domain 7 - socio-cultural and ethical aspects - treviso (2).pptx
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Domain 7: Socio-cultural, ethical and legal aspects:
Socio-Cultural and
Ethical Aspects Alison Bowes
University of Stirling, Scotland, UK
Treviso, 9 February 2012
Social , Ethical and Legal Issues
Key ethical questions: • Does the applica-on challenge cultural, religious or moral beliefs?
• Does it raise any new ethical ques-ons? (such as new responsibili-es for pa-ents?)
• Does it increase/decrease pa-ent autonomy? • Does it increase/decrease access to care? • Does it bring benefit/harm to pa-ents?
Key socio-cultural issues • Changes to pa-ents’ roles in daily life, including work, family, social life. • Understandings of technology (pa-ents, rela-ves and others) – informed consent? privacy? • Changes in the societal and poli-cal context -‐ effects o the general model of healthcare and access to it? • Changes in responsibili-es of pa-ents, rela-ves and/or professionals? • Gender issues – any implica-ons or effects? Equality of access?
Reporting
NB. Core ethical principles Autonomy – dignity, free will and informed consent
Justice - equity
Beneficence/non-maleficence – benefit and no harm • All reports should comment on adherence of the work to these principles, and on any issues that arose.
Ethical review
Points to include • Was ethical review undertaken? If not, why
not? • What type of committee? (research? clinical?) • What were the results of the review? • Did the review request any changes? If so,
what were they? • Were any particular ethical issues encountered
during the work? How were these resolved?
Checklist of ethical issues
Follows Marziali et al (2005) • Pa-ent autonomy – informed consent, withdrawal, capacity
issues, privacy, impacts on autonomy, involvement of others • Access and equity – equality impacts, cogni-ve capacity
issues, upholding dignity and privacy, any exclusions related to access issues
• Norma-ve codes = professional codes used and their applicability, any issues and how resolved
• Assessment of risk and benefit – how assessed, any problems. Feedback, what would happen if we didn’t do this?
• Complexity of these issues: cross country variation but also regional, social class, education, age, gender, ethnicity, locality, • Data • Minimum dataset (but no specific
requirements) • Additional research • Less systematically recorded material
• ESSENTIAL – be clear about what data are being used
Reporting socio-cultural issues
• Changes in pa-ent’s role in major life areas – focus on work, family, community life and the difference (if any) the applica-on has made)
• Pa-ent’s rela-ves’ and others’ understanding of the technology – significant others’ perspec-ves, any effects for them, and how they respond to the applica-on
• Societal, poli-cal context and changes – impacts for the system and society as wholes
• Changes in responsibility – how pa-ents and their supporters handle any new tasks, how professionals helped them, impacts for professionals of changed responsibili-es, any par-cular challenges and how addressed
• Gender – any gender impacts? Was this assessed? Any other differen-a-ng issues?
(all have specific ques-ons in the guidance)
Checklist of socio-cultural issues
Tables for reporting – ethical issues
• Start with account of ethical review • Give outcomes • Any changes required/made • Use table to report wider ethical issues as follows:
Creating and filling the ethical issues table
Ethical Issue How issue was addressed
Date Evidence
Pa-ent autonomy Eg Consent to treatment
Month 1 A pa-ent informa-on pack was created, nurses were trained to deliver oral guidance with the printed informa-on, and pa-ents’ consent was recorded in wri-ng. A two week cool-‐off period was introduced to allow pa-ents to withdraw aVer considering the wriWen guidance provided by the nurses.
Access and equity
Norma-ve codes
Assessment of risks and benefits
Creating and filling the socio-cultural Issues table
Socio-‐cultural issue Key findings Evidence
Changes in pa-ents’ roles Eg Receiving their treatment at home to a regular -metable enabled pa-ents to stay in the labour force, as they did not need to take -me off to visit clinics
Eg Ques-onnaires to 200 pa-ents, interviews with 20 professionals, report from a senior doctor. 70% of those pa-ents in work reported this benefit. (Research report available at www.renewinghealth.etc)
Pa-ents’ rela-ves and others
Societal poli-cal and context changes
Changes in responsibili-es
Gender issues -‐ equity