clinical research in developing countries: ethical issues

Inpharma 1375 - 22 Feb 2003 ■ Ethical considerations surrounding clinical research in developing countries mean that researchers have a "moral duty to make a concrete contribution to overcome inequalities" in these countries, according to an Opinion released by the European Group on Ethics in Science and New Technologies, reports Marketletter. The Opinion emphasises that, in countries which differ culturally or economically from the western European context, EU- funded research should be in accordance with the Charter of Fundamental Rights. Research activities should comply with the health priorities of the host country and should not be regarded as an economic activity subject to market rules, says the Opinion. It also states that if the scientific and ethical evaluation of research protocol is unable to provide an independent local representative, then the trial should not proceed in that country. Moreover, placebo- controlled trials in developing countries should be governed by the same regulations as those that cover trials operating in European nations, says the Opinion. Clinical research in developing countries: EU panel stresses moral duty. Marketletter [Copy 2] 30: 11, 17 Feb 2003 800925503 1 Inpharma 22 Feb 2003 No. 1375 1173-8324/10/1375-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

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Page 1: Clinical research in developing countries: ethical issues

Inpharma 1375 - 22 Feb 2003

■ Ethical considerations surrounding clinicalresearch in developing countries mean thatresearchers have a "moral duty to make a concretecontribution to overcome inequalities" in thesecountries, according to an Opinion released by theEuropean Group on Ethics in Science and NewTechnologies, reports Marketletter. The Opinionemphasises that, in countries which differ culturally oreconomically from the western European context, EU-funded research should be in accordance with theCharter of Fundamental Rights. Research activitiesshould comply with the health priorities of the hostcountry and should not be regarded as an economicactivity subject to market rules, says the Opinion. Italso states that if the scientific and ethical evaluationof research protocol is unable to provide anindependent local representative, then the trial shouldnot proceed in that country. Moreover, placebo-controlled trials in developing countries should begoverned by the same regulations as those that covertrials operating in European nations, says the Opinion.Clinical research in developing countries: EU panel stresses moral duty.Marketletter [Copy 2] 30: 11, 17 Feb 2003 800925503

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