Biomedical Research in Developing Countries - UNICRI

therapeutic methods identified by the study.” Sharp debate within the World
Medical Association between 2001 and 2003, led the Assembly to establish, in
September 2003, a Working Group to clarify the controversies of the paragraph. In
May 2004, the Working Group concluded that no amendment to paragraph 30 was
to be made. A note of Clarification was instead included in the Declaration, stating
the necessity “during the study planning process, to identify post trial access by
study participants to prophylactic, diagnostic and therapeutic procedures identified
as beneficial in the study or access to other appropriate care. Post-trial access
arrangements or other care must be described in the study protocol so the ethical
review committee may consider such arrangements during its review”.
In the course of 2008 the Declaration of Helsinki was put under further revision, to
be approved by the end of the year. The paragraphs are increased, due to the fact
that some paragraphs have been subdivided to better specify concepts relevant to the
subject of the Declaration.
Former paragraphs 13 and 14 are being reorganized and clarified so as to ensure
that the protocol (new 14) and the revision by the research ethics committee (new
15) have each its own devoted paragraph.
In the paragraph regarding protocol submission (new 14), investigators are
encouraged to carefully consider the ethical aspects of their research, as they should
not only state the ethical considerations involved in the study, but also indicate how
the principles of the DoH are addressed, instead of just indicating the compliance
with its principles as previously enunciated. This paragraph also incorporates the
controversial paragraph 30 and its note of clarification, regarding arrangements for
post-study access by study participants, to methods identified as beneficial in the
study or access to other appropriate care or benefit. The new paragraph also
requests to specify, in the protocol, provisions for treating and/or compensating
subjects who are harmed as a consequence of participation in the research study.
The new paragraph 15 specifies and increases the importance of the role of research
ethics committees. The paragraph clearly states that research ethics committees
should have the authority to approve or not approve a research protocol. Research
ethics committees should exist wherever medical research is conducted and should
not have to be specially appointed to deal with specific protocols. In addition, if the
research is to be conducted in a country different from the one in which the
committee approval is sought, the committee should ensure that the research is not
in conflict with the laws and regulations of the host country. No change in the
protocol should be made without prior consideration and approval by the
committee.
Justification for research based on the benefit resulting for the community in which
the study is conducted, has been changed to allow for phase I clinical trials on
diseases primarily affecting developing countries to be carried out also in developed
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