Ethical dimension of the EDCTP programme
Because clinical trials involve
human participants, highest ethical standards should be applied when
setting up and conducting clinical trials.
International conventions, declarations and ethical guidelines such
as the Opinion 17 (PDF: 207 kB) of the European Group on Ethics on Ethical
aspects of clinical research in developing countries (4 February 2003) and Declaration of
Helsinki (1) should be applied.
A. Setting up a clinical trial
A number of safeguards must be in
place before a clinical trial can take place:
Local, regional and national ethics committees:
The clinical trials should be examined by a local, regional or
national ethics committee in the countries where the trial will
be performed. The creation of ethics committees and the training
of ethics committee members in countries should be encouraged.
B. Undertaking a clinical trial
When undertaking a clinical trial,
the following issues should be addressed on a case by case basis,
respecting the fundamental ethical principles as defined in
international declarations and in dialogue with local, regional or
national ethics committees and national authorities.
It is required to obtain the
consent of each persons participating in a clinical trial. First,
information must be provided to participants in a way that these
persons can understand. This requires also trained staff able to
communicate the objectives of the research and the risks and
benefits such research may entail for the participants.
Protection of confidentiality
The researchers must keep
personal medical information confidential.
Level of care for the trial participants
The level of care, which will be
offered to the participants should be specified and conform
requirements set by the local, regional or national ethics
committee and the national authorities. The level of care includes
also appropriate provision of effective alternative prevention and
the non-exposure of participants to undue risks.
The use of placebo in randomised
clinical trials has raised in the past important ethical concerns,
especially when the disease is life threatening or severely
The European Group on Ethics in
its opinion 17 recommends that (section 2.10) the use of placebo
should be regulated by the same rules as in EU countries.
"Any exception must be justified: an obvious one is when the
primary goal of the clinical trials is to try to decrease the
costs of treatment for countries where the standard treatment is
not available for logistic reason or inaccessible because of the
Benefits for the population after the end of
At the beginning of each clinical
trial, the benefits for the local community where the trial takes
place should be specified. Special attention should be given to
the possibility of a future access to the new treatment. But other
possible benefits should be examined such as: improvement of
access to health care or capacity building.
European Group on Ethics
World Medical Association - Declaration
CIOMS - International Ethical Guidelines for
Biomedical Research Involving Human Subjects
SARETI is a joint effort by the University of Pretoria
and the University of Natal (South Africa) to offer advanced
learning in bioethics and health research ethics. http://shsph.up.ac.za/sareti/sareti.htm
Contact point at the European Commission
(1) Declaration of Helsinki on
"Ethical Principles for Medical Research Involving Human
Subjects" - World Medical Association – (adopted by the 18th
WMA General Assembly, Helsinki, Finland, June 1964, and revised by
the 52nd WMA General Assembly, Edinburgh, Scotland, October 2000)