ABSTRACT
There is wide variation in norms and laws regulating biomedical research both within and outside Europe.2 Some countries have statutory regimes, whilst others rely on softer forms of regulation including administrative or professional ethical rules.3 In the case of research involving adults and children, the procurement of consent prior to medical interventions is usually a legal requirement, but there is no uniform norm on the level of information that patients should be given to ensure that consent is adequate or informed.4 Neither is there a clear consensus on the circumstances in which consent can be dispensed with.5 Forms and procedures for obtaining consent vary. So do other control mechanisms, such as the legal status, role and composition of Research Ethics Committees.6 In the fast developing field of research involving the application of new biotechnologies such as stem cell research or research on human tissue, the law tends to lag behind the science. There is often a legal vacuum as policy makers strive to reach a consensus on guiding principles for regulation. The conduct of clinical trials by pharmaceutical corporations in the developing world, resulting in drugs which are then out of reach of the local populations, has also raised the question of whether universal standards of research can be formulated irrespective of inequality of health resources and wealth. In the light of geographical variations in the regulation of medical research, the adoption of a legally binding treaty which aspires to capture fundamental values as well as bringing ‘greater unity between its members’ is therefore an important step toward European and international harmonisation of norms in the field of biomedicine. The Convention on Human Rights & Biomedicine’s (CHRB’s) aspiration to capture fundamental universal values is clear from the preamble’s resolve to ‘take such measures as are necessary to safeguard human dignity and the fundamental rights and freedoms of the individual with regard to the application of biology and medicine’. However, the aspiration has to be reconciled with the reality of the diversity of forms and norms of regulation of medical research across Europe and the rest of the world.
