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 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.

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 Exploring the risk/benefit balance in biomedical research: some considerations

2017 ◽  
Vol 25 (2) ◽  
pp. 320-327
Author(s):  
Derrick E. Aarons
Keyword(s):  
Research Ethics ◽  
Biomedical Research ◽  
Ethics Committees ◽  
Responsibility To Protect ◽  
Ethical Review ◽  
Research Ethics Committees ◽  
Risks And Benefits ◽  
Potential Benefits ◽  
Human Participants ◽  
Risk And Benefit

Abstract Risk and benefit assessment is one of the fundamental requirements in the ethical review of research involving human participants. As a result, researchers should evaluate and seek to minimize all foreseeable risks involved in their proposed research and members of research ethics committees should evaluate and balance the risks and potential benefits involved in each research proposal as a part of their ethical obligations regarding research protocols. However, current literature provides little detailed guidance on the specifics of how this balancing process should occur. Consequently, this article provides some details of the process to balance risks and benefits in biomedical research and reminds members of research ethics committees of their responsibility to protect those who are vulnerable from exploitation in research projects.

scholarly journals Issues and Guidance in Research Ethics

2007 ◽  
Vol 2 (1) ◽  
Author(s):  
Ronald D. Francis ◽  
Anona Armstrong
Keyword(s):  
Research Ethics ◽  
Natural Extension ◽  
Ethics Committees ◽  
Research Ethics Committees ◽  
Peer Reviews ◽  
Ethical Approval ◽  
The Common ◽  
Conducting Research ◽  
Human Participants ◽  
Scientific Endeavour

This paper addresses the principles that govern the outlook and decisions of research ethics committees. The purpose of the paper is to outline such underlying principles in order to aid understanding for researchers into aspects of social and commercial behaviour. Prior to conducting research in any corporate area there is an obligation toward any human participants. That obligation is set out most clearly in the information and forms put out by the various ethics committees charged with examining the proposal, and with giving formal ethical approval. The principles that invest the understanding of ethics committees are those of protecting the vulnerable, and of protecting justifiably good reputations. Ethics committees should be seen as enabling and protecting rather than as a barrier to research. Peer reviews should be seen to include ethics matters in research, and are thus a natural extension of the common scientific endeavour. To this end the article outlines and discusses the issues commonly addressed by research ethics committees. By highlighting these principles, this paper aims to give insights and suggestions that should make the ethics application task easier.

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.

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