In this essay the ethical issues related to the ‘standard of care’ are discussed together with the implications for the treatment of the control group in transnational clinical trials. It is argued that the human right to health and the duty of justice formulate the moral basis on which this case should be debated.
VarmusHSatcherMD. Ethical complexities of conducting research in developing countries. New Engl J Med1997; 337: 1003–05.
2.
BenatarSRDaarASSingerPA. Global health ethics: The rationale for mutual caring. Int Affairs2003; 79: 107–138.
3.
BenatarSRSingerPA. Responsibilities in international research: a new look revisited. J Med Ethics2010; 36: 194–97.
4.
WendlerDEzekielEJLieRK. The standard of care debate: can research in developing countries be both ethical and responsive to those countries’ needs?Am J Publ Hlth2004; 94: 923–28.
5.
AngellM. Investigators’ responsibilities for human subjects in developing countries. New Engl J Med2000; 342: 967–69.
6.
LuriePWolfeSM. Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. In bioethics, an anthology. KuhseHESingerP. eds. Oxford: Blackwell Publishing, 2006.
7.
LieRKEmanuelEGradyCWendlerD. The standard of care debate: The Declaration of Helsinki versus the international consensus opinion. J Med Ethics2004; 30: 190–93.
8.
MacklinR. International research: ethical Imperialism or ethical pluralism?Accountability in Research1999; 7: 59–83.
9.
Zulueta deP. Randomised placebo-controlled trials and HIV-invented pregnant women in developing countries. Ethical imperialism or unethical exploitation? Bioethics2001; 15: 4.
10.
FarmerPCamposNG. New malaise: Bioethics and human right in global era. J. Law Med Ethics2004; 32: 243–51.
11.
CIOMS. International ethics guidelines for biomedical research involving human subjects. Geneva: Council for International Organisations of Medical Sciences, 2002.
12.
BenatarSR. Imperialism, research ethics and global health. J Med Ethics1998; 24: 221–22.
13.
LevineRJ. The ‘best proven therapeutic method’ standard in clinical trials in technologically developing countries. Ethics Hum Res1998; 20: 5–9.
14.
World Medical Organization (1996), Declaration of Helsinki, British Medical Journal, Vol. 313 (7070), p.1448–1449.
15.
AngellM. The ethics of the clinical research in the third world. New Engl J Med1997; 337: 847–49.
16.
BrennanTA. Proposed revisions to the Declaration of Helsinki — will they weaken the ethical principles underlying human research?New Engl J Med1999; 341: 527–31.
17.
BuchananDRMillerFG. Justice and fairness in the Kennedy Krieger Institute lead paint study: The ethics of public health research on less expensive, less effective interventions. Am J Publ Hlth2006; 96: 781–87.
18.
EhniHJ. The definition of adequate care in externally sponsored clinical trials: the terminological controversy about the concept ‘standard of care’. Sci Eng Ethics2006; 12: 123–30.
19.
SchuklenkU. Protecting the vulnerable: testing times for clinical research ethics. Soc Sci Med2000; 51: 969–77.
20.
EdejerTTT. North-South research partnerships: the ethics of carrying out research in developing countries. BMJ1999; 319: 438–41.
21.
WolffJ. Global justice and health: the basis of global health duty. In Global justice and bioethics. EmanuelEMullianJ. eds. New York: Oxford University Press, 2011 (forthcoming).
22.
EmanuelEJWendlerDGradyC. What makes clinical research ethical?JAMA2000; 283: 2701–11.
23.
BuchananDRMillerFG. A public health perspective on research ethics. J Med Ethics2006; 32: 729–33.
24.
ZumlaACostelloA. Ethics of health care research in developing countries, J Roy Soc Med2002; 95: 275–76.