Research governance framework for health and social care.

Foreword The Research Governance Framework outlines principles of good governance that apply to all research within the remit of the Secretary of State for Health. Research governance is one of the core standards for health care organisations. This second edition takes account of several developments. Much published guidance refers to health research, and particularly clinical trials. Regulations on clinical trials involving medicines took effect in 2004. The change in the law stimulated wide debate on good practice and risk­based regulatory process. We have drawn lessons throughout this edition. The Research Governance Framework remains grounded on principles that apply generally to research in health and social care. It applies to the full range of research types, contexts and methods. While research across health and social care should meet the same general standards of governance, there are also important differences. The mechanisms by which we achieve the standards depend on the context. I am delighted an implementation plan for research governance in social care has been published. There has been new legislation on human tissue and on mental capacity, with provisions to protect those who participate in research. Whatever the context, the interests of research participants come first. Those responsible must be satisfied they have taken all reasonable steps to protect the dignity, rights, safety and well­being of participants. We have to be frank about risks, and businesslike about managing them. John Reid, the Secretary of State for Health, said in the House of Commons on 22 March 2004, " investment in research saves lives, and that is why the Government wishes to make Britain the best place for R&D and innovation ". Public confidence in research, built on internationally recognised standards of good practice, is vital if we are to achieve that ambition.