scholarly journals Ethics review, reflective equilibrium and reflexivity

2021 ◽  
pp. 096973302110032
Author(s):  
Julie Morton
Keyword(s):  
Research Ethics ◽  
Creative Thinking ◽  
Reflective Equilibrium ◽  
Ethics Committees ◽  
Ethical Considerations ◽  
Ethics Review ◽  
Universal Principles ◽  
Health And Social Care ◽  
Human Participants ◽  
The University

Background: Research Ethics Committees (RECs) or their equivalent review applications for prospective research with human participants. Reviewers use universally agreed principles i to make decisions about whether prospective health and social care research is ethical. Close attention to understanding how reviewers go about their decision-making work and consider principles in practice is limited. Objective: The study aimed to understand how reviewers made decisions in the contexts of meetings and to understand more about how reviewers approach their work. The purpose of this article is to draw on data and findings and to show how reflective equilibrium as a theoretical frame can (1) deepen understanding of ethics review and (2) permit a reflexive examination of the habitual processes of review. Design and participants: Methods captured the day-to-day work of the RECs. Seventeen applications were heard during eight observations. There were 12 formal interviews with reviewers (n = 12) and with researchers (n = 8) which are not reported on in this article. Ethical considerations: Organisational permission for the study was given by the National Research Ethics Service (NRES) whose functions became part of the Health Research Authority (HRA) during the study. The study was given favourable opinion by the University of Salford's REC (Reference HSCR11/17). Findings: Data were analysed using constructed grounded theory resulting in eight themes which revealed attention to procedure and engagement with applications. Reflective equilibrium was used as a qualitative frame to interpret themes distilling them into three processes at work in review: emotion and intuition; imagination and creative thinking; and intuition and trust. Discussion: Reviewers went back and forth between universal principles and considered these in the contexts of each application using the above processes. Conclusions: Reflective equilibrium offers a coherent and grounded account of review work. Reflexivity in training for reviewers is essential for improving practices. The challenges reflexivity presents can be assisted by using reflective equilibrium as a tool to illuminate tacit review processes.

scholarly journals Implementing a National Approach to Research Ethics Review during a Pandemic – the Irish Experience

2020 ◽  
Vol 3 ◽  
pp. 63
Author(s):  
Aileen Sheehy ◽  
Jennifer Ralph James ◽  
Mary Horgan
Keyword(s):  
Research Ethics ◽  
Ethics Committees ◽  
Well Being ◽  
Lessons Learned ◽  
Research Ethics Committees ◽  
Ethics Review ◽  
Research Ethics Review ◽  
Human Participants ◽  
High Standards ◽  
National Approach

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.

Principled Ethics Review: Governance Arrangements for University Research Ethics Committees

2009 ◽  
Vol 5 (3) ◽  
pp. 110-112 ◽  
Author(s):  
Timothy Stibbs
Keyword(s):  
Research Ethics ◽  
Ethics Committees ◽  
University Research ◽  
Ethical Review ◽  
Research Ethics Committees ◽  
Basic Principles ◽  
The Third ◽  
Ethics Review ◽  
The University ◽  
Governance Arrangements

This, the third seminar organised by the AREC university sector committee, included short presentations followed by parallel workshops. These proposed and explored basic principles for ethical review in the context of current models within the university REC sector. In this report, following an introduction, each of the speakers/workshop leaders summarizes their own perspective on the issues raised and discussed.

A University Wide Model for the Ethical Review of Human Subjects Research

2005 ◽  
Vol 1 (2) ◽  
pp. 39-44 ◽  
Author(s):  
Bryn Williams-Jones ◽  
Søren Holm
Keyword(s):  
Clinical Research ◽  
Research Ethics ◽  
Human Subjects ◽  
Ethics Committees ◽  
Ethical Review ◽  
Research Ethics Committees ◽  
Ethics Review ◽  
Wide System ◽  
Tiered System ◽  
The University

In the United Kingdom (and elsewhere), there are moves to extend formal ethical review of research involving human subjects beyond the traditional oversight by NHS local or multi-centre research ethics committees of medical or clinical research, to also encompass all ‘non-clinical’ research involving human subjects. This paper describes and analyses the development and implementation of a model for ethical review within the university sector. At Cardiff University, a devolved or two-tiered system of ethics review has been created in which a top-level university research ethics committee provides policy advice to and oversight of school-based research ethics committees that engage in formal ethics review of research conducted in their respective schools. We describe the system and reflect on the challenges and benefits of implementing such a coordinated and comprehensive university-wide system of ethics review.

scholarly journals Implementing a National Approach to Research Ethics Review during a Pandemic – the Irish Experience

2020 ◽  
Vol 3 ◽  
pp. 63
Author(s):  
Aileen Sheehy ◽  
Jennifer Ralph James ◽  
Mary Horgan
Keyword(s):  
Research Ethics ◽  
Ethics Committees ◽  
Well Being ◽  
Lessons Learned ◽  
Research Ethics Committees ◽  
Ethics Review ◽  
Research Ethics Review ◽  
Human Participants ◽  
High Standards ◽  
National Approach

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.

Differences between research ethics committees

2007 ◽  
Vol 23 (1) ◽  
pp. 17-23 ◽  
Author(s):  
Sarah J. L. Edwards ◽  
Tracey Stone ◽  
Teresa Swift
Keyword(s):  
Research Ethics ◽  
Ethics Committees ◽  
Institutional Review Boards ◽  
Research Ethics Committees ◽  
Ethical Considerations ◽  
Local Conditions ◽  
Ethical Judgments ◽  
Risks And Benefits ◽  
The United Kingdom ◽  
Institutional Review

Objectives:To examine differences in the ethical judgments made by Research Ethics Committees (RECs) or Institutional Review Boards (IRBs).Methods:We did a review of the literature and included any study that attempted to compare the ethical judgments made by different RECs or IRBs when reviewing one or more protocol.Results:There were twenty-six articles reporting such discrepancies across Europe, within the United Kingdom, Spain, and United States. Of these studies, there were only five reports of some RECs approving while others rejecting the same protocol. All studies, however, reported differences in the clarifications and revisions asked of researchers regarding consent, recruitment, risks and benefits, compensation arrangements, and scientific issues.Conclusions:The studies were generally anecdotal reports of researchers trying to do research. New rules requiring a single ethical opinion for multi-site research at least in European Member States may simply conceal problematic issues in REC decision making. In the last analysis, we should expect a certain degree of variation and differences if we are to keep a committee system of review, although there is a pressing need to investigate the way in which RECs make these judgments. In particular, we need to identify the source of any aberrations, distortions, or confusions that could arbitrarily affect these judgments. Furthermore, local conditions remain important ethical considerations and should not be sidelined in pursuit of greater “consistency.”

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.

Problems and development strategies for research ethics committees in China’s higher education institutions

2020 ◽  
pp. medethics-2020-106768
Author(s):  
Jiyin Zhou
Keyword(s):  
Higher Education ◽  
Research Ethics ◽  
Administrative Support ◽  
Higher Education Institutions ◽  
Human Head ◽  
Ethics Committees ◽  
Developed Countries ◽  
Research Ethics Committees ◽  
The Usa ◽  
Human Participants

The establishment of research ethics committees (REC) in China’s higher education institutions (HEI) is lagging far behind western developed countries. This has at least partly directly led to anomie in scientific research ethics, as seen in the recent controversies involving a proposed human head transplant and gene-edited babies. At present, the problems for REC in China’s HEI include lack of regulation, informal ethics reviews, lack of supervision and insufficient ethics review capacity. To counteract these problems, suggested measures include mandatory formation of formal ethics committee, administrative support from HEI, ethics approval letter prior to funding application, formulation of regulations and standard operating procedures, selecting and training for members and independent consultants, training for secretaries and staff, ethics training for investigators, and learning from the experience of HEI outside of China, such as the USA and Canada. The establishment of REC in China’s HEI will greatly enhance the overall quality of ethics reviews in China. In addition to better protecting the rights and welfare of human participants, it is also conducive to maintaining the reputation of China’s HEI.

scholarly journals In defence of governance: ethics review and social research

2017 ◽  
Vol 44 (10) ◽  
pp. 710-716 ◽  
Author(s):  
Mark Sheehan ◽  
Michael Dunn ◽  
Kate Sahan
Keyword(s):  
Social Sciences ◽  
Research Ethics ◽  
Social Research ◽  
Human Flourishing ◽  
Ethical Considerations ◽  
Ethics Review ◽  
The Social ◽  
Growing Body ◽  
Governance Arrangements ◽  
Constitutive Element

There is a growing body of literature that has sought to undermine systems of ethical regulation, and governance more generally, within the social sciences. In this paper, we argue that any general claim for a system of research ethics governance in social research depends on clarifying the nature of the stake that society has in research. We show that certain accounts of this stake—protecting researchers’ freedoms; ensuring accountability for resources; safeguarding welfare; and supporting democracy—raise relevant ethical considerations that are reasonably contested. However, these accounts cannot underpin a general claim in favour of, or against, a system of research ethics governance. Instead, we defend governance in social research on the grounds that research, as an institutionalised form of enquiry, is a constitutive element of human flourishing, and that society ought to be concerned with the flourishing of its members. We conclude by considering the governance arrangements that follow from, and are justified by, our arguments.

Implementation of the EU clinical trial regulation transforms the ethics committee systems and endangers ethical standards

2020 ◽  
pp. medethics-2020-106757
Author(s):  
Vilma Lukaseviciene ◽  
Joerg Hasford ◽  
Dirk Lanzerath ◽  
Eugenijus Gefenas
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Research Ethics ◽  
Ethics Committees ◽  
Ethics Committee ◽  
Negative Consequences ◽  
Ethics Review ◽  
Clinical Trial Directive ◽  
Favourable Environment ◽  
The Eu

The upcoming Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use (Regulation), which will replace the current Clinical Trial Directive at the end of 2021, has triggered a significant reform of research ethics committee systems in Europe. Changes related to ethics review of clinical trials in the EU were considered to be essential to create a more favourable environment to conduct clinical trials in the EU. The concern is, however, that the role of the research ethics committees will weaken in at least some of the Member States because the new Regulation allows narrowing down the scope of ethics review as compared with the currently valid Clinical Trial Directive. Although the new Regulation may lead to faster approval procedures for clinical trials, which is especially relevant in the context of pandemics, high-quality ethics reviews integrating methodological aspects of a clinical trial should nevertheless be ensured. To maintain high research ethics standards as well as to foster measures to mitigate potential negative consequences of the reform, it is therefore of vital importance to start debating and sharing the reflections about the potential consequences of these transformations and trends as soon as possible.

scholarly journals Researchers’ views on, and experiences with, the requirement to obtain informed consent in research involving human participants: a qualitative study

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Antonia Xu ◽  
Melissa Therese Baysari ◽  
Sophie Lena Stocker ◽  
Liang Joo Leow ◽  
Richard Osborne Day ◽  
...  
Keyword(s):  
Informed Consent ◽  
Research Ethics ◽  
Information Disclosure ◽  
Ethics Committees ◽  
Structured Interviews ◽  
Worst Case ◽  
Human Research Ethics ◽  
Written Information ◽  
Human Participants ◽  
The Relationship

Abstract Background Informed consent is often cited as the “cornerstone” of research ethics. Its intent is that participants enter research voluntarily, with an understanding of what their participation entails. Despite agreement on the necessity to obtain informed consent in research, opinions vary on the threshold of disclosure necessary and the best method to obtain consent. We aimed to investigate Australian researchers’ views on, and their experiences with, obtaining informed consent. Methods Semi-structured interviews were conducted with 23 researchers from NSW institutions, working in various fields of research. Interviews were analysed and coded to identify themes. Results Researchers reported that consent involved information disclosure, understanding and a voluntary decision. They emphasised the variability of consent interactions, which were dependent on potential participants’ abilities and interests, study complexity and context. All researchers reported providing written information to potential participants, yet questioned the readability and utility of this information. The majority reported using signed consent forms to ‘operationalise’ consent and reported little awareness of, and lack of support in implementing more dynamic informed consent procedures, such as verbal informed consent, that was fit for the purposes of their studies. Views on Human Research Ethics Committees (HRECs) varied. Some reported inconsistent, arduous inputs on the information form and consent process. Others expressed reliance on HRECs for guidance, viewing them as institutional safeguards. Conclusions This study highlights the importance of transparent relationships, both between researchers and participants, and between researchers and HRECs. Where the relationship with study participants was reported as more robust, researchers felt that they were better able to ensure participants made better, more informed decisions. Where the relationship with HRECs was reported as more robust, researchers were more likely to view them as institutional safeguards, rather than as bureaucratic hindrances. Conscientious and mindful researchers are paramount to ensuring the procedure accommodates individual requirements. This study advocates that when designing ethical informed consent practices, researchers should be integrated as autonomous players with a positive input on the process, rather than, in the worst case, predatory recruiters to be curtailed by information forms and oversight.

Sign in / Sign up

Export Citation Format

Share Document