scholarly journals Regulating Research: The Origins and Institutionalization of Research Ethics Committees in Sweden

2021 ◽  
pp. 1-20
Author(s):  
Helena Tinnerholm Ljungberg
Keyword(s):  
Medical Research ◽  
Research Ethics ◽  
Ethical Issues ◽  
Ethics Committees ◽  
Medical Community ◽  
Ethical Review ◽  
Research Ethics Committees ◽  
Karolinska Institute ◽  
Swedish Society ◽  
The 1960S

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.

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

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
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.

Guidelines for Ethical Review of Qualitative Research

2005 ◽  
Vol 1 (3) ◽  
pp. 90-96 ◽  
Author(s):  
J. Walker ◽  
I. Holloway ◽  
S. Wheeler
Keyword(s):  
Health Care ◽  
Qualitative Research ◽  
Research Ethics ◽  
Ethical Issues ◽  
Ethics Committees ◽  
Ethical Review ◽  
Research Ethics Committees ◽  
Different Types ◽  
Ethical Approval ◽  
Key Questions

In recognition of the important ethical issues posed by qualitative research in health care, the authors present key questions to aid ethical review. The purpose is to assist lay and professional members of research ethics committees in their assessment of applications involving qualitative research methods and to inform researchers intending to submit such applications for ethical approval. For the benefit of those less familiar with this type of research, the authors include an overview of different types of qualitative research, together with an explanation of terms commonly used by qualitative researchers.

scholarly journals A review of ethics in developing country in perspective of dental research

2014 ◽  
Vol 5 (1) ◽  
pp. 11-19 ◽  
Author(s):  
Md Haider Ali Khan ◽  
Shamima Parvin Lasker
Keyword(s):  
Developing Countries ◽  
Research Ethics ◽  
Developing Country ◽  
Health Research ◽  
Ethical Issues ◽  
Ethics Committees ◽  
Ethical Review ◽  
Ethical Standards ◽  
Research Ethics Committees ◽  
Dental Research

The objectives of this review were to examine the ethical issues in research in developing country and perspective of dental research. In this review, we performed the systematic literature search, screening process through the web in existing published and unpublished articles and reports that related to our topics between1990 to 2013. In the past few decades, the research and discoveries in the discipline of dentistry have increased dramatically. Recently many dental Institutes in developing country is constantly looking for opportunities to borrow, enhance, and integrate knowledge from biomedical and technological research by using modern technology. The retrieved information in this review reflect that to make any research involving human subjects ethically acceptable, a number of key features have to be considered by the researchers. Those who conduct oral health research are compelled by regulations and convention to follow established ethical standards to protect human rights. Bioethics and in ethical review of research in developing countries reveals many major gaps and have seen that there are indeed many ethical issues to be considered to clinical trials taking place in developing countries. Professional societies have a major influence in shaping the moral tone and ethical climate for research through the adoption of standards, the development of educational programs designed to reinforce those standards. Research ethics committees or institutional ethical review committees is to ensure that studies involving human research participants are designed to conform the relevant ethical standards and that the rights and welfare of participants are protected. Research ethics committees should not function under the influence of others and should ensures the favorable balance of potential benefits and risks. In developing country it is necessary to strengthen local capacity and manpower by developing innovative training models for ethics that are cost-effective and sustainable. The actions required to move ahead in this field include strengthening bioethics capacity, linking health research to community needs in a transparent and participatory process and increasing communication between scientists and ethicists in industrialized and developing countries. DOI: http://dx.doi.org/10.3329/bioethics.v5i1.18443 Bangladesh Journal of Bioethics 2014 Vol.5(1): 11-19

Human research ethics committees members: ethical review personal perceptions

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

scholarly journals Is It Time to Re-Evaluate the Ethics Governance of Social Media Research?

2018 ◽  
Vol 13 (4) ◽  
pp. 452-454 ◽  
Author(s):  
G. Samuel ◽  
W. Ahmed ◽  
H. Kara ◽  
C. Jessop ◽  
S. Quinton ◽  
...  
Keyword(s):  
Social Media ◽  
Research Ethics ◽  
Ethical Issues ◽  
Real Life ◽  
Ethics Committees ◽  
Research Ethics Committees ◽  
Media Ethics ◽  
Research Institution ◽  
Media Research ◽  
Social Media Research

This article reports on a U.K. workshop on social media research ethics held in May 2018. There were 10 expert speakers and an audience of researchers, research ethics committee members, and research institution representatives. Participants reviewed the current state of social media ethics, discussing well-rehearsed questions such as what needs consent in social media research, and how the public/private divide differs between virtual and real-life environments. The lack of answers to such questions was noted, along with the difficulties posed for ethical governance structures in general and the work of research ethics committees in particular. Discussions of these issues enabled the creation of two recommendations. The first is for research ethics committees and journal editors to add the category of ‘data subject research’ to the existing categories of ‘text research’ and ‘human subject research’. This would reflect the fact that social media research does not fall into either of the existing categories and so needs a category of its own. The second is that ethical issues should be considered at all stages of social media research, up to and including aftercare. This acknowledges that social media research throws up a large number of ethical issues throughout the process which, under current arrangements for ethical research governance, risks remaining unaddressed.

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

2020 ◽  
Vol 5 (4) ◽  
pp. e001942 ◽  
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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