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Biomedical Research in Developing Countries - UNICRI

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Algiers<br />

Declaration<br />

2008<br />

M<strong>in</strong>isterial<br />

Conference on<br />

<strong>Research</strong> for<br />

Health <strong>in</strong> the<br />

African Region<br />

In preparation for the Bamako Meet<strong>in</strong>g <strong>in</strong><br />

November, the African Conference<br />

adopted the Algiers Declaration, which<br />

commits countries <strong>in</strong> the Region to work<br />

together to strengthen national health<br />

research, <strong>in</strong>formation and knowledge<br />

systems through the optimization of<br />

<strong>in</strong>vestments, better co-ord<strong>in</strong>ation and<br />

enhanced management <strong>in</strong> order to improve<br />

the health of the people of Africa. The<br />

ethical conduct and evaluation of research<br />

is also a strong po<strong>in</strong>t of the Declaration.<br />

The M<strong>in</strong>isters called on the World Health<br />

Organization (WHO) to establish an<br />

African Health <strong>Research</strong>, Information and<br />

Knowledge Systems Observatory.<br />

PUBLICATION ETHICS<br />

Editors of scientific journals have a responsibility <strong>in</strong> the way cl<strong>in</strong>ical trials results<br />

are submitted for publish<strong>in</strong>g. That is why we <strong>in</strong>cluded, <strong>in</strong> this chapter, a description<br />

of all the <strong>in</strong>itiatives that have been implemented by publish<strong>in</strong>g editors to ensure the<br />

respect of the good practices <strong>in</strong> the report<strong>in</strong>g of cl<strong>in</strong>ical trials, so as to avoid the<br />

publication of unethical or scientifically unsound results.<br />

International Committee of Medical Journal Editors (ICMJE)<br />

The ICMJE released the Uniform Requirements for Manuscripts Submitted to<br />

<strong>Biomedical</strong> Journals <strong>in</strong> 1997 <strong>in</strong> an attempt to promote and systematize the good<br />

practices when submitt<strong>in</strong>g a manuscript for publication <strong>in</strong> scientific journals. The<br />

Uniform Requirements were subsequently revised <strong>in</strong> 1999, 2000, 2001, 2004.<br />

In 2004, <strong>in</strong> order to foster a “comprehensive, publicly available database of cl<strong>in</strong>ical<br />

trials 30 ” the ICMJE mandated that cl<strong>in</strong>ical trials would be considered for publication<br />

<strong>in</strong> its member journals 31 only if registered <strong>in</strong> one of the five ICMJE approved<br />

registries, before the enrollment of the first patient, start<strong>in</strong>g from July 1, 2005. 32<br />

Initial opposition by researchers and sponsors that registration would complicate<br />

30 De Angelis C., Drazen J.M., Frizelle F.A., et al. Cl<strong>in</strong>ical trial registration: a statement from the International<br />

Committee of Medical Journal Editors. Lancet. 2004; 364:911-2<br />

31 Currently, the ICMJE member journals are: Annals of Internal Medic<strong>in</strong>e, British Medical Journal, Canadian<br />

Medical Association Journal, Croatian Medical Journal, JAMA, Nederlands Tijdschrift voor Geneeskunde, New<br />

England Journal of Medic<strong>in</strong>e, New Zealand Medical Journal, The Lancet, The Medical Journal of<br />

Australia,Tidsskrift for Den Norske Llegeforen<strong>in</strong>g, and Ugeskrift for Laeger. However, more and more journals<br />

<strong>in</strong>clude <strong>in</strong> their selection criteria for publication the ICMJE Uniform Requirements , <strong>in</strong>clud<strong>in</strong>g data on registration<br />

of cl<strong>in</strong>ical trials.<br />

32 The ICMJE accepted registries are: www.actr.org.au; www.cl<strong>in</strong>icaltrials.gov; www.ISRCTN.org;<br />

www.um<strong>in</strong>.ac.jp/ctr/<strong>in</strong>dex/htm; www.trialregister.nl<br />

52

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