Research bureaucracy in the United Kingdom
http://www.100md.com
《英国医生杂志》
EDITOR—Jones and Bamford express surprise and frustration that their study was temporarily halted after they introduced an interview to the existing protocol without research ethics committee approval.1 They seem not to have recognised that introducing a new aspect to their project may bring additional ethical considerations and problems for their existing research aims.
They say that they did not mention this interview in the patient information sheets or consent forms, and they seem to have introduced it after data collection had begun. Whether the interview itself had ethical problems that required consideration is unclear, but that is why ethics committee approval is required before beginning a research project. In addition, their interview, however well meant, may have asked sensitive or inappropriate questions that might affect the validity of the data they were collecting.
This is not an issue of researchers accidentally filling in the wrong form or some other minor deviation. Jones and Bamford began what is in effect a new study without approval from the research ethics committee. Their intentions were no doubt good, and no harm may have ultimately resulted, but the ethics committee has a responsibility to assess research on ethical grounds before allowing it to proceed.
This article shows that research governance is, in fact, working well. Far from being an "over-reaction" that destroyed "the quality of the research," a potential breach of care for research subjects was identified and needed to be considered, just as a new project must be. More efficient and satisfying ways to resolve research governance issues may exist, but the primary concern of the research ethics committee must be to protect research participants. Any ethical implications related to loss of time and money to the researchers, although clearly frustrating, are secondary and should not cloud the issues.
Justin T Denholm, hospital medical officer
Austin Hospital, Heidelberg, VIC 3081, Australia neuromalacia@hotmail.com
Competing interests: None declared.
References
Jones AM, Bamford B. The other face of research governance. BMJ 2004;329: 280-1. (31 July.)
They say that they did not mention this interview in the patient information sheets or consent forms, and they seem to have introduced it after data collection had begun. Whether the interview itself had ethical problems that required consideration is unclear, but that is why ethics committee approval is required before beginning a research project. In addition, their interview, however well meant, may have asked sensitive or inappropriate questions that might affect the validity of the data they were collecting.
This is not an issue of researchers accidentally filling in the wrong form or some other minor deviation. Jones and Bamford began what is in effect a new study without approval from the research ethics committee. Their intentions were no doubt good, and no harm may have ultimately resulted, but the ethics committee has a responsibility to assess research on ethical grounds before allowing it to proceed.
This article shows that research governance is, in fact, working well. Far from being an "over-reaction" that destroyed "the quality of the research," a potential breach of care for research subjects was identified and needed to be considered, just as a new project must be. More efficient and satisfying ways to resolve research governance issues may exist, but the primary concern of the research ethics committee must be to protect research participants. Any ethical implications related to loss of time and money to the researchers, although clearly frustrating, are secondary and should not cloud the issues.
Justin T Denholm, hospital medical officer
Austin Hospital, Heidelberg, VIC 3081, Australia neuromalacia@hotmail.com
Competing interests: None declared.
References
Jones AM, Bamford B. The other face of research governance. BMJ 2004;329: 280-1. (31 July.)