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2022, Number 1

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Revista Colombiana de Bioética 2022; 17 (1)

Companies in research on innovations in medicines

Gamboa-Bernal GA

Language: Spanish
References: 43
Page:
PDF size: 154.91 Kb.


ABSTRACT

Purpose/Background. The role of the pharmaceutical industry can be examined from multiple angles. The presence of these companies during the pandemic has been forced by the need to have, in the shortest possible time, vaccines capable of preventing infections and effective drugs to treat those affected, that is, the development of innovative products.
Methodology/Approach. From a bioethical perspective, it reflects on four issues related to the role of these companies in analogous circumstances: the responsibilities of the Sponsors in the research processes; contracting with Contract Research Organizations; the relationship with researchers and interaction with the Research Ethics Committees (IRB); and, finally, on a way to contain the double standard in research.
Results/Findings. The Sponsors have precise responsibilities that are guided by international documents and guidelines; there is a need for greater clarity in the work of CROs; researchers can improve interaction with IRBs; ethical dumping must be avoided.
Discussion/Conclusions/Contributions. It is concluded that the pharmaceutical industry has a role of co-responsibility in the production processes of innovative medicines with other actors, with whom it must maintain a transparent and fluid dialogue and must be guided not only by the Good Clinical Practice Guidelines, but mainly because of the Declaration of Helsinki. One medium can help eliminate the double standard in research: the TRUST Code; thus, pharmaceutical companies can contribute to improving the ethical culture of research.


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