Challenges of emerging countries: a relatively positive view for the future

Ruiz, Milton Artur

doi:10.5581/1516-8484.20120040

Cited by 4 publications

(4 citation statements)

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“…The increasingly bureaucratic, complex, and regulatory culture of research in wealthy countries places great burdens on investigators in terms of "compliance, documentation, and training" [1]. These hindrances can be easily overcome by outsourcing clinical trials to developing countries where, "the population size alone offers the promise of expanding markets" [2]. Trials in phases II and III can be easily conducted in these locations, "with the permission of the respective country's government and health authority" [3].…”

Section: Introductionmentioning

confidence: 99%

How can Clinical Research Trials Conducted in Developing Countries Minimize Exploitation?

Mukherjee¹

2021

ABCA

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Western scholars, pharmaceutical companies, and academic institutions are and have been conducting research in developing countries for many years. These locations boast substantial cost savings, expedited timelines, and little to no regulatory oversight, making them attractive to developed-world researchers. Residents of these communities are impoverished, often illiterate, unemployed, and with untreated health conditions. Because established ethical protocols for international research are often compromised or misconstrued by researchers and/or their sponsors, these individuals are left vulnerable to exploitation and abuse. In this paper, I explore how current utilization of ethical guidelines is enabling exploitation. I identify ethical questions regarding subject recruitment, informed consent, standard of care, and the post-trial obligations of researchers. I then examine specific situations in which exploitation occurred because of drug, vaccine, or clinical trials. I conclude by offering recommendations to create a more streamlined approach to international research that takes into account the experiences and needs of vulnerable populations. This approach helps ensure that participants are fully involved in the ethical approval process; able to choose whether or not to participate without any undue influence or pressure; treated with the standard of care best suited to their context and surroundings; and reasonably given access to any interventions proven effective during the course of the trial.. A respect for beneficence, justice, and self-autonomy should guide researchers’ interactions with subjects before, during, and after the trial.

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Section: Introductionmentioning

confidence: 99%

How can Clinical Research Trials Conducted in Developing Countries Minimize Exploitation?

Mukherjee¹

2021

ABCA

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“…In scientific terms, this can be seen in previous editorials of the Revista Brasileira de Hematologia e Hemoterapia (RBHH) and by checking the Scimago Journal Rank (SJR - www.scimagojr.com). We note that the scientific production of Brazil is increasing rapidly with the forecast that it will be one of the top ten science-producing nations in the not too distant future (1,2) .…”

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confidence: 96%

Reviews and guidelines: Evidence of progress and a starting point for standardization and changes

Ruiz¹

2013

Revista Brasileira De Hematologia E Hemoterapia

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“…Even with the difficulties of a scientific journal that relies on its own finances, it is necessary to learn from the lessons of this and previous events: to overcome barriers, organize the journal's structure, to prepare a fearless and dedicated editorial staff, to expand the editorial board with international members, to start to publish in English and after two years in Lilacs, ExtraMed Scopus and SciELO become indexed in PubMed thereby giving definitive and international visibility to articles (8-11) . We consider this moment in the history of the journal to be an extremely special, but emblematic, one as achieving indexation in PubMed should just be considered another step in the evolution of the journal, a step that gives a greater degree of responsibility to the hematology and transfusion medicine community as a whole.…”

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confidence: 99%

Challenges of emerging countries: a relatively positive view for the future

Cited by 4 publications

References 4 publications

How can Clinical Research Trials Conducted in Developing Countries Minimize Exploitation?

How can Clinical Research Trials Conducted in Developing Countries Minimize Exploitation?

Reviews and guidelines: Evidence of progress and a starting point for standardization and changes

The journal in PubMed and the lessons of the SciELO/Fapesp seminar on journal performance

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