Politics and Clinical Trials in the Province of Cordoba
It 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 orga
- PDF / 142,743 Bytes
- 17 Pages / 439.37 x 666.142 pts Page_size
- 10 Downloads / 172 Views
Politics and Clinical Trials in the Province of Cordoba Antonio Ugalde and Nuria Homedes
5.1
The Clinical Trial Regulatory Framework in Cordoba
As explained in Chap. 4, Argentina is a federation of 23 provinces and the autonomous Federal Capital. Each province has its own executive, legislative, and judicial governments. Each province has its own Ministry of Health that is responsible for the regulation of the health sector and the provision of medical care services for the poor. It is estimated that one third of all clinical trials conducted in the country take place in the Province of Cordoba, which houses about one tenth of the national population (Ferna´ndez 2005a). Recognizing this situation, the provincial government initiated the development of standards for clinical research involving humans. In 2001, the bioethics department of the provincial Ministry of Health designed a program for ethics in health research, which included the creation of a Provincial Commission for Ethics in Health Research (COPEIS in Spanish) to develop ethical standards, train professionals in research ethics, establish criteria for accreditation of Institutional Research Ethics Committees (IRECs), create a Provincial Registry for Health Research (RHR), and evaluate research protocols that could threaten the wellbeing of clinical trial participants. During the first two years (2001 and 2002), almost 200 professionals were trained in five-month classroom courses. The COPEIS started functioning in 2002 as part of a supervision unit of the provincial Ministry of Public Health, a status that
The authors would like to thank Juan Carlos Tealdi and Susana Vidal for their assistance and comments during the preparation of this chapter. The authors have sole responsibility for analysis and interpretation of the data. A. Ugalde Department of Sociology, University of Texas, Austin, TX, USA N. Homedes (*) School of Public Health, Division of Management Policy and Community Health, University of Texas Houston Health Science Center, El Paso, TX, USA e-mail: [email protected] N. Homedes and A. Ugalde (eds.), Clinical Trials in Latin America: Where Ethics and Business Clash, Research Ethics Forum 2, DOI 10.1007/978-3-319-01363-3_5, © Springer International Publishing Switzerland 2014
113
114
A. Ugalde and N. Homedes
gave it legitimacy and sanctioning powers. The beginning of the following year (2003) saw the approval of Ministerial Resolution 729/02, which included the criteria for accreditation of the IRECs and the model for the evaluation of research protocols. Only hospital-based IRECs would be accredited; ethics committees in non-hospital settings, such as those established by foundations or other research centers, would not be accredited in the Province of Cordoba, although they could be accredited in other parts of the country. At the end of 2003, 11 IRECs had been accredited in the Province, and the RHR was operational (Vidal 2006). Parts of the legislation – including the functions of the COPEIS and the decision to accredit only hospi
Data Loading...
