Ethical Review of Adult Social Care Research: Practice issues & resources Deborah Rutter (SCIE)

What lies within... Sources of review for social care research Social Care REC Research governance & ethics issues:  For Social Care REC  For social care researchers Future developments

Sources of review for research on humans University RECs (URECs) – most accessible service for academic researchers & students NRES RECs – for NHS and HSC studies (includes independent AAPEC Committees; Social Care REC) = increasing remit for NRES but reduced number of NRES RECs (200+ down to 99 in July 2010); reduced differentiation

Result?  More studies per REC = more pressure on volunteer members  ‘Demand’ for rapid reviews (‘proportionate’)  Double jeopardy from local RECs attached to institutions has gone... ... but R&D Depts have replaced some of this scrutiny in sometimes less transparent ways  NRES has tried to make itself lean in anticipation of Rawlins (AcMS) Review & government cuts  HEI URECs may still feel marginalised

Background to Social Care REC  Following a lengthy period of consultation with stakeholders in the social care sector, the Department of Health asked SCIE to appoint a new national Social Care Research Ethics Committee  Appointing Authority SCIE has no place on REC: so no conflict of interest

The case for a social care REC: Views from the social care community:  Social work & social services practice & research (eg ADASS/JUCSWEC/SSRG)  Social care research governance (DH)  Social science research governance (ESRC)  Jan Pahl reports  Gaps in provision  Inappropriately resourced provision

Social Care Research Ethics Committee  Funded by Department of Health (no contribution from DCSF, so adults only)  Operates within the framework (audit & SOPs) & funding of National Research Ethics Service (NRES – was part of now abolished National Patient Safety Agency)  IRAS form version redesigned (within limits) to include SC REC  First monthly meeting held in June 2009

Social Care Research Ethics Committee  Fifteen members appointed in December 2008 through open advertisement  Membership reflects the social care context and includes researchers, academics, ethicists plus providers, users and carers of social care  REC complements, NOT replaces, other RECS by addressing gaps in provision  Takes on specialist roles  University RECs and NHS Healthcare RECs will continue to review social care proposals where appropriate

Social Care REC primary responsibility ( under GAfREC) “2.2 The purpose of a Research Ethics Committee in reviewing the proposed study is to protect the dignity, rights, safety and well-being of all actual or potential research participants. It shares this role and responsibility with others, as described in the Research Governance Framework for Health and Social Care. 2.3 RECs are responsible for acting primarily in the interest of potential research participants and concerned communities, but they should also take into account the interests, needs and safety of researchers who are trying to undertake research of good quality. However, the goals of research and researchers, while important, should always be secondary to the dignity, rights, safety, and well-being of the research participants.” GAfREC 2001 (DH)

Social Care Research Ethics Committee Some key Principles from ‘Securing Ethics Review’: see 1. No investigator should have to seek ethics review from more than one REC. 2. Social care community accepts a wider definition of what constitutes research e.g. most service evaluations would be accepted as suitable for review by the SC REC. Chief investigator & sponsor decide whether to seek REC review (except if MCA applies). 3. Different concept of ‘risk’ or potential damage from that pertaining to invasive health studies.

What Social Care REC reviews: 1. All studies should concern adults. SC REC has no authority to review studies concerning children’s social care services, although the REC has given opinions on ‘inter-generational’ studies (with NRES approval). 2. Social care studies funded by the Department of Health, including Information Centre surveys; NIHR social care studies, primarily School for Social Care Research

3. Social care research that may involve adults lacking mental capacity to consent to involvement. SC REC is flagged (& trained) to review Mental Capacity Act research 4. Social care research that involves sites in England and another UK country. Informal agreement with Wales, NI and Scotland to avoid double-handling of such research (pending new governance arrangements)

5. Studies where investigators do not have access to other review systems e.g. private sector contractors not affiliated to universities, especially those carrying out government sector contracts; social care research led by service- user researchers 6. Councils with Social Services responsibilities ‘own account’ research with ethical issues they consider substantial

7. Studies of integrated services (health and social care), or multi-site studies involving both health and social care contexts, provided there is no clinical intervention or change to clinical practice involved. (Again, we tend to consult policy advisors at NRES.) NOT student research, unless it concerns Mental Capacity Act

Further guidance on applications  What is social care research? Can we recognise it by context?  Research with social care staff/students/service users  Research in care homes, and domiciliary care: vital but difficult, often with people lacking capacity  Personalisation, self-funding contexts  How is research defined?  The Mental Capacity Act research guidance  Access – permission from host organisations – is not in gift of any REC: needs to be negotiated with host organisations  Access to NHS staff may require clearance with R&D offices: (reported to be non-standardised, demanding, over-zealous given nature of research)  ADASS review of design & procedure for 4+ LAs  Research Register for Social Care Visit:

Common ethical issues in social care applications (REC concerns)  Who can access (first contact) the social care service user? Providers can; researchers cannot (need to opt in). Process often inadequately described  The questions: are they offensive? Are the questions (survey or interview) ‘answerable’?  Review by service users, piloting with recipients, desirable.  Introductory letter, outlining purpose, with full contact details (for opt-out of reminders & follow-ups).  Is the follow-up reasonable? Or harrassment? Are response rates an ethical concern?

 Payment (inducement or reward? Impact on benefit profile?)  Exclusion of people from minority backgrounds; ‘hard’ to reach; service drop-outs & refusers  Very poor understanding of Mental Capacity Act (use of proxies?)  Researchers need to have a protocol for following up notification of adult abuse. The respondent should know what would happen (eg brief explanation in covering letter).  Quantitative material: anonymising data.  Plan for dissemination: is it likely the respondents will be interested in results?

Research applicant concerns  The IRAS form & online submission  The time it takes: <60 days from submission to opinion (nearer 30 for SC REC, clock stops while applicant responds)  Ethics review impinging on design/methods  Consistency of decisionmaking by RECs  Incremental (qualitative) research: how to describe for the review?  Uncertainty over what ‘requires’ ethics review; what should require it; how to avoid it!  Double jeopardy (URECs, ADASS, etc)

General feedback on REC system Academy of Social Sciences submission to Rawlins Review  Favour single regulator for HSC (only) with broader philosophy/culture (less medical, more social); integrated with NHS permissions  Valued new Social Care REC  More use should be made of HEI RECs  NHS requirements remain a key problem, discouraging inter-disciplinary work  Feedback from SC REC customer survey:  Broadly positive, esp. coordinator support  Concern about “re-design”: over- stepping boundaries of ethical concerns

Mental capacity: issues  Act requires research allowed under MCA to concern treatment or care of person unable to consent (ALC)  Act requires that research cannot be conducted as effectively with people who have capacity  Inability to understand/recall purpose & content of research (the test for valid consent) almost certainly suggests lack of capacity to understand questions (you cannot use carers as proxies)  Those who lose capacity during research? We are trying to get the IRAS form to provide a suitable option for single contact interview studies.  Lack of clarity where consultee is also informant in capacity of carer

Forthcoming developments  New harmonised GAfREC (to include SC REC, URECs): may include easier access to NHS staff as participants; will include MCA and Proportionate Review;  New Standard Operating Procedures (some SC REC specific);  Rawlins Review to report;  A new home for National Research Ethics Service (NRES);  An ethics review facility for children’s social care and education???

Booking and Queries Contact: Barbara Cuddon, SCREC Coordinator Social Care Institute for Excellence Goldings House 2 Hay’s Lane London SE1 2HB Tel: See flowchart, dates, guidance at