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

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.

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 Hence informed consent should primarily be a Process of Communication

History Nuremberg Code – 1947, post war legal code 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.

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

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

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

Information – how much & what sort? 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 Subjective or personal standard – as much as the subject would like

Capacity / competence Capacity is a continuum or spectrum rather than an absolute Presumed to be present unless proven otherwise 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

Obstacles in deciding capacity Difficult concepts such as randomisation, risk and probability 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 Use of financial incentives may undermine compromise capacity Research in children, psychiatric patients, elderly

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

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

Conclusions Educate young researchers….more! 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) 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 FIRST – DO NO HARM!

Model consent form Have you read the info provided? Y/N Have you had an opportunity to ask questions and discuss the study? Y/N Have all questions been answered satisfactorily? Y/N 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 agree to take part in this study? Y/N