1. Research Ethics for adult social care in practice John Woolham Research Fellow, with contributions from Paul Dolan, Birmingham City Council

2. Structure –Definitions –Context and origins –Research governance in different settings –Issues

3. Definitions a.governance: ‘setting standards, defining mechanisms to deliver standards, monitoring and assessing arrangements, improving research quality and safeguarding the public (by enhancing ethical and scientific quality, promoting good practice, reducing adverse incidents ensuring that lessons are learned and preventing poor performance and misconduct)’ (DH 2001 p.2) b.Ethics: ‘ the moral principles governing conduct. The branch of knowledge concerned with moral principles’ (Oxford Shorter) c.Research: ‘ the attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods’ (RGF 2005 p.3)

4. Context and origins Why have research governance and ethics reviews systems in social care Adults (and children)? Because we’re told we have to Because we think it’s a good idea Can protect vulnerable people and staff from ‘bad’ research Can help to raise standards Can co-ordinate activity locally and regionally (preventing unnecessary duplication, over-researching of local groups etc) Can help ‘plug’ research in, so findings are accessible and are used.

5. Context 2001 – DH Research Governance Framework – Codified standards –Ethics (ensuring dignity, well-being, rights & safety of participants) –Science (ensuring design and methods are independently reviewed) –Information (ensuring findings are freely available to the public) –Health & Safety (ensuring safety of participants at all times) –Finance (ensuring financial probity)

6. Context RGF defines accountabilities –Investigators (to develop sound proposals, ensure they’re reviewed) –REC (to provide independent expert opinion re ethics of proposed study) –Sponsor (to ensure everything is in place including REC review to allow study to take place) –Funder – (to declare if they want to be a ‘sponsor’) –Employing organisation ( to support but also to hold researchers accountable for their work) –Care organisation (to sponsor in house and to check external research is properly ‘sponsored’) –Responsible professional (to make sure standards are maintained) Extended to CSSRs in 2004 with modifications….

7. Research governance in different settings: NHS National Research Ethics Service NRES Has had LRECS since 1991. NHS guidance formalised ad hoc arrangements Lay and clinical volunteer panel members Responsible for all research in NHS settings & research involving adults with impaired mental capacity (SCREC now a REC responsible for reviewing activity in this area) High volume of applications – restrictive definitions of ‘research’ Well resourced Centralised approach standard documentation

8. Research governance in different settings: HEIs Universities /HEIs Most URECs probably set up since 2000. Responsible for research carried out by university staff and students – not quasi-research though. Volume of applications may vary Decentralised & heterogenous: different structures (committee, electronic, university, faculty or school wide. Some also have self-assessed triage arrangements by likely level of risk). Some (2003) did not cover student projects. Funded through existing HEFC resources All universities are likely to have RECs now: major funding agencies won’t fund, and journals won’t publish non-reviewed proposals.

9. Research governance in different settings: Local Authorities Local authorities: social care Unknown how many CSSRs have governance arrangements – last survey: 50% CSSRs have RG systems & a further 39% had plans to introduce by end of 2006. (n=98) RG leads listed in 2010. Responsible for all in-house research and external research Quite a lot of research activity in CSSRs Decentralised and heterogenous. Some CSSRs have adopted similar application forms, structures and processes. Very poorly resourced. Internal funding.

10. Research governance in different settings: ADASS/ADCS ADASS Role of ADASS in research review: gatekeeping Value to local authorities & vfm for CSSR time - not ethics or methods per se. ADASS sees the success of Research Governance in CSSRs as linked with wider questions of resources to support research activity.

11. Where to go for a review? SCREC or NRES REC if study involves NHS staff, patients, patients relatives or carers, or people with impaired mental capacity, or if there’s no other place for a review. Ethics only? University if study is to be carried out by student or staff of the university. Ethics at REC, methods by supervisor or peer review. CSSR/Local authority if the study is in-house or not reviewed elsewhere. Ethics – but also methods?

12. Issues: Policy Is there a need for statutory regulation in social care research? –Current systems mostly based on guidance –No PIs or national monitoring –Pressure for more consistency in decision-making by ethics committees from researchers - Who would pay? Inconsistent definitions of research –What’s research and what’s not? (NHS REC definitions may be restrictive and can be evaded: variability in universities and CSSRs/local authorities Gaps in coverage –RGF applies to people who use CSSRs, staff and relatives. What about self funders or personal budget holders? Duty of care issues.

13. Issues: Facing Sponsors Does the RGF apply to Government departments and regulatory agencies? How independent are research governance systems? Just ethics? –DH now complies with its own guidance but others do not. How can reviews be ‘proportional’ to risk or ‘light touch’? –Can’t evaluate risk without having effectively carried out a full review –Can’t equate particular kinds of research design / method with higher or lower risks to participants. Who does the research? Students & inexperienced researchers –Does one learn to swim best in the water or in a library? Analogy correct? Understanding by NHS of social science methodologies –Is this still a problem?

14. Issues For Researchers 1 Asymmetry in relationship between different sources of review –Reciprocity, respect and avoidance of double handling are key principles – but NRES won’t accept the currency of reviews by CSSRs or universities on NHS research. –Favourable review means no major changes can be made without going back for a further review. –Only NRES committees may review research involving adults with impaired mental capacity. What actually gets reviewed, and when in the project? –NRES systems extremely thorough: University and CSSR/local authority reviews less so sometimes and less well documented? –Methodological review often overlooked.

15. Issues for Researchers 2 Speed of response/ADASS and ADCS involvement –Varies from place to place – can be time consuming for the researcher. Workload and capacity issues –High volume applications – burden on researchers & temptation to cut corners or triage out proposals that should really be reviewed. Knowledge, skills experience & backgrounds of volunteer reviewers –CSSR reviewers in particular lack access to training Compliance –How much research activity goes on that’s not been reviewed? (Re- badging, deliberate evasion etc.)

16. Concluding thoughts Vulnerable people and staff now probably safer from bad research but price has been high for professional researchers May have been an impact on the nature of research carried out – better standards but risk of less research on some groups e.g. people with impaired mental capacity Continuing disparities in resources, access to training, skills and experience within the different sectors Continuing problems a reflection of wider societal ambivalence to risk and protection? Solutions may require shifts in power, more sharing of resources, changes to organisational/professional culture, investment in training and informed dialogue.

17. References Boddy, J., & Warman, A., (2003) Mapping the Field for the Research Governance Framework: research activity in eight CSSRs. DH London. Department of Health (2005) The Research Governance Framework for Health and Social Care 2 nd edition. DH London. Hunter, D., Proportional ethical review and the identification of ethical issues (2007) Journal of Medical Ethics, 33 p 241-245 Hunter, D., The ESRC Research Ethics Framework and research ethics review at UK universities: re-building the tower of Babel REC by REC (2008) Journal of Medical Ethics 34 p. 815-820. Pahl, J. (2002) Research Governance in Social Care: The findings of the Baseline Assessment Survey. DH London. Pahl, J., (2006) Findings of the 2005 Baseline Assessment Exercise. DH London. Department of Health(2004) The Research Governance Framework for Health and Social Care Implementation Plan for Social Care. DH London. Tinker, A., & Coomber, V., (2004) University Ethics Committees: their role, remit and conduct. KCL London.