Meeting the challenges of research governance.

Editorial Meeting the challenges of research governance There is a tangible sense of hostility being expressed among UK clinical researchers at present, directed at NHS Trusts' implementation of the Department of Health's (DOH) Research Governance Framework (RGF) [1–4]. Researchers fear a decline in the UK's impressive research record due to the obstacles resulting from lengthy, complex, bureaucratic implementation procedures presented by research managers in NHS Trusts [5]. In addition, the UK health service has undergone radical organi-sational change, adding further complexities in the delivery of high quality research. Here we evaluate the impact of RGF particularly to multicentre clinical trials and contribute to the debate by sharing our personal experiences. There is no doubt that patients must be assured that clinical research is undertaken to the highest standards, and an integral part of such an assurance includes improved standards of accountability. Urgent action has been required to address the crisis of public confidence in medical research, following the experiences of Bristol, and Alder Hey. The RGF, introduced in 2001 [6], sought to address perceived weaknesses in the way collaborative clinical research has historically been organised. It challenges researchers and their employers to make their responsibilities explicit and forces new standards and structures to improve safeguards for research participants. From 2001, NHS trusts in secondary care settings, particularly those in receipt of NHS R&D funds, proceeded to establish the necessary policies and procedures to comply with the RGF. This was driven by the NHS research governance implementation plan (2001) and Controls Assurance Standards, (recently replaced by the Health and Social Care Standards). A key component of Trusts' implementation of the RGF has been the development of a complex bureaucracy for approval of research projects. Full implementation of the RGF in Primary Care was delayed until 2003, when specific money was provided centrally to defined groups of Research Management and Governance Primary Care Trusts (RM&G PCTs), to establish a national network to streamline their RGF arrangements. Often, primary care research studies cross a number of PCT boundaries, and the DOH's aim was to provide a unified approach, to reduce duplication and bureaucracy. Since 2003 there has been an explosion of activity as PCTs have embraced their new role. However, across both primary and secondary care, a wide range of organizational models and procedures are being adopted. Research studies have shown that there is confusion regarding the processes involved [7]. Our experience in …