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Clin Ethics 2008;3:85-90
doi:10.1258/ce.2008.008014
© 2008 Royal Society of Medicine Press

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Empirical Ethics

Ethics and research governance: the views of researchers, health-care professionals and other stakeholders

Nina Hallowell *  , Sarah Cooke * , Gill Crawford {dagger} , Michael Parker {ddagger}  and Anneke Lucassen {dagger} 

* Public Health Sciences, University of Edinburgh, Edinburgh {dagger} Princess Anne Hospital and University of Southampton, Southampton {ddagger} The Ethox Centre, University of Oxford, Oxford, UK

E-mail: nina.hallowell{at}ed.ac.uk

The objective of this study is to describe researchers', health-care providers' and other stakeholders' views of ethical review and research governance procedures. The study design involved qualitative semi-structured interviews. Participants included 60 individuals who either undertook research in the subspecialty of cancer genetics (n = 40) or were involved in biomedical research in other capacities (n = 20), e.g. research governance and oversight, patient support groups or research funding. While all interviewees observed that oversight is necessary to protect research participants, ethical review and research governance (ERG) arrangements were described negatively throughout these interviews. Interviewees identified a number of problems with ERG, including: over-bureaucratization, over-standardization of information requirements for different types of research, a lack of standardization in the types of information required by different committees for the same research and a lack of consistency in different committees' responses. A number of solutions were proposed including streamlining application procedures and harmonizing committees' responses and information requirements. Recent reports suggest that ethical review procedures and research governance arrangements threaten the possibility of undertaking clinical research in the UK, hence the introduction of the Integrated Research Application System (IRAS) is long overdue. However, while IRAS may solve some of the problems identified by interviewees, it remains to be seen to what extent it will impact upon the very negative perceptions of ethics and research governance procedures reported here.


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