scholarly journals “An Official Conscience and Warranting Agency”: Institutional Isomorphism and the Rise of Dutch Ethics Review in the 1970s and 1980s

Author(s):  
Noortje Jacobs

Abstract Why did medical research involving human subjects, a practice that is arguably as old as medicine itself, come to be regulated by research ethics committees in the late twentieth century? In this essay, I answer this question for the Netherlands, by querying the rise of ethics review in the 1970s and 1980s through the lens of “institutional isomorphism”. Drawing on the classic work of Paul Dimaggio and Walter Powell, I argue that extra-national changes to funding and publishing requirements in this period were identifiably more important for the emergence of ethics review in the Netherlands than were ethical concerns for research misconduct – a process that was marked by definitive elements of internationally coercive, and perhaps also of mimetic isomorphism. In addition, I detail how, as a consequence of these developments, those involved in Dutch ethics review came to consider “variation and inconsistency” as one of the system’s biggest problems in the late 1980s. To remedy this, numerous normative isomorphic attempts were undertaken in the late twentieth century to make all Dutch research ethics committees act in the same way. This emphasis on institutional homogeneity has been borne out in the Netherlands, even though it has repeatedly been criticized for hampering democratic and ethical decision-making.

2020 ◽  
Vol 3 ◽  
pp. 63
Author(s):  
Aileen Sheehy ◽  
Jennifer Ralph James ◽  
Mary Horgan

The surge of coronavirus disease 2019 (COVID-19) research studies involving human participants in response to the pandemic has meant that research ethics committees across the world have been challenged to adapt their processes to meet demand while retaining high standards of review. Ethics review during this pandemic remains essential to ensure the safety, dignity and well-being of research participants, however research ethics committees are now faced with new, and often complex, ethics considerations and logistical challenges. This Open Letter looks specifically at the Irish experience of establishing a national approach to research ethics review amidst a global pandemic. This represents Ireland’s first National Research Ethics Committee, which provided the research community with an expedited and ‘single national opinion’ for ethics review for COVID-related research. The insights gleaned and lessons learned from the Irish experience may inform emergency responses to future pandemics or public health emergencies.


2016 ◽  
Vol 26 (3) ◽  
pp. 378-400 ◽  
Author(s):  
Tehseen Noorani ◽  
Andrew Charlesworth ◽  
Alison Kite ◽  
Morag McDermont

This article illustrates how medicalized epistemologies and methodologies significantly influence the institutional ethical review processes applied to sociolegal research in law schools. It argues this development has elevated particular renderings of mental distress and objectivity to universal definitions, potentially placing a straitjacket on methodological innovation. The authors use two case studies from their experiences as researchers in a UK Law School, alongside a small-scale survey of sociolegal researchers in other UK law schools, to illustrate the problems that can arise in securing ethical approval for sociolegal research, in particular with participatory research designs that mobilize ideas of mental distress and objectivity not premised on conventional medical understandings. The article develops key proposals that the authors feel merit further inquiry. First, there should be a comprehensive evaluation of how the jurisdiction of ethical review for sociolegal research is established. Second, sociolegal scholarship can contribute to debates concerning the discursive, material and procedural constitution of institutional ethics approval processes. Finally, we might rethink the nature of, and relationship between, university-based research ethics committees and National Health Service research ethics committees, by placing both within wider ecologies of capacities for ethical decision-making.


2017 ◽  
Vol 18 (4) ◽  
pp. 341-348 ◽  
Author(s):  
Boitumelo Mokgatla ◽  
Carel IJsselmuiden ◽  
Doug Wassenaar ◽  
Mary Kasule

Ethnography ◽  
2020 ◽  
pp. 146613812098386
Author(s):  
Kirsten Bell ◽  
LL Wynn

Ethnographers’ concerns about institutional ethics review are by now well-known and several hypotheses have been advanced to explain their complaints. Many have highlighted the lack of epistemological fit between ethnographic methods and ethics review paradigms. Others point to the existence of a “victim narrative” and suggest that circulating horror stories are unrepresentative of ethnographers’ experiences, or argue that ethnographers’ complaints disguise a self-interested and un-reflexive desire to avoid oversight. A final explanation suggests that resistance is restricted to an ageing cohort of scholars raised in an era before ethics review became the norm. Drawing on two surveys of ethnographers conducted a decade apart, we conclude that the most convincing explanation for the longstanding “chorus of complaint” is the fundamental epistemological conflict between ethnographic methods and the way ethics review is currently constituted. We conclude that the time has come to radically reframe and restructure ethics review regimes.


2016 ◽  
Vol 17 (1) ◽  
pp. 95-117 ◽  
Author(s):  
Elaine Doyle ◽  
Patrick Buckley

The research ethics review systems within universities evolved from the positivist biomedical model but have expanded to include all non-clinical research involving human subjects. However, the application of the biomedical paradigm to qualitative research often creates significant problems. This article highlights the fundamental differences between biomedical and humanities and social science (HSS) research, illustrating that one size does not fit all when it comes to research ethics review. Recognising the resource constraints faced by many higher level education institutions, we develop a model which encompasses the traditional research ethics concepts without requiring separate oversight procedures. After its original construction based on extent research ethics literature, the model was evolved based on findings from qualitative interviews carried out with expert members of research ethics committees. The model can be adapted to multiple contexts through the application of different levels of tolerance in each domain. Our contribution is twofold: (1) to synthesise from the literature an explicit rationale for differentiating research contexts when it comes to research ethics oversight; and (2) to provide research ethics committees with a workable visual model that can be used to aid decision making in diverse research domains.


PLoS ONE ◽  
2021 ◽  
Vol 16 (7) ◽  
pp. e0255040
Author(s):  
R. IJkema ◽  
M. J. P. A. Janssens ◽  
J. A. M. van der Post ◽  
C. M. Licht

Background During the beginning of the COVID-19 pandemic there was an urgent need for accelerated review of COVID-19 research by Medical Research Ethics Committees (MRECs). In the Netherlands this led to the implementation of so-called ‘fast-track-review-procedures’ (FTRPs) to enable a swift start of urgent and relevant research. The objective of this study is to evaluate FTRPs of MRECs in the Netherlands during the COVID-19 pandemic and to compare them with the regular review procedures (RRPs). Methods and findings An explanatory sequential mixed method study was conducted. Online questionnaires and four group interviews were conducted among MREC representatives and investigators of COVID-19 research. In addition, data from a national research registration system was requested. Main outcome measures are differences in timelines, quality of the review and satisfaction between FTRPs and RRPs. The total number of review days was shorter in FTRP (median 10.5) compared to RRPs (median 98.0). Review days attributable to the MRECs also declined in FTRPs (median 8.0 versus 50.0). This shortening can be explained by installing ad hoc (sub)committees, full priority given to COVID-19 research, regular research put on hold, online review meetings and administrative leniency. The shorter timelines did not affect the perceived quality of the review and ethical and legal aspects were not weighted differently. Both MREC representatives and investigators were generally satisfied with the review of COVID-19 research. Weaknesses identified were the lack of overview of COVID-19 research and central collaboration and coordination, the delay of review of regular research, and limited reachability of secretariats. Conclusions This study shows that accelerated review is feasible during emergency situations. We did not find evidence that review quality was compromised and both investigators and MRECs were content with the FTRP. To improve future medical ethical review during pandemic situations and beyond, distinguishing main and side issues, working digitally, and (inter)national collaboration and coordination are important.


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