Páez-Moreno R

Language: Spanish
References: 21
Page: 637-643
PDF size: 101.94 Kb.

ABSTRACT

Several ethical standards defined in guidelines for international biomedical research in humans have outlined what is considered just in research conducted in middle to lowincome countries. Compliance with the standards outlined by these guidelines results in direct benefits to the health of the patients, who benefit from improvements in infrastructure, increased local research capacity, and decrease in the burden of disease. In an overall view of the ethical standards, the benefits that need to be distributed equitably can be classified as: addressing the needs and/or priorities of the local research, making post-trial benefits available, fostering ancillary-care benefits, making the new theoretical and practical knowledge available, supporting health services as well as health and ethics research, and including in the informed consent the potential benefits that can be expected. It is necessary that those who deal with international research have knowledge about these ethical guidelines and their potential benefits to public health.

REFERENCES

1. Glickman S, McHutchison J, Peterson E, Cairns Ch, Harrington R, Califf R, et al. Ethical and scientific implications of the globalization of clinical research. N Engl JMed 2009;360:816-823.

2. Macklin R. Research multinational. En: Post S, comp. Encyclopedia of bioethics. 3a. ed. Nueva York: Mac Millan, 2004;4:2347-2357.

3. Páez R, García de Alba J. International research and just sharing of benefits in Mexico. Dev World Bioeth 2009;(9):65-73.

4. Cohen E, O’Neill J, Joffres M, Upshur R, Mills E. Reporting ethics issues in registered trials. Dev World Bioeth 2009;(9):74-80.

5. Asociación Médica Mundial. Declaración de Helsinki [monografía en internet]. Ferney-Voltaire: AMM, 2008 [consultado: 2012 enero 25]. Disponible en: http://www.wma.net/es/30publications/10policies/b3/17c_es.pdf.

6. Council for International Organization of Medical Sciences. International ethical guidelines for biomedical research involving human subjects [monografía en internet]. Geneva: CIOMS, 2002 [consultado: 2012 enero 25]. Disponible en: http://www.paho.org/Spanish/BIO/CIOMS.pdf.

7. United Nations Educational Scientific and Cultural Organization. Universal declaration on bioethics and human rights [monografía en internet]. Paris: UNESCO, 2005 [consultado: 2012 enero 25]. Disponible en: http://portal.unesco.org/en/ev.php-URL_ID=31058&URL_DO=DO_ TOPIC&URL_SECTION=201.html.

8. Groupe Européen d’Èthique des Sciences et des Nouvelles Technologies auprès de la Commission Européenne. Aspects ethiques de la recherche clinique dans les pays en developpement. Bruxelles: GEE, 2003 [consultado: 2012 enero 25]. Disponible en: http://ec.europa.eu/bepa/ european-group-ethics/docs/cp17_fr.pdf.

9. National Bioethics Advisory Commission. Ethical and policy issues in international research: clinical trials in Developing Countries [monografía en internet]. Bethesda, MD: NBAC, 2001 [consultado: 2012 enero 25]. Disponible en: http://bioethics.georgetown.edu/nbac/clinical/ExecSum.pdf.

10. Nuffield Council of Bioethics. The ethics of research related to care in developing countries [monografía en internet]. London: NCB, 2002 [consultado: 2012 enero 25]. Disponible en: http://www.nuffieldbioethics. org/sites/default/files/Ethics%20of%20research%20related%20to%20 healthcare%20in%20developing%20countries%20I.pdf.

11. Comite Consultatif National d’Ethique pour les Sciences de la Vie et de la Sante. La coopération dans le domaine de la recherche biomédicale entre équipes françaises et équipes de pays en voie de développement économique. Avis No. 41 [monografía en internet]. Paris: CCNE, 1993 [consultado: 2012 enero 25]. Disponible en: http://www.ccne-ethique.fr/ docs/fr/avis041.pdf.

12. Beall R, Kuhn R. Trends in compulsory licensing of pharmaceuticals since the Doha Declaration: a database analysis. PLoS Med [serie en internet] 2012 [consultado 2012 febrero 3]; 9: [aprox. 9 pp]. Disponible en: http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal. pmed.1001154.

13. Cahoon L. Companies throw their weight behind new antiobesity drugs. Nat Med 2010;16:136.

14. Páez R. La investigación de la industria farmacéutica: ¿condicionada por los intereses del mercado? Acta Bioeth [serie en internet] 2011 [consultado 2012 febrero 3]; 17: 237-246. Disponible en: http://www.scielo.cl/ pdf/abioeth/v17n2/a10.pdf.

15. Global Forum for Health Research. 10/90 Report on Health Research 2003/2004 [monografía en internet]. Geneve: GFHR, 2004 [consultado: 2012 enero 25]. Disponible en: http://bibliotecas.salud.gob.mx/gsdl/collect/ publin1/index/assoc/HASHc1e3.dir/doc.pdf

16. The Participants in the 2001 Conference on Ethical Aspects of Research in Developing Countries. Moral Standards for Research in Developing Countries. From “Reasonable Availability” to “Fair Benefits.” Hastings Cent Rep 2004;34:17-27.

17. Macklin R. Ética de la investigación internacional. El problema de la justicia hacia los países menos desarrollados. Acta Bioeth [serie en internet] 2004 [consultado 2012 febrero 3];10:27-35. Disponible en: http:// www.scielo.cl/pdf/abioeth/v10n1/art04.pdf.

18. Belsky L, Richardson H. Medical researchers’ ancillary clinical care responsibilities. BMJ 2004;328:1494-1496.

19. Participants in the 2006 Georgetown University Workshop on the Ancillary-Care Obligations of Medical Researchers Working in Developing Countries. The ancillary-care obligations of medical resarchers working in developing countries. PLoS Med [serie en internet] 2008 [consultado 2012 febrero 3]; 5: 709-713. Disponible en: http://www.scielo.cl/ pdf/abioeth/v10n1/art04.pdf.

20. Drahos P, Braithwaite J. Informational feudalism. London: Earthscan Publications, 2002:1-18.

21. Ballantyne A. Benefits to research subjects in international trials: do they reduce exploitation or increase undue inducement? Dev World Bioeth 2008;8:178-191.