SELECTED BIBLIOGRAPHY

This list is not intended to be exhaustive. Please send suggestions for additional entries on research ethics in Latin America and the Caribbean to Ken Goodman.

Web resources for investigators

The U.S. Office for Human Research Protections Website has links to the following resources in Spanish:

•  45 CFR 46, subparts A, B, C, and D
•  Step-by-Step Instructions to Register an IRB
•  Instructions for IRB Updates
•  Terms of the Federalwide Assurance (FWA)
•  Step-by-Step Instructions for an FWA application
•   Instructions for FWA Updates

Publications

Angell M. Investigators Responsibilities for Human Subjects in Developing Countries. N Engl J Med 2000; 342 :967-69.

Angell M. Ethics in international collaborative research. N Engl J Med 1988; 319 : 1081-83.

Benatar S. Imperialism, research ethics and global health. J Med Ethics. 1998; 24: 221-222.

Benatar S. Global disparities in health and human rights: A Critical Commentary. Am J Publ Health 1998; 88: 295-300.

Beecher H. Ethics and Clinical Research. N Engl J Med 1996; 274:1354-60.

Brennan T. Proposed revisions to the Declaration of Helsinki.. N Engl J Med. 1999; 341:531-34.

Castro Fernández JD. Costa Rica: ¿es impune la experimentación en seres humanos? Medicina Legal Costa Rica 2002;19(2):103-116.

Christakis N. Ethics are local, engaging cross-cultural variation in the ethics of clinical research. Social Science and Medicine 1992; 35:1079-91.

Childress J et al. Public Heath Ethics, mapping the terrain. Journal of Law Medical Ethics. 2002 ; 30(2): 170-78.

Christie B. Doctors revise Declaration of Helsinki. BMJ 2000 ; 321:913-915.

Emanuel M. How to do it: Get patients' consent to enter clinical trials. BMJ 1995; 311:734-737.

Edwards SJL et al Ethical issues in the design and conduct of randomized controlled trials. Health Technol Assess 1998 ; 2: 1-130.

Faden, R. HIV research, ethics and the developing world. American Journal of Public Health 1998; 88:548-50.

Fairchild AL, Bayer R. Uses and abuses of Tuskegee. Science 1999; 284:919-921.

Figueroa, J. Is serious research possible in the Caribbean?. Ethnicity and Disease 1998 ; 2: 368-78 .

Fitzgerald, D, Wassuna A. Ten questions Institutional Review Boards should ask when reviewing international clinical research protocols. IRB Ethics & Human Research 2003 ; 25 : 2 : 14-1.

Freedman B. Equipoise and the ethics of clinical research. N Eng JMed 1987; 317:141-145.

Goodman KW, Meta- Analysis: Conceptual, Ethical and Policy Issues. In Ethics, Computing and Medicine. Goodman KW, ed. Cambridge: Cambridge University Press, 1998: 150-153.

Halsey, NA, Sommer A. Ethics and international research. BMJ 1997;345 :965-66.

Hrobjartsson A. Is the placebo powerless? N Engl J Med 2001 ; 344:1594-1602.

Kass, N et al. Ethical oversight of research in developing countries. IRB Ethics & Human Research 2003 ; 25 No 2 : 1-10.

Killen J et al. ethics of clinical research in the developing world. Nature 2002 ;2 : 210.

Lansang F P Crawley. The ethics of international biomedical research. BMJ 2000 ; 321: 777 - 778.

Levine R. The need to revise the Declaration of Helsinki. N Engl J Med 1999; 341:527-34.

Lolas F. Bioética en Chile. Actualidad y Perspectivas. Boletín de la Oficina Sanitaria Panamericana ( Washington) 1990; 108 : 536-41.

Lolas F. La investigación clínica como innovación relevante. Acta Psiquiatrica y Psicológica de América Latina 1996;42: 216-21.

Lolas F. Los experimentos de hipotermia en Dachau. Acerca del control ético de la investigación médica. Creces. Santiago 1990; 11(9): 26-27.

Lolas F.Etica de la publicación médica: legalidad y legitimidad. Acta Bioethica 2000; 6 (2): 285.

Lolas F. La investigación clínica como innovación relevante. Acta Psiquiatrica y Psicológica de América Latina 1996; 42: 216-221.

Lolas F. Ética de la investigación biomédica: Aspectos, perspectivas, contextos, en Bioética y Antropología Medica. Ed Mediterráneo; 2000 : 142-150.

Lolas F, Quezada A Editores. Pautas éticas de investigación en sujetos humanos: Nuevas perspectivas. Serie Publicaciones 2003. Programa Regional de Bioética. OMS-OPS.

Lurie P, Wolf S. Unethical trials of interventions to reduce perinatal transmission of the Human Immunodeficiency Virus in developing countries. N Engl J Med 1997 ; 337: 853-856.

Macklin R. Ethics and collaborative research. ASBH Exchange 1998 ; 2 : 2-5.

Macpherson C. Research Ethics Committees, a regional approach. Theoretical Medicine and Bioethics 1999 ; 20: 161-79.

Mac Queen K . Back to the rough ground: Working in international HIV prevention as ethical debates. Continue Ethics & Human Research 2003; 2: 11-13.

Mainetti et al. Bioethics in Argentina. In Pepin J, Cherry Mark Ed. Regional Perspectives on Bioethics, Netherlands : Swets & Zeitlinger Publishers, 2003: 71-89.

Moreno J. Updating protection for human subjects involved in research. JAMA.1998. 280: 1951-1956.

Nuffield Council. The Ethics of Research Related to Healthcare in Developing Countries. London: Nuffield Council of Bioethics, 2001. http://lawgenecentre.org/links/about.php?linkID=997. Accessed 29 June 2004.

Oliva Linares JE, Bosch Salado C, Carballo Martinez R, et al. El consentimiento informado, una necesidad de la investigación clínica en seres humanos. Revista Cubana Investigastiones Biomédicas 2001;20(2):150-158.

Rivera R, Ezcurra E. Composition and operation of selected research ethics review committees in Latin America .IRB: Ethics and Human Research 2001 September-October; 23(5): 9-12 18.2; 21.1 http://www.georgetown.edu/research/nrcbl/irb/v23/irb23n5p09.pdf

Sanchez M. El consentimiento informado: un derecho del enfermo y una forma distinta de tomar las decisiones. Cuadernos del Programa Regional de Bioética, OPS, Santiago de Chile 1996; 2:77-92.
39. Tan Torres E. North-South Research Partnerships: The ethics of carrying out research in developing countries. BMJ 1997; 319: 438-441.

Umaña DM. Siguen investigaciones en humanos: Notables piden intervención del Congreso. Al Dia, San Jose, 19 October 2004. http://www.aldia.co.cr/ad_ee/2004/octubre/19/nacionales1.html#187366. Accessed 24 May 2005. (Costa Rican daily newspaper report on issues and problems in human subjects protection.)

Varmus H , Satcher D. Ethical complexities of conducting research in developing countries. N Engl J Med 1999 ; 337: 853-55.

Weijer C, Anderson JA. The ethics wars. Disputes over international research. Hasting Centers Report 2001 ; 31(3):18-20.

Weijer C, Shapiro SH, Clinical equipoise and not the uncertainty principle is the moral underpinning of the randomized controlled trials. BMJ 2000; 321:756-758.