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Informed Consent

Informed Consent. Hemantha Senanayake Chairman, Research Ethics Committee, Faculty of Medicine, University of Colombo. The Nuremberg Code. “the voluntary consent of the human subject is absolutely essential”. Later guidelines i.e Helsinki, CIOMS reassert the primacy

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Informed Consent

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  1. Informed Consent Hemantha Senanayake Chairman, Research Ethics Committee, Faculty of Medicine, University of Colombo

  2. The Nuremberg Code “the voluntary consent of the human subject is absolutely essential”

  3. Later guidelines i.e Helsinki, CIOMS reassert the primacy of informed consent

  4. Informed Consent • An effort to uphold respect for the individual

  5. Informed Consent • Many people (wrongly) believe informed consent makes clinical research ethical • Not sufficient – one of many components • In some instances not necessary

  6. Components of Informed Consent • Information • Understanding • Voluntariness • Decision making capacity

  7. Components of Informed ConsentInformation • The best way is to design consent forms and other information materials to a “reasonable person standard” • Supplement with conversations

  8. Components of Informed ConsentTypes of information • Nature and purposes of experiment • Procedures involved • Foreseeable risks and benefits • Alternatives to participating in the research • Protection of confidentiality • Reassurance about leaving the study without forfeiture of care

  9. DON’T FORGET! The Tamil information sheet/consent form

  10. Components of Informed ConsentUnderstanding • A level of appreciation that is adequate for a meaningful deliberation about the decision • The decision must reflect what the participant intends to authorize • Informational material must be written at an appropriate level • Test the subject’s comprehension

  11. Components of Informed ConsentVoluntariness Authorization that is • Given freely • Representing one’s own will • Not another’s • Not controlled by anyone other than the participant

  12. Components of Informed ConsentVoluntariness • Consent obtained by fraud, deception or coercion is invalid Special situations: • Very ill cancer patients • Teacher & student • Poor patients infected with HIV • Doctor & patient • Refugees

  13. Components of Informed ConsentDecision Making Capacity • Needs a certain level of maturity • Vulnerable populations (e.g. prisons, some healthcare facilities, certain relationships) • Proxy consent in people who have lost or never developed decision making capacity

  14. Informed Consent in “Unethical” Research • Malignant melanoma cells were transplanted from her daughter to her “volunteering and informed” mother • In the hope of gaining a better understanding of cancer immunity • Also hoping the tumour antibodies might help in the treatment of the patient • Patient was in critical condition and died the day after From: Beecher HK, New Engl J Med, 1996

  15. Informed Consent in “Unethical” Research • Primary implant in the mother was widely excised on the 24th day after placement • She died on day 451st day, of widespread melanoma From: Beecher HK, New Engl J Med, 1996

  16. Is informed consent always necessary?

  17. Informed Consent May Not be required • In investigations that do not directly involve human subjects – e.g. Audits • Use of data that is publicly available • No personally identifiable data • Written consent may pose a risk to the individual – studies on recreational drug use, sexual deviations

  18. Informed Consent in Special Situations

  19. Informed Consent in Research on Children

  20. Children • Legally and (often) developmentally incapable of granting valid consent • Guidelines have sought to protect children • Primarily by restricting the level of research risk • Parents as decision makers • Assent of the child

  21. Assent • Sought in children over 8 years old • Depends on the complexity of the research and....... • Individual variations of the child’s development • ERC must consider the balance • Dissent must be honoured

  22. Research in pregnant women

  23. Pregnant women • In the socio-cultural context of Sri Lanka should the husband be asked? • Concerns regarding potential for creating abnormalities

  24. People with Cognitive impairments

  25. Cognitive impairments • Consent from ‘legally authorized’ person • Close relative or guardian • Depression – essentially a mood disorderwould understand the risksbut not care about the risks?

  26. Captive Populations

  27. Captive Populations • Internally displaced persons • Soldiers • Prisoners • Students

  28. Captive Populations • Choices may be less than voluntary • Situation may compromise their ability to give informed voluntary consent • Justice in selection of participants may be affected

  29. Medical Students • Data from West show they do not feel coerced • Autonomous, smart • Many be the ideal research participant • Understands information • May get an educational benefit • Special protections have been described as ‘overprotective paternalism’

  30. Medical Students Would this be true of Sri Lankan Medical students?

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