Politics and Clinical Trials in the Province of Cordoba

Abstract

AbstractIt is estimated that about one third of the clinical trials conducted in Argentina occur in the province of Cordoba, home to only 10 % of the country’s total population. This chapter describes the evolution of the provincial regulatory framework, the organizational environment that allowed the development of a private research center within the premises of a public hospital, and the ensuing collusion between researchers and clinicians.Changes of the regulatory system coincide with political changes in the municipal and provincial governments. An investigation unveiled a series of problems including the diversion of public resources, the improper management of ethics committees and protocol approvals, and the use of coercive methods to expedite the recruitment of patients – often without informed consent. When, as a result of the investigation, the researchers were banned from the municipal hospital and health centers the provincial political leaders opened the doors of provincial health facilities, where they continued the implementation of clinical trials. In one instance, they conducted a trial despite the objection of the National Ministry of Justice. Eventually, one principal investigator and the research sponsor were fined for implementing a vaccine trial without informed consent.This chapter illustrates how the political context can allow financial and power gain to trump ethical and scientific considerations, and how the decentralization of the health sector led to poor collaboration between the national and provincial health authorities.KeywordsPrincipal InvestigatorPrivate InstitutionMunicipal HospitalPrivate CenterExpert ReportThese keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.