Alzheimer Disease Ethics—Informed Consent and Related Issues in Clinical Trials: Results of a Survey Among the Members of the Research Ethics Committees in Sweden

2003 ◽  
Vol 15 (2) ◽  
pp. 157-170 ◽  
Author(s):  
Gunbrith Peterson ◽  
Anders Wallin
Keyword(s):  
Informed Consent ◽  
Research Ethics ◽  
Ethical Issues ◽  
Ethics Committees ◽  
Informed Consent Process ◽  
Research Ethics Committees ◽  
Biomedical Sciences ◽  
Men And Women ◽  
Decision Making Capacity ◽  
Participation In Research

The rapid advances in biomedical sciences have induced special moral and ethical attitudes, which ought to be taken into account. One of the most essential issues is the principles for participation in research of subjects with reduced decision-making capacity. We conducted a questionnaire survey among members of the research ethics committees in Sweden to find out their attitudes to a range of ethical issues related to research on subjects with Alzheimer's disease. One hundred thirty-six of those approached responded (66%), and 117 of the responses (56%) were considered substantially complete. There were 16 questions with fixed reply alternatives. Some central questions concerned the informed consent process. With a few exceptions, there were no significant differences in attitudes between the experts and laypersons, between persons of different ages, and between men and women. However, women and laypersons were in general keener to preserve the patient's integrity and the experts were more willing than the laypersons to allow participation of subjects with dementia in placebo-controlled trials.

scholarly journals Informed Consent: Is it Sacrosanct?

2005 ◽  
Vol 1 (3) ◽  
pp. 77-83 ◽  
Author(s):  
Alison Assiter
Keyword(s):  
Informed Consent ◽  
Medical Ethics ◽  
Research Ethics ◽  
Ethical Issues ◽  
Personal Data ◽  
Ethics Committees ◽  
Research Ethics Committees ◽  
Patient Consent ◽  
Human Participants ◽  
Alder Hey

Following Alder Hey and the earlier and much more extreme practices at Nuremberg, legislation has been developed governing the practice of medical ethics and research involving human participants more generally. In the medical context, relevant legislation includes GMC guidance, which states that disclosure of identifiable patient information without consent, for research purposes, is not acceptable unless it is justified in the public interest. There is a presumption, in other words, in favour of the view that patient consent ought to be obtained before any piece of research is conducted. The Data Protection Act, furthermore, requires informed consent to be given before any use of identifiable personal data is made for any purpose. Moreover, ensuring that the informed consent of participants is gained is common practice on most research ethics committees. I argue, in this paper, that applying the principle of ‘informed consent’ too mechanistically in the research ethics context risks undermining the very principle it is designed to support – the principle of autonomy. This issue has been much discussed in medical ethics but not so much, so far, in the research ethics context. It will be argued that a more discerning and a less rigid and mechanistic approach, applied by research ethics committees, may help ensure that ethical issues are properly considered.

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 Knowledge, awareness, and attitudes about research ethics committees and informed consent among resident doctors

2019 ◽  
Vol Volume 12 ◽  
pp. 141-145 ◽  
Author(s):  
Saddam Al Demour ◽  
Karem H Alzoubi ◽  
Anas Alabsi ◽  
Sadam Al Abdallat ◽  
Ashraf Alzayed
Keyword(s):  
Informed Consent ◽  
Research Ethics ◽  
Ethics Committees ◽  
Research Ethics Committees

scholarly journals Informed consent in cluster randomised trials: a guide for the perplexed

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e054213
Author(s):  
Hayden P Nix ◽  
Charles Weijer ◽  
Jamie C Brehaut ◽  
David Forster ◽  
Cory E Goldstein ◽  
...  
Keyword(s):  
Informed Consent ◽  
Research Ethics ◽  
Randomised Trial ◽  
Ethics Committees ◽  
Cluster Randomised Trial ◽  
Research Ethics Committees ◽  
Randomised Trials ◽  
Research Participants ◽  
Inappropriate Use ◽  
Cluster Randomised

In a cluster randomised trial (CRT), intact groups—such as communities, clinics or schools—are randomised to the study intervention or control conditions. The issue of informed consent in CRTs has been particularly challenging for researchers and research ethics committees. Some argue that cluster randomisation is a reason not to seek informed consent from research participants. In fact, systematic reviews have found that, relative to individually randomised trials, CRTs are associated with an increased likelihood of inadequate reporting of consent procedures and inappropriate use of waivers of consent. The objective of this paper is to clarify this confusion by providing a practical and useful framework to guide researchers and research ethics committees through consent issues in CRTs. In CRTs, it is the unit of intervention—not the unit of randomisation—that drives informed consent issues. We explicate a three-step framework for thinking through informed consent in CRTs: (1) identify research participants, (2) identify the study element(s) to which research participants are exposed, and (3) determine if a waiver of consent is appropriate for each study element. We then apply our framework to examples of CRTs of cluster-level, professional-level and individual-level interventions, and provide key lessons on informed consent for each type of CRT.

scholarly journals Negotiating Responsibility for Navigating Ethical Issues in Qualitative Research: A Review of Miller, Birch, Mauthner, and Jessop’s (2012) Ethics in Qualitative Research, Second Edition

2015 ◽  
Author(s):  
Michelle McCarron
Keyword(s):  
Qualitative Research ◽  
Research Ethics ◽  
Ethical Issues ◽  
Ethics Committees ◽  
Institutional Review Boards ◽  
Research Ethics Committees ◽  
The United Kingdom ◽  
Institutional Review ◽  
Technological Advances ◽  
Research Ethics Boards

Ethics in Qualitative Research (Miller, Birch Mauthner, & Jessop, 2012), now in its second edition, uses a feminist framework to present a variety of issues pertinent to qualitative researchers. Topics include traditional challenges for qualitative researchers (e.g., access to potential participants, informed consent, overlapping roles), as well as those that have garnered more attention in recent years, particularly with regard to uses and consequences of technological advances in research. The book is critical of committees whose function it is to review proposed research and grant research ethics approval (e.g., University Research Ethics Committees [URECs], Research Ethics Boards [REBs], and Institutional Review Boards [IRBs]). The authors of this book are situated within the United Kingdom. The editors take the position that ethics oversight by the researchers themselves is preferable and that such boards and committees are not well equipped to review qualitative research. A rebuttal to this position is presented within this review. Ethics in Qualitative Research provides a good overview of ethical issues that researchers face and is effective in merging theory with practice. It would be strengthened by avoiding the debate over URECs or by offering concrete suggestions for how URECs can improve their reviews of qualitative research.

scholarly journals Correction to: Regulatory, scientific, and ethical issues arising from institutional activity in one of the 90 Italian Research Ethics Committees

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
G. Benfatto ◽  
◽  
F. Drago ◽  
Keyword(s):  
Research Ethics ◽  
Ethical Issues ◽  
Ethics Committees ◽  
Research Ethics Committees

An amendment to this paper has been published and can be accessed via the original article.

scholarly journals Protecting Patients—Managing Persons

1970 ◽  
Vol 7 (1) ◽  
Author(s):  
Susanne Langer
Keyword(s):  
Multiple Sclerosis ◽  
Informed Consent ◽  
Research Ethics ◽  
Decision Process ◽  
Ethics Committees ◽  
Research Ethics Committees ◽  
Individual Choice ◽  
Culturally Specific ◽  
Local Research

This paper is based on my experience of applying for ethics approval from two different Local Research Ethics Committees (LRECs) in the context of fieldwork with people suffering from multiple sclerosis (MS) in the Manchester area. I argue that LRECs are a form of audit intended to remove relationships from the decision process and to change practice. By focusing on the category of ‘informed consent’ and how it is conceptually and bureaucratically constructed, I analyse the ways in which ethics committees are able to preserve the notion of individual choice while at the same time defining its parameters. In so doing, ethics committees interfere with the efforts of people, such as the ones I worked with, to become productive in culturally-specific ways, for instance by being involved in research. I conclude by reflecting on how the removal of the relational dimension of research through bureaucratic technologies, such as ethics committees, affects anthropologists.

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.

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