A 55 kg paper mountain: The impact of new research governance and ethics processes on mental health services research in England.

Background: The guidelines about research ethics and research governance, implemented by the Department of Health, present new challenges to undertaking mental health service research within the National Health Service (NHS). Aims: This paper describes how these new ethical and research governance procedures have adversely affected three multi-centre mental health service research studies, funded by the Department of Health. Methods: The workload, time, and cost of meeting these requirements for each study is described. Conclusion: The implementation of Government guidance has resulted in a level of bureaucracy that threatens the future of the type of research that underpins policy development and service planning. For the researcher, the work involved in meeting these new requirements can be greater than the work of data collection, and for the trust, greater than the cost of participation in the research itself. The Department of Health has made recommendations to streamline the research ethics process. However this will not address the tension between research ethics systems and localized research governance procedures. Declaration of interest: None. [ABSTRACT FROM AUTHOR]