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