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2019, Number 1

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Revista Colombiana de Bioética 2019; 14 (1)

Ethics committees in research and the protection of subjects involved in clinical trials

Homedes N, Ugalde A

Language: Spanish
References: 59
Page: 146-160
PDF size: 263.04 Kb.


ABSTRACT

Introduction: The responsibility for protecting human beings involved in research has been delegated to the research ethics committees. The industry and the researchers consider that the CEI delay unnecessarily the initiation of the investigation and the Bioeticistas say that they do not have the resources to carry out their functions. The objective of this article is to identify the deficiencies and problems that affect the performance of the CEI that approve the protocols of clinical trials financed by the industry and the proposed solutions.
Methods: Review of the literature describing the characteristics of CEI located in high-income countries reviewing industry-financed clinical trials, performance, and strengthening suggestions.
Results: The problems affecting the functioning of the CEI have been known since the end of the last century, both regulatory entities and researchers have proposed ways to strengthen them, but only a few have been tried and none has been Institutionalized. It is striking that there are still no minimum training standards for CEI members, nor have they been provided with the resources to adequately monitor the implementation of the trials.
Conclusions: the need to professionalize the CEI benefits the industry. CEI, by reviewing protocols and monitoring the implementation of clinical trials and speaking with subjects, can detect behaviors that affect the quality of information collected and the safety of volunteers.


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