Ethical criteria in clinical research in developing countries: is there a global standard?

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This paper, recently published on the Italian Journal of Tropical Medicine
(Vol 15, N 1-4, 2010), reports on a debate that took place during the 6th
European Conference of Tropical Medicine in 2009, on some topics of great
interest for GlobalHealthTrials.org: is there a global standard for clinical
research? Should standards be adapted in developing countries? How to
encourage research while preventing the exploitation of vulnerable
individuals or groups? Five "debate questions" were addressed by Professor
Nick White and by Dr. Lumuli Mbonile, and discussed with the moderator
(Raffaella Ravinetto) and the audience.

There was agreement that clinical researchers in developing countries face
multiple challenges related to contextual constraints, poor regulation and
vulnerability of trials' subjects. The World Health Organization issued in
1995 its Good Clinical Practices (GCP) Guidelines, setting globally
applicable standards for clinical trials. Non-compliance with GCP principles
leaves room for misconduct and abuse, while a rigid interpretation of GCP
processes and procedures may unnecessarily increase the research costs and
even prevent research relevant to public health from being carried out.
 
Ethical principles and scientific standards governing research are universal
and should be adopted everywhere, to ensure persons' protection and data's
reliability, while avoiding any North-South ethical divide. However,
principles should be translated into simple and effective processes and
procedures, which ensure quality of the research and subjects' protection,
without putting unnecessary obstacles to public-health oriented research.

It is time to "reinvent" GCP, by updating the 1995 WHO Guidelines in light of
the 15-year experience of worldwide implementation. The revision should
include old and new stakeholders (including academic institutions from the
South and the North, NGOs, public-private partnerships, donors, patients
associations etc.) and could, by making clearer distinction between essential
and procedural requirements, help researchers and sponsors to design new
patient-centered tools and practices. 

We hope that this call may be discussed and promoted in
GlobalHealthTrials.org.