Ethics and the Ruling Relations of Research Production

2003 ◽  
Vol 8 (1) ◽  
pp. 70-80 ◽  
Author(s):  
Carole Truman
Keyword(s):  
Research Ethics ◽  
Ethics Committees ◽  
Research Process ◽  
Research Governance ◽  
Community Mental Health Service ◽  
Moral Obligations ◽  
Research Participants ◽  
Research Production ◽  
Health And Social Care ◽  
Ethical Approval

The role of research ethics committees has expanded across the UK and North America and the process of ethical review has become re-institutionalised under proposals for research governance proposed by government. Ethics committees have gained a powerful role as gatekeepers within the research process. Underpinning the re-constitution of ethical guidelines and research governance, are a range of measures which protect institutional interests, without necessarily providing an effective means to address the moral obligations and responsibilities of researchers in relation to the production of social research. Discussion of research ethics from the standpoint of research participants who in this paper, are service users within health and social care, provides a useful dimension to current debate. In this paper I draw upon experiences of gaining ethical approval for a research study which focused on user participation within a community mental health service. I discuss the strategies used to gain ethical approval and the ‘formal concerns’ raised by the ethics committee. I then describe and discuss ethical issues which emerged from a participants’ perspective during the actual research as it was carried out. These experiences are analysed using aspects of institutional ethnography which provides a framework to explore how the experiences of research participants are mediated by texts which govern the processes of research production. The paper highlights incongruities between the formal ethical regulation of research, and the experiences of research participants in relation to ethical concerns within a research process.

scholarly journals Heterogeneity of Human Research Ethics Committees and Research Governance Offices across Australia: An observational study

2016 ◽  
Vol 9 (2) ◽  
pp. 33-39 ◽  
Author(s):  
Elisabeth De Smit ◽  
Lisa Kearns ◽  
Linda Clarke ◽  
Jonathan Dick ◽  
Catharine Hill ◽  
...  
Keyword(s):  
Observational Study ◽  
Research Ethics ◽  
Ethics Committees ◽  
Research Governance ◽  
Research Ethics Committees ◽  
Human Research ◽  
Human Research Ethics

scholarly journals A review of informed consent and how it has evolved to protect vulnerable participants in emergency care research

2020 ◽  
Vol 5 (2) ◽  
pp. 73-79
Author(s):  
Rajpal Nandra ◽  
Alan F. Brockie ◽  
Faisal Hussain
Keyword(s):  
Informed Consent ◽  
Emergency Care ◽  
Ethics Committees ◽  
Moral Obligations ◽  
Ethical Considerations ◽  
Vulnerable Patients ◽  
Ethical Approval ◽  
Life Threatening ◽  
Time Critical

A vulnerable participant in research lacks capacity to consent or may be exposed to coercion to participate. Capacity may be temporarily impaired due to loss of consciousness, hypoxia, pain and the consumption of alcohol or elicit substances. To advance emergency care, providing life-threatening measures in life-threatening circumstances, vulnerable patients are recruited into research studies. The urgent need for time-critical treatment conflicts with routine informed consent procedures. This article reviews ethical considerations and moral obligations to safeguard these participants and preserve their autonomy. A particular focus is given to research methodology to waive consent, and the role of ethics committees, research audits, research nurses and community engagement. Research on the acutely unwell patient who lacks capacity is possible with well-designed research trials that are led by investigators who are sufficiently trained, engage the community, gain ethical approval to waive consent and continuously audit practice. Cite this article: EFORT Open Rev 2020;5:73-79. DOI: 10.1302/2058-5241.5.180051

scholarly journals COREC: the end of trainee-driven clinical research?

2007 ◽  
Vol 89 (9) ◽  
pp. 328-329
Author(s):  
N Patel ◽  
B George ◽  
A Chandratreya ◽  
S Bollen
Keyword(s):  
Research Ethics ◽  
Central Office ◽  
Ethics Committees ◽  
Research Ethics Committees ◽  
Application Process ◽  
The United Kingdom ◽  
Ethical Approval ◽  
The Government ◽  
Set Up ◽  
Local Research

Since 1 March 2004 anyone who wishes to set up clinical trials in the United Kingdom has to go through an extensive application process to gain ethical approval. The Central Office for Research Ethics Committees (COREC) was set up by the government both to standardise and centralise the process and to address concerns regarding patient care, safety and confidentiality. We are encouraged to complete this online (http://www.corec.org.uk/). Here awaits a 60-page form, which although not all its pages are applicable, is time-consuming. There is also a research and development (RD) form (http://www.rdform.org.uk/) to complete, which deals with cost issues and a Caldicott form dealing with patient confidentiality. On top of all that there may be other local forms to complete. There is already evidence that applications to local research ethics committees are down by around 40% in the years 2003–2004.

scholarly journals Could providing financial incentives to research participants be ultimately self-defeating?

2016 ◽  
Vol 12 (3) ◽  
pp. 137-148 ◽  
Author(s):  
TL Zutlevics
Keyword(s):  
Intrinsic Motivation ◽  
Research Ethics ◽  
Financial Incentives ◽  
Financial Incentive ◽  
Ethics Committees ◽  
Ethical Guidelines ◽  
Research Participants ◽  
Human Research Ethics ◽  
Institutional Review ◽  
The Individual

Controversy over providing financial incentives to research participants has a long history and remains an issue of contention in both current discussions about research ethics and for institutional review bodies/human research ethics committees which are charged with the responsibility of deciding whether such incentives fall within ethical guidelines. The arguments both for and against financial incentives have been well aired in the literature. A point of agreement for many is that inducement in the form of financial incentive is permissible when the risk of harm to the individual is negligible in terms of degree and probability of occurrence. In the absence of harm to the individual, encouraging more people to participate in research would appear to be a good thing in so far as it will lead to statistically more robust research outcomes, which can then be translated into better healthcare and other practice. Whilst, on the face of it, this position seems highly defensible, I will explore the possibility that it is counterproductive – that is, providing individuals with financial incentives to become research participants may have the unintended outcome of reducing participation rates in some areas of research. In exploring this idea I will draw on empirical findings from the literature on crowding-out – the hypothesis that providing monetary incentives to people can backfire by overall reducing intrinsic motivation, in this instance intrinsic motivation to behave altruistically or undertake civic duties.

Making Ethics Work in Collaborative Projects

2005 ◽  
Vol 11 (3) ◽  
pp. 101
Author(s):  
Emily Mauldon
Keyword(s):  
Health Care ◽  
Primary Health Care ◽  
Research Ethics ◽  
Health Care Professionals ◽  
Ethics Committees ◽  
Research Process ◽  
Ethical Review ◽  
Ethical Research ◽  
Team Members ◽  
Primary Health

This article discusses problems a research team had managing their ethical obligations during a short project, and considers the implications of these problems for better understanding and carrying out ethical research in the future. Two key points will be proposed. Initially, it will be argued that the culture of ethical research as articulated within the research community may not be universally accepted within the primary health care sector. The nature of "ethical conduct" within clinical practice, service provision and research is not the same. Further, practical difficulties the researchers experienced while trying to gain approval from ethics committees and implement the proposed research plan highlight some ways in which institutional ethical review processes are structurally unsuited to the requirements of small collaborative projects. Understanding the different ways in which the term "ethics" is used will allow for a more expedient translation of concepts between different health professionals. Recognising the practical constraints ethical review places on the research process may help reduce some of the frustration primary health care professionals can experience when faced with the requirements of research ethics committees. Due to the history of, and cultural commitment to, ethical research within the university sector, those with formal academic training in research are well placed to assume responsibility for managing the ethics process when involved in cross-sectoral research. This responsibility may include the need to educate team members and study participants about the importance of research ethics.

Protecting vulnerable research participants: A Foucault-inspired analysis of ethics committees

2011 ◽  
Vol 18 (5) ◽  
pp. 640-650 ◽  
Author(s):  
Truls I Juritzen ◽  
Harald Grimen ◽  
Kristin Heggen
Keyword(s):  
Research Ethics ◽  
Academic Freedom ◽  
Ethics Committees ◽  
Research Ethics Committees ◽  
Research Practices ◽  
Research Participants

History has demonstrated the necessity of protecting research participants. Research ethics are based on a concept of asymmetry of power, viewing the researcher as powerful and potentially dangerous and establishing ethics committees as external agencies in the field of research. We argue in favour of expanding this perspective on relationships of power to encompass the ethics committees as one among several actors that exert power and that act in a relational interplay with researchers and participants. We employ Michel Foucault’s ideas of power as an omnipresent force which is dynamic and unstable, as well as the notion that knowledge and power are inextricably intertwined. The article discusses how research ethics committees may affect academic freedom. In addition it is pointed out that research participants could be harmed — not only by unfortunate research practices, but also by being subjected to the protective efforts of ethics monitoring bodies.

Payment of research participants: current practice and policies of Irish research ethics committees

2012 ◽  
Vol 39 (9) ◽  
pp. 591-593 ◽  
Author(s):  
Eric Roche ◽  
Romaine King ◽  
Helen M Mohan ◽  
Blanaid Gavin ◽  
Fiona McNicholas
Keyword(s):  
Research Ethics ◽  
Current Practice ◽  
Ethics Committees ◽  
Research Ethics Committees ◽  
Research Participants

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 Involving Patients in Research? Responsible Research and Innovation in Small- and Medium-Sized European Health Care Enterprises*

2018 ◽  
Vol 28 (1) ◽  
pp. 144-152 ◽  
Author(s):  
KALYPSO IORDANOU
Keyword(s):  
Health Care ◽  
Research Ethics ◽  
Innovation Process ◽  
Ethics Committees ◽  
Research Process ◽  
Responsible Research And Innovation ◽  
Research And Innovation ◽  
Governance Tools ◽  
European Health ◽  
Responsible Research

Abstract:Health research is generally undertaken to resolve existing health problems or enhance existing solutions. Research ethics committees have been the main governance tool for research for more than half a century. Their role is to ensure that research is undertaken ethically. To close the increasing gap between science and society, other governance tools are required. The European Commission recommends and actively promotes the policy of responsible research and innovation (RRI). In addition to sound research ethics, a key feature of RRI is the involvement of different societal stakeholders throughout the research process.But how accepted is the involvement of societal stakeholders in the research of small- and medium-sized enterprises (SMEs) in the health care sector? This question is examined based on 18 in-depth interviews with private health care industry representatives from across Europe in companies focusing on developing medical device technology. Findings suggest that SMEs are reluctant to undertake research involving patients, especially in the early stages of the research and innovation process. For some SMEs this is due to concerns about the dangers of raising expectations they cannot meet, while for others the main concerns are increasing costs and producing less competitive products. Implications of the research findings are discussed.

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