Informed consent in research ethics

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. • 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 • Hence informed consent should primarily be a Process of Communication

4. 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.

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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!

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/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