Biomedical Research in Developing Countries - UNICRI

countries. Assessment of risks and burdens of research study should be done not
only with regard to individuals but also in considering its repercussions for the
entire community.
A separate paragraph (new 19) stresses the need for clinical trials to be registered in
a publicly accessible database before recruitment of the first subject.
With regard to the paragraphs dealing with informed consent, customs typical of
some cultural settings are considered. For example, participation to medical research
by legally competent individuals must be voluntarily expressed and cannot be
replaced by consultation with family members or community leaders. In addition
to that, “legally competent human subjects” as opposed to “legally incompetent
subjects”, such as children or people with mental disabilities substitute the term
“human subjects”. A separate paragraph deals with subjects physically or mentally
incapable of giving consent but who are not legally incompetent (such as
unconscious persons). A new paragraph deals with informed consent in research
with human tissues or data. Given the fact that in certain developing contexts,
another physician may not be available, in the event of a dependent relationship
between physician and patient, an appropriately qualified individual, who is
completely independent of this relationship, can seek informed consent.
Additional protection for research subjects is provided for in the new paragraph 31
and 32 (former 28 and 29) that considers medical research combined with medical
care and the use of placebo. Research combined with medical care is justified only
for its preventive, diagnostic or therapeutic value and if the physician considers that
participation to the research study does not adversely affects the health of patients.
With regard to the use of placebo, the contents of the note of clarification have been
fully incorporated in the new paragraph and the term “best current proven method”
is used to identify the control therapy.
Paragraph 33 (former paragraph 30) states that at the conclusion of the study,
participants are entitled to be informed about the outcome of the study. The new
paragraph 14 deals with the requirements regarding post trial access to treatment.
Paragraphs 34 and 35 (former 31 and 32) have been simplified and clarified.
The International Ethical Guidelines for Biomedical Research Involving
Human Subjects (1982, rev. 1993, 2002)
Published by the Council for International Organizations of Medical Sciences
(CIOMS), established under the auspices of WHO and UNESCO in 1949, this
document was prepared to provide a guidance for application of the Declaration of
Helsinki to research, especially done in developing countries. The 1993 revision is
influenced by the issues brought upon by the HIV/AIDS pandemic and the necessity
32