by Martin Stevens, Senior Research Fellow at the Social Care Workforce Research Unit at King’s College London. (2,114 words)
The Health Research Authority (HRA) is currently consulting on various aspects of research regulation in health and social care in preparation for replacing the Research Governance Framework (RGF). The Social Care Workforce Research Unit (SCWRU) has had a long involvement with the implementation of Research Governance in social care and has made a response to part of this consultation. The HRA is currently asking ‘What are the risks to research because of perceived risks of research? and has published a report explaining its proposed approach. There is much with which we agree in the consultation report, specifically:
- the focus on clear and consistent definitions of terms;
- the emphasis on collaboration;
- the promotion of sound arrangements between the different organisations involved in research;
- the promotion of a quality research culture, within research organisations and also in care organisations; and,
- the need for more explicit support for a high quality research culture.
However, despite the focus on good collaboration and the need to involve all stakeholders, the document needs to better reflect the experiences of social care researchers, and those responsible for research governance in local authorities.
It is important to acknowledge that social care research often covers highly sensitive and potentially distressing topics. Research participants also may have severe dementia or learning disabilities, for example, and be unable to consent for themselves. Consequently, at least a similar level of scrutiny (compared with clinical research) is required to ensure research undertaken is sound and ethical. In 2003, the Department of Health (DH) published The Research Governance Framework for Health and Social Care: Implementation Plan for Social Care, which set out reasons why a separate approach is needed for social care. While 11 years have passed, many of these points remain valid:
While all research will meet the same standards of governance, it is recognised that there are important differences in the health and social care contexts. These differences relate to the nature and volume of research, to local service structures, and to the mix of stakeholders and academic disciplines. While the commitment to core principles is shared, the specific mechanisms by which these principles are implemented may not be the same in social care as in the NHS. The research culture in social care and the arrangements for its governance are less evenly developed than in much of the NHS. Care has to be taken therefore to ensure that the requirements of good governance work as far as possible with, and not against, existing systems and structures. DH 2003: 1
Some progress has been made since 2003, but the differences in organisational contexts, the variations of focus on research culture, and disparities in funding to support a research infrastructure remain. Local authorities are still the lead organisations for social care, but the increasing outsourcing of all aspects of social care, including, in some areas, statutory social work functions, represents an increase in complexity of organisations potentially involved with research. Furthermore, there are 150 local authorities, each with separate research governance processes, meaning social care researchers encounter a huge variety of forms and different expectations and requirements.
Consequently, a new RGF needs to be informed by engagement or at least involvement of the social care research community in discussions about how to implement this in social care settings.
The report covers the Research Governance Framework, financial restraint and a quality research culture. However a number of sub-themes are important within these:
- Coverage of the RGF: There is a need to raise awareness about the fact that research governance applies equally to social care research. Responsibilities need to be clarified particularly in respect of research undertaken in private and voluntary sector care homes, where the organisational responsibility for the welfare of potential research participants is complex. Local authorities retain a duty of care for people whose care home fees are paid by local government, in addition to the care home, and this should be made explicit. While the RGF makes it clear that local authorities have Research Governance responsibilities, in our experiences this is sometimes not understood, and procedures vary considerably between areas.
- Previously the definition of research used in the RGF was ‘the attempt to derive generalizable new knowledge by addressing clearly defined questions with systematic and rigorous methods’. This has been applied differently in health and social care, which may be appropriate, but some revisiting of this different application may be useful. Different forms of research and research-like activity have different impacts in social care settings, and so may require research governance scrutiny, whereas in the NHS, this may not be the case.
- Terminology: Consideration needs to be given to ensure that terminology is clearly applicable to social care settings, taking into account that local authorities have implemented research governance very differently compared with NHS Trusts.
- Training: There is a need to make appropriate training available to local authority research governance leads. Between 2005 and 2008, the Department of Health (DH), in collaboration with the Social Services Research Group (SSRG) and SCWRU ran a series of highly successfully workshops aimed at supporting local authority leads. More such work would be needed in order to implement changes, and this would be a good way of revitalising research governance in social care.
- Costs of hosting research: Local authorities are faced with even greater financial restraint than the NHS. Social care budgets have reduced by 25%. There has never been central financial support for the costs of hosting research undertaken in local authorities. Increasingly, such funds have to be found out of research grants or are absorbed by the local authorities. Without funding, it is becoming impossible to engage some local authorities. Explicit acknowledgement of the costs faced by local authorities in terms of collation of data, allowing staff time to be interviewed and facilitating access to service users as potential research participants would support specific funding requests. Similarly, guidance could be developed for researchers and research funders about the needs to allow for this when making and assessing research grant applications.
- Quality research culture: Research Governance leads are not supported enough in many local authorities to support the development of a quality research culture within local authorities. Some work has been done to promote good quality research, but progress has been very variable. Links could be made with organisations aiming to promote the value of evidence-informed research, for example Making Research Count, Research-in-Practice for adults and the Social Care Evidence in Practice project, to increase capability in research understanding and awareness of the importance of good quality research.
- The financial restraints implemented since 2010 has meant local authorities have had to re-structure themselves frequently and many staff have been made redundant or moved jobs. This has affected research governance personnel as much if not more than other groups of staff. Consequently, the factors noted about the capacity and capability in NHS R&D are strongly reflected in local authority settings. Some guidance about the role of local authority Research Governance leads and, in particular, recommendations about the level of skills and experience required for the role might be of value, enabling these key professionals to support a high quality research culture more effectively.
- Promotion of the new Framework with local authority senior management and local government leaders (for example the Association of Directors of Adult Social Services and the Local Government Association) and elected members will also be crucial in promoting a quality research culture.
- Variability in approval times is also an important issue in social care research governance – affecting the operation, particularly, of multi-site research. Work to develop common application and review procedures would help address this.
- Collaboration between the various organisations involved in social care research is crucial to successful research and research governance. For local authorities, the independent care providers in their localities—often also participants in social care research—are part of the frame of reference for local authority leads. Clarification of responsibilities for research governance within care providers, as suggested above would help collaboration. Compared with clinical research, there are fewer national or regional organisations influencing research governance leads in social care, as national direction and regulation of research governance have been prominent drivers in local authorities. Research also tends not to be mediated through national or regional organisations; researchers tend to approach local authorities directly.
- Oversight of Projects from Funding to Reporting: The report gives a good ‘ideal typical’ view of the responsibilities of the various organisations involved in research governance (Figure 4, p.14).
However, this does not reflect our experience in social care. Applications for large scale, multi-site social care research, which are usually reviewed for science and affordability by funders, are often reviewed again by some local authorities as part of their research governance approval process. Similarly, research is submitted for approval to a NRES/HRA (and/or University) Research Ethics Committee and local authority Research Governance processes review it for ethics once more. Ensuring that host organisations (i.e. local authorities, for social care research) accept the results of previous reviews of science and ethics would greatly facilitate multi-site research, which can be seriously delayed by the need for multiple approvals. Where previous approvals for ethics and science from recognised bodies have been made, applications should only be reviewed on the basis of capacity, capability and legal compliance. Harmonising applications procedures across local authorities would also be helpful and important to support this goal and maximise resources available for undertaking research.
The HRA report contains a number of recommendations, most of which are highly positive, in principle. However, several additional factors need to be considered when applying the recommendations to the social care setting:
- Clarify the purpose of the Research Governance Framework: Developing national standards and operational detail and ensuring that it applies to all studies and within all local authorities is highly welcome. It will be of great importance to work with the social care research community, researchers, local authorities, care providers and service users, in order to develop appropriate operational models. In particular, the new framework must acknowledge the limited infrastructure for research in local authorities.
- Define principles for interface management between stakeholders: Again this is potentially very positive. A set of principles would help in planning research studies as well as research governance. Principles would need to cover:
- Mutual acceptance of ethic and science reviews;
- Openness about the costs of participating in research;
- Agreements on funding the costs of taking part in research incurred by local authorities (including research funders);
- Commitments about the kinds of data required and availability;
- Lines of communication.
- Finding ways to encourage collaboration between research organisations and local authorities would be very important. Making Research Count could be useful partners in this. Making Research Count operates as a series of university hubs providing research based input to local authority staff. Developing these relationships into more formal engagement for conducting research as well as knowledge exchange may be a useful avenue to promote good collaboration.
- Make the high quality research culture explicit and relevant to all stakeholders: While this is a very laudable aim, there is much to do in supporting a research culture in local authorities. A number of prerequisites are important: More access to research training for professionals and others involved in social care provision; more prominent leadership roles for those responsible for research governance; and, a higher profile for research governance in social care.
- Focus on learning and sharing good practice: This would be very welcome for social care settings—but requires resources. Initiatives such as the programme of workshops for local authority research governance personnel, supporting organisations such as the SSRG and Making Research Count to provide networking opportunities for these workers, are all possible ways to foster shared learning.
- Coverage of the RGF: We would wish to see greater engagement with the Department for Education about ethical processes concerning children. The DH RGF covered adults only and research concerning children is not included in Social Care Research Ethics Committee approvals. We consider that this gap needs to be filled.
- Multi-site studies: We would also recommend that there is effort in respect of the portability of ‘research passports’, which are only accepted in some settings and so appear to have limited impact.
In conclusion, there is a lot of positive intent in the consultation report, but there is a great need for engagement with the social care research community (researchers, funders, local authorities, care providers and service users) in order to ensure applicability in the social care sector. We are keen to participate fully in the social care consultation that the HRA is planning.
Dr Martin Stevens is Senior Research Fellow at the Social Care Workforce Research Unit at the Policy Institute @ King’s. He is chair of the National Social Care Research Ethics Committee.