response from research in practice to

Ethics Review of Social Care Research: Options appraisal and guidelines

introduction

We welcome the opportunity to participate in the Department of Health’s (DoH) consultative exercise on ethics review of social care research. We feel that the development of a national standard in the ethics domain will make a crucial contribution to the ongoing drive to develop a more robust framework for the conduct of social care research. Following consultation with our network of agencies, the preferred system for research in practice is one that combines aspects of Models 3 and 4.

Below we make general observations pertaining to all four main options (or models) for a national social care ethics review system, identifying the specific questions attached to each option where appropriate.

1. The present initiative, as part of the wider proposals to develop a national Research Governance Framework (RGF) for Health and Social Care, has the potential to encourage and promote excellence in research standards, to clarify the roles of all those involved in the research process, to ensure transparency in decision making, and to secure the delivery of research that is better targeted to the needs of all stakeholders. We feel, however, that there needs be a tight definition of what constitutes ‘research’, using a definition of research as the ‘production of generalisable knowledge’.

2. In addition to defining what we mean as encompassed by the term ‘research’, there is also the issue of being transparent in our understanding of what constitutes ‘social care research’. ‘Social care research’ may not refer exclusively to research undertaken within Social Service Departments (SSDs) but may also involve health trusts. As partnership working between SSDs, Health and Education progresses, for example, in Children’s Trusts, it is possible that the boundaries will become more blurred (Model 2, Question 3). However, it is in our view very important that the definition used in connection with research governance is limited to just those situations where social care is provided by a CSSR or its agents.

3. It is important to differentiate between large and small-scale research proposals, between research that is potentially low risk and that which is high risk, in deciding on the appropriate level of review. We feel that Models 1 and 2 would be too complex and bureaucratic and do not make allowance for a proportionate response to the viewing of research proposals. Model 3, which has a tiered-decision making process, offers a way of scrutinizing and reviewing research proposals according to scale and levels of risk. It should be possible to incorporate some of these levels into the devolved option that is advocated in Model 4. Whoever conducts research, it should be of the highest standard. Students, for example, need to engage in practical research as part of the learning process and it is essential that their research is as ethical as someone who is more experienced. We feel that the dilemma of scrutinizing at the right level could be addressed within the tiered approach of Model 3, and this would also mean that research proposals were only scrutinized once.

4. We are pleased that the value of involving service users and carers in the process of review of individual projects, and also in more general decisions surrounding the setting up of a process of ethics review, is recognized in the consultation document. It is important to remind ourselves why ethics review is needed – it is to:

‘protect the dignity, rights, safety and well-being of research participants (primarily all actual or potential research participants and concerned communities, but also researchers)’.

We hope that in the development of a national set of ethics guidelines for social care research the needs of service users and frontline practitioners will continue to be of paramount importance, as both these groups have been marginal to social care research in the past.

The development of national ethics guidelines holds the capacity to reflect and champion the needs and requirements of vulnerable individuals, specifically children and their families. We are also pleased, therefore, that the giving of informed consent by service users and carers (especially children) has been addressed in the consultative process. We would not wish to advocate, however, that ethical review should be carried out on the behalf of vulnerable individuals; rather, that it should be carried out with them. Informed consent should therefore be given, wherever possible, by the service user or carer, and not by the organization that provides a service to them. Access to obtain this consent should not, if suitably carried out, be restricted by the service organization. This is consistent with the protocol of the Declaration of Helsinki, which states that:

‘Special attention is … required for those who cannot give or refuse consent for themselves, for those who may be subject to giving consent under duress … and for those whom the research is combined with care’ (World Medical Association Declaration of Helsinki, 2000).

However, we would stress that ethics review should be independent of the research host, which is also consistent with the Declaration of Helsinki.

5. Issues remain surrounding the recruitment and training of those individuals who would be involved in committees or panels. We are pleased to note that this issue has begun to be addressed by the DoH with the funding of introductory workshops to the RGF (including ethics) for local authorities in England and Wales. These will be run by Dr. Chris Russell in association with the Social Services Research Group and other collaborating agencies (including research in practice) and will take place in Feburary/March 2005. We are also pleased to note the role of Involve in the consultation process with service users. These are positive examples of how raising awareness of research issues in the implementation of the RGF, of developing a regional approach, and in progressing with a business case, may be tackled. It also makes very transparent the commitment to bringing service users and frontline workers into the process from the outset, for if these two groups are to be at the heart of service delivery and review then this kind of effort needs to be expended in engaging them with the findings and implications of research.

However, we do have reservations concerning the emphasis on electronic methods of communication and virtual groups in Model 3. Although this should speed up the decision making process and reduce the level of bureaucracy involved, it may also disenfranchise many service users and front-line workers. We feel this is an issue that must be addressed.

6. Much emphasis is rightly being placed on obtaining a favourable ethics review, of getting past the gateway and beginning research. However, the monitoring or accreditation (Model 4, Question 2) of the subsequent research process is not similarly addressed. Ethical review is the starting point of a Research Governance Framework that should be followed by good ethical conduct throughout all the stages of a research study. Monitoring should be an integral component of this. The costs involved in appropriate ethical review, monitoring, dissemination and implementation of research, as stages of the entire research process, should be fully appreciated and budgeted for from the outset (see Point 7 below).

We also feel that greater control by those who most need good research - service users and practitioners - requires that both groups should play an active role in ethical review and monitoring. Models 3 and 4 are best placed to do this.

7. Social care research has meagre funding, and it is imperative that all additional costs of ethical review be fully funded as an addition to current research resources.

8 . Finally, we would recommend that the DoH collaborate with other organizations that are also involved in drawing up ethical review systems, such as the Economic and Social Research Council.

Conclusion

We urge the government to adopt an ethics review system that is specifically tailored to social care, rather than attempting to utilise systems already developed by the Central Office for Research Ethics Committees (Model 1, Question 3), or attempting to combine the review of social care research with that of health services and public health research (Model 2, Question 3). We do not believe that the National Health Service (NHS) Research Ethics Committees (RECs) are the appropriate forums for the ethical review of social care research. Although acknowledging that health research is not limited to clinical trials and increasingly utilizes a qualitative approach, we feel it important to recognise that social care research draws on different academic disciplines, utilizes a diverse range of research approaches, and involves service users/carers and research participants in a way that differs significantly from other research that is undertaken within the NHS. Further, the NHS RECs are already overburdened.

It seems to make sense to us to build on the substantial progress already made within a number of social care service and research institutions, for example, West Sussex and Essex, in developing a regional level system (Model 3). If this model of a tiered system were to be developed regionally in tandem with a central organization for handling studies that involved several authorities, we would have the best of Models 3 and 4. These two models (3 and 4) reflect most closely the current situation where local solutions are being developed and refined in response to local problems, as is evidenced in Children’s Trusts, and correspond most closely to what happens in the social care field generally.

research in practice was established in 1996 as an initiative of the Association of Directors of Social Services (ADSS) and is the largest children and families research implementation project in England and Wales. It is a department of The Dartington Hall Trust run in collaboration with the ADSS , The University of Sheffield and a network of over 80 participating agencies in the UK.

research in practice’s mission is to promote positive outcomes for children and families through the use of research evidence.

research in practice’s purpose is to identify effective methods of understanding and using research by providing services to a collaborative network of committed agencies.

More details can be found here on our website.

Contact for this response:

Margaret Casey Research Officer, research in practice

m.casey@sheffield.ac.uk 0114 222 6464

research in practice, Department of Sociological Studies, Elmfield, Northumberland Road, University of Sheffield, S10 2TU

Director:

Celia Atherton, research in practice, Blacklers, Park Road, Dartington, Totnes, Devon TQ9 6EQ celia@rip.org.ukcelia@rip.org.uk 01803 867 692

December 2004