The Role of Research Ethics Committees and of the Law in the Ethical Review of Medical Research: a Critical Discussion

Abstract The year 1966 saw the birth of Sweden’s first formal Research Ethics Committee (rec) at the medical university Karolinska Institute (ki). In the following years other ethical committees were institutionalized, coordinated by a working group steered by the Swedish Medical Research Council (smrc). Research ethical issues of a principled nature were also discussed by the Ethics Delegation of the Swedish Society of Medicine (ssm). Between 1966 and 1975, around 500 research proposals were assessed by rec s in Sweden, and the medical community started to follow certain protocols when preparing applications for ethical review. This paper traces the origins and early development of the rec system in Sweden and offers an analysis of their practices, discussions, and assessments through the reading of meeting protocols and correspondence between central actors. The aim is to sketch out how and why the system of research ethics committees emerged, became institutionalized, and developed in Sweden from the 1960s to the early 1980s. This paper connects to the recent empirical turn in historical research on medical research ethics and regulations, by focusing on how the insiders, i.e., the medical community, reacted to new demands of ethical review. The analysis illustrates how the medical researchers interacted with transnational funders, the Patients Association, a broader public, governmental authorities, and parliamentary politics when developing the Swedish rec system.

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Ethical review of COVID-19 research in the Netherlands; a mixed-method evaluation among medical research ethics committees and investigators

PLoS ONE ◽

10.1371/journal.pone.0255040 ◽

2021 ◽

Vol 16 (7) ◽

pp. e0255040

Author(s):

R. IJkema ◽

M. J. P. A. Janssens ◽

J. A. M. van der Post ◽

C. M. Licht

Keyword(s):

The Netherlands ◽

Medical Research ◽

Research Ethics ◽

Mixed Method ◽

Ethics Committees ◽

Ethical Review ◽

Research Ethics Committees ◽

Registration System ◽

Medical Research Ethics

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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Philosophers in research ethics committees—what do they think they’re doing? An empirical-ethical analysis

Medicine Health Care and Philosophy ◽

10.1007/s11019-021-10044-1 ◽

2021 ◽

Author(s):

Charlotte Gauckler

Keyword(s):

Research Ethics ◽

Applied Ethics ◽

Ethics Committees ◽

Research Ethics Committees ◽

Structured Interviews ◽

Discussion Section ◽

Philosophical Perspective ◽

Level 3 ◽

Practical Level

AbstractResearch ethics committees in Germany usually don’t have philosophers as members and if so, only contingently, not provided for by statute. This is interesting from a philosophical perspective, assuming that ethics is a discipline of philosophy. It prompts the question what role philosophers play in those committees they can be found in. Eight qualitative semi-structured interviews were conducted to explore the self-perception of philosophers regarding their contribution to research ethics committees. The results show that the participants generally don’t view themselves as ethics experts. They are rather unanimous on the competencies they think they contribute to the committee but not as to whether those are philosophical competencies or applied ethical ones. In some cases they don’t see a big difference between their role and the role of the jurist member. In the discussion section of this paper I bring up three topics, prompted by the interviews, that need to be addressed: (1) I argue that the interviewees’ unwillingness to call themselves ethics experts might have to do with a too narrow understanding of ethics expertise. (2) I argue that the disagreement among the interviewees concerning the relationship between moral philosophy and applied ethics might be explained on a theoretical or on a practical level. (3) I argue that there is some lack of clarity concerning the relationship between ethics and law in research ethics committees and that further work needs to be done here. All three topics, I conclude, need further investigation.

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Human research ethics committees members: ethical review personal perceptions

Bioethics News ◽

10.1007/s40592-021-00130-8 ◽

2021 ◽

Author(s):

Boris Handal ◽

Chris Campbell ◽

Kevin Watson ◽

Marguerite Maher ◽

Keagan Brewer ◽

...

Keyword(s):

Research Ethics ◽

Ethics Committees ◽

Ethical Review ◽

Research Ethics Committees ◽

Human Research ◽

Human Research Ethics ◽

Personal Perceptions

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Justice: a key consideration in health policy and systems research ethics

BMJ Global Health ◽

10.1136/bmjgh-2019-001942 ◽

2020 ◽

Vol 5 (4) ◽

pp. e001942 ◽

Cited By ~ 2

Author(s):

Bridget Pratt ◽

Verina Wild ◽

Edwine Barasa ◽

Dorcas Kamuya ◽

Lucy Gilson ◽

...

Keyword(s):

Health Policy ◽

Research Ethics ◽

Ethics Committees ◽

Ethical Review ◽

Research Ethics Committees ◽

Systems Research ◽

The Social ◽

Principle Of Justice ◽

The Rich ◽

Health Policy And Systems

Health policy and systems research (HPSR) is increasingly being funded and conducted worldwide. There are currently no specific guidelines or criteria for the ethical review and conduct of HPSR. Academic debates on HPSR ethics in the scholarly literature can inform the development of guidelines. Yet there is a deficiency of academic bioethics work relating to justice in HPSR. This gap is especially problematic for a field like HPSR, which can entail studies that intervene in ways affecting the social and health system delivery structures of society. In this paper, we call for interpreting the principle of justice in a more expansive way in developing and reviewing HPSR studies (relative to biomedical research). The principle requires advancing health equity and social justice at population or systems levels. Drawing on the rich justice literature from political philosophy and public health ethics, we propose a set of essential justice considerations to uphold this principle. These considerations are relevant for research funders, researchers, research ethics committees, policymakers, community organisations and others who are active in the HPSR field.

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Should Research Ethics Committees Be Observing the Law or Working by Ethical Principles?

Research Ethics ◽

10.1177/174701610500100105 ◽

2005 ◽

Vol 1 (1) ◽

pp. 23-26 ◽

Cited By ~ 4

Author(s):

Charles Warlow

Keyword(s):

Clinical Research ◽

Research Ethics ◽

Public Interest ◽

Ethics Committees ◽

Unintended Consequences ◽

Research Ethics Committees ◽

Individual Interest ◽

The Public ◽

The Law ◽

The Individual

Recent laws, and their interpretation, have made clinical research more difficult to do, and sometimes impossible. Furthermore the results of that research which can be done may even be unreliable. This is certainly against the public interest, and indeed the individual patient interest as well. But ethics committees have to abide by the law and so even though it is surely unethical to work against the public and individual interest that is exactly what ethics committees now have to endorse. The unintended consequences of the new regulations must be reduced by amending the law.

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