Research Ethics review and the Mental Capacity Act 2005: Safeguarding people or stifling research

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Research Ethics review and the Mental Capacity
Act 2005 Safeguarding people or stifling
research?

• Professor Jonathan Parker (Bournemouth
  University), Professor David Stanley (Northumbria
  University Bridget Penhale (University of
  Sheffield)
• (Acknowledgements to SCIE Department of Health
  for funding this research)

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Background to and implications of the Act 1

• Mental Capacity Act 2005
• Scrutiny and approval through appropriate body
• Health research focus
• S31 REC must be satisfied that
• research concerns an impairing condition or
  treatment
• research could not be undertaken with people who
  could give consent
• Potential benefit, not too burdensome

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Background to and implications of the Act 2

• Social work/social care need for evidence base
• Changing demography
• Health improvements
• Fluctuating capacity/assumptions of
  capacity/enabling decision-making

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Research ethics scrutiny a problematic concern

• Research ethics central to social work/ social
  science BASW Code of Ethics JUC SWEC Research
  Ethics ESRC Code of Ethics SPA, BSA etc
• DH prior consultation over time leading to
  Social care Research Ethics Committee
• Ethics creep
• Problematic isomorphism
• Lack of fit/restrictive

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Study methodology 1

• Aim assess initial impact of MCA on social work
  research teams and navigation through RECs

• Two-stage data collection
• Stage 1 Current custom and practice in
  universities
• Stratified randomised sample of 30 RECs across
  HEIs on-line documentation surveyed
• Stage 2 semi-structured interviews of social
  work/care researchers (n12, purposive sample)
• Ethics approval through university REC DH
  governance process

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Study methodology 2

• Data analysis
• Documentary analysis of existing on-line REC
  policy, procedure and other documentation
• Thematic analysis of interview data shared
  across research team

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Findings1 Stage 1

• Pre- post-1992 no significant differences in
  ethical scrutiny
• MCA rarely mentioned however, signposting to NHS
  RECs common (anticipation of appropriate body)
  rarely referred to other bodies
• Diversity in continuing to scrutinise when
  referred on risk averse, quality, audit
• Policy implementation gap? guidance?

• limitations web-based survey some password
  protected preventing access to material
  potential for human error in identifying material
• Theoretical saturation achieved with sample

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Findings 2 Stage 2

• Few submitting recent proposals
• Misunderstandings as to scrutiny required and
  implications of Act
• Concern over DH research governance requirements,
  demands from local authorities, MCA

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Findings 3 University processes and RECs

• Differences in structure and process
• Rigour/suspicion self-assessment scrutiny
  risk-averse service user involvement
• NRES process standard for people who lack
  capacity
• Fit for purpose?
• Lack of mention of MCA but vulnerability
  considered
• Dual scrutiny university REC external review
  but not a rubber stamp

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Findings 4 Research undertaken by respondents

• Not been through process of submitting proposals
  relating to people lacking capacity under Act
• Dual scrutiny valuable in highlighting issues and
  assisting in determining capacity and consent
• Concerns
• My own recent application about the MCA did not
  specifically involve service users but included
  professionals. On reflection, I think I
  specifically avoided (including service users,
  which is an interesting observation, and I think
  that such research may be becoming seen as
  difficult. I think that researchers may think
  there are obstacles to doing this type of
  research and could see this area as too difficult
  in terms of gaining approval and so may avoid
  this type of research.
• URECs considering concept and capacity in
  narrow health/medical ways may militate against
  research

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Findings 5 Insights into the requirements of the
MCA

• Medical orientation recognised and training
  sought to navigate the Acts requirements
• Capacity issues and protection vs right to
  participate
• there is the issue that not all people with
  dementia lack capacity to decide whether or not
  to take participateand indeed nobody is quite
  sure when a person loses capacity or whether they
  have it. So, were quite pleased there are
  specialist committees for consideration of these
  issues.
• very much inclined to believe theres a spectrum
  of decision-making abilities and that people have
  the right to participate in research rather than
  always trying to exclude them.

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• Provided a catalyst for deeper reflection on
  capacity
• forced me to go back and do a lot more work and
  think about vulnerable peoples capacity to make
  decisions
• Uncertainty as to application of the Act if not
  in NHS settings
• All of these groups have been recruited as
  organisations independent in the community and it
  shouldnt have to go through NRES

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• Complexity of informed consent
• someone may lack the capacity to be involved in
  a research programme but may be perfectly able to
  answer research questions. Capacity to take part
  in a research project is very abstract whereas
  capacity to answer questions may be clearer to
  individuals.

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Concern for restrictions despite increased rigour
in scrutiny

• it is my job to stop research on exploited
  people
• There is some concern that one can only do
  research into the reason for the lack of capacity
  and it is not possible to include anything else
  within research. Whilst I accept it would be
  irresponsible to involve people without capacity
  in certain forms of research I do wonder now if
  we may get to a point where we feel that weve
  excluded a section of the population from
  participation in research.

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Different levels of harm

• I think its less of a problem in social care
  than in health research. The potential for harm
  is less and it doesnt involve experimenting with
  people, or use invasive medical procedures (but)
  the Act firms up the clear message concerning
  risk, harm and benefit to those taking part.

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Findings 6 Guidance

• Health focused
• Minimal
• Code of Practice (para 11.4) improving care
• General call for case oriented guidance/exploratio
  n, power issues
• Some concern that there is too much guidance

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Guidance to ensure research continues

• I would hate the outcome of MCA implementation to
  be a framework in which people/researchers felt
  that they could not do this type of research
  because of the interpretation of the MCA.
  Speaking personally, guidance would be most
  helpful in terms of how best to construct a case
  re service user research (and) how to undertake
  such work successfully and ethically. I think
  this would also assist researchers to be more
  ethical in their practice.

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Implications Safeguarding or stifling

• Limited by sample size
• Lack of proposals developed
• Limited focus on researchers and REC policies and
  processes

• Duplicate review will continue
• Legal, ethical, scientific reasons
• Time extension/ bureaucracy in review may hamper
  research
• Health orientation not always social care
  specific
• Stifling of research lack of understanding of
  capacity, consent, meanings of research

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The future the Social Care Research Ethics
Committee and ways forward

• On-going, creative and circular informed consent
• Clarity and development of understandings

• DH working on a MCA factsheet for social
  scientists awaiting final review from DH RD
• MCA research covered issues where informed
  consent cannot be obtained implications for
  social care research
• Social Care REC care/treatment seem as covering
  same areas
• Appropriate body under Act