In the UK, ethics and governance are closely intertwined. Historically, once ethical approval had been obtained from the appropriate committee there was no monitoring of the subsequent research study, which rendered the system open to abuse. Governance processes are designed to promote monitoring of all aspects of research studies, in particular methods of obtaining consent, data protection and data storage. In the UK, governance departments must review 10% of all studies they approve each year.

This governance domain is concerned with ensuring that the research that is carried out in the health and social care arena is scientifically robust, subject to expert review in its early stages and based as far as is practicable upon existing sources of information. This ensures that research is seen as a linear process with new work building upon that which has gone before. It requires potential researchers to show a thorough examination of the literature when submitting proposals for both ethical review and governance approval.

Research that is not disseminated in the public domain is ‘dead’ research. Nonetheless a significant amount of research projects are completed without the results being made available to the interested parties. This is a particular concern with postgraduate research (Teacher Training Agency 1998). Even more projects are lodged in the public domain but are only accessible to a highly specialised or technical audience. Many grant-making bodies are now insisting that researchers should provide information for both the professional and the lay readership (Joseph Rowntree Foundation 2005). The governance province of ‘information’ helps to address the issue of research which is wasted through failure to disseminate, which in turn leads to failure to implement research findings. In an effort to ensure that research findings are implemented in health care practice, all proposed research projects must have considered how the anticipated findings will be disseminated across all interested parties. In the UK, the National Research Register records all NHS Trust research activities. This provides the public with information about ongoing and completed research projects.

This area of governance can be seen to address two significant areas. Firstly, it is connected to protection of participant well-being. Informed by the EU Clinical Trials Directive (2001/20/EU), published in May 2001, governance became part of UK legislation in 2003, and was fully implemented by 2004; the health and safety domain of governance frameworks requires that researchers have the protection and safety of participants in mind at all times. Prior to the development of governance frameworks and, for European countries, the drafting of the EU clinical trials directive (European Commission 2001), researchers were not obliged to report or disclose the health and safety issues inherent in their research. Additionally, in the UK, researchers who are not NHS employees, but who are carrying out research on NHS user/employee populations are required to obtain an honorary contract from the participating trust prior to commencing data collection. Concerns have been mooted that this often protracted process has the overall effect of, at best, slowing down research and, at worst, acting as a disincentive to health service research (Howarth & Kneafsey 2004). However, it does act as an additional protection for participants since it allows NHS establishments to satisfy themselves about the credibility and ability of the researcher who wishes to undertake research within their organisation.

The second area of health and safety concern addressed by this aspect of governance is focused upon the safety of the researchers themselves. This may mean assessing whether the researcher is likely to be exposed to ionising radiation or noxious substances during the course of the research study (not usually an issue for the majority of health and social care research studies for which nurses are likely to be responsible) or, more importantly, may concentrate upon issues such as visiting research participants in their own homes, or late night working. For the first time, researchers are encouraged to think about their personal safety.

Organisations involved in research activity must be able to demonstrate that research funds can be managed appropriately in line with any financial legislation. This includes compliance with audit requirements and the ability to compensate research participants in the event of negligent harm. In the UK, there is no strategy for the provision of compensation in the event of non-negligent harm. However, if the researcher is employed by an organisation which does provide indemnity against non-negligent harm, the organisation must also be able to demonstrate that they can offer that compensation.

Other considerations within the ‘finance’ governance domain overlap with the domain of intellectual property (see below) in that arrangements must be in place to protect and exploit any commercial benefit that may accrue from research studies.

This aspect of research governance focuses upon clear identification of responsibility amongst the research team. The UK model proposes that strong research leadership should be allied to the promotion and support of research studies that reflect the national research agenda and the local priorities of the trust. Research governance frameworks set out definitions of the various roles within the research process such as:

Responsibility for the safe, robust conduct of the research lies with the principal investigator; however, the investigator’s employing institution is also responsible for ensuring that the appropriate quality monitoring mechanisms are in place. Thus, the intention of research governance strategies is to improve research quality and safeguard the public by giving due consideration to all aspects of research project management via these five domains. Inherent to this intention are a number of prerequisites which are key conditions if the twin goals of improvement and protection are to be achieved. These are outlined in Table 12.1.

These prerequisites form the basis of most of the approaches that have been taken to the management of research governance. For example, the European Forum for Good Clinical Practice overtly incorporated them into its recommendations and guidelines for European ethics committees (EFGCP 1997) whilst the OECD (2003) have taken a broader approach, using these concepts less explicitly as a framework for recommendations. The National Health and Medical Research Council of Australia (NHMRC 2004) have, in a draft document, produced governance guidelines that closely mirror those of the UK but which are far more directive.