scholarly journals UK Research Ethics Committee’s review of the global first SARS-CoV-2 human infection challenge studies

2021 ◽  
pp. medethics-2021-107709
Author(s):  
Hugh Davies
Keyword(s):  
Research Ethics ◽  
Human Infection ◽  
Good Faith ◽  
Ethical Review ◽  
Wrong Decision ◽  
Who Criteria ◽  
Research Designs ◽  
Alternative Research ◽  
Research Questions ◽  
The Uk

This paper describes the UK Research Ethics Committee’s (REC) preparations and review of the global first SARS-CoV-2 human infection challenge studies. To frame our review, we used the WHO guidance and our UK Health Research Authority ethical review framework. The WHO criteria covered most issues we were concerned about, but we would recommend one further criterion directing RECs to consider alternative research designs. Could research questions be equally well answered by less intrusive studies? The committee met virtually, ensuring broad representation across the UK nations and also ensuring applicants could attend easily. We worked in collaboration with the applicants but while we recognise that such proximity might raise the accusation of ‘collusion’, we made every effort to maintain ‘moral distance’ and all decisions were made by the committee alone. Prior existing processes and policy facilitated training and review but even with this preparation, review took time and this could have hindered a rapid response to the emergency. Review for the various follow-on studies will now be speedier and once the pandemic has subsided, our group could be reconvened in future emergencies. In conclusion, we have tried to make decisions in good faith. We know there is controversy and disagreement and reasonable people may feel we have made the wrong decision. A more detailed analysis, built on the WHO guidance, is provided in online supplemental material.

Creating a ‘FatherConfessor’: the origins of research ethics committees in UK military medical research, 1950–1970. Part I, context and causes

2019 ◽  
Vol 165 (4) ◽  
pp. 284-290
Author(s):  
Ulf Schmidt
Keyword(s):  
Research Ethics ◽  
Ethics Committees ◽  
Chemical Warfare ◽  
Legal Responsibility ◽  
Ethical Review ◽  
Government Officials ◽  
Staff Members ◽  
Human Experiments ◽  
The Creation ◽  
The Uk

Part I provides the historiographical context and examines the causes which led to the creation of the first independent research ethics committee (REC) at Porton Down, Britain’s biological and chemical warfare establishment, in operation since the First World War. The papers in part I and part II argue that the introduction of RECs in the UK stemmed from concerns about legal liability and research ethics among scientists responsible for human experiments, and from the desire of the UK military medical establishment to create an external organisation which would function both as an ‘internalspace’ for ethical debate and as an ‘externalbody’ to share moral and legal responsibility. The paper asks: What factors were responsible for causing military scientists and government officials to contemplate the introduction of formalised structures for ethical review within the UK military? It argues that Porton may have been exempt from public scrutiny, but it was not above the law of the land. By the mid-1960s evidence of serious ill effects among staff members and service personnel involved in tests could no longer be ignored. Whereas the security of the British realm had previously trumped almost any other argument in contentious debates about chemical warfare, the role of medical ethics suddenly moved to the forefront of Porton’s deliberations, so much so that tests with incapacitants were temporarily suspended in 1965. It was this crisis, examined in detail in part II, which functioned as a catalyst for the creation of the Applied Biology Committee as the responsible body, and first point of call, for authorising human experiments at Porton Down.

scholarly journals Does CSR Activity Amount to Socially Responsible Management?

2021 ◽  
Author(s):  
M. John Foster
Keyword(s):  
Corporate Social Responsibility ◽  
Social Responsibility ◽  
Local Community ◽  
Annual Reports ◽  
Socially Responsible ◽  
Responsible Management ◽  
Exploratory Investigation ◽  
Research Questions ◽  
The Uk ◽  
Corporate Social

AbstractIn essence firms or companies are usually thought to exist to make products for or provide services of some sort to third parties, other companies or individuals. The philosophical question which naturally arises then is ‘to the benefit of whom should a firm’s activities be aimed?’ Possible answers include the owners of the firm, the firm’s employees or wider society, the firm’s local community or their host nation. It is because of firms’ location within a wider society that the issue of corporate social responsibility arises. The issue is do they contribute in a positive way to the fabric of society. In this paper we conduct an exploratory investigation whose research questions, broadly, are whether there is public evidence of corporate social responsibility activity by firms listed in the UK and to what extent, if any, such activities may amount to genuinely socially responsible management by the firms. We examined the most up to date annual reports of a split sample of 36 firms listed in the FTSE 350. The short answers to the two research questions above are: to some degree and no by some margin, based on data from the sample firms.

A Novel Framework for Reflecting on the Functioning of Research Ethics Review Panels

2007 ◽  
Vol 14 (1) ◽  
pp. 99-116 ◽  
Author(s):  
Colin Macduff ◽  
Andrew McKie ◽  
Sheelagh Martindale ◽  
Anne Marie Rennie ◽  
Bernice West ◽  
...  
Keyword(s):  
Health Care ◽  
Nursing Education ◽  
Research Ethics ◽  
Health Care Professionals ◽  
Rapid Change ◽  
Health Care Research ◽  
Ethical Review ◽  
Review Panel ◽  
Ethics Review ◽  
Research Ethics Review

In the past decade structures and processes for the ethical review of UK health care research have undergone rapid change. Although this has focused users' attention on the functioning of review committees, it remains rare to read a substantive view from the inside. This article presents details of processes and findings resulting from a novel structured reflective exercise undertaken by a newly formed research ethics review panel in a university school of nursing and midwifery. By adopting and adapting some of the knowledge to be found in the art and science of malt whisky tasting, a framework for critical reflection is presented and applied. This enables analysis of the main contemporary issues for a review panel that is primarily concerned with research into nursing education and practice. In addition to structuring the panel's own literary narrative, the framework also generates useful visual representation for further reflection. Both the analysis of issues and the framework itself are presented as of potential value to all nurses, health care professionals and educationalists with an interest in ethical review.

scholarly journals Implementation of the StandingTall programme to prevent falls in older people: a process evaluation protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e048395
Author(s):  
Morag E Taylor ◽  
Chris Todd ◽  
Sandra O'Rourke ◽  
Lindy M Clemson ◽  
Jacqueline CT Close ◽  
...  
Keyword(s):  
Older People ◽  
Research Ethics ◽  
Process Evaluation ◽  
Ethics Committee ◽  
Community Dwelling ◽  
Innovative Technology ◽  
Local Health ◽  
Research Ethics Committee ◽  
Personal Impact ◽  
The Uk

IntroductionOne in three people aged 65 years and over fall each year. The health, economic and personal impact of falls will grow substantially in the coming years due to population ageing. Developing and implementing cost-effective strategies to prevent falls and mobility problems among older people is therefore an urgent public health challenge. StandingTall is a low-cost, unsupervised, home-based balance exercise programme delivered through a computer or tablet. StandingTall has a simple user-interface that incorporates physical and behavioural elements designed to promote compliance. A large randomised controlled trial in 503 community-dwelling older people has shown that StandingTall is safe, has high adherence rates and is effective in improving balance and reducing falls. The current project targets a major need for older people and will address the final steps needed to scale this innovative technology for widespread use by older people across Australia and internationally.Methods and analysisThis project will endeavour to recruit 300 participants across three sites in Australia and 100 participants in the UK. The aim of the study is to evaluate the implementation of StandingTall into the community and health service settings in Australia and the UK. The nested process evaluation will use both quantitative and qualitative methods to explore uptake and acceptability of the StandingTall programme and associated resources. The primary outcome is participant adherence to the StandingTall programme over 6 months.Ethics and disseminationEthical approval has been obtained from the South East Sydney Local Health District Human Research Ethics Committee (HREC reference 18/288) in Australia and the North West- Greater Manchester South Research Ethics Committee (IRAS ID: 268954) in the UK. Dissemination will be via publications, conferences, newsletter articles, social media, talks to clinicians and consumers and meetings with health departments/managers.Trial registration numberACTRN12619001329156.

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
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