Department of Health

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Research governance

The Research Governance Framework for health and social care defines the broad principles of good research governance and is key to ensuring that health and social care research is conducted to high scientific and ethical standards.

Research governance framework for health and social care

Second edition issued April 2005

Research governance implementation plan for social care

Recognising that implementation of the RGF in social care required separate consideration from its implementation in the NHS, the Department of Health undertook a process of consultation and information gathering. The results of the consultation informed the final draft of the Implementation Plan for Social Care (May 2004).

Procedure for investigating research misconduct

The Procedure for the Investigation of Allegations of Misconduct in Research  provides researchers’ employers with standards that are thorough and fair to all parties. The standards, prepared by the UK Panel for Research Integrity in Health and Biomedical Sciences, are applicable to all fields of research.

The Department welcomes the publication of the procedures, as it recognises that some high-profile cases have heightened public awareness of poor research practice, affecting public confidence in clinical research. Though rare, when bad research practice does occur, it can have wide-ranging and damaging consequences. These are made worse if they are not addressed appropriately. The Department is committed to promoting research governance processes that are proportionate to risk and to ensuring that procedures are rationalised.

The research passport

The research passport is a new initiative that simplifies administrative procedures when issuing honorary research contracts. The Department of Health recommends the research passport to the NHS, to higher education institutions and to other research employers working in partnership with the National Institute for Health Research.

Aims and objectives - health and social care research in the Department of Health

Outlines departmental objectives for health and social care research and the main aims of the government science strategy.

Registration of clinical trials and public access to findings.

The Department of Health welcomes the statement in the 2008 amendment of the World Medical Association's Declaration of Helsinki asserting the principle that clinical trials should appear on public registers. It is government policy to promote public access to information about research and research findings affecting health and social care. That includes the voluntary registration of trials on public registers. Because of this long-standing policy, DH supports registers and registries that conform to the standards published by the World Health Organisation.

We recognise, in accordance with UK law on freedom of information, that exceptionally the public interest might not always require the WHO trial registration data set to appear on a public register before recruitment can start ethically and lawfully. The model agreements recommended by DH for use between NHS trusts and the pharmaceutical and medical devices industries provide for contractual arrangements that ensure appropriate registration in the circumstances.

Guidance, notes and examples of best practice

Guidance on clinical trials in the NHS. guidance on compiling annual reports, guidance for honorary NHS contracts and other notes and explanations.

Research sponsors

A number of organisations have confirmed with DH that they would be willing and able to be a sponsor for research. This does not imply a commitment for any particular study or area of research. It is necessary to check with the relevant organisation about the kind of research that they would be prepared to undertake.

Research involving the NHS – retention of records

Keeping records is an important part of research activity.  Records are a valuable resource because of the information they contain. High-quality research information supports improvements in clinical effectiveness and patient care and provides important information for future research. It is therefore important that researchers and others take account of relevant legislation and policies.

Report of the Ad Hoc Advisory Group on the Operation of NHS Research Ethics Committees

he Ad Hoc Group's report was announced on 6th June 2005. Its recommendations are designed to streamline the procedures for ethical review and ensure that committees work more intensively and efficiently, helped by stronger administrative support. The report has now been passed to the NPSA to take forward consultation work on how best to implement these recommendations. Hard copies can be obtained free of charge by contacting the DH Publications Order Line (0870 1555 455) or by email, (dh@prolog.uk.com) quoting order number: 268110.

Ethical governance and regulation of student projects

Professor Len Doyal reported on ethical review of student research in the NHS in 2005. The findings of this report were considered by the working party on research ethics in the NHS set up by Lord Warner. This report is now being used by the National Patient Safety Agency to implement the recommendations of the Warner review, develop student protocols and inform policy development for student research in the NHS.

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