ARGENTINA

National Guidance

A National Advisory Committee in Research Ethics was established in 1988.
Decree 426 (1998)

The regulatory body for clinical trials and pharmaceuticals in Argentina is ANMAT. (Administracion Nacional de Medicamentos y Tecnologia Medica [National Administration for Drugs, Food and Medical Technology]), under the Ministry of Health. An ANMAT decree established a set of procedures for clinical trials.Decree 5330 (1997).

ANMAT guidelines for the submission and approval of research protocols involving human subjects.Guidelines

Legislation proposed in 2004 would regulate research ethics committees. Text of Proposed Law

Provincial Guidance

Buenos Aires

Law 24.742 (1996) establishes hospital ethics committees, but the roles of clinical ethics committees and research ethics committees are not clearly defined.

Río Negro State

Law 3099 (1997) establishes a Provincial Ethics Committee, although the functions are not clearly defined.

Other Resources

A quasi-governmental ombudsman issues a report in 2002 about irregularities in cancer drug research, especially regarding multicenter studies of off-label drug use.
Ombudsman Report
Criticism of Cancer Protocols by Academician

Presentation from AMA (Argentine Medical Association) during the commemoration of the 120th anniversary of the organization . This presentation offers a set of rules and proposals for monitoring and evaluating clinical trials in Argentina and it goes beyond the official current regulations.
PowerPoint Presentation

Bioetica.org, a leading Argentinian bioethics organization, maintains a Website with resources on a variety of topics, including human subjects protection guidance and legislation.