Ethical Review of Adult Social Care Research:

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

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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

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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

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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 RD 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

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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

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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

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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

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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

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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)

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Social Care Research Ethics Committee

• Some 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.

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What Social Care REC reviews

• 1. All studies should concern adults. SC REC has
  no authority to review studies concerning
  childrens 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

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• 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)

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• 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

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• 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

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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
  RD 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

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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?

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• 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?

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Research applicant concerns

• The IRAS form online submission
• The time it takes lt60 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)

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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

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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

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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 childrens social
  care and education???

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Booking and Queries

• Contact
• Barbara Cuddon, SCREC Coordinator
• Social Care Institute for Excellence
• Goldings House
• 2 Hays Lane
• London SE1 2HB
• Tel [phone]
• See flowchart, dates, guidance at
• www.screc.org.uk

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