Research Governance in Social Care

1. Research Governance in Social Care Where to next? Paul Dolan,Birmingham City Council SSRG Annual Workshop, Manchester 2008

2. Where have we come from? • Research governance – some definitions • RESEARCH. systematic attempt to obtain soundly based generalisable knowledge, through rigorous methods • GOVERNANCE. arrangements for ensuring activity is ethically legally and methodologically sound, and conforms to clear standards of accountability & quality

3. Comments on thesedefinitions • Broad idea of research: quantitative, qualitative; desk; field; survey; audit; evaluation. • Governance implies external appraisal of soundness of research, independent of researcher views • Broad range of risks associated with research, dependent on context • Predictive judgments: Absence of harm/= Benefit?

4. Social Services Research Regulation: Long Term Context • Duty of care to vulnerable people • ADSS national advisory system on multi-site projects: usually academic, never DH or CSCI surveys • Seen as more than advice system by researchers, despite ADASS disclaimer • SSRG not a constituted quality review body

5. Research Regulation Context in the NHS • Local committees for Ethics Review of health research • Methods to be reviewed by sponsor • Drug trial/risk assessment model • Research defined to exclude evaluative, audit activity- pragmatic because of vol. • Evasion, malpractice in late 1990s

6. Department of Health: formal Research Governance Framework • RGF 2001, 2005: for the NHS • DH Social Care Implementation Plan 2004, non-mandatory, after resistance • Wider definition of research than NHS • Children & Adults social care • implementation – DH/SSRG/ADSS resource pack, seminars; encouragement: no resources except one off start-up grant

7. Nuts & Bolts of Social Care RG implementation 2004 -6 • Timetable on external, then own account research • Baseline assessment, then follow up survey of progress and intentions • No audit, inspection or formal target • Over half authorities report having or intending to have systems, but no quality assurance

8. Meanwhile… COREC is reviewed by O’Higgins: becomes NRES • Critics say COREC time-consuming and bureaucratic • Model retained after review: of academic plus student research • Peer reviews of methods assumed, NRES model of ethics as preliminary to R & D gatekeeping – hon. contracts • No change to definition of research eg patient surveys excluded • Committee and meeting based approach in NRES [LRECs, MRECs]

9. policy dynamics 2007NHS, Academic & Council • Anecdotal criticism of COREC from academic community, esp. on drug trials model of research • Criticism of culture of review excluding service users – “lay”= retired health professionals/vicars • More recent drug trial disaster: not an ethical failure? • Desire from academics for as little review as possible, and specialised for Social Care • Low resource profile for social care and social care as site of research.

10. Dynamics 2007 Research coverage • Unresolved issue of non academic research review coverage. • Student research downgraded in new NHS networks • Context of quasi-research activity CSIP;CSED;CSCI; new policy implementation “pilots”.

11. Dynamics 2007Dept of Health – not Dept of Children, Schools, Families. • Sponsors much academic research • Promotes a national social care research ethics body: negotiation with NRES • Inserts element in Mental Capacity Act [MCA]2005: first statutory requirement for REC approval • National SC research register, separate from NHS research register

12. ADASS Position 2007 • Reluctant to concede, after 5 years, on definitions and limiting to ethical review • Especially as councils moving to consortia as well as own RG arrangements • Reviving ADASS review system • Acknowledge: no govt or researcher investment in infrastructure for social care research.

13. ADASSProposals 07 • National forum for advice and review • Standard-setting • Regional structures inputting • Involving wide range of stakeholders, incl SCIE, universities, RiP etc. • Support and capacity building not just review and not just ethics • Fees: but these insufficient to support on own unless sponsors underpin

14. Dept. of Health 2008 • DH announcement of SCREC, located in SCIE, but operating within NRES definitions and procedures: • budget level: any one off start-up costs covered, or minimalist flagged committee? • Multi-site projects for ethics review by new committee, recruited as per NRES • 2nd ed of SSRG/DH Resource Pack

15. Prospective Issues in the NRES context • Can the SCREC add value to both researchers and councils, while operating within GAFREC 2001,the NRES Standard Procedures and the definition of research? [or will it sidestep them?] • How far has NRES moved from COREC in its style/culture? [ user involvement] • SCREC/SCIE aware that RECs not legally competent?

16. Prospective Issues for SCIE standard operating procedures • Will non-traditional research projects be referred and accepted for ethics review - especially where Mental Capacity Act [MCA] issues emerge –CSCI,CSIP? • How far in practice will SCREC form and convey a view on methods and organisation of projects as well as ethical consideration?

17. Issues for SCIE as they take on role • Transparency of review and advice-giving process? • How much review for Committee meetings and how much delegated to chair [ as in COREC and current NRES]? • Automatic entry on national Social Care Research Register? and removal if later local ethics review negative?

18. Issues for the research communities & sponsors • The SCREC adds a layer of electronic application and review to that of ADASS,ADCS: costs as well as local “site-specific” review by Councils. • Reviewer competence, speed. • Is there a realistic opportunity to influence research review and practice in Councils, when academic researchers are the main direct users of the SCREC?

19. Issues for Councils • Will Councils refer [in] eligible projects for review to ADASS and SCREC, and in what order? • Specifically, MCA issues in multi-site and local/own account projects? • How much evidence of consideration of issues/research tools will Councils expect of SCREC via researchers?

20. Conclusions • Assuring Quality in research v gate-keeping monitoring • Changing social care terrain: meaningful duty of care? • Where will the big research scandal be: local or multi-site? [compare NHS] • Where will the routine limits be? MCA? • SCIE has an opportunity and faces threats…