‘Moral distress in end-of-life care
in the intensive care unit’
Ethical Considerations in studies
Una St Ledger
R&D Research Fellow,
Queen’s University, Belfast
Study funded by
Research & Development Office, Public Health Agency
Adopted & supported by
NICRN & TRG Critical Care
Registered with INVOLVE
Trinity Annual Multi-disciplinary Conference, Doctoral Colloquium
06.11.2012
Presentation overview
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Ethical considerations in research
Study – background, rationale, methods
Key ethical issues relating to this study
References
Acknowledgements
Ethical Considerations in Research
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Aristotle
2nd world war Nuremberg Code
Declaration of Helsinki (WMA, 1964; 2008)
HSC Research Governance Framework (DoH, 2005)
Protect and safeguard: dignity, rights, safety and
well-being
Principles
• Respect for Autonomy – self determination (veracity,
informed consent, refuse, retract participation)
• Non-maleficence – ‘do no harm’ (assess and manage risks)
• Beneficence – ‘do good’ (benefits, risks, burdens)
• Justice – fair distribution (benefits, risks, costs)
• Right to Privacy, Confidentiality , Anonymity
• Fidelity – conflicts of interest
(Holloway & Wheeler, 2008)
Study Aim
• Aim – ‘Explore experiences of moral distress in
healthcare professionals and relatives in endof-life decisions in ICU’
Background
• What is Moral distress?
‘A state of anguish that individuals
experience when they know what the
morally right thing to do is but they are
prevented from doing it due to internal or
external constraints’
(McCarthy and Deady, 2008)
Rationale
• 19% patients die in ICU
• Decisions to withdraw or withhold treatment (Sprung
et al, 2003; ICNARC, 2009)
• Potential for Moral Distress
• End-of-Life Care Strategy (DoH, 2008)
• Neglected feature in palliative care and ICU
education programmes
• Studies mainly North American- major nursing focus
• Impact on patient’s families unknown
Methods
• Design - Narrative Inquiry Case Study Design
• Cases - (1) Withdrawal (2) Non-escalation (3) Brain
Stem Death
• Purposive Sample – 1 nurse, 1 doctor, and 2
relatives per case
• Data Collection – in-depth narrative interviews
• Narrative Analysis – thematic, content
• Dissemination – relatives interviews video/audio
recorded and copyrighted to ‘healthtalkonline’
website
Research Ethics Approval
• Office for Research Ethics Committee
Northern Ireland (ORECNI)
• Challenged to think about ethics of design:
Rationale
Methodology
Processes – who, how, where, when
Knowledge, skills, & training required
Participant and research team welfare
Specific issues
• Recruitment - who
- how
- when
• Informed consent
• Narrative research
• Confidentiality & anonymity
• Narrative interviewing
• Participant welfare
Who - is it right to study the
recently bereaved?
• Marginalised from research (Seymour, 2005; Addington-Hall
& McPherson, 2001)
• Our discomfort or on basis of well-founded evidence?
• Risk of distress no greater than that currently experienced
(Morse & Corbin, 2004)
• Talking about experiences - helpful, therapeutic ? (Grinyer,
2004; Hynson et al. 2006; Reid, 2009; Koffman et al. 2012)
• Altruistic (Scott et al. 2002; Hynson et al. 2006; Koffman et al.
2012)
• Improve systems and practice
• Social justice – voices of bereaved empowered and heard
The how & when of recruitment
• Potential for Coercion
Identification of and approach to participants
• Causing or adding to Emotional Distress
Timing of approach to participants
Sensitivity of approach
Volume of study information
Timing of follow-up phone call to relatives
Timing of data collection
Consent: an on-going process
• Study information - clearly communicated, comprehensive,
understandable language
• Participants need to know:
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purpose
what is expected
benefits and burdens
how findings used
Who will have access
Confidentiality, anonymity, data management arrangements
Issues of malpractice and patient safety
Background and contact details of researcher team
how to make a compliant
• ‘Cool off period’
• Right to decline, withdraw at any time
• Written consent
Informed consent: relatives
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Training - consenting and recording
Informed consent 2 stage process (before and after interview)
Demonstration of www.healthtalkonline.org
Inform - potential loss of anonymity
- avoid names of others/places
Consent form
Option - use own name/alias
- interview video/audio recorded
- HTO clips video/audio/or fully anonymised written only
Copy of transcript to review and edit
Copyright Form
Process consent - may withdraw consent at any time - even after website
gone live. Interview removed, recordings and transcripts destroyed
Raises issues of Internet Ethics
Narrative Research & Ethics
• Narrative research - interactive and relational
(Holloway and Freshwater, 2007)
• Specific ethical issues (Elliott, 2005)
 Researcher/participant relationship
 Impact of research on all involved
 Personal narrative - meaning of life experiences and self identity
 Identity and coherence – threatened by deconstruction and
interpretation of narrative
 Risks to confidentiality and anonymity
 Analysis and interpretation of stories presented using participants
voices.
Anonymity and Confidentiality
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Pseudo names - transcripts and quotes
Restricted data access -research team
Avoid using names (people, places, hospitals)
Transcripts and recordings – names edited out
HTO - Participants can be identified by own or
pseudo name (family names not used)
Data Storage
• Data password protected
• University computers, secure server
• Desktop security – usernames,
updated passwords, back-up
procedures
• Personal info stored separate from
transcripts, recordings
• Recordings and transcripts anonymised PIN
• Locked cabinet, locked office
• Restricted access
• Study info archived – university
requirements
Narrative interview
• Safe environment – describe experience to
interested, empathetic person
• In-depth qualitative interview – participant
determines pace and direction of interview and
discusses what they feel is important
• Informal, intimate and conversational manner
• May disclose confidential and intimate information
• Talking about painful or unresolved event – raw
emotions may surface
Welfare of participants
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key ethical consideration
Pre, during, and after interview
Sensitivity and timing of approach
Consenting
Interview potentially emotionally charged experience
Potential to re-traumatise participants
Talking about experiences maybe helpful and
therapeutic
Support Strategy: minimise harm
• Researcher – experienced ICU nurse and facilitator
• Interviewing vulnerable populations and managing challenging interviews
training
• PIS – alert to accessing painful emotions, feelings of loss and grief
• Process consent
• Participant distress strategy - interview on hold, terminate, reschedule
• Information pack – support services
• Post-interview debrief - normalise
• CRUSE Bereavement Care counselling services (relatives)
• Inform family doctor
• 2 weeks post interview - follow-up phone call - thank relatives and
ascertain emotional well-being
• Staff Care and Here for U initiatives (HCPs)
Research Team Safety/Support
Dickson-Swift et al (2007)
Researcher
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Safety/Support Protocol
Training
Lone worker protocol
Debrief & counselling
• (1) supervisors
• (2) university student
counselling
• Support networks
• Spacing /scheduled breaks
Supervisors
• Safety/Support Protocol
• Supervisors - access to
Occupational Health
Services
Transcriber
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Regular contact
Support of researcher
Space recordings
Counselling
To conclude
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Position of trust and privilege
Responsibility
Sensitivity, empathy and compassion
Minimise harm
Maximise benefits
‘At the heart of all robust and ethical
research is respect for individuals and
protection of those who may be
vulnerable’.
(RCN, 2009 p.11)
References
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Addington-Hall, J., McPherson, C. (2001) After-Death Interviews with Surrogates/Bereaved Family Members: Some issues of validity.
Journal of Pain and Symptom Management, 22(3), 784-790.
Corbin J. & Morse J. (2003) The Unstructured Interactive Interview: Issues of Reciprocity and Risks when Dealing with Sensitive Topics.
Qualitative Inquiry 9(3), 335-354.
Department of Health (2005) Research Governance Framework for Health & Social Care. 2nd Edition. Department of Health, London.
Department of Health (2008) End of Life Care Strategy: Promoting high quality care for all adults at the end of life. Department of
Health, London.
Dickson-Swift, V., James, EL., Kippen, s. et al (2007) Doing sensitive research: what challenges do qualitative interviewers face?
Qualitative Research, 7(3), 327-353.
Elliott, J. (2005) Using Narrative in Social Research: Qualitative and Quantitative Approaches. London: Sage.
Holloway, I., Freshwater, D. (2007) Narrative Research in Nursing. Oxford: Blackwell Publishing Ltd.
Hynson, JL., Aroni, R., Bauld, C., Sawyer, SM. (2006) Research with bereaved parents: a question of how not why. Palliative Medicine,
20(8), 805-11.
Intensive Care National Audit and Research Centre (ICNARC). Case Mix Programme Summary Statistics. www.icnarc.org. Accessed on
08/06/09.
Koffman, J., Higginson, IJ., Hall, S., Riley, J et al (2012) Bereaved relatives’ views about participating in cancer research. Palliative
Medicine, 26(4), 379-83.
McCarthy, J., Deady, T. (2008) Moral distress reconsidered. Nursing Ethics, 15(2), 254-262.
Reid, J. ((2009) Conducting qualitative research with palliative cancer patients and their families: Ethical considerations. International
Journal of Palliative Nursing, 15(1): 30-3.
Royal College of Nursing (2009) Research Ethics: RCN guidance for nurses. RCN, London.
Scott, DA., Valery, PC., Boyle, FM., Bain, CJ. (2002) Does research into sensitive areas do harm? Experiences of research participation
after a child’s diagnosis with Ewing’s sarcoma. Medical Journal of Australia, 177(9), 507-10.
Seymour, J., Rietjens, J., Brown, J., van der Heide, A. et al (2011) The perspectives of clinical staff and bereaved informal care-givers on
the use of continuous sedation until death for cancer patient. BMC Palliative Care, 10:5 http://www.biomedcentral.com/1472684x/10/5 [accessed 20.10.12]
Sprung, C.L., Cohen, S.L., Sjokvist, P., Baras, M., Bulow, H.H., Hovilehto, S., Ledoux, D., Lippert, A., Maia, P., Phelan, D., Schobersberger,
W., Wennberg, E., Woodcock, T. Ethicus Study Group. (2003) End-of-life practices in European intensive care units: the Ethicus study.
Journal of the American Medical Association 290, 790-797.
Webster, C.G., Baylis, F. (2000) Moral residue. In: Rubin, SB, & Zoloth, L. (Eds). Margin of error. The ethics of mistakes in the practice of
medicine. University Publishing Group, Hagerstown, MD.
Acknowledgements
Research Team
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Dr Bronagh Blackwood (CI) – Senior
Lecturer, School of Medicine, Dentistry &
Biological Sciences, QUB
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Dr Ann Begley – Lecturer in Ethics, Virtual
University of Uganda
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Prof Lindsay Prior – Professor of Sociology,
School of Sociology, Social Policy & Social
Work, QUB
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Dr Joanne Reid - Lecturer, School of Nursing,
QUB
Prof Danny McAuley (PI) - Consultant &
Professor Intensive Care Medicine, RICU,
BHSCT, & School of Medicine, Dentistry &
Biological Sciences, QUB
Advisory Group
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Barry Williams – Patient & Relatives
Committee Chair (Intensive Care Society)
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Stephen Carter – Independent Patient and
Family Representative, Organ Donation
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Monica Hackett - Team Manager, Organ
Donation Services Team (NHS BT)
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Heather Russell – Bereavement Co-ordinator
(BHSCT)
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Lesley Rutherford – Nurse Consultant in
Palliative Care (Marie Curie, BHSCT, QUB)