View from the research and development office
http://www.100md.com
《英国医生杂志》
1 Avon and Wiltshire Mental Health Partnership NHS Trust, Bath BA1 3QE
Correspondence to: Health Training and Research Centre, University of the West of England, Bristol BS16 1QY tony.soteriou@uwe.ac.uk
English NHS trusts are obliged to implement research governance for all NHS health and social care research.1 The NHS trust that I work for, which funded the research highlighted by Jones and Bamford,2 sees research as integral to providing high quality health and social care services, and research governance is paramount to our research strategy.
Research involving NHS patients or service users should be reviewed by the NHS research ethics committee and be of appropriate scientific quality. If a research protocol changes, then it needs to be reassessed for the new methods and research ethics. Research not meeting these ethical and quality standards can represent a potential risk to patients, researchers, and wider NHS research, as shown by the Alder Hey and other inquiries.3-5 Trusts therefore need to implement training for researchers, together with governance and guidelines on good practice. Researchers and clinicians engaged in research also have a professional responsibility to take steps to increase their knowledge of NHS research governance.
In the case highlighted here, communication about the reasons behind the actions of the research and development office was clearly not adequate, and we regret that the researchers felt unduly stressed. The office is continually developing research governance communication and is keen to discuss how best to handle difficult research management decisions with researchers.
Why the study stopped
The research in question was a small pilot project funded from the trust's research and development budget through an open call for research applications. When the change to the approved study methods came to my office's attention, the research protocol had not yet been adapted to reflect the additional qualitative component and the patient information and consent sheets had not been updated to describe the qualitative research. Most importantly, some people had already participated in the qualitative research without being initially presented with accurate information about the qualitative nature of the research. It could therefore be argued they had not given full informed consent, potentially representing a serious breach to participants' rights.
After discussion with the research ethics committee, we decided that the alterations to the protocol, patient information, and consent needed to be reviewed by the committee after the revised protocol had been peer reviewed. This was to ensure that the decision to convert and extend a validated quantitative measure to a qualitative interview had sufficient rigour.
We therefore advised the researchers to halt the research temporarily. Continuation of the research would have involved further data collection from participants who had not fully consented. The pilot research project was non-interventional, and no treatments were withheld. Our analogy with a cancer patient's prescription was to highlight that if a complaint had been made by participants or other staff then a formal investigation would have been required.
Overcoming the problem
As lack of training had contributed to this research being conducted without appropriate ethics committee and methodological review, we held discussions with the researchers and clinical team to increase familiarity with ethical and best practice guidelines. We worked with the researchers to revise the protocol to match the research design, and advised on qualitative data analysis (which the researchers were unfamiliar with) and resubmission to the ethics committee.
To minimise disruption, funding was continued to allow the research team to develop the protocol and patient information sheets before resubmission. If the researchers had expressed concern that this represented misuse of resources, the funding could have been re-profiled. Trust approval was given two months later for the pilot research project to restart, after a favourable opinion from the research ethics committee. Subsequently, we worked with the researchers to provide funding to extend their data collection and analysis.
Introduction of a qualitative component represents an important change to a study, originally peer reviewed and funded as a quantitative study. Research participants have a right to be presented with accurate and complete information when being asked for informed consent. However, further public debate is needed on research governance measures implemented in the NHS—for example, on linking research project management more closely with risk assessment. Such public debate will help ensure that NHS research is conducted according to research governance and ethical standards.
Competing interests: TS chairs the national NHS Research and Development Forum's research governance working group.
References
Department of Health. Research governance framework for health and social care. London: DoH, 2001. www.dh.gov.uk/assetRoot/04/01/47/57/04014757.pdf 2 (accessed 8 July 2004).
Jones AM, Bamford B. The other face of research governance. BMJ 2004;329: 280-1.
Royal Liverpool Children's Inquiry. Report of the Royal Liverpool Children's Inquiry. London: Stationary Office, 2001. www.rlcinquiry.org.uk/index.htm (accessed 8 July 2004).
Bristol Royal Infirmary Inquiry. The inquiry into the management of care of children receiving complex heart surgery at the Bristol Royal Infirmary 1984-1995. London: Stationery Office, 2001 (CM 5207.)
Department of Health. The Isaacs report: the investigation of the events that followed the death of Cyril Mark Isaacs. London: DoH, 2003.(Tony Soteriou, director o)
Correspondence to: Health Training and Research Centre, University of the West of England, Bristol BS16 1QY tony.soteriou@uwe.ac.uk
English NHS trusts are obliged to implement research governance for all NHS health and social care research.1 The NHS trust that I work for, which funded the research highlighted by Jones and Bamford,2 sees research as integral to providing high quality health and social care services, and research governance is paramount to our research strategy.
Research involving NHS patients or service users should be reviewed by the NHS research ethics committee and be of appropriate scientific quality. If a research protocol changes, then it needs to be reassessed for the new methods and research ethics. Research not meeting these ethical and quality standards can represent a potential risk to patients, researchers, and wider NHS research, as shown by the Alder Hey and other inquiries.3-5 Trusts therefore need to implement training for researchers, together with governance and guidelines on good practice. Researchers and clinicians engaged in research also have a professional responsibility to take steps to increase their knowledge of NHS research governance.
In the case highlighted here, communication about the reasons behind the actions of the research and development office was clearly not adequate, and we regret that the researchers felt unduly stressed. The office is continually developing research governance communication and is keen to discuss how best to handle difficult research management decisions with researchers.
Why the study stopped
The research in question was a small pilot project funded from the trust's research and development budget through an open call for research applications. When the change to the approved study methods came to my office's attention, the research protocol had not yet been adapted to reflect the additional qualitative component and the patient information and consent sheets had not been updated to describe the qualitative research. Most importantly, some people had already participated in the qualitative research without being initially presented with accurate information about the qualitative nature of the research. It could therefore be argued they had not given full informed consent, potentially representing a serious breach to participants' rights.
After discussion with the research ethics committee, we decided that the alterations to the protocol, patient information, and consent needed to be reviewed by the committee after the revised protocol had been peer reviewed. This was to ensure that the decision to convert and extend a validated quantitative measure to a qualitative interview had sufficient rigour.
We therefore advised the researchers to halt the research temporarily. Continuation of the research would have involved further data collection from participants who had not fully consented. The pilot research project was non-interventional, and no treatments were withheld. Our analogy with a cancer patient's prescription was to highlight that if a complaint had been made by participants or other staff then a formal investigation would have been required.
Overcoming the problem
As lack of training had contributed to this research being conducted without appropriate ethics committee and methodological review, we held discussions with the researchers and clinical team to increase familiarity with ethical and best practice guidelines. We worked with the researchers to revise the protocol to match the research design, and advised on qualitative data analysis (which the researchers were unfamiliar with) and resubmission to the ethics committee.
To minimise disruption, funding was continued to allow the research team to develop the protocol and patient information sheets before resubmission. If the researchers had expressed concern that this represented misuse of resources, the funding could have been re-profiled. Trust approval was given two months later for the pilot research project to restart, after a favourable opinion from the research ethics committee. Subsequently, we worked with the researchers to provide funding to extend their data collection and analysis.
Introduction of a qualitative component represents an important change to a study, originally peer reviewed and funded as a quantitative study. Research participants have a right to be presented with accurate and complete information when being asked for informed consent. However, further public debate is needed on research governance measures implemented in the NHS—for example, on linking research project management more closely with risk assessment. Such public debate will help ensure that NHS research is conducted according to research governance and ethical standards.
Competing interests: TS chairs the national NHS Research and Development Forum's research governance working group.
References
Department of Health. Research governance framework for health and social care. London: DoH, 2001. www.dh.gov.uk/assetRoot/04/01/47/57/04014757.pdf 2 (accessed 8 July 2004).
Jones AM, Bamford B. The other face of research governance. BMJ 2004;329: 280-1.
Royal Liverpool Children's Inquiry. Report of the Royal Liverpool Children's Inquiry. London: Stationary Office, 2001. www.rlcinquiry.org.uk/index.htm (accessed 8 July 2004).
Bristol Royal Infirmary Inquiry. The inquiry into the management of care of children receiving complex heart surgery at the Bristol Royal Infirmary 1984-1995. London: Stationery Office, 2001 (CM 5207.)
Department of Health. The Isaacs report: the investigation of the events that followed the death of Cyril Mark Isaacs. London: DoH, 2003.(Tony Soteriou, director o)