Research Ethics for adult social care in practice

1

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

2
Structure

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

3
Definitions

• 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
  p.3)

4
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.

5
Context

• 2001 DH Research Governance Framework Codified
  standards
• 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)

6
Context

• 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
  place)
• Funder (to declare if they want to be a
  sponsor)
• 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.

7
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

8
Research governance in different settings
HEIs

• 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
  projects.
• 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.

9
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
  processes.
• Very poorly resourced. Internal funding.

10
Research governance in different settings
ADASS/ADCS

• ADASS
• 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.

11
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
  methods?

12
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
  authorities
• 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.

13
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
  participants.
• Who does the research? Students inexperienced
  researchers
• Does one learn to swim best in the water or in a
  library? Analogy correct?
• Understanding by NHS of social science
  methodologies
• Is this still a problem?

14
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
  project?
• NRES systems extremely thorough University and
  CSSR/local authority reviews less so sometimes
  and less well documented?
• Methodological review often overlooked.

15
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
  training
• Compliance
• How much research activity goes on thats not
  been reviewed? (Re-badging, deliberate evasion
  etc.)

16
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.

17
References

• 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.