, May 2022.

Asymptomatic COVID‐19 testing programmes are being introduced in higher education institutions, but stakeholder views regarding the acceptability of mandating or incentivizing participation remain little understood. A mixed‐method study (semi‐structured interviews and a survey including open and closed questions) was undertaken in a case study university with a student testing programme. Survey data were analysed descriptively; analysis for interviews was based on the framework method. Two hundred and thirty‐nine people participated in the study: 213 in the survey (189 students, 24 staff), (...) and 26 in interviews (19 students, 7 staff). There was majority (62%) but not universal support for voluntary participation, with a range of concerns expressed about the potentially negative effects of mandating testing. Those who supported mandatory testing tended to do so on the grounds that it would protect others. There was also majority (64%) opposition to penalties for refusing to test. Views on restricting access to face‐to‐face teaching for non‐participants were polarized. Three‐quarters (75%) supported incentives, though there were some concerns about effectiveness and unintended consequences. Participants emphasized the importance of communication about the potential benefits of testing. Preserving the voluntariness of participation in student asymptomatic testing programmes is likely to be the most ethically sound policy unless circumstances change. (shrink)

Ethical review of applications to conduct research projects continues to be a focus of scrutiny and controversy. We argue that attention to the actual practices of ethical review has the potential to inform debate. We explore how research ethics committees (RECs) establish their position and authority through the texts they use in their correspondence with applicants. Using a discursive analysis applied to 260 letters, we identify four positions of particular interest: RECs positioned as disinterested and responsible; as representing the interests (...) of potential participants; as facilitating ethically sound, high-quality research; and as engaged in dialogue. These positions are used strategically to deflect criticism or complaint. This analysis has implications for reducing contestation between researchers and RECs, suggesting that more dialogic rather than hierarchical approaches to positioning might be helpful. (shrink)

In a recent issue of Journal of Medical Ethics (JME), we discussed the ethical review of evaluations of interventions that would occur whether or not the evaluation was taking place. We concluded that standard research ethics frameworks including the Ottawa Statement, which requires justification for all aspects of an intervention and its roll-out, were a poor guide in this area. We proposed that a consideration of researcher responsibility, based on the consequences of the research taking place, would be a more (...) appropriate way delineate the scope of research ethics review. Weijer and Taljaard present a counterargument to our proposal, which we address in this reply. They claim that a focus on researcher responsibility will weaken the protection of research participants and link it to ‘unethical research’ and a ‘government experimenting on its own people’. However, the moral responsibility of researchers is defined in terms of the consequences of the research on human welfare and harm, not in opposition to it. Weijer and Taljaard argue that researchers must justify what they are studying whether or not they have any control over it and that governments must justify their programmes, including by demonstrating equipoise, to a research ethics committee if they implement them in a randomised way. We strongly disagree that this is a defensible way to define the scope of research ethics review and argue that this provides no further protections to research participants beyond what we propose, but places a potential barrier to learning from government programmes. (shrink)