Biomedical Research in Developing Countries - UNICRI

Chapter 5 is dedicated to scientific research and provides strict guidance for the
protection of participants. In article 16, research on persons can be carried out only
if certain conditions are met, i.e. if there is no comparable effective research
instrument, the risk is proportionate to the benefit, the research has been approved
by a competent independent body for its scientific and ethical integrity and
importance, the informed consent has been duly obtained and can be documented.
Article 17 sets out detailed provisions for persons unable to give consent. It states
that research on persons who cannot give consent should be carried out only if there
is a direct benefit to their health and condition. However, when the research has not
the potential to produce results of direct benefit, exceptions, under the protective
conditions of the law, can be applied when the research has the aim of contributing,
“through significant improvement in the scientific understanding of the individual’s
condition, disease or disorder, to the ultimate attainment of results capable of
conferring benefit to the person concerned or to other persons in the same age
category or afflicted with the same disease or disorder or having the same
condition” and when “the research entails only minimal risk and minimal burden
for the individual concerned”. Chapter 8 regards infringements, obligation to
sanction and compensation for damage resulting from an intervention. Article 23
states that “the Parties shall provide appropriate judicial protection to prevent or to
put a stop to an unlawful infringement of the rights and principles set forth in this
Convention at short notice” while article 24 requires adequate compensation from
damage suffered according to conditions and procedures prescribed by law. Article
25 requests parties to the convention to provide appropriate sanctions in the event
of infringement.
The Convention stresses out, in Chapter 10, the importance of promoting a public
debate and consultation on questions raised by the development of biology and
medicine. The only restrictions are those prescribed by law and which are necessary
in a democratic society in the interest of public safety, for the prevention of crime,
for the protection of public health or for the protection of the rights and freedoms
of others. However, such restrictions cannot be placed on the following Articles: 11
(no discrimination of genetic make-up), 13 (interventions on the human genome),
14 (no selection of sex in medically assisted procreation), 16 (protection of persons
undergoing research), 17 (protection of persons not able to consent to research) 19
(organ and tissue removal from living donors for transplantation purposes), 20
(protection of persons not able to consent to organ removal) and 21 (the human
body and its parts shall not give rise to financial gain).
The Convention allows for clarification and interpretation mechanisms that can be
exercised by the Steering Committee on Bioethics (CDBI), or by any other committee
designated by the Committee of Ministers or the Parties and request the European
Court of Human Rights to give advisory opinions on legal questions concerning its
interpretation 28 .
28 Zilgalvis P.V., Ethics Committees: the European Convention on Human Rights and Biomedicine and ethical review of
biomedical research, Acta Medica Lituanica, 2006, 13:1, pp.2-5
40