Research Ethics for adult social care in
practice
John Woolham Research Fellow, with
contributions from Paul Dolan, Birmingham City
Council
Structure
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Definitions
Context and origins
Research governance in different settings
Issues
Definitions
a. 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)
b. Ethics:
‘the moral principles governing conduct. The branch of
knowledge concerned with moral principles’ (Oxford Shorter)
c. Research:
‘the attempt to derive generalisable new knowledge by
addressing clearly defined questions with systematic and
rigorous methods’ (RGF 2005 p.3)
Context and origins
Why have research governance and ethics reviews systems in
social care Adults (and children)?
•Because we’re told we have to
•Because we think it’s a good idea
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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.
Context
• 2001 – DH Research Governance Framework –Codified standards
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Ethics (ensuring dignity, well-being, rights & safety of participants)
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Science (ensuring design and methods are independently reviewed)
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Information (ensuring findings are freely available to the public)
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Health & Safety (ensuring safety of participants at all times)
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Finance (ensuring financial probity)
Context
• RGF defines accountabilities
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Investigators (to develop sound proposals, ensure they’re 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….
Research governance in different settings: NHS
National Research Ethics Service NRES
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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: 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 won’t fund, and journals won’t publish non-reviewed
proposals.
Research governance in different settings: Local Authorities
Local authorities: social care
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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. (n=98) 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.
Research governance in different settings:
ADASS
Role of ADASS in research review: gatekeeping
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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.
ADASS/ADCS
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
there’s 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?
Issues: Policy
• Is there a need for statutory regulation in social care research?
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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
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What’s research and what’s not? (NHS REC definitions may be restrictive
and can be evaded: variability in universities and CSSRs/local authorities
• Gaps in coverage
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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?
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DH now complies with its own guidance but others do not.
• How can reviews be ‘proportional’ to risk or ‘light touch’?
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Can’t evaluate risk without having effectively carried out a full review
Can’t equate particular kinds of research design / method with higher or
lower risks to participants.
• Who does the research? Students & inexperienced researchers
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Does one learn to swim best in the water or in a library? Analogy correct?
• Understanding by NHS of social science methodologies
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Is this still a problem?
Issues For Researchers 1
• Asymmetry in relationship between different sources of review
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Reciprocity, respect and avoidance of double handling are key principles –
but NRES won’t 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?
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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
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Varies from place to place – can be time consuming for the researcher.
• Workload and capacity issues
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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
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CSSR reviewers in particular lack access to training
• Compliance
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How much research activity goes on that’s not been reviewed? (Rebadging, deliberate evasion etc.)
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.
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.