Title
A View from Inside: Regulation and Ethical Conflicts in Peru
Date Issued
01 January 2014
Access level
metadata only access
Resource Type
book part
Author(s)
Publisher(s)
Springer Science and Business Media B.V.
Abstract
In 1981 the President of Peru issued a decree to regulate pharmaceutical research in the country but the Ministry of Health did not register any clinical trial involving humans until 1995. The rapid growth in the number of clinical trials and trial participants that occurred during the following years led the Ministry of Health to revise the entire system for the authorization and supervision of clinical research in 2003. The authors of this chapter participated in the review, and they describe the process, the content of the different versions of the new regulations and the tension between the different stakeholders. The detailed description of the interests behind the annulment of a carefully crafted law regulating biomedical research only a few months after its approval reveals the political forces behind the big business that clinical trials respresent in Peru. In addition, this chapter provides information on the number of trials that have been conducted in Peru, the research centers involved, the sponsors and products tested, and characteristics of the research participants; it analyzes the capacity of the research ethics committees to fulfill their task, provides information on the results of the clinical trial inspections conducted by the regulatory authority and outlines the main challenges for the system of protection of human research participants.
Start page
251
End page
274
Volume
2
Language
English
OCDE Knowledge area
Políticas de salud, Servicios de salud
Subjects
Scopus EID
2-s2.0-85103847961
Source
Research Ethics Forum
ISSN of the container
22129529
Sponsor(s)
The co-operatives include: the Eastern Cooperative Oncology Group (ECOG); the European Organization for Research and Treatment of Cancer (EORTC); the Radiation Therapy Oncology Group (RTOG); the Gynecologic Oncology Group (GOG), and the Children’s Oncology Group (COG). Clinical trials conducted by the Cooperative Groups are sponsored by the US National Cancer Institute, one of the USNIH institutes, and by the pharmaceutical companies.
Supported the National Network of Ethics Committees, sponsored by NAMRID, whose operation is inconsistent with the institutional goals of OGITT – to safeguard the rights and safety of research subjects
Sources of information:
Directorio de Producción Científica
Scopus