The Ethics of Clinical Research in the Third World

Angell, Marcia

doi:10.1056/nejm199709183371209

Cited by 687 publications

(285 citation statements)

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“…Existen sobrados argumentos en contra de esta consideración, amparados todos en el principio ético de la justicia (3,5). Sin embargo, y aunque parezca increíble, hay quienes defienden el uso de estándares locales o incluso placebos, alegando que no tiene utilidad alguná para un pais en vías de desarrollo, someter individuos a una intervención reconocida como eficaz pero muy costosa y, por tanto, fuera de su alcance (4).…”

Section: La Revista Biomédica Del Lnstituto Nacional De Iunclassified

La responsabilidad ética en la fase III de los ensayos clínicos

Rodríguez¹

1999

biomedica

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Section: La Revista Biomédica Del Lnstituto Nacional De Iunclassified

La responsabilidad ética en la fase III de los ensayos clínicos

Rodríguez¹

1999

biomedica

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“…Some of those who believe that investigators have therapeutic obligations argue that study participants in the control arm are owed the worldwide best established intervention, independent of where they live (Angell, 1997;Nuffield, 2002;Macklin, 2004). For example, in the AZT trials described earlier, these commentators argued that the use of a placebo control was unacceptable and participants in the control arm should have received the long course of AZT, which was the best treatment available worldwide at the time.…”

Section: 'Acceptable' Risk From Withholding Treatment In Research In mentioning

confidence: 99%

“…A series of high-profile articles in The New England Journal of Medicine questioned the ethics of the then ongoing AZT (zidovudine) trials in LMICs (Angell, 1997;Lurie and Wolfe, 1997). Researchers were testing a short course of AZT to reduce the risk of maternal-infant HIV transmission, given that the complex and costly standard regimen in use in high-income countries (HICs) was neither feasible nor affordable in resource-poor settings.…”

Section: Controversy Around Placebo-controlled Trialsmentioning

confidence: 99%

Placebo-Controlled Trials, Ethics of

Graaf

Rid

2015

International Encyclopedia of the Social &Amp; Behavioral Sciences

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There are often good scientific and ethical reasons for using placebo controls in clinical trials. At the same time placebo use is controversial, especially when an established effective treatment is being withheld from the control group. This article gives an overview of the key ethical positions in the controversy around placebo-controlled trials. While some argue that placebo controls can only be used when withholding or delaying an established effective treatment poses no or negligible risks to participants, others hold that the risks should be low or acceptable in light of the social value of the knowledge to be gained from the research. The article also describes different positions on placebo use in trials in low-and middle-income countries where study participants may not have had access to an established effective treatment outside the trial.

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“…Short-course AZT was expected to be less effective than the standard AZT treatment available in developed countries. Critics argued that using placebo controls, rather than standard treatment as an active control, constituted a double standard-research forbidden on the wealthy would be carried out on the poor (2,3). Supporters countered that it is permissible to offer research participants in developing countries less-effective interventions than those used in developed countries if doing so (i) is scientifically necessary to answer an important question; (ii) does not deny anyone treatment they would otherwise receive; and (iii) is intended to develop interventions that will benefit the developing country (4).…”

Section: Four International Bioethical Issuesmentioning

confidence: 99%