Presentation on theme: "Informed consent in research ethics"— Presentation transcript:
1 Informed consent in research ethics Mario VassalloResearch Ethics CommitteeFaculty 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.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 researcherHence informed consent should primarily be aProcess of Communication
4 History Nuremberg Code – 1947, post war legal code Declaration of Helsinki – 1964, drawn up by physicians for physicians as professional guidelinesInternational 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 PrinciplesTraditional physician beneficence / paternalism – physician’s primary allegiance is to the patient’s best interestsRespecting subject autonomy / self-determination / freedom to choose should be paramount
6 Ethical principles: exceptions Emergency situationsWaiver exception i.e. patient-requested non-informed consent‘Therapeutic privilege’ exceptionOther issues: use of body parts or fluids, using data from old studies
7 Essential elements Provision of adequate information to subject Capacity or competence of individual to understand and make a choiceChoice 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 languageToo 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 interestSubjective or personal standard – as much as the subject would like
9 Capacity / competenceCapacity is a continuum or spectrum rather than an absolutePresumed to be present unless proven otherwiseSpecific to each situation and decision to be takenUnderstanding 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 probabilitySick people may be emotionally unstable and rational judgement impairedSubjects from lower socio-economic groups and ethnic minorities may be deprived and limited in their capabilitiesUse of financial incentives may undermine compromise capacityResearch in children, psychiatric patients, elderly
11 ChoiceChoice has to be uncoerced, explicit (written), and revocable at any timeProblematic when the researcher is also involved in the patient’s clinical care, especially in therapeutic researchDouble-blind approach – does this invalidate choice?Understating risks and/or overstating benefits may influence choice
12 Practical considerations Who should consent the subject?Oral and written information, Maltese & EnglishUse of audio or video tapesRepeat information/allow time for questionsModel consent form (see appendix)Witnessed consentSetting and timing, ‘cooling off period’Test understanding
13 Conclusions Educate young researchers….more! Differences between research ethics and the ethics of clinical medical care should be emphasizedThe 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 itLack of time and money, and urgency of need are significant obstacles to informed consentFIRST – DO NO HARM!
14 Model consent form Have you read the info provided? Y/N Have you had an opportunity to ask questions and discuss the study? Y/NHave all questions been answered satisfactorily? Y/NWho 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/NDo you agree to take part in this study? Y/N