The ongoing debate on research involving human beings
Keywords:
BIOETHICAL ISSUES, ETHICS IN HUMAN RESEARCHAbstract
Research involving human beings enables improvement of diagnosis and treatment of diseases. Without prejudice of its doubtless benefits for humanity, we need to bear in mind that historically, this kind of research proved that every time it moved away from moral reflection and social control, aberrant facts took place and several human rights were ran over (before, during and after World War II). Today, we witness the ongoing debate between trends that favor an increased ethical flexibility that allows better times and costs of research, and the opposite trends that believe a double ethical standard resulting in vulnerable people and populations being mere means for the accomplishment of benefits for humanity or science is unacceptable. The debate focuses on whether or not to open the door to the use of placebo in controlled clinical trials when there is a well known treatment, and whether or not to ensure participants are guaranteed the benefits of treatment for free. Until now, the relevant legal provisions in force (Decree 379/008) have endured the trend to increase flexibility.
However, our country cannot ignore the global debate on this issue.
Ethical regulations need to be revised through an ongoing ethical reflection. Notwithstanding this process, this update must not give up agreed ethical standards that prioritize the protection of participants in research over any other interest.
References
(2) Tealdi JC. Historia y significado de las normas éticas internacionales sobre investigaciones biomédicas. In: Keyeux G, Penschaszadeh V, Saada A, coords. Ética de la Investigación en seres humanos y políticas de salud pública. Bogotá: Instituto de Genética. Universidad Nacional de Colombia, 2006:33-62.
(3) Pressel DM. Nuremberg and Tuskegee: lessons for contemporary American medicine. J Natl Med Assoc 2003; 95(12):1216-25.
(4) Beecher HK. Ethics and clinical research. N Engl J Med 1966; 274(24):1354-60.
(5) Thomas SB, Quinn SC. The Tuskegee Syphilis Study, 1932 to 1972: implications for HIV education and AIDS risk education programs in the black community. Am J Public Health 1991; 81(11):1498-505.
(6) França Tarragó O, Anón F, García C, Grauert R, Núñez J, Wodowooz O, et al. Ética en la investigación clínica: una propuesta para prestarle la debida atención. Red Méd Urug 1988; 14(3):192-201.
(7) Consejo Editorial. La Declaración de Helsinki en debate. Rev Méd Urug 2008; 24(2):67-8.
(8) Garrafa V, Lorenzo C. Helsinque 2008: redução de proteção e maximização de interesses privados. Rev Assoc Méd Bras 2009; 55(5):514-8.
(9) Angell M. The ethics of clinical research in the Third World. N Engl J Med 1997; 337(12):847-9.
(10) Lurie P, Wolfe SM. Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. N Engl J Med 1997; 337(12):853-6.
(11) Macklin R. Ética de la investigación internacional: el problema de la justicia hacia los países menos desarrollados. Acta Bioeth 2004; 10(1):27-37.
(12) Lie RK, Emanuel E, Grady C, Wendler D. The standard of care debate: the Declaration of Helsinki versus the international consensus opinion. J Med Ethics 2004; 30(2):190-3.
(13) Mastroleo I. Acceso post investigación obligatorio para los participantes de las investigaciones biomédicas: la discusión en torno al párrafo 30 de la Declaración de Helsinki. Cuad Trab Centro Investig Éticas - Univ Nac Lanús 2009; 11:27-43.
(14) Zong Z. Should post-trial provision of beneficial experimental interventions be mandatory in developing countries? J Med Ethics 2008; 34(3):188-92.