Research ethics committees: preserving research integrity and the public trust

2007 ◽  
Vol 56 (2) ◽  
Author(s):  
AM Mullings
Keyword(s):  
Research Ethics ◽  
Research Integrity ◽  
Ethics Committees ◽  
Public Trust ◽  
Research Ethics Committees ◽  
The Public

Should Research Ethics Committees Be Observing the Law or Working by Ethical Principles?

2005 ◽  
Vol 1 (1) ◽  
pp. 23-26 ◽  
Author(s):  
Charles Warlow
Keyword(s):  
Clinical Research ◽  
Research Ethics ◽  
Public Interest ◽  
Ethics Committees ◽  
Unintended Consequences ◽  
Research Ethics Committees ◽  
Individual Interest ◽  
The Public ◽  
The Law ◽  
The Individual

Recent laws, and their interpretation, have made clinical research more difficult to do, and sometimes impossible. Furthermore the results of that research which can be done may even be unreliable. This is certainly against the public interest, and indeed the individual patient interest as well. But ethics committees have to abide by the law and so even though it is surely unethical to work against the public and individual interest that is exactly what ethics committees now have to endorse. The unintended consequences of the new regulations must be reduced by amending the law.

scholarly journals Patient and public involvement prior to trial initiation: lessons learnt for rapid partnership in the COVID-19 era

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Zahra Jamal ◽  
◽  
Alexander Perkins ◽  
Christopher Allen ◽  
Richard Evans ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Research Ethics ◽  
Public Involvement ◽  
Ethics Committees ◽  
Patient And Public Involvement ◽  
Research Ethics Committees ◽  
The Public ◽  
Clinical Trials Unit ◽  
The Uk

Plain English summary Patient and Public Involvement (PPI) describes the active involvement of patients and the public in the research process. Through PPI, patients and members of the public are increasingly involved in the design and conduct of clinical trials. PPI has been shown to improve the quality and relevance of research. During the COVID-19 pandemic, clinical trials have been playing a vital role in helping us find ways to prevent and treat the infection and improve our understanding of the virus. It is important that patients and the public are actively involved in deciding how COVID-19 research is carried out. Unfortunately, Research Ethics Committees in the UK have seen far less PPI for COVID-19 research studies compared with research before the pandemic. A key reason for this is that research is being designed much faster than normal and researchers may feel they do not have time to properly involve patients and the public. In this paper, we share our experiences of PPI for a COVID-19 clinical trial. We show that it is possible to rapidly involve patients and the public in COVID-19 clinical trials. We also explain how the design of the clinical trial was changed in response to feedback from public contributors. Lastly, we discuss the wider learning from this process which might be useful for researchers planning PPI activities for COVID-19 clinical trials in the future. Abstract Background: Clinical trials are playing a critical role in the global public health response to the COVID-19 pandemic. Despite the increasing recognition of the value of PPI in clinical trials, just 22% of the COVID-19 research proposals reviewed by Research Ethics Committees in the UK at the start of the pandemic reported PPI. There is a perception that PPI might result in delays in delivering research and therefore delays in obtaining important results. In this paper, we report our experience of rapid PPI for a COVID-19 clinical trial. Methods: RAPID-19 is a COVID-19 clinical trial which was planned to be submitted for fast-track ethics review in the United Kingdom. During the development of the trial protocol, the PPI Panel at the London School of Hygiene & Tropical Medicine Clinical Trials Unit was involved in the design of the study. The meeting with the PPI Panel lasted just over 1 h and was conducted by teleconference. Results: Although we only had a short period of time to explore the study with the PPI Panel, we were able to gain valuable insight into how the trial would be perceived by potential trial participants. Substantive changes were made to the trial to improve the acceptability of the research without compromising the study timelines. Having access to public contributors with relevant lived experience is an important resource for a Clinical Trials Unit and is critical for rapid PPI. The move to remote working due to lockdown required virtual discussions which helped to overcome some of the barriers to organising face-to-face meetings at short notice. Conclusions: PPI for clinical trials can be conducted in a time-efficient manner within the pressured environment of a pandemic. Involving PPI contributors at an early stage in protocol development maximised the opportunity to shape and influence the trial as well as limited potential delays which could occur if changes to the protocol had to be made at a later stage.

scholarly journals Philosophers in research ethics committees—what do they think they’re doing? An empirical-ethical analysis

2021 ◽  
Author(s):  
Charlotte Gauckler
Keyword(s):  
Research Ethics ◽  
Applied Ethics ◽  
Ethics Committees ◽  
Research Ethics Committees ◽  
Structured Interviews ◽  
Discussion Section ◽  
Philosophical Perspective ◽  
Level 3 ◽  
Practical Level

AbstractResearch ethics committees in Germany usually don’t have philosophers as members and if so, only contingently, not provided for by statute. This is interesting from a philosophical perspective, assuming that ethics is a discipline of philosophy. It prompts the question what role philosophers play in those committees they can be found in. Eight qualitative semi-structured interviews were conducted to explore the self-perception of philosophers regarding their contribution to research ethics committees. The results show that the participants generally don’t view themselves as ethics experts. They are rather unanimous on the competencies they think they contribute to the committee but not as to whether those are philosophical competencies or applied ethical ones. In some cases they don’t see a big difference between their role and the role of the jurist member. In the discussion section of this paper I bring up three topics, prompted by the interviews, that need to be addressed: (1) I argue that the interviewees’ unwillingness to call themselves ethics experts might have to do with a too narrow understanding of ethics expertise. (2) I argue that the disagreement among the interviewees concerning the relationship between moral philosophy and applied ethics might be explained on a theoretical or on a practical level. (3) I argue that there is some lack of clarity concerning the relationship between ethics and law in research ethics committees and that further work needs to be done here. All three topics, I conclude, need further investigation.

scholarly journals Preventing ethics dumping: the challenges for Kenyan research ethics committees

2020 ◽  
pp. 174701612092506
Author(s):  
Kate Chatfield ◽  
Doris Schroeder ◽  
Anastasia Guantai ◽  
Kirana Bhatt ◽  
Elizabeth Bukusi ◽  
...  
Keyword(s):  
Research Ethics ◽  
Resource Constraints ◽  
Ethics Committees ◽  
Shared Responsibility ◽  
Standards Of Care ◽  
Primary Data ◽  
Research Ethics Committees ◽  
Governance System ◽  
Middle Income ◽  
System Resource

Ethics dumping is the practice of undertaking research in a low- or middle-income setting which would not be permitted, or would be severely restricted, in a high-income setting. Whilst Kenya operates a sophisticated research governance system, resource constraints and the relatively low number of accredited research ethics committees limit the capacity for ensuring ethical compliance. As a result, Kenya has been experiencing cases of ethics dumping. This article presents 11 challenges in the context of preventing ethics dumping in Kenya, namely variations in governance standards, resistance to double ethics review, resource constraints, unresolved issues in the management of biological samples, unresolved issues in the management of primary data, unsuitable informed consent procedures, cultural insensitivity, differing standards of care, reluctance to provide feedback to research communities, power differentials which facilitate the exploitation of local researchers and lack of local relevance and/or affordability of the resultant products. A reflective approach for researchers, built around the values of fairness, respect, care and honesty, is presented as a means of taking shared responsibility for preventing ethics dumping.

Research ethics committees

BMJ ◽  
1990 ◽  
Vol 300 (6724) ◽  
pp. 608-608
Author(s):  
M. Drury
Keyword(s):  
Research Ethics ◽  
Ethics Committees ◽  
Research Ethics Committees
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