Consent for research and persons with dementia

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Consent for research and persons with dementia

• Dr Jan Dewing
• Independent Consultant Nurse
• Honorary Research Fellow Institute of Nursing
  research University of Ulster Visiting Fellow
  Northumbria University.
• Professorial Fellow in Aged Care and Practice
  Development School of Nursing Midwifery and
  Indigenous Health Studies
• University of Wollongong NSW Australia

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My 3 key messages

• For moral reasons, persons living with dementia
  need to be included and enabled to participate in
  consent (and subsequent research) even when they
  lack legal capacity.
• Including persons living with dementia in the
  process of consent is consistent with the core
  principles of capacity legislation.
• We need to reframe informed consent for those
  living with advancing dementia and all of us find
  more creative/dementia sensitive ways of enabling
  inclusion to happen.

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Capacity Legislation

• 5 key principles
• Assumption that capacity exists
• Support for making decisions
• Respecting values and beliefs underpinning
  decisions
• Best interests principle
• Least restriction on human rights and freedom

• New safeguards regarding research
• Consultation with others
• honouring signs of unwillingness to participate
• Honouring advance directives and known statements
• Approved documentation
• Direct benefit and no harm or distress
• Loss of capacity during existing research

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Assessing capacity

• In assessing capacity researchers will need to be
  assured that the person being invited to
  participate in their project can
• Understand and retain the information they are
  given in relation to the project.
• Use that information in order to make a decision
  about their participation in the project.
• Communicate their decision using speech, sign
  language, or other means.

• In assessing a persons ability to make choices
  researchers will need to be assured that the
  person being invited to participate in their
  project can
• Make sense of information they are given in
  relation to the project
• Use their experience and meaning making to make
  choices about participation
• Communicate their decision using speech, sign
  language, or other means.

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Research responsibilities

• Consider ways of achieving maximum opportunity
  for inclusion and active participation
• Establish type of relationship to be used
• How capacity and making choices will be assessed
• How information will be presented in dementia
  sensitive ways
• How others will be involved, their boundaries and
  how information will be presented
• How critical incidents and complex situations
  will be explored
• Balance protection with freedom

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Summary

• Persons with dementia
• Keep a capacity for decision making after the
  legal threshold has been crossed. This is
  better thought of as making choices.
• Demonstrate wide ranging variations in capacity,
  which can be extremely situational and temporal.
• Keep and even build on sensory and experientially
  based capacity.
• Communicate through behaviours, verbal and other
  non verbal means their preferences and meaning
  making about choices.

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Process consent a model for inclusion

• Dewing J (2002) From ritual to relationship a
  person centred approach to consent in qualitative
  research with older people who have a dementia.
  Dementia The International Journal of Social
  Research and Practice. 1 (2) 156-171.
• Dewing J (2007) Participatory research A method
  for process consent with persons who have
  dementia. Dementia The International Journal of
  Social Research Practice 6 (1) 11-25.

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5 key areas to work with

• One preparation
• the initial social engagement starts when the
  person is in a state of well being
• permission for access gained from staff,
  relatives or another named person relative to
  roles and responsibilities
• Biographical background is central
• As a minimum, cues about how the person usually
  presents themselves when in a state of
  well-being.

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• Two establishing basis for capacity to consent
• the persons usual level of ill being/well being.
• Cognitive abilities
• identification of triggers that influence a
  decrease in level of well being
• noting ways in which decreasing level of well
  being can be recognised
• note any significant conversation or behaviour
  that might be indicative of a deeper
  psychotherapeutic need.

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• Three exploring initial consent
• introducing self and study in various ways
• providing information in a meaningful mode at
  comfortable level for the person
• responding to the persons reactions, feelings and
  thoughts

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• Four initial consent revisited and
  re-established on every event/within the same
  event
• increase the level of transparency by someone
  else known to the person to function as a
  validator
• At the end of each event level of well being
  noted by description of behaviour, verbal and
  non-verbal signs of well being/ill being
• The method allows for an independent observer to
  track the well being of the person with dementia

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• Five responding to the transition
• support for the person to make the transition
  back from the research context into another
  context such as their day to day one
• feedback to others confidentiality
• documentation and field notes
• supervision

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Summary

Persons with dementia can participate in various
types of research in health and social
care. Beyond capacity, persons with dementia can
still make meanings, make choices and make their
preferences known. Research ethics must look at
how persons with dementia can be included,
especially with consent. This is a shared
responsibility.