Advisory group to review NHS research ethics committees
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《英国医生杂志》
The UK government has appointed an advisory group to review the operation of research ethics committees controlling research in the NHS in England, with the aim of streamlining procedures.
In a written statement on 16 November health minister Lord Warner told the House of Commons that he had asked a small ad hoc group of scientists and lay members to review the system that supports NHS research ethics committees in England and to make recommendations for further steps to improve their operation. The group will meet for the first time this month and will report to health ministers by the end of March 2005.
The advisory group has been asked to provide independent advice to the government on the effectiveness of procedures used by NHS research ethics committee when they review proposals for research that will be carried out in the NHS in England involving individuals, their organs, tissue, or data. Group members will look at developments and trends affecting the remit, administration, operation, and workload of NHS research ethics committees in England.
They will also review the relationship between these committees and other research approval requirements and consider any regulatory blocks that might be impeding research.
Clinical researchers in the United Kingdom have reported that they find the procedures used by research ethics committees increasingly burdensome. Five separate research groups reported a range of problems earlier this year in the BMJ (2004;329:277-9, 280-1, 282-4, 286-7, 288-9, 31 Jul), showing how ethics committee impeded, delayed, and sometimes distorted research. One group considered that ethical committees?requirements on patient confidentiality resulted in a poor response rate from their community controls. A 68 page application form took another research group 40 hours to fill in.
Dr Richard Smith, then editor of the BMJ, commented in Editor抯 Choice in the same issue: "There must, of course, be a balance between the needs of research and the interests of patients—but, as healthcare workers lack evidence for much of what they do, research is important. It is unlikely to be in the public interest to make it more difficult to do research."
Lord Warner has asked the group to make recommendations on how to reduce the time required by ethics committees of researchers starting research while maintaining "the focus of health and social care research governance on protecting the dignity, rights, safety and well-being of individuals (including their organs, tissue or confidential data) when the NHS owes them a duty of care."
It is also going to explore the development of a single point of entry and consistent process appropriate for all the types of research needing decisions by NHS research ethics committees. Another aim is to look for ways to strengthen the systems, structures, and processes supporting the work of these committees, to make their business processes as efficient as possible, and to improve the experience of users and committee members.
The advisory group will clarify whether the existing operational boundaries within which NHS research ethics committees work are suitable and make proposals for containing rising costs and burdens on research, identifying any necessary associated investment.
The minister has asked Michael O扝iggins, a managing partner of PA Consulting Group, to chair the advisory group, which will include scientists and lay members. Members will include Professor Alex Markham, chief executive of Cancer Research UK; Professor Janet Darbyshire, director of the Medical Research Council抯 Clinical Trials Unit; Professor Michael Parker, reader in medical ethics at the Oxford Centre for Ethics and Communication in Health Care; and Harry Cayton, the government抯 tsar for patients and the public, who advises government ministers, the Department of Health, and the NHS on the involvement of patients and the public.
Meetings will also include observers: Michael Stevens, of the Chief Scientist Office, Scotland; Louise Haines, Wales Office of NHS R&D; Stephanie Harcourt, Social Services and Public Safety in the Northern Ireland Department of Health; and Sue Williams, joint chief executive of the National Patient Safety Agency, a special health authority created in July 2001 to coordinate the efforts across England to report and to learn from mistakes and problems that affect the safety of patients.(London Susan Mayor)
In a written statement on 16 November health minister Lord Warner told the House of Commons that he had asked a small ad hoc group of scientists and lay members to review the system that supports NHS research ethics committees in England and to make recommendations for further steps to improve their operation. The group will meet for the first time this month and will report to health ministers by the end of March 2005.
The advisory group has been asked to provide independent advice to the government on the effectiveness of procedures used by NHS research ethics committee when they review proposals for research that will be carried out in the NHS in England involving individuals, their organs, tissue, or data. Group members will look at developments and trends affecting the remit, administration, operation, and workload of NHS research ethics committees in England.
They will also review the relationship between these committees and other research approval requirements and consider any regulatory blocks that might be impeding research.
Clinical researchers in the United Kingdom have reported that they find the procedures used by research ethics committees increasingly burdensome. Five separate research groups reported a range of problems earlier this year in the BMJ (2004;329:277-9, 280-1, 282-4, 286-7, 288-9, 31 Jul), showing how ethics committee impeded, delayed, and sometimes distorted research. One group considered that ethical committees?requirements on patient confidentiality resulted in a poor response rate from their community controls. A 68 page application form took another research group 40 hours to fill in.
Dr Richard Smith, then editor of the BMJ, commented in Editor抯 Choice in the same issue: "There must, of course, be a balance between the needs of research and the interests of patients—but, as healthcare workers lack evidence for much of what they do, research is important. It is unlikely to be in the public interest to make it more difficult to do research."
Lord Warner has asked the group to make recommendations on how to reduce the time required by ethics committees of researchers starting research while maintaining "the focus of health and social care research governance on protecting the dignity, rights, safety and well-being of individuals (including their organs, tissue or confidential data) when the NHS owes them a duty of care."
It is also going to explore the development of a single point of entry and consistent process appropriate for all the types of research needing decisions by NHS research ethics committees. Another aim is to look for ways to strengthen the systems, structures, and processes supporting the work of these committees, to make their business processes as efficient as possible, and to improve the experience of users and committee members.
The advisory group will clarify whether the existing operational boundaries within which NHS research ethics committees work are suitable and make proposals for containing rising costs and burdens on research, identifying any necessary associated investment.
The minister has asked Michael O扝iggins, a managing partner of PA Consulting Group, to chair the advisory group, which will include scientists and lay members. Members will include Professor Alex Markham, chief executive of Cancer Research UK; Professor Janet Darbyshire, director of the Medical Research Council抯 Clinical Trials Unit; Professor Michael Parker, reader in medical ethics at the Oxford Centre for Ethics and Communication in Health Care; and Harry Cayton, the government抯 tsar for patients and the public, who advises government ministers, the Department of Health, and the NHS on the involvement of patients and the public.
Meetings will also include observers: Michael Stevens, of the Chief Scientist Office, Scotland; Louise Haines, Wales Office of NHS R&D; Stephanie Harcourt, Social Services and Public Safety in the Northern Ireland Department of Health; and Sue Williams, joint chief executive of the National Patient Safety Agency, a special health authority created in July 2001 to coordinate the efforts across England to report and to learn from mistakes and problems that affect the safety of patients.(London Susan Mayor)