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) 2001-2006 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 CommitteeSome key Principles from ‘Securing Ethics Review’:

see www.screc.org.uk

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: www.screc.org.uk

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 systemAcademy 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: 0207 089 6899

See flowchart, dates, guidance at

www.screc.org.uk