'Research governance' is a term used to describe best practice in all health and social care research.  In March 2001 the Department of Health published a framework document outlining the principles of research governance, summarised below.  The 2^nd Edition of this document was published in June 2005 (1)

Research governance is seen as necessary in order to maintain good standards of practice and ethics in research and development.  It is a way of ensuring that research involving patients, their data or tissue is both relevant to health and social care practice and within the best interests of patients and service users. 

Principles of Research Governance

Sets standards and defines mechanisms to deliver those standards

• Described monitoring and assessment arrangements
• Improves research quality and safeguards the public by enhancing ethical and scientific quality, promoting good practice, reducing adverse incidents and ensuring lessons are learned, and preventing poor performance and misconduct.

Research governance has relevance for all who participate in research, host research in their organisation, fund research proposals or infrastructure, manage research and undertake research.  Research governance is relevant to all individuals and professional groups, no matter how senior or junior.  Further information is available at the Department of Health official website www.doh.gov.uk

Most professional bodies will have an existing code of conduct which adheres to the principles of research governance, and issues such as informed consent, confidentiality, and protection of participants remain central to research conduct.  In this way breaches in research governance can also result in breaches in professional practice.  For examples of professional codes of research practice visit www.gmc-uk.org, www.mrc.ac.uk, www.bps.org.uk .

It is fair to say that the vast majority of researchers agree to these principles and uphold them.  However, in trying to do the right thing they often fall foul to the overwhelming bureaucratic processes adopted by individual NHS organisations, which are struggling to minimise the bureaucracy associated with implementing monitoring systems needed to uphold the principles of research governance.  Research governance is a core standard within the Department of Health's 'Standards for Better Health' (2).  Consequently, there is pressure on NHS Trusts to achieve and improve upon systems to support the research governance framework. 

This pressure to achieve standards has resulted in variable and individualised approval systems within NHS Trusts.  Rather unfairly, the individual researcher pays the price because interpreting approval systems is not always straight forward or easy.  The penalties are even greater for those researchers conducting studies over a number of NHS sites, as they will inevitably face a different system of approval at each NHS Trust.   

It is ironic that the research governance framework was introduced to protect and enhance NHS and social care research yet many professional groups are of the opinion that it kills off research by increasing bureaucracy, duplication, delays and cost (3, 4).  It is clear that a balance needs to be struck on both sides.        

A solution is apparently underway.  In Spring 2006 the Department of Health launched a national research strategy, Best Research for Best Health (5).   Within the numerous implementation plans was a plan to 'Bust Bureaucracy' (6).  Therefore, in 2007 we can expect a national portal that will support researchers, enable single entry of information, and act as a central information resource.  Additionally, there will be improved R&D information management systems reducing the administrative burden of applications for individual researchers. In short, the new plan claims to simplify approval processes and save time.  Many remain cynical about the timely delivery of this new system but that remains to be seen.  Further information can be obtained from the National Institute of Health Research www.nihr.ac.uk.       

Until the new system is up and running, there are some issues to take into account if you are conducting health and social care research.  Firstly, factor in time for research governance approval, a minimum of six weeks.  Secondly, befriend your local NHS R&D office(s) and make early contact to obtain any approval documentation and useful information.  Research approval committees within NHS Trusts may only meet on a monthly basis, so awareness of deadlines for submission of documentation is essential.  A list of all R&D contacts is available on the National R&D forum website www.rdforum.nhs.uk.

References

(1) Department of Health.  Research Governance Framework for Health and Social Care 2^nd Edition, 2005. 

(2) Department of Health.  Standards for Better Health, 21 July 2004.

(3) Elwyn G., Seagrove A., Thorne K., Cheung W Y. Ethics and research governance in a multicentre study: add 150 days to your study protocol.  BMJ 2005 330:847.

(4) Hill J., Foster N., Hughes R., & Hay E. Meeting the challenges of research governance.  Rheumatology 2005 44(5) 571-572. 

(5) Department of Health.  Best Research for Best Health: A New National Research Strategy.  The NHS contribution to health research in England,  2006. 

(6) Department of Health. Best Research for Best Health Implementation Plan 4.1. Bureaucracy Busting: Governance, Advice and Ethics Systems. Version 3 January 2007.