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South African Journal of Bioethics and Law

versão On-line ISSN 1999-7639


RAGO, L  e  ZWEYGARTH, M. The CIOMS consensus report on clinical research in resource-limited settings. SAJBL [online]. 2022, vol.15, n.3, pp.1-4. ISSN 1999-7639.

BACKGROUND: Responsible clinical research drives the advancement of healthcare. Despite tremendous improvements in the global research and development environment since the 1950s, low- and middle-income countries (LMICs) are often left behind. There are several reasons for this. Firstly, operational, social, ethical and regulatory challenges in LMICs make it difficult for researchers to conduct clinical studies in those settings in line with international requirements. Secondly, many people living in low-resource settings distrust research because some past studies have not benefited the participants or the communities involved OBJECTIVES: To present the consensus recommendations by a Council for International Organizations of Medical Sciences (CIOMS) Working Group on how to advance good-quality, ethical clinical research in resource-limited settings METHODS: CIOMS convened a Working Group of senior scientists from drug regulatory authorities, the pharmaceutical industry, public-private partnerships for product development, and academia RESULTS: This article summarises the Working Group's report CONCLUSION: The report recommendations can foster the creation of a more enabling ecosystem for clinical research and promote collaboration between policymakers, regulators, researchers and funders

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