The cultural framework for the ethical review of clinical research in Latin America

Drug Information Journal

Volumn 36, Issue 4, 2002, Pages 727-737

  Cavazos, Nora ^a   Forster, D ^a   Orive, Otto ^a   Kaltwasser, Gustavo ^b   Bowen, A J ^a  

^a Western Institutional Review Board   (United States)

^b Western International Review Board   (Chile)

Author keywords

Clinical research; Culture; Ethical review; Latin America

Indexed keywords

ANTIDEPRESSANT AGENT; ANTIDIARRHEAL AGENT; CORTICOSTEROID; PLACEBO;

ADULT; ASTHMA; CENTRAL AMERICA; CHILD; CHILDHOOD DISEASE; CLINICAL RESEARCH; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORTICOSTEROID THERAPY; CULTURAL FACTOR; DEPRESSION; DEVELOPING COUNTRY; DIARRHEA; DOCTOR PATIENT RELATION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; ETHICS; FEMALE; HEALTH CARE ACCESS; HEALTH STATUS; HUMAN; INFORMED CONSENT; MAJOR CLINICAL STUDY; MALE; MEDICAL ETHICS; MEDICAL RESEARCH; MEDICAL TECHNOLOGY; PRIORITY JOURNAL; QUALITY OF LIFE; REVIEW; SIDE EFFECT; SOCIOECONOMICS; SOUTH AMERICA; TREATMENT OUTCOME;

EID: 0036973134     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150203600402     Document Type: Review

References (41)

1. Bhagat K, Nyazema NZ. Ethics and HIV research in Zimbabwe. Cent Afr J Med. 2000;46:105-107.
2. Charatan F. Surfactant trial in Latin American infants criticized. Br Med J. 2001;322:575.
3. Levine RJ. Some recent developments in the international guidelines on the ethics of research involving human subjects. Ann NY Acad Sci. 2000;918:170-178.
4. Angell M. Investigators' responsibilities for human subjects in developing countries. N Engl J Med. 2000 Mar 30;342(13):967-969.
5. PAHO Core Health Data System. Basic Country Health Profiles for the Americas, Summaries 1999. www.paho.org/english/sha/profiles.hmt (Accessed Feb 13, 2001).
6. Bertranon FM. Are market oriented health insurance reforms possible in Latin America? The cases of Argentina, Chile and Colombia. Health Policy. 1999;47:19-36.
7. Titelman D, Uthoff A, Jimenez LF. Towards a new social security in the 21st century: without financing solidarity there will be no universality. Rev Panam Salud Publica. 2000;8:122-127.
8. Banco Interamericano de Desarrollo. Seminario Internacional, Reformas a la Política Social en América Latina. Washington, DC: May 1999.
9. Londono JL, Frenk J. Structured pluralism: towards an innovative model for health system reform in Latin America. Health Policy. 1997;41:1-36.
10. Rosenberg H, Andersson B. Rethinking social protection in health in Latin America and the Caribbean. Rev Panam Salud Publica. 2000;8:118-125.
11. Celedon C, Noe M. Health care reform and social participation. Rev Panam Salud Publica. 2000;8:99-104.
12. Drane JF. Some personal reflections on PAHO's involvement with bioethics In: Pellegrini A, Macklin R. Research on Human Subjects: International Experience. PAHO/WHO. Publication Series 1999. Santiago, Chile: Impresos Universitaria; 1999;21-32.
13. Macklin R. International collaborative research: recent developments. In: Pellegrini A, Macklin R. Research on Human Subjects: International Experience. PAHO/WHO. Publication Series 1999. Santiago, Chile: Impresos Universitaria; 1999;45-57.
14. De Abajo FJ, Gracia DM. Ética del uso de placebo en investigación clínica. Investigación y ciencia. November 1997;90-99.
15. Gracia D. Research on human subjects: logical, historical and ethical implications. In: Pellegrini A, Macklin R. Research on Human Subjects: International Experience. PAHO/WHO. Publication Series 1999. Santiago, Chile: Impresos Universitaria; 1999;59-78.
16. Macklin R. Research ethics committees: a regional approach. Theor Med Bioeth. 2000;20:161-179.
17. International Conference on Harmonisation Guideline for Good Clinical Practice. Geneva, Switzerland: International Conference on Harmonisation; May 1, 1996.
18. US Code of Federal Regulations. 21 CFR Part 56.
19. Rivera R, Ezcurra E. Composition and operation of selected research ethics review committees in Latin America. IRB: Ethics and Human Research. 2001;23:9-12.
20. Serrano LaVertu D, Linares AM. Ethical principles of biomedical research on human subjects: their application and limitations in Latin America and the Caribbean. Bull Pan Am Health Organ. 1990;24:469-479.
21. Macpherson CC. Research ethics committees: a regional approach. Theor Med Bioeth. 1999;20:161-179.
22. The Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Federal Register Document 79-12065.
23. Martinez-Cairo S, Amato-Martinez JD. Ethical principles of medical research using human subjects. Gac Med Mex. 1995;131:251-257.
24. Brazilian Resolution No. 196, National Board of Health, October 10, 1996.
25. National Bioethics Advisory Commission. Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries. Washington, DC: National Bioethics Advisory Commission; April 18, 2001.
26. Council for International Organizations of Medical Sciences. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva, Switzerland: Council for International Organizations of Medical Sciences; 1993.
27. Levine RJJ. Ethics and Regulation of Clinical Research. New Haven, CT and London, England: Yale University Press; 1988;8-10.
28. World Medical Assembly. 52nd Revision of the Declaration of Helsinki. General Assembly. Edinburgh, Scotland: World Medical Assembly; October 2000.
29. Dispositions ANMAT no 5330/97. Buenos Aires, Argentina: National Administration of Drugs, Food and Medical Technology; 1997.
30. Regulations for the realization of clinical trials of pharmaceutical products in human beings. Santiago, Chile: Ministry of Health; December 1, 1999.
31. Regulation for research with human participants. San Jose, Costa Rica: Ministry of Health; September 16, 1998.
32. Decree for the creation of the bioethics commission. Bogotá, Colombia: Ministry of Health; 2000.
33. Regulations of the General Law of Health in relation to research in health. Mexico, DF, Mexico: Ministry of Health; February 3, 1983.
34. Law of pharmaceutical products. Title VI. About clinical trials. Caracas, Venezuela: Ministry of Health: August 3, 2000.
35. Levine RJ. Informed consent: some challenges to the universal validity of the Western model. Law Med Health Care. 1991;19:207-213.
36. Arboleda-Florez J. Research on human subjects: vulnerable populations. In: Pellegrini A, Macklin R. Research on Human Subjects: International Experience. PAHO/WHO. Publication Series 1999. Santiago, Chile: Impresos Universitaria; 1999;79-92.
37. Bader MB. The international transfer of medical technology - an analysis and a proposal for effective monitoring. Int J Health Services. 1997;7:443-458.
38. Harris E, Tanner M. Health technology transfer. Br Med J. 2000;321:817-820.
39. DeYoung K, Nelson D. Latin America is ripe for trials, and fraud. Washington Post. December 21, 2000; A01.
40. Faden R, ed. Human Radiation Experiments: Final Report of the President's Advisory Committee. New York, NY: Oxford University Press; 1996.
41. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT). Ensayos Clínicos: Recomendaciones para participar, Boletín para Consumidores. No. 8, July 2000.