clinical research governance framework

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UK Policy Framework for Health and Social Care Research

This policy framework sets out principles of good practice in the management and conduct of health and social care research in the UK. 

These principles protect and promote the interests of patients, service users and the public in health and social care research, by describing ethical conduct and proportionate, assurance-based management of health and social care research, so as to support and facilitate high-quality research in the UK that has the confidence of patients, service users and the public.

It is for organisations and individuals that have responsibilities for health and social care research. This includes funders, sponsors, researchers and their employers, research sites and care providers.

The policy framework applies to health and social care research involving patients, service users or their relatives or carers. This includes research involving them indirectly, for example using information that the NHS or social care services have collected about them.

The Health Research Authority and the health departments in Northern Ireland, Scotland and Wales have developed the policy framework following  public consultation . It replaces the separate Research Governance Frameworks in each UK country with a single, modern set of principles for the whole UK.

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• v.98(11); 2005 Nov

Research governance: where did it come from, what does it mean?

For a variety of historical and social reasons, research has become increasingly formalized and regulated. This change has potential benefits (reduction in fraud and misconduct, protection of vulnerable groups, financial probity) but also disadvantages (increased paperwork, time delays, constraints on research freedom).

The terms ‘research’ and ‘governance’ mean different things in different contexts. Even with explicit guidance, ambiguities must be resolved by human judgement. Variation in the nature and outcome of approval decisions is therefore a fact of life.

The type of approval needed for a research study depends on the official remit of the approval body, the question to be addressed; the methods to be used; the context in which the work will take place; the level of analysis and interpretation; and the plans for how the findings will be presented and used.

INTRODUCTION

In many countries, research has moved from being a largely unregulated endeavour undertaken by interested individuals working independently of external controls to a highly formalized, regulated and institutionalized activity. 1 This change has a number of historical and social causes, including an increase in the scale of research and national funding to support it, the expectation for greater accountability in the public sector; the active input of service users (e.g. gay men and AIDS 2 ), and the exposure of fraud and misconduct in research—especially on groups who have lacked the ability or opportunity to give informed consent (Box 1). 3

Box 1 Fraud and misconduct in medical research: disproportionate impact on vulnerable groups

Minority ethnic groups

Between the 1930s and 1960s in Tuskegee in the South of America 400 poor, Black men from rural areas were recruited without their knowledge or consent into a long-term follow-up trial of the prognosis of untreated syphilis; effective treatments were withheld from them for decades. 26 Jews, Gypsies and Slavs were included within human experiments throughout the Holocaust, particularly those relating to warfare such as the testing of effects of gas attacks, battle injury or surviving freezing temperatures subjected to a range of experimentation [Ref. 3 ].

Institutionalized groups

Prisoners [Refs 3 , 27 ] and military personnel [Ref. 3 ] have not always been given the opportunity to give full informed consent or opt out of research without changes in their care or status.

Developing countries

Poor communities in developing countries have occasionally been targeted by pharmaceutical companies for trials of medicinal products that would not meet stringent restrictions in the countries where the company is based [Refs 28 , 29 ].

Socially excluded groups

Studies of ‘treatments’ for homosexuality up to the 1970s can, with the wisdom of hindsight, be classified as ideologically driven research that supported and perpetuated social prejudice and exclusion [Ref. 30 ].

The recently dead

The Alder Hey Hospital scandal highlighted the removal and retention of children’s organs and body parts for scientific study without full parental consent or knowledge [Ref. 31 ].

In the UK, the rapid growth of systems and procedures for research management and governance has generated confusion and resentment in the research community. They bemoan the rising burden of paperwork, the curtailment of research freedom, expensive delays caused by lengthy application procedures, inconsistent decisions, and in some cases, the halting of entire research programmes by allegedly heavy-handed but misinformed ethics committees. 4 – 7 The BMJ recently launched a campaign to revitalize academic medicine which aims to promote better public understanding of research and ensure that high quality studies that will benefit patients are supported rather than suppressed.

This is the first in a series of three papers that look at research governance from both a theoretical and a practical perspective. We consider definitions of research and governance from different standpoints and attempt to clarify and explain (but not to defend uncritically) the current systems for regulating research. Our main example is the UK National Health Service, but we draw on examples from other countries and sectors. Papers two and three in the series will explore issues of risk, indemnity, and ethics.

WHAT IS RESEARCH?

Implicit in the human condition is an insatiable curiosity and the desire to acquire and analyse knowledge. For instance:

• A teenager might look for information on the Internet to complete a piece of homework
• A manager might review attendance figures at a sexual health clinic with a view to changing clinic times to increase accessibility
• A public health consultant might study data on the incidence of breast cancer in her locality following the introduction of mammography screening
• An oncology nurse might collect data from patients entered in a trial of a new cancer drug
• A social scientist might analyse the messages from a public access Internet discussion about the safety of vaccines.

All these activities might be perceived as research by the person undertaking them (Box 2). Whether a study is research in the sense that it requires formal regulation and monitoring (e.g. approval from a research ethics committee) depends on: ( a ) the defined remit of the regulatory body; ( b ) the specific question being addressed; ( c ) the method(s) chosen to address the question; ( d ) the context in which the work takes place; ( e ) the nature and depth of analysis and interpretation; and ( f ) the plans for publication and the use to which the findings will be put.

WHAT IS GOVERNANCE?

Governance is the system of administration and supervision through which research is managed, participants and staff are protected, and accountability is assured. Governance is not the remit of any single institution (indeed, a guiding principle is that it is everyone’s business). It is therefore not surprising that tensions exist (and always will exist) between regional, national or international (e.g. European Union) codes of practice; national and European law; and professional standards, norms and values.

Box 2 Definitions of research

The lay person’s definition...

Research is about asking a question and systematically looking for the answer [Ref. 32 ].

The medical editor’s definition...

Research is concerned with discovering the right thing to do and audit is about ensuring that it is done right [Ref. 33 ].

The World Medical Association’s definition...

The primary purpose of medical research involving human subjects is to improve prophylactic, diagnostic and therapeutic procedures and the understanding of the aetiology and pathogenesis of disease [Ref. 17 ].

The OECD’s definition...

Research is creative work undertaken on a systematic basis in order to increase the stock of knowledge, including knowledge of man, culture and society, and the use of this stock of knowledge to devise new applications [Ref. 34 ].

The hospital’s definition...

Research is about creating new knowledge about what works and what doesn’t. It provides the foundations for national and/or local agreement about the kind of clinical treatment and care we should be providing, i.e. helps to answer the question ‘what is best practice?’ [Ref. 35 ].

The taxman’s definition...

Research and development for tax purposes takes place when a project seeks to achieve an advance in science or technology [Ref. 36 ].

The social scientist’s definition...

Research is a codified, scholarly and professional mode of knowledge production that has its prime institutional loci in universities, policy analysis units of government departments or international organizations and private research institutes and produced by academics, think-tank experts and development professionals [Ref. 37 ].

In the UK, the main reference point is the Research Governance Framework for Health and Social Care, 8 whose stated purpose is to enhance ethical and scientific quality, promote good practice, reduce adverse incidents and ensure lessons are learned. The Framework, which reflects EU regulations (see below) sets out the responsibilities of the individuals and organizations involved in research, including funders, researchers, organizations employing researchers, and healthcare organizations 8 and goes some way to dispelling the persistent view of research management as something separate from the science of research.

GAINING APPROVAL FOR A RESEARCH STUDY

Different regulatory and approval bodies have different remits and agendas. The question ‘does my study need approval by a particular body?’ must be answered with reference to what that body considers within its remit, rather than in relation to what the researchers themselves consider to be the key ethical and scientific issues. The different definitions of research used by different bodies reflect their particular agendas and priorities (e.g. pure versus applied, biomedical versus psychosocial, wet versus dry), and are sometimes couched in oppositional terms (that is, describing what research, for their purposes, is not ). 9

Box 3 Overview of processes for governing research in selected countries

Canada and USA

• Both countries have nationally coordinated and regulated ethics committee structures and procedures and additional provision for review of multi-centre studies. Whereas Canadian Research Ethics Boards are responsible for reviewing and approving clinical trial protocols and informed consent forms for research with human subjects, US Institutional Review Boards formally review all research activities involving human subjects
• Both appear to have other institutional arrangements in place to review, for instance, legal and contract matters, liability or billing issues
• Governmental and regulatory agencies concerned with the conduct of research include the US Office for Human Research Protections and the Canadian Institutes for Health Research. The Canadian national policy statement is notable in acknowledging that studies employing social science methods may require different procedures to those used for clinical or intervention studies.
• NHS Research Ethics Committees (RECs) review all research involving NHS patients, premises, staff and tissue samples. The same form is used for review of all research projects, with RECs required to provide a decision within 60 working days
• Other committees, such as those in universities, also review health-related research
• Research of this kind must also gain formal NHS management approval from the relevant local NHS trust(s) where the study is taking place and all clinical trials of new medicinal products must now gain a European Clinical Trials Database reference before proceeding.
• No national ethical review process is in place but individual committees with voluntary processes appear to be developing on an ad hoc and voluntary basis
• No legal or formal system of ethical or research management approval appears to be available through which research involving human subjects can proceed, although international collaborative projects should seek approval from their centre (e.g. in the USA or the UK).

In practice, however, projects often prove difficult to classify even with explicit written guidance. 10 For example, many types of applied research (action research, 11 evaluation of services, 12 quality improvement research, 13 and so on) seek to generate new knowledge as well as providing direct benefits to patients and practitioners locally, so it is meaningless to state which is the ‘main’ purpose of the project. The inherently fuzzy nature of much contemporary research means that algorithmic tools (in which a flow chart of questions leads to one of two categories: ‘research’ or ‘not research’; 14 ‘trial’ or ‘not trial’, 15 etc.) may have limited potential for removing ambiguity.

If an official research approval body (such as a local research ethics committee in the UK) deems a particular project outside its remit (e.g. if the study does not involve NHS staff, patients or tissue samples and takes place off NHS premises), this does not mean the project team can pursue their work unrestrained. It would be highly unusual if the study did not fall within the remit of at least one (and possibly several) other regulatory bodies. Clinical audit, for example, will be the remit of the acute or primary care trust under clinical governance arrangements. 13 , 16 A student PhD study based in a UK university, but with all fieldwork conducted abroad, will be covered by the university under its internal supervision and ethics procedures. A survey of school pupils generally needs approval from the school’s board of governors. And so on. In addition, researchers are professionally (though not legally) bound by generic codes of practice (e.g. Declaration of Helsinki 17 ). And, of course, we all have responsibility to obey the law and behave decently towards our fellow citizens—e.g. following ethical principles of respect for human dignity, beneficence, non-malefience and justice. 18

There are instances when official regulations appear to have obvious ambiguities. For instance, an investigative journalist employed by a TV company and an academic researcher employed by a university might both collect the narratives of people taking an antidepressant drug. But, whereas the journalist must do no more than stay within the law (e.g., the Data Protection Act), the researcher is bound by an additional set of formal and statutory procedures by virtue of the classification of the study as academic research.

Where there is doubt as to the status of a proposed study, it is quite in order to ask advice from the Central Office for Research Ethics Committees who may also liaise with relevant committee/s (see [ www.corec.org.uk ] for contact details). Judgement will be applied on a case-by-case basis, drawing on local precedent and the definitions in Box 2.

RESEARCH GOVERNANCE IN AN INTERNATIONAL CONTEXT

Box 3 gives examples of the broad systems for reviewing and approving research involving human participants outside the UK. They are the product of the prevailing social, healthcare and research environments in different countries and will inevitably vary in focus and aims. 19 Some carry legal weight or are formalized in some other way, others have looser terms of reference or are entirely voluntary. Similarly, professional codes and guidance vary widely within and across countries. 19

This international variation is more than a curiosity. Although international standards for research have been encouraged since Nuremberg, for studies that span several countries, governance requirements in the partner centres may still differ to such an extent that it is impossible to achieve a single common protocol for recruiting participants, gaining informed consent, managing the project, and storing data. 6 As with all complex research studies, time must be built into the planning and preparation stage for multiple applications to be processed.

Where systems are not in place or appear inadequate for the task at hand, researchers may find it useful to refer to generic guidance (e.g. Declaration of Helsinki, 17 International Conference on Harmonisation of Good Clinical Practice, 20 MRC Guidelines on Research in Developing Countries 21 —see Box 4 for further examples). However, these recommendations are not always legally binding and may be differently interpreted (or prove impossible to implement) in different countries. For example, all the international guidelines relating to health research recommend local ethical review, but ethics committees have yet to become a worldwide phenomenon.

Member countries of the European Union are increasingly encouraged to work together to achieve convergence of policies in a number of fields including research and development. An EU Directive on 1 May 2004 introduced new legal restrictions on the testing of medical products, including an onus on the lead researcher to register all pharmaceutical trials at inception and ensure that appropriate insurance arrangements are in place. 22 The implementation process has been a cause for concern, not least in questioning whether important publicly funded research may falter due to the rising complexity and costs associated with increased bureaucracy.

IMPLICATIONS FOR SERVICE ORGANIZATIONS

In the UK, a healthcare organization that hosts research (that is, allows research to be undertaken on its premises) has a number of statutory responsibilities including duty of care to all patients, ensuring scientific review of proposals and monitoring research 8 . It incurs additional responsibilities for the initiation, management and conduct of a research project if it decides to act as a research sponsor 8 . The NHS R&D Forum (see Box 4) provides a list of NHS institutions who act as research hosts and/or sponsors.

Box 4 Regulations and guidance relating to health research

International / EU codes and regulations relating to health research

• The first major international code of ethical principles in medical research was the Declaration of Helsinki, produced by the World Medical Association in 1964. The Declaration was last up-dated in 2000 [ www.wma.net/e/policy/b3.htm ] with related documents [ www.wma.net/e/ethicsunit/helsinki.htm ]
• Council for International Organizations of Medical Sciences (CIOMS) established by WHO and UNESCO has provided international guidelines for biomedical research involving human subjects [ www.cioms.ch/frame_guidelines_nov_2002.htm ]
• The Council of Europe produced the Convention on Human Rights Protection and Biomedical Science and more recently a protocol on Biomedical research [ www.coe.int/T/E/Com/Files/Themes/Bioethics/default.asp ]
• The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) promotes the harmonization of the regulation of pharmaceutical drugs. 1996 Good Clinical Practice guidelines [ www.ich.org ] under guidelines and efficacy topics
• The World Health Organization has an ethics programme and associated publications [ www.who.int/ethics/en ]
• European Union Clinical Trials Directive 2001/20/EC relates to the conduct of clinical trials on medicinal products for human use and new legislation implemented in Member States in May 2004 [ http://europa.eu.int/eur-lex/pri/en/oj/dat/2001/l_121/l_12120010501en00340044.pdf ].

Guidance on conducting research in developing countries

• The Medical Research Council has published an ethics guide on research involving human participants in developing societies [ http://www.mrc.ac.uk/pdf-devsoc.pdf ]
• The European Group on Ethics in Science and New Technologies published their discussions of the ethical aspects of clinical research in developing countries [ http://europa.eu.int/comm/european_group_ethics/docs/tb1oc_en.pdf ]
• The Nuffield Council on Bioethics has produced a report on The Ethics of Research Related to Healthcare in Developing Countries [ http://www.nuffieldbioethics.org/go/ourwork/developingcountries/introduction ].

UK Research Governance and Ethics

• The Medical Research Council Ethics and Best Practice pages include guidelines on clinical trials, ethics and peer review [ http://www.mrc.ac.uk/index/publications/publications-ethics_and_best_practice.htm ]
• The Department of Health Research Governance pages include information on the development of policy, guidance on specific issues and implementation plans [ http://www.dh.gov.uk/PolicyAndGuidance/ResearchAndDevelopment/ResearchAndDevelopmentAZ/ResearchGovernance/fs/en#4840302 ]
• The NHS R&D Forum have produced a documentation guide for research governance which provides links to all relevant sites [ http://www.rdforum.nhs.uk/workgroups/primary/pcinfoguide/introduction.htm ] and provides a list of contact details in order to obtain local NHS R&D approval for research [ http://www.rdforum.nhs.uk/links/locallinks.htm ]
• The Central Office for Research Ethics Committees (COREC) provides the most up-to-date information and forms relating to NHS ethical review, including New Operational Procedures [ http://www.corec.org.uk/ ]
• Ethics Research Information Catalogue (ERIC) holds a collection of articles related to the ethics of medical research on humans at [ http://www.eric-on-line.co.uk/index.php ]
• The Medicines and Healthcare products Regulatory Agency (MHRA) provides information on the Clinical Trials Directive [ http://www.mhra.gov.uk/ ] and a joint site between the DH and MHRA has a Clinical Trials Toolkit [ http://www.ct-toolkit.ac.uk/ ]
• Each university in the UK has its own rules, regulations and processes [ http://www.scit.wlv.ac.uk/ukinfo/ ].

These new infrastructure requirements place a high burden on NHS organizations. Historically, little emphasis was placed on the management and administration of research studies, which tended to be seen as the creative pursuits of individual clinicians. To some extent, then, service organizations must undergo a cultural change as well as invest in the necessary infrastructure to support research. Recent surveys have shown that most health service staff feel positive about the principles and aspirations of the Research Governance Framework but find them confusing and difficult to implement in practice. 1 , 5 , 8

There is also the issue of proportionality—i.e. the punishment should fit the crime. The principles, structures and systems associated with research governance apply whether undertaking a large multi-centre clinical trial or a small local project. In secondary care (e.g. acute hospital trusts), considerable research infrastructure already exists, and the implementation of research governance has been fairly non-contentious. This has not been the case in primary care, where research has not historically been part of core business and R&D infrastructure is underdeveloped. 23 PCTs who are just beginning to develop a research culture and build research capacity must make considerable short-term investment in the initial setting-up of systems—a step that many will find prohibitive.

IMPLICATIONS FOR INDIVIDUAL RESEARCHERS

Table 1 draws on Richard Doll’s 50-year longitudinal study of the outcome of smoking in British doctors to explore how the research process and governance procedures have changed over time. 24 It points to several areas relating to research governance and ethics that researchers must consider before commencing a study, many of which are established features of good research practice, but until recently only the individual researcher was officially accountable for them.

The research process explored through 50 years of observations on smoking in British doctors

Some of the changes highlighted in Table 1 have raised concerns about over-regulation, 4 , 6 and the creation of additional and unwelcome layers of bureaucracy across the research environment. Doll himself was willing to go to prison in defiance of new regulations, believing they are suffocating clinical medical research. Many of these areas will be discussed in more detail in papers two and three of this series.

Only time will tell if research governance procedures will achieve the goal of raising standards, protecting participants and assuring quality—and whether the inevitable constraints on research freedom will be worth the candle. Nevertheless, the procedures are now official, and cutting corners constitutes fraud and/or professional misconduct. Depending on the particular regulations breached, the researcher may face criminal charges, removal or restriction of professional privileges, loss of institutional indemnity, or dismissal from employment. Where genuine ambiguity exists about the status of a proposed study, it may be a false economy to try to sell it as non-research in order to avoid having to complete the paperwork, since if the work is subsequently submitted to an academic journal, confirmation of research ethics approval may be a condition for publication.

On a positive note, NHS research ethics committees are now required to deliver decisions on valid applications within 60 working days, with similar arrangements throughout the EU 6 . They are also being encouraged to move from an ethos of policing research to one of quality assurance and facilitation. The UK Department of Health is reviewing the barriers to research caused by new governance systems. 25 Hopefully, this will lead to a slackening of red tape, streamlining of procedures, and specific measures in research fields for which current regulations have proved unworkable.

Acknowledgments

Our thanks go to the late Sir Richard Doll for his comments on this paper.

This is the first in a series of three articles on research governance.

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• Improving the quality...

Improving the quality of care through clinical governance

• Related content
• Peer review
• Stephen Campbell , research fellow ,
• Martin Roland , professor, general practice ( m.roland{at}man.ac.uk ) ,
• David Wilkin , professor, health services research
• National Primary Care Research and Development Centre, University of Manchester, Manchester M13 9PL
• Correspondence to: M Roland

This is the third in a series of five articles

The UK government has set a challenging agenda for monitoring and improving the quality of health care. It is based on a series of national standards and guidelines, a strategy for quality improvement termed “clinical governance,” and a framework for monitoring the quality of care in and performance of NHS organisations (box). Clinical governance is “a framework through which NHS organisations are accountable for continually improving the quality of their services, safeguarding high standards by creating an environment in which excellence in clinical care will flourish.” 1 To be successful this strategy requires effective leadership by clinicians who have responsibility for improving quality; it must engage the doctors and nurses who provide care on a daily basis; and it must have commitment and support from managers within the NHS.

Summary points

Primary care groups and trusts are responsible for implementing clinical governance, including monitoring and improving the quality of care

In their first two years they have concentrated on educating and supporting health professionals and encouraging shared learning

Information about the quality of care provided in general practice is being shared between practices and with the public, often in a form that permits practices to be identified

Many groups and trusts are offering incentives to practices to promote improvements in the quality of care

Sanctions and disciplinary action are rarely used when dealing with poor performance

Limited resources and the pace of change are potential obstacles to future success in improving the quality of care

Goals of quality improvement strategies in the NHS

National service frameworks, National Institute for Clinical Excellence —set standards, develop guidelines

Clinical governance —deliver care, improve quality

National performance framework, annual appraisal of doctors, Commission for Health Improvement, national surveys of patients —monitor quality and performance

Clinical governance

Primary care groups and trusts are responsible for implementing clinical governance in primary care. These new organisations bring together general practitioners, nurses, other primary care professionals, and managers to develop services, raise quality standards, commission hospital services, and improve the health of populations of about 100 000 people. Operating initially as subcommittees of existing health authorities, all are expected to become free standing primary care trusts controlling their own budget for the health care of their populations by 2004. 2 In the past, primary and community services in the NHS have been fragmented, and general practices have not usually worked together as part of a larger organisation. One of the challenges facing primary care groups and trusts in implementing clinical governance is to develop a more corporate culture in which quality improvement becomes a shared enterprise. This will entail greater use of shared learning—that is, joint education and training during which different professions working in primary care learn together and from each other—and a greater openness and willingness to exchange information about quality. It will require the development both of incentives and methods for tackling poor performance.

Primary care groups were established in England in April 1999. Progress in clinical governance during their first year was largely confined to putting in place an appropriate infrastructure, conducting baseline assessments, and establishing priorities. 3 At the end of their second year we can begin to assess how they are implementing clinical governance. In this article we concentrate on the broad approaches to quality improvement that are being adopted; we use evidence from a recent survey. 4

National tracker survey

The national tracker survey is a longitudinal survey of 72 of the 481 primary care groups established in England; it aims to evaluate their achievements and identify features associated with success in performing their core functions, including quality improvement. The first survey was completed in December 1999 3 and the second in December 2000. 4 By October 2000, two of the groups in our original sample had merged with each other, and five had become trusts. Details of the survey were summarised in the first article in this series. 5 The evidence cited in this article is derived from postal questionnaires returned by 49 (68%) of those who were in charge of clinical governance for their group or trust in 1999 and by 58 (81%) of those who were in charge in 2000. Forty eight (83%) of those responsible for clinical governance were general practitioners, but 20 (34%) groups and trusts had a general practitioner and a nurse who shared lead responsibility for implementing clinical governance. In these cases, only one of them completed the questionnaire.

Shared learning and partnerships

Primary care groups and trusts are using education to improve quality. By December 2000, 54 of 58 (93%) were actively encouraging development plans for their practices and implementing personal learning plans for general practitioners, compared with only two (4%) of those surveyed in 1999. Many of the initiatives created opportunities for learning to be shared and partnerships to be developed with other organisations (table 1 ).

Most common clinical governance schemes for sharing learning and developing partnerships among primary care groups and trusts, October 2000 4

• View inline

Half day educational events organised for the whole primary care group were a notable initiative, promoting shared learning and reducing the isolation of practices. The commonest model used was for all practices in a primary care group to close for one afternoon a month, with emergency cases being covered by doctors from a neighbouring group. Sometimes these meetings were attended only by doctors and sometimes by the entire primary care team. In some cases regular attendance rates were higher than 95%.

These activities will represent a new point of departure for general practice in the United Kingdom. Before primary care groups were established, general practitioners worked largely independently of each other and may never have needed even to speak to doctors practising nearby. General practitioners and other practice staff are reported to be keen to take up opportunities to meet and learn together even though participation is voluntary. Similarly, encouraging cross practice audits of clinical care and working to develop local guidelines provide opportunities for health professionals to work together on quality improvement.

As well as facilitating shared learning between members of the group, many of those responsible for clinical governance also reported engaging in initiatives with other groups, including hospital trusts and providers of community health services.

Sharing information

To be successful, shared learning and other joint activities require a willingness to exchange information about quality of care. Successfully implementing clinical governance requires developing this willingness. In the past, information about the quality of care provided by doctors and nurses in general practice may not even have been shared with colleagues in the same practice depending, for example, on whether the practice undertook a clinical audit. However, information from a clinical audit was hardly ever shared outside a practice. This is changing rapidly. Primary care groups and trusts already have access to routine data on practice activities, such as rates of cervical cytology and immunisation, and will increasingly have access to the results of cross practice audits.

(Credit: SUE SHARPLES)

There is an increasing move towards making information about quality of care more widely available. Virtually all groups and trusts surveyed were making anonymised information on quality available, but many were also providing information—to board members and other practices—that permitted individual practices to be identified (table 2 ). This represents an important change in both the practice and culture of primary care, where even sharing information with professional colleagues has been rare. Making such information available to the public is an even more radical step, and while plans to do this are much less advanced, some primary care groups and trusts are beginning to take tentative steps in this direction.

Providing incentives

Promoting shared learning and disseminating information help improve quality by increasing the acceptability of the need for improvement and through peer pressure. Although the surveys showed that some practices are still hostile to these changes, the majority reported that they had at least acquiesced to the new agenda if not enthusiastically embraced it.

Additionally, primary care groups and trusts are using financial incentives to promote quality improvement. Excluding prescribing incentive schemes, 50% (29/58) reported using specific quality incentive schemes in 2000, compared with 29% (14/49) in 1999. In general, these were associated with participating in audit activities or rewarding those who met targets.

During the past three years the government has been experimenting with new types of contracts for general practice (for example, the personal medical services pilot scheme) in which the nature and quality of services to be provided can be more closely specified. Altogether, 29% (17/58) of those responsible for clinical governance reported using contractual arrangements to improve quality. It seems likely that this trend will continue, and modifications to the main contract for general practitioners are likely to include specific payments linked to the quality of the care provided.

Primary care groups and trusts sharing information on quality of care, October 20004

Dealing with poor performance

The approaches taken by groups and trusts to deal with poor performance in practices have been supportive and educational. Those responsible for clinical governance described their strategies as including having informal discussions, providing training for practices, and allocating resources to give extra to poorly performing practices. Conducting clinical audit and sharing information were also used as means of addressing poor performance; these approaches were taken to try to engage poorly performing practices with the quality improvement strategies being used by their peers.

Only 3% (2/58) of those responsible for clinical governance said that they intended to withdraw resources from poorly performing practices, and only 9% (5/58) had established any formal disciplinary procedures.

During 1999 and 2000, the NHS established formal procedures to identify poorly performing general practitioners. In most cases, these operate at the level of the health authority (that is, among several primary care groups in a geographical area). Because of this, groups and trusts have been able to adopt a supportive role, leaving disciplinary procedures to a higher tier of the NHS. Many of those responsible for clinical governance told us that in order to engage health practitioners in quality improvement, it is essential for them to be seen as helpful to and supportive of practices. However, this may become more difficult as groups become primary care trusts, a move that will ensure that they take on more responsibility for the quality of care provided by clinicians in their area.

Can groups and trusts improve quality?

The strategy developed by the UK government to improve the quality of health care is ambitious and wide ranging. Reports on progress in implementing this strategy come from those with responsibility for it, so their views may not fully reflect the activity under way or the views of grass roots primary care doctors and nurses. However, our research in primary care suggests that the strategy is resulting in substantial activity that is beginning to bring about a significant cultural change among both managers and clinicians in primary care. In many cases clinical governance is building on previous initiatives, such as the work of medical audit advisory groups. Nevertheless, the changes that have taken place have been impressive given that clinical governance and primary care groups were only 18 months old at the time of the survey reported in this paper.

What has not yet been shown is that any of this activity has improved the quality of care because it is still too early to tell. However, the educational approaches being taken, which emphasise engaging practitioners in regular quality improvement activities, are soundly based. Furthermore, the managerial agenda is relatively well aligned with what primary care practitioners themselves wish to achieve—that is, better care for important health problems such as coronary heart disease. Again, this is likely to encourage clinicians to participate in quality improvement.

Implementing clinical governance is not without its problems. Limited time and resources remain important constraints restricting the speed at which change can take place. Altogether, 41% (24/58) of those responsible for clinical governance did not have a budget to support the implementation of clinical governance and 35% (20/58) said that they had little or no support. In some respects general practitioners seem to have engaged enthusiastically with shared learning activities, but our research suggests that the pace of reform in the NHS risks making them feel disengaged.

There is also a significant tension between the desire to engage practices in quality improvement and the need to ensure that poor performance is addressed. Primary care groups and trusts are focusing their energies on facilitating shared learning and offering support to practices. Where such supportive approaches fail to improve performance, it may be necessary to adopt other tactics. If responsibility for poor performance moves from health authorities to primary care trusts, the conflict between these two roles is likely to become more evident to those who are responsible for clinical governance.

Much has been achieved by primary care groups and trusts in their first 18 months. The elements of clinical governance, while varying according to local needs, are now mostly in place and changes are beginning to take effect. However, the task is formidable and the barriers should not be underestimated. Quality improvement cannot be imposed by decree but needs to be maintained and developed by adequately funded infrastructures. There remains a risk that the organisational structures that have been developed are not sufficiently established or funded to ensure that the expected improvements in the quality of health care can be delivered.

Series editor: David Wilkin

Funding The national tracker survey is funded by the Department of Health and carried out by the National Primary Care Research and Development Centre in collaboration with the King's Fund.

Competing interests None declared.

• Secretary of State for Health
• Dowswell T ,

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Research Governance Guidelines

Published: 10 June 2022

Version: 3 - January 2023

Please contact your nominees before you give us their names, to ascertain their availability and willingness to be appointed.

Trial Steering Committees and Study Steering Committees

All projects with an element of primary research are required to establish a Steering Committee. The following lists provide guidance on its role, constitution, composition, meeting requirements and primary reporting line. This information can be used as a template terms of reference.

The role of the Steering Committee

The role of the Steering Committee is to provide overall supervision for a project on behalf of the study's Sponsor and Funder and to ensure that it is conducted to the rigorous standards set out in the  UK Policy Framework for Health and Social Care and the Guidelines for  Good Clinical Practice. The day-to-day management of the study is the responsibility of the Chief Investigator, and as such the Chief Investigator may wish to set up a separate Study Management Group to assist with this function. The main features of the Steering Committee are as follows:

• To provide advice, through its Chair, to the study's funder, sponsor, Chief Investigator, host institution, and contractor
• To concentrate on the study's progress, adherence to the protocol, and patient safety (where appropriate), and to consider new information of relevance to the research question
• To uphold the rights, safety and well-being of the participants: these are the most important considerations and should prevail over the interests of the research
• To ensure appropriate ethical and other approvals are obtained in line with the project plan
• To agree proposals for substantial protocol amendments and provide advice to the sponsor and funder regarding approvals of such amendments
• To provide advice to the investigators on all aspects of the study

Constitution of a Steering Committee

• The relevant NIHR Programme Director will review the nominees and appoint the Chair and members
• Independent members must make up a minimum of 75% of the Committee membership (see definition of independence below)
• The minimum quoracy for any Steering Committee meeting to conduct business is 67% (two thirds) of the appointed membership
• Only appointed members will be entitled to vote (irrespective of their level of independence) and the Chair will have a casting vote
• The Chair and members must sign and maintain a log of potential conflicts and/or interests
• Attendance at Steering Committee meetings by non-members is at the discretion of the Chair
• The primary Steering Committee reporting line is via the Chair to the relevant NIHR Programme Director; however, communication is likely to be between the Chair and the NIHR Research Manager who has day to day responsibility for the study.

Please note: We advise you to keep the number of members on your Steering Committee to an easily manageable number, but preferably to no more than eight members in total.

Composition of the Steering Committee

• An Independent Chair (holding a substantive UK based appointment), the Steering Committee Chair does not need to be a study-specific content expert but needs to ensure that sufficient content expertise is available for the group to perform its oversight function effectively.
• An independent statistician or other person with expertise in the main methods used in the study
• At least one public member, preferably independent
• Others with clinical or other expertise relevant to the project, such as in health economics, social care, public health etc.
• Ideally, the Steering Committee should invite observers, including representatives of the sponsor and research network to meetings
• Justification for proposing members based overseas should be provided when you submit nominations

Steering Committee meetings

• Although there may be periods when more frequent meetings are necessary, the Steering Committee should meet at least annually
• Where a Data Monitoring and Ethics Committee (DMEC) is required, Steering Committee meetings should be scheduled to follow shortly after their meetings so that reports from the DMEC can be considered if appropriate
• Minutes of meetings should be sent to all members, the sponsor, and the funder, and be retained in the study master file

The responsibility for calling and organising Steering Committee meetings lies with the Chief Investigator, in association with the Chair.

The NIHR reserves the right to attend any meeting, therefore should be included in relevant invitations. In exceptional circumstances there may be occasions when the study Sponsor or NIHR will organise and administer these meetings.

The Role of the Chair of the Steering Committee

The Chair of the Steering Committee is directly answerable to the relevant NIHR programme, as funder. The Chair’s responsibilities include:

• Liaising with the Chief Investigator to arrange a meeting to finalise the protocol and to set up a schedule of meetings to align with the project plan
• Establishing clear reporting lines to the Funder, Sponsor, etc.
• Being familiar with relevant guidance documents and with the role of the DMEC if appropriate.
• Providing an independent, experienced opinion if conflicts arise between the needs of the research team, the funder, the sponsor, the participating organisations and/or any other agencies
• Leading the Steering Committee to provide regular, impartial oversight of the study, especially to identify and pre-empt problems
• Ensuring that changes to the protocol are debated and endorsed by the Steering Committee; letters of endorsement should be made available to the study team when requesting approval from the funder and sponsor for matters such as changes to the protocol
• Being available to provide independent advice as required, not just when Steering Committee meetings are scheduled
• Commenting on any extension requests and, where appropriate, providing a letter to the funder commenting on whether the extension request is supported or otherwise by the independent members of the Committee.
• Commenting in detail (when appropriate) regarding the continuation, extension or termination of the study.

Data Monitoring and Ethics Committee (DMEC)

The formation of a Data Monitoring and Ethics Committee (DMEC) is needed when there are particular risk factors involved in a study.

Most studies with an element of primary research are required to establish a DMEC. The following provides guidance on the role, constitution, composition and meeting requirements for a DMEC. This information can be used as a template terms of reference.

The role of the DMEC

The Data Monitoring and Ethics Committee's main role is as follows:

• In the case of a study with blinded/masked data, the DMEC is the only body involved that may have access to the unblinded comparative data. For other study types it has oversight of any primary data collected from participants, including qualitative data
• The role of DMEC members is to monitor these data and make recommendations to the Steering Committee on whether there are any ethical or safety reasons why the study should not continue
• The DMEC should uphold the safety, rights and well-being of the study participants: these are paramount considerations
• The DMEC should consider the need for any interim analysis advising the Steering Committee regarding the release of data and/or information
• The DMEC may be asked by the Steering Committee, Study Sponsor or Study Funder to consider data emerging from other related studies
• There are also rare occasions when the DMEC chair might be asked by the Study Funder, through the chair of the Steering Committee, to provide advice based on a confidential interim or futility analysis if serious concerns are raised about the viability of the study or if the research team are requesting significant extensions
• Criteria should be agreed (where appropriate) relating to the point at which continuation of the study is considered futile, and in the case of a randomised trial, the DMEC would only indicate if these had been passed or not as this would limit the potential for un-blinding.

Constitution of a DMEC

• Only appointed members will be entitled to vote and the Chair will have a casting vote
• The minimum quoracy for a meeting to conduct business is 67% (two thirds) of appointed members
• Attendance at DMEC meetings by non-members is at the discretion of the Chair
• The primary DMEC reporting line is via the Chair to the Steering Committee.

Composition of a DMEC

• All DMEC members are to be independent (with at least one member being UK based and/or holding a substantive UK based appointment)
• Membership of the DMEC should be small (3- 4 members) and comprise experts in the field, e.g. a clinician with experience in the relevant area and expert statistician. Membership might, on occasion, include members of the public.

DMEC meetings

• Responsibility for calling and organising DMEC meetings lies with the Chief Investigator, in association with the Chair of the DMEC. The study team should provide the DMEC with a comprehensive report, the content of which should be agreed in advance by the Chair of the DMEC
• The DMEC should meet at least annually, or more often as appropriate, and meetings should be timed so that reports can be fed into the Steering Committee
• Minutes of meetings should be sent to all members, the sponsor, the funder, and the Steering Committee, and a copy should be placed in the study master file. It should be noted that the minutes may have ‘in camera’ items redacted from some copies.

Independence

Independence (for both the Steering Committee and the Data Monitoring and Ethics Committee) is defined as follows:

• Not part of the same institution as any of the applicants or members of the study team
• Not part of the same institution that is acting as a recruitment or investigative centre, including Patient Identification Centres (PIC), identifying and referring patients to a recruitment or investigative centre (In both cases above ‘not part of the same institution’ means holding neither a substantive nor honorary contract or title with said institution)
• Not related to any of the applicants or study team members
• No other actual or perceived conflicts of interest
• For the Chair only; where competing bids for the same NIHR call were head to head the chair cannot have been an applicant on one of the competing applications

It is recognised that independence status of individual members of the above committees may change during the duration of the project, for example, a member may move from one institution to another, meaning that they would no longer be independent. It is the responsibility of the Chief Investigator to ensure that the funder is notified of such changes, and that the committees maintain the necessary level of experise and independence.

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Research Governance

Research Governance may be defined as the broad range of regulations, principles and standards of good practice that exist to achieve, and continuously improve, research quality in the UK and worldwide.

Research Governance Team (R&D) at OUH

The Research Governance team's role is to ensure that research which is using OUH NHS resources including NHS patients:

• is compliant with the relevant regulations (e.g. Data Protection Act)
• follows Clinical Research Principles (e.g. Good Clinical Practice (GCP) and The Department of Health UK Policy Framework for Health and Social Care)
• has relevant approvals in place (e.g. Research Ethics Committee, Health Research Authority, Medicines and Healthcare Products Regulatory Authority)
• is of a high scientific standard.

The Research Governance Team provides support throughout the research journey, from acting as sponsor for certain studies to providing local Trust Management Approval and GCP compliant training.

Ongoing oversight is maintained through collection of recruitment figures, progress reports and safety data, and through monitoring and audit responsibilities.

Who does it apply to and why do we need it?

Research Governance applies to everyone connected to Clinical Research, whether as a Chief Investigator, Care Professional, Researcher, their employer(s) or support staff.

By Clinical Research, we mean any health-related research that involves humans, their tissue and/or data.

Research Governance is needed to :

• safeguard participants in research
• protect researchers / investigators (by providing a clear framework within which to work)
• enhance ethical and scientific quality
• mitigate risk
• monitor practice and performance
• promote good practice and ensure that lessons are learned.

Is my study research?

There are times when the classification of a project is unclear; i.e. whether it is a research study, audit or service evaluation.

Clinical audit

Measures existing practice against evidence-based clinical standards. All clinical audits must comply with the clinical audit governance requirements. If the project is audit it should be registered with the trust clinical audit team.

Generates new knowledge where there is no or limited research evidence available and which has the potential to be generalisable or transferable. All research must comply with research governance requirements of the Oxford University Hospitals.

Service review

Incorporates both service/practice development and service/practice evaluation.

Service / practice development

Introduces a change in service delivery or practice for which there is evidence derived from research or from other health/social care settings that have already introduced and evaluated the change. New developments should always be evaluated.

Service / practice evaluation

Evaluates the effectiveness or efficiency of an existing or new service/practice that is evidence based, with the intention of generating information to inform local decision-making. This type of activity is sometimes referred to as a clinical effectiveness study, baseline audit, activity analysis, organisational audit and benchmarking. All service review activity should comply with clinical governance requirements.

The above definitions are from the following document :

Healthcare Quality Improvement Partnership (HQIP) A Guide for Clinical Audit, Research and Service Review (pdf) - www.hqip.org.uk

Additional information can be found on the HRA website :

Is my study research? - www.hra-decisiontools.org.uk/research

Classification Group

In order to establish an authoritative and collective opinion on such projects, the Governance team and the Clinical Trials and Research Governance team in the University have an established group which meets to review project outlines and give a considered opinion.

The group meets at least monthly, or more often where there is high demand.

If you are unsure, please complete the classification form below and email it to us with your queries:

Governance form (Word, 774 KB)

Email: [email protected]

In this section

Clinical Governance: a Framework and Models for Practice

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• Irene Scott  

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The term ‘governance’ has featured highly in recent years on the NHS agenda and has aimed to ensure excellence in the corporate governance and the financial governance of health institutions. In essence, the focus has been on the organisational management and financial probity of healthcare, resulting in control being focused on the managers of the systems. Today’s approach to clinical governance has presented a new challenge to healthcare in embracing the very clinical professionals who are at the heart of healthcare delivery, in achieving excellence and in ensuring the very raison d’être of the NHS – equity of access, and equity of expected and anticipated outcome. This chapter discusses the development of clinical governance, its role in today’s health system and its challenges to the professions and the institutions. In an aim to provide readers with an opportunity to explore their own position within clinical governance, I will discuss some commonly raised questions: What is clinical governance? How will we recognise it? How will we monitor and measure it? What is my role in clinical governance? What is clear at this point is that clinical governance is not necessarily tangible; it is a concept and a way of life, a way of life that requires a considerable change in the culture of healthcare and healthcarers, as described in Chapter 1.

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© 2001 Veronica Bishop

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Scott, I. (2001). Clinical Governance: a Framework and Models for Practice. In: Bishop, V., Scott, I. (eds) Challenges in Clinical Practice. Palgrave, London. https://doi.org/10.1007/978-1-4039-3737-7_3

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