CONTENTS

FOREWORD, 5

INTRODUCTORY REMARKS, 7

REPORT OF THE INTERNATIONAL BIOETHICS COMMITTE ON CONSENT

I.  INTRODUCTION, 11

II.  GENERAL FRAMEWORK, 15
II.1. Content of the information, 15
II.2. Conditions of obtaining consent, 16
II.3. Manner of expressing consent, 17
II.4. Withdrawal of consent, 17

III. CIRCUMSTANCES OF APPLICATION, 21
III.1. Consent in various categories of practices, 21
III.1.1. Clinical practice, 21
Primary medical care, 21
Invasive medical interventions,
III.1.2. Biomedical and clinical research,22
III.1.3. Epidemiological research, 23
Data collected for one study used other studies
III.1.4. Public health, 24
III.1.5. Emergency situations, 26
III.1.6. Organ, tissue and cell donation, 27
III.2. Consent in various categories of persons requering special protection, 28
III.2.1. Lack of capacity to consent, 28
III.2.2. Groups of persons without the capacity to consent, 29
Neonates
Children
Clinically confused patients
Patients with learning difficulties
Mentally ill patients
Unconscious patients
III.3. Consent in various categories of contexts, 33
III.3.1. Economic context, 33
Level of training of medical professionals
Lack of time for the  number of patients
Lack of means of health-care professionals
Lack of means of populations for covering their health car
III.3.2. Context of populations with a low level of ducation, 34
Difficult access to information
Difficulties in documenting consent
III.3.3. Social and cultural context, 35
Communal and individual consent
Decision-making process in the family unit
Integration of information in social perceptions and religious beliefs
Authority of knowledge
Constrained individuals

IV. APPLICATION AND PROMOTION, 41
IV.1. Teaching of information providers, 41
IV.2. Communication: process and materials, 41
IV.3. Public involvement, 42
IV.4. Role of States, 42

V.  EXECUTIVE SUMMARY AND CONCLUSIONS, 45
Why is consent a fundamental principle in bioethics?
When and how should we seek consent?
What are the main elements of consent?
What are the most important aspects of information provided?
What are the different forms of expressing consent?
Are consent procedures different in various circumstances of application?
What are the most important features of consent in clinical practice?
What are the most important features of consent in biomedical/clinical research?
Are there exceptions to consent procedures in epidemiological research?
What are examples of public health interventions that are carried on without consent of individuals?
What are the most important features of consent in emergency situations?
What are most important features of consent in organ, tissue and cell donation?
What procedures should be followed dealing with persons unable to consent?
Is scientific research on persons unable to consent justifiable?
How does the practice of consent depend on the economic context?
How do social and cultural contexts influence consent?

APPENDIXES, 51
International Legal Context, 53
Further reading, 55
Composition of the International Bioethics Committee (IBC) in 2006-2007, 61