UK proposes reforms for research ethics committees
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《英国医生杂志》
NHS research ethics committees (RECs) should work more closely with each other, have a clearer remit, and improve training for their members. These were the recommendations of a report published this week that was designed to streamline the procedures for ethical review of research proposals for studies to be done in the NHS.
The committees give independent advice on whether proposals for research studies in the NHS comply with ethical standards. The report, from the UK Department of Health, was developed in response to criticisms from researchers that the committees are uncoordinated, application procedures are time consuming, and decisions are unpredictable.
The report recommended that committees should work in a more coordinated way as a nationally networked system, with fewer committees meeting more often: "We believe that a smaller number of research ethics committees, perhaps one for each strategic health authority, with a limited number of exceptions, would be more appropriate. Their operations would be more intense than at present, with a greater use of electronic communications."
Research ethics committees should also work to a clearer remit, the report argued. In particular, it stated that they should not reach decisions based on scientific review. Instead, the report recommended the creation of "scientific officers" to take on much of the preliminary assessment and review of research proposals.
Consistency between committees should be improved through better training of members and implementation of systems to share information on issues for which ethical arguments have already been explored. The report noted, "We strongly encourage NHS research hosts to adopt common national systems."
Recommendations were also made to streamline ethical review for researchers, making the application process more user friendly and intuitive. Application forms should take more explicit account of differences between types of research and give more space to ethical issues. And greater investment in computer systems would mean that researchers do not have to submit duplicate information to different committees.
The report also recognised that a proportion of the delays were due to local research and development procedures. It called for improvements to these procedures and their interaction with ethical review, including the ability to make multiple use of information supplied by researchers to reduce bureaucracy and timescales.
Charles Warlow, professor of medical neurology at Edinburgh University, said, "This is a very sympathetic report to the concerns of researchers and indeed to the burdens on research ethics committee members. It is very interesting that the review states that RECs should not be another form of review of the science. I absolutely agree. RECs are mostly incompetent to judge the science." However, he cautioned, "The real problem nowadays is the departments in all the various hospitals doing their own thing. They are under-resourced, often clueless, seemingly obstructive, and pose a complete nightmare for multicentre studies."(Susan Mayor)
The committees give independent advice on whether proposals for research studies in the NHS comply with ethical standards. The report, from the UK Department of Health, was developed in response to criticisms from researchers that the committees are uncoordinated, application procedures are time consuming, and decisions are unpredictable.
The report recommended that committees should work in a more coordinated way as a nationally networked system, with fewer committees meeting more often: "We believe that a smaller number of research ethics committees, perhaps one for each strategic health authority, with a limited number of exceptions, would be more appropriate. Their operations would be more intense than at present, with a greater use of electronic communications."
Research ethics committees should also work to a clearer remit, the report argued. In particular, it stated that they should not reach decisions based on scientific review. Instead, the report recommended the creation of "scientific officers" to take on much of the preliminary assessment and review of research proposals.
Consistency between committees should be improved through better training of members and implementation of systems to share information on issues for which ethical arguments have already been explored. The report noted, "We strongly encourage NHS research hosts to adopt common national systems."
Recommendations were also made to streamline ethical review for researchers, making the application process more user friendly and intuitive. Application forms should take more explicit account of differences between types of research and give more space to ethical issues. And greater investment in computer systems would mean that researchers do not have to submit duplicate information to different committees.
The report also recognised that a proportion of the delays were due to local research and development procedures. It called for improvements to these procedures and their interaction with ethical review, including the ability to make multiple use of information supplied by researchers to reduce bureaucracy and timescales.
Charles Warlow, professor of medical neurology at Edinburgh University, said, "This is a very sympathetic report to the concerns of researchers and indeed to the burdens on research ethics committee members. It is very interesting that the review states that RECs should not be another form of review of the science. I absolutely agree. RECs are mostly incompetent to judge the science." However, he cautioned, "The real problem nowadays is the departments in all the various hospitals doing their own thing. They are under-resourced, often clueless, seemingly obstructive, and pose a complete nightmare for multicentre studies."(Susan Mayor)