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Informed consent in research ethics Mario Vassallo Research Ethics Committee Faculty of Medicine and Surgery.

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Presentation on theme: "Informed consent in research ethics Mario Vassallo Research Ethics Committee Faculty of Medicine and Surgery."— Presentation transcript:

1 Informed consent in research ethics Mario Vassallo Research Ethics Committee Faculty of Medicine and Surgery

2 What is informed consent? Informed consent is an ongoing process of agreement by a person to receive treatment, undergo procedures or participate in research, after risks, benefits and alternatives have been adequately explained. Informed consent is an ongoing process of agreement by a person to receive treatment, undergo procedures or participate in research, after risks, benefits and alternatives have been adequately explained. Not a ritual or a legal safeguard. Not a ritual or a legal safeguard.

3 Process vs Documentation Ongoing process of ensuring that the research subject understands what is being done and establishing trust between the individual and the researcher Ongoing process of ensuring that the research subject understands what is being done and establishing trust between the individual and the researcher Hence informed consent should primarily be a Hence informed consent should primarily be a Process of Communication Process of Communication

4 History Nuremberg Code – 1947, post war legal code Nuremberg Code – 1947, post war legal code Declaration of Helsinki – 1964, drawn up by physicians for physicians as professional guidelines Declaration of Helsinki – 1964, drawn up by physicians for physicians as professional guidelines International Ethical Guidelines for Biomedical Research Involving Human Subjects – prepared by the Council for International Organisations of Medical Sciences and the World Health Org. International Ethical Guidelines for Biomedical Research Involving Human Subjects – prepared by the Council for International Organisations of Medical Sciences and the World Health Org.

5 Ethical Principles Traditional physician beneficence / paternalism – physicians primary allegiance is to the patients best interests Traditional physician beneficence / paternalism – physicians primary allegiance is to the patients best interests Respecting subject autonomy / self- determination / freedom to choose should be paramount Respecting subject autonomy / self- determination / freedom to choose should be paramount

6 Ethical principles: exceptions Emergency situations Emergency situations Waiver exception i.e. patient-requested non-informed consent Waiver exception i.e. patient-requested non-informed consent Therapeutic privilege exception Therapeutic privilege exception Other issues: use of body parts or fluids, using data from old studies Other issues: use of body parts or fluids, using data from old studies

7 Essential elements Provision of adequate information to subject Provision of adequate information to subject Capacity or competence of individual to understand and make a choice Capacity or competence of individual to understand and make a choice Choice has to be completely voluntary, especially in non-therapeutic research Choice has to be completely voluntary, especially in non-therapeutic research

8 Information – how much & what sort? Full and frank disclosure (professional practice standard) as the highest standard but not in complex and technical language Full and frank disclosure (professional practice standard) as the highest standard but not in complex and technical language Too much can be as bad as too little – appropriate standard (reasonable person standard) should be one of adequate information to make a reasoned choice, including purpose of study, procedures, risks, discomforts, benefits, alternatives, financial incentives for researchers, conflicts of interest Too much can be as bad as too little – appropriate standard (reasonable person standard) should be one of adequate information to make a reasoned choice, including purpose of study, procedures, risks, discomforts, benefits, alternatives, financial incentives for researchers, conflicts of interest Subjective or personal standard – as much as the subject would like Subjective or personal standard – as much as the subject would like

9 Capacity / competence Capacity is a continuum or spectrum rather than an absolute Capacity is a continuum or spectrum rather than an absolute Presumed to be present unless proven otherwise Presumed to be present unless proven otherwise Specific to each situation and decision to be taken Specific to each situation and decision to be taken Understanding of the situation and choice at hand should be assessed for valid consent to research Understanding of the situation and choice at hand should be assessed for valid consent to research

10 Obstacles in deciding capacity Difficult concepts such as randomisation, risk and probability Difficult concepts such as randomisation, risk and probability Sick people may be emotionally unstable and rational judgement impaired Sick people may be emotionally unstable and rational judgement impaired Subjects from lower socio-economic groups and ethnic minorities may be deprived and limited in their capabilities Subjects from lower socio-economic groups and ethnic minorities may be deprived and limited in their capabilities Use of financial incentives may undermine compromise capacity Use of financial incentives may undermine compromise capacity Research in children, psychiatric patients, elderly Research in children, psychiatric patients, elderly

11 Choice Choice has to be uncoerced, explicit (written), and revocable at any time Choice has to be uncoerced, explicit (written), and revocable at any time Problematic when the researcher is also involved in the patients clinical care, especially in therapeutic research Problematic when the researcher is also involved in the patients clinical care, especially in therapeutic research Double-blind approach – does this invalidate choice? Double-blind approach – does this invalidate choice? Understating risks and/or overstating benefits may influence choice Understating risks and/or overstating benefits may influence choice

12 Practical considerations Who should consent the subject? Who should consent the subject? Oral and written information, Maltese & English Oral and written information, Maltese & English Use of audio or video tapes Use of audio or video tapes Repeat information/allow time for questions Repeat information/allow time for questions Model consent form (see appendix) Model consent form (see appendix) Witnessed consent Witnessed consent Setting and timing, cooling off period Setting and timing, cooling off period Test understanding Test understanding

13 Conclusions Educate young researchers….more! Educate young researchers….more! Differences between research ethics and the ethics of clinical medical care should be emphasized Differences between research ethics and the ethics of clinical medical care should be emphasized The only true protection afforded research subjects comes from a well-trained, well-meaning investigator (Beecher and Koski) The only true protection afforded research subjects comes from a well-trained, well-meaning investigator (Beecher and Koski) Subjects should become willing partners in a joint enterprise rather than mere tools in it Subjects should become willing partners in a joint enterprise rather than mere tools in it Lack of time and money, and urgency of need are significant obstacles to informed consent Lack of time and money, and urgency of need are significant obstacles to informed consent FIRST – DO NO HARM! FIRST – DO NO HARM!

14 Model consent form Have you read the info provided?Y/N Have you read the info provided?Y/N Have you had an opportunity to ask questions and discuss the study?Y/N Have you had an opportunity to ask questions and discuss the study?Y/N Have all questions been answered satisfactorily?Y/N Have all questions been answered satisfactorily?Y/N Who have you spoken to about the study? Who have you spoken to about the study? Do you understand that you are free to withdraw from the study at any time, without reason and without affecting your care?Y/N Do you understand that you are free to withdraw from the study at any time, without reason and without affecting your care?Y/N Do you agree to take part in this study?Y/N Do you agree to take part in this study?Y/N


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