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Research Ethics for adult social care in practice


Research Ethics for adult social care in practice John Woolham Research Fellow, with contributions from Paul Dolan, Birmingham City Council * * Structure Definitions ... – PowerPoint PPT presentation

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Title: Research Ethics for adult social care in practice

  • Research Ethics for adult social care in practice
  • John Woolham Research Fellow, with contributions
    from Paul Dolan, Birmingham City Council

  • Definitions
  • Context and origins
  • Research governance in different settings
  • Issues

  • governance
  • setting standards, defining mechanisms to
    deliver standards, monitoring and assessing
    arrangements, improving research quality and
    safeguarding the public (by enhancing ethical and
    scientific quality, promoting good practice,
    reducing adverse incidents ensuring that lessons
    are learned and preventing poor performance and
    misconduct) (DH 2001 p.2)
  • Ethics
  • the moral principles governing conduct. The
    branch of knowledge concerned with moral
    principles (Oxford Shorter)
  • Research
  • the attempt to derive generalisable new
    knowledge by addressing clearly defined questions
    with systematic and rigorous methods (RGF 2005

Context and origins
  • Why have research governance and ethics reviews
    systems in social care Adults (and children)?
  • Because were told we have to
  • Because we think its a good idea
  • Can protect vulnerable people and staff from
    bad research
  • Can help to raise standards
  • Can co-ordinate activity locally and regionally
    (preventing unnecessary duplication,
    over-researching of local groups etc)
  • Can help plug research in, so findings are
    accessible and are used.

  • 2001 DH Research Governance Framework Codified
  • Ethics (ensuring dignity, well-being, rights
    safety of participants)
  • Science (ensuring design and methods are
    independently reviewed)
  • Information (ensuring findings are freely
    available to the public)
  • Health Safety (ensuring safety of participants
    at all times)
  • Finance (ensuring financial probity)

  • RGF defines accountabilities
  • Investigators (to develop sound proposals, ensure
    theyre reviewed)
  • REC (to provide independent expert opinion re
    ethics of proposed study)
  • Sponsor (to ensure everything is in place
    including REC review to allow study to take
  • Funder (to declare if they want to be a
  • Employing organisation ( to support but also to
    hold researchers accountable for their work)
  • Care organisation (to sponsor in house and to
    check external research is properly sponsored)
  • Responsible professional (to make sure standards
    are maintained)
  • Extended to CSSRs in 2004 with modifications.

Research governance in different settings NHS
  • National Research Ethics Service NRES
  • Has had LRECS since 1991. NHS guidance
    formalised ad hoc arrangements
  • Lay and clinical volunteer panel members
  • Responsible for all research in NHS settings
    research involving adults with impaired mental
    capacity (SCREC now a REC responsible for
    reviewing activity in this area)
  • High volume of applications restrictive
    definitions of research
  • Well resourced
  • Centralised approach standard documentation

Research governance in different settings
  • Universities /HEIs
  • Most URECs probably set up since 2000.
  • Responsible for research carried out by
    university staff and students not
    quasi-research though.
  • Volume of applications may vary
  • Decentralised heterogenous different
    structures (committee, electronic, university,
    faculty or school wide. Some also have
    self-assessed triage arrangements by likely level
    of risk). Some (2003) did not cover student
  • Funded through existing HEFC resources
  • All universities are likely to have RECs now
    major funding agencies wont fund, and journals
    wont publish non-reviewed proposals.

Research governance in different settings
Local Authorities
  • Local authorities social care
  • Unknown how many CSSRs have governance
    arrangements last survey 50 CSSRs have RG
    systems a further 39 had plans to introduce by
    end of 2006. (n98) RG leads listed in 2010.
  • Responsible for all in-house research and
    external research
  • Quite a lot of research activity in CSSRs
  • Decentralised and heterogenous. Some CSSRs have
    adopted similar application forms, structures and
  • Very poorly resourced. Internal funding.

Research governance in different settings
  • Role of ADASS in research review gatekeeping
  • Value to local authorities vfm for CSSR time -
    not ethics or methods per se.
  • ADASS sees the success of Research Governance in
    CSSRs as linked with wider questions of resources
    to support research activity.

Where to go for a review?
  • SCREC or NRES REC if study involves NHS staff,
    patients, patients relatives or carers, or people
    with impaired mental capacity, or if theres no
    other place for a review. Ethics only?
  • University if study is to be carried out by
    student or staff of the university. Ethics at
    REC, methods by supervisor or peer review.
  • CSSR/Local authority if the study is in-house or
    not reviewed elsewhere. Ethics but also

Issues Policy
  • Is there a need for statutory regulation in
    social care research?
  • Current systems mostly based on guidance
  • No PIs or national monitoring
  • Pressure for more consistency in decision-making
    by ethics committees from researchers
  • - Who would pay?
  • Inconsistent definitions of research
  • Whats research and whats not? (NHS REC
    definitions may be restrictive and can be evaded
    variability in universities and CSSRs/local
  • Gaps in coverage
  • RGF applies to people who use CSSRs, staff and
    relatives. What about self funders or personal
    budget holders? Duty of care issues.

Issues Facing Sponsors
  • Does the RGF apply to Government departments and
    regulatory agencies? How independent are research
    governance systems? Just ethics?
  • DH now complies with its own guidance but others
    do not.
  • How can reviews be proportional to risk or
    light touch?
  • Cant evaluate risk without having effectively
    carried out a full review
  • Cant equate particular kinds of research design
    / method with higher or lower risks to
  • Who does the research? Students inexperienced
  • Does one learn to swim best in the water or in a
    library? Analogy correct?
  • Understanding by NHS of social science
  • Is this still a problem?

Issues For Researchers 1
  • Asymmetry in relationship between different
    sources of review
  • Reciprocity, respect and avoidance of double
    handling are key principles but NRES wont
    accept the currency of reviews by CSSRs or
    universities on NHS research.
  • Favourable review means no major changes can be
    made without going back for a further review.
  • Only NRES committees may review research
    involving adults with impaired mental capacity.
  • What actually gets reviewed, and when in the
  • NRES systems extremely thorough University and
    CSSR/local authority reviews less so sometimes
    and less well documented?
  • Methodological review often overlooked.

Issues for Researchers 2
  • Speed of response/ADASS and ADCS involvement
  • Varies from place to place can be time
    consuming for the researcher.
  • Workload and capacity issues
  • High volume applications burden on researchers
    temptation to cut corners or triage out
    proposals that should really be reviewed.
  • Knowledge, skills experience backgrounds of
    volunteer reviewers
  • CSSR reviewers in particular lack access to
  • Compliance
  • How much research activity goes on thats not
    been reviewed? (Re-badging, deliberate evasion

Concluding thoughts
  • Vulnerable people and staff now probably safer
    from bad research but price has been high for
    professional researchers
  • May have been an impact on the nature of research
    carried out better standards but risk of less
    research on some groups e.g. people with impaired
    mental capacity
  • Continuing disparities in resources, access to
    training, skills and experience within the
    different sectors
  • Continuing problems a reflection of wider
    societal ambivalence to risk and protection?
  • Solutions may require shifts in power, more
    sharing of resources, changes to
    organisational/professional culture, investment
    in training and informed dialogue.

  • Boddy, J., Warman, A., (2003) Mapping the Field
    for the Research Governance Framework research
    activity in eight CSSRs. DH London.
  • Department of Health (2005) The Research
    Governance Framework for Health and Social Care
    2nd edition. DH London.
  • Hunter, D., Proportional ethical review and the
    identification of ethical issues (2007) Journal
    of Medical Ethics, 33 p 241-245
  • Hunter, D., The ESRC Research Ethics Framework
    and research ethics review at UK universities
    re-building the tower of Babel REC by REC (2008)
    Journal of Medical Ethics 34 p. 815-820.
  • Pahl, J. (2002) Research Governance in Social
    Care The findings of the Baseline Assessment
    Survey. DH London.
  • Pahl, J., (2006) Findings of the 2005 Baseline
    Assessment Exercise. DH London.
  • Department of Health(2004) The Research
    Governance Framework for Health and Social Care
    Implementation Plan for Social Care. DH London.
  • Tinker, A., Coomber, V., (2004) University
    Ethics Committees their role, remit and conduct.
    KCL London.