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Response to Prof Eva Bjork-Akesson Informed Consent

Response to Prof Eva Bjork-Akesson Informed Consent. Pro Marj Concha. UN Convention of Human Rights. Respect for the inherent dignity, individual autonomy including the freedom to make one’s own choices and independence of persons. Equality

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Response to Prof Eva Bjork-Akesson Informed Consent

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  1. Response to Prof Eva Bjork-AkessonInformed Consent Pro Marj Concha

  2. UN Convention of Human Rights • Respect for the inherent dignity, individual autonomy including • the freedom to make one’s own choices and • independence of persons. • Equality • Full and effective participation and inclusion in society • Respect for difference • Accessibility Ref: E Bjorck-Akesson

  3. In SA Informed consent – Governed by: • UN Convention • International guidelines for biomedical research - Council for International Organisations of medical Sciences in Collaboration with WHO • SA Constitution – Autonomy and self determination – Bill of Rights • The right to inherent dignity and the right to protection of dignity • The right to privacy • Declaration of Helsinki • Professional Code of Ethics

  4. Ethical Principles governing informed consent • Respect for persons • Autonomy • The right to self determination • Beneficence • Justice Council for International Organisations of Medical Sciences in collaboration with WHO – International ethical guidelines for biomedical research involving human subjects. Geneva 2002

  5. SA Levels of consent in the community Ethical approval from a recognised body eg research committee • Government structure • Village leaders / Local Gov • Head of the family • Individual • Mother of Child • Child himself (assent) All need various forms of language to insure understanding Including Translation

  6. Information that the individual needs to give informed consent Same as Sweden Who Where What How Consequences Voluntary participation and right to withdraw at any time What will be done with the information Participant confidentiality Risk

  7. SA Context – Factors that restrict a person’s ability to exercise their autonomy and give consent • Language – • Translations and • Translators- the right person and training • Cultural eg • Chieftain gives consent for whole village to participate in research • Head of family my say yes but participant says no or vice versa • Legacy of apartheid – • white person – agree • Answer in a way that they think will please • Quantity of information needed for informed consent • Privacy

  8. Problems in SA

  9. Questions: • How to overcome language barriers and still maintain integrity of information needed for consent? • Quantity of information • Getting an honest opinion

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