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

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

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

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

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

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

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

8. 8 Meanwhile… COREC is reviewed by O’Higgins: becomes NRES Critics say COREC time-consuming and bureaucratic Critics say COREC time-consuming and bureaucratic Model retained after review: of academic plus student research 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 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 No change to definition of research eg patient surveys excluded Committee and meeting based approach in NRES [LRECs, MRECs] Committee and meeting based approach in NRES [LRECs, MRECs]

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

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

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

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

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

14. 14 Dept. of Health 2008 DH announcement of SCREC, located in SCIE, but operating within NRES definitions and procedures: 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? 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 Multi-site projects for ethics review by new committee, recruited as per NRES 2 nd ed of SSRG/DH Resource Pack 2 nd ed of SSRG/DH Resource Pack

15. 15 Prospective Issues in the NRES context 1. 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?] 2. How far has NRES moved from COREC in its style/culture? [ user involvement] 3. SCREC/SCIE aware that RECs not legally competent?

16. 16 Prospective Issues for SCIE standard operating procedures 1. Will non-traditional research projects be referred and accepted for ethics review - especially where Mental Capacity Act [MCA] issues emerge –CSCI,CSIP? 2. How far in practice will SCREC form and convey a view on methods and organisation of projects as well as ethical consideration?

17. 17 Issues for SCIE as they take on role 1. Transparency of review and advice- giving process? 2. How much review for Committee meetings and how much delegated to chair [ as in COREC and current NRES]? 3. Automatic entry on national Social Care Research Register? and removal if later local ethics review negative?

18. 18 Issues for the research communities & sponsors 1. 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. 2. Reviewer competence, speed. 3. 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. 19 Issues for Councils 1. Will Councils refer [in] eligible projects for review to ADASS and SCREC, and in what order? 2. Specifically, MCA issues in multi-site and local/own account projects? 3. How much evidence of consideration of issues/research tools will Councils expect of SCREC via researchers?

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