Summary

Research and Development (R&D) in health and social care is dependent on funding from government or charitable sources, public confidence and concrete support. Therefore it is essential that R&D be conducted according to regulations that are both stringent and transparent. In the UK, R&D, carried out by organisations and individuals, is subject to the Research governance framework for health and social care (DH, 2005). This framework, which is overseen by the relevant government department, aims to enhance the promotion and quality of R&D and to ensure a sustainable research culture. Research governance compliance criteria include the need for independent scientific review of the research proposal; ethical approval; and sponsorship and supervision by responsible health and social care professionals. The ethical implications of the patient's autonomy and consent within the framework, alongside those of monitoring, accountability, leadership and management, will be examined in this chapter. Shortcomings in the conduct of R&D and subsequent evidence-based practice will also be considered.

Introduction

The World Health Organisation (WHO) urges countries to create a climate in which research for health will flourish. It proposes universal ethical standards, a wider view of health with more civil society involvement and more financial investment from governments (WHO, 2004). Research governance is not unique to the UK. Governance in some form or another is undertaken in a number of countries throughout the world. According to Alexander et al (2003), health research governance should include the plan for setting and monitoring organisational goals and developing strategies by a board of trustees or directors, to which the chief administrator reports. In the UK, the Research governance framework for health and social care is implemented through a strategic plan developed by the board within the R&D department at the Department of Health (DH) and the reporting administrator to this board is the responsible person in a hospital's R&D department.

In research, as in other aspects of care, all individuals have rights in order to protect them and maintain their confidentiality (DH, 1995; 1998 Data Protection Act; 1998 Human Rights Act). Abuse of these rights can lead to litigation. Research governance creates a climate in which research can be carried out without contravening an individual's rights. This is done through assigning roles and responsibilities to all involved, encompassing researchers, funders, research sponsors, care organisations and formal carers. It is also intended to prevent misconduct and fraud.