Trends in research involving human beings in Brazil.

Developing countries have experienced a dramatic increase in the number of clinical studies in the last decades. The aim of this study was to describe 1) the number of clinical trials submitted to the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, Anvisa) from 2007 to 2012 and the number of human-subject research projects approved by research ethics committees (RECs) and the National Research Ethics Committee (Comissão Nacional de Ética em Pesquisa, CONEP) in Brazil from 2007 to 2011 and 2) the diseases most frequently studied in Brazilian states in clinical trials approved in the country from 2009 to 2012, based on information from an Anvisa databank. Two databases were used: 1) the National Information System on Research Ethics Involving Human Beings (Sistema Nacional de Informação Sobre Ética em Pesquisa envolvendo Seres Humanos, SISNEP) and 2) Anvisa's Clinical Research Control System (Sistema de Controle de Pesquisa Clínica, SCPC). Data from the SCPC indicated an increase of 32.7% in the number of clinical trials submitted to Anvisa, and data from the SISNEP showed an increase of 69.9% in those approved by RECs and CONEP (from 18 160 in 2007 to 30 860 in 2011). Type 2 diabetes (26.0%) and breast cancer (20.5%)-related to the main causes of mortality in Brazil-were the two most frequently studied diseases. The so-called “neglected diseases,” such as dengue fever, were among the least studied diseases in approved clinical trials, despite their significant impact on social, economic, and health indicators in Brazil. Overall, the data indicated 1) a clear trend toward more research involving human beings in Brazil, 2) good correspondence between diseases most studied in clinical trials approved by Anvisa and the main causes of death in Brazil, and 3) a low level of attention to neglected diseases, an issue that should be considered in setting future research priorities, given their socioeconomic and health effects.

Barriers to conducting clinical research in reproductive medicine: Latin America.

Societies in Latin America are not scientifically driven and therefore, the allocation of human and economic resources to research is meager, as a reflection of this as well as other cultural and economic realities.

Moral imperialism and multi-centric clinical trials in peripheral countries.

Moral imperialism is expressed in attempts to impose moral standards from one particular culture, geopolitical region or culture onto other cultures, regions or countries. Examples of Direct Moral Imperialism can be seen in various recurrent events involving multi-centric clinical trials promoted by developed (central) countries in poor and developing (peripheral) countries, particularly projects related to the theory of double standards in research. After the WMA General Assembly refused to change the Helsinki Declaration - which would have given moral recognition to the above mentioned theory - the USA abandoned the declaration and began to promote regional seminars in peripheral countries with the aim of "training" researchers on ethical perspectives that reflect America's best interests. Individuals who received such training became transmitters of these central countries' ideas across the peripheral countries, representing a form of Indirect Moral Imperialism. The paper proposes the establishment of regulatory and social control systems for clinical trials implemented in peripheral countries, through the formulation of ethical norms that reflect the specific contexts of these countries, along with the drawing up and validation of their own national norms.

Ethical issues in the NIMH Collaborative HIV/STD Prevention Trial.

OBJECTIVE: To develop decision rules regarding key ethical dimensions in scientific protocols for the National Institute for Mental Health (NIMH) Collaborative HIV/STD Prevention Trial taking place in five countries (China, India, Peru, Russia, and Zimbabwe). DESIGN: Countries had HIV rates from 27 to 0.1%, the standard of care varied from access to antiretroviral drugs to no availability, and the reporting of sexually transmitted diseases (STD) to government agencies was mandatory in some countries and not in others. These variations presented challenges when developing decision rules that could be uniformly adopted across countries and simultaneously follow the ethical principles of beneficence, respect, and justice. METHODS: We used several strategies to identify and resolve ethical dilemmas for this international HIV prevention trial. First, we identified key principles, especially those derived for clinical therapeutic, biomedical preventive, or device trials. We convened a 'workgroup on protecting human participants' and charged them with identifying and implementing optimal procedures for ensuring the ethical and equitable treatment of participants and making recommendations to minimize physical, psychological, and social harm to the participants. Each site had a community advisory board, essential in identifying local ethical issues and possible resolutions to them. The NIMH established a data safety and monitoring board with ultimate responsibility for adjudicating ethical dilemmas and decisions. The protocols were deliberated thoroughly by the Trial steering committee, and approved by nine United States and five in-country institutional review boards. RESULTS: We summarize the decision rules adopted to resolve the ethical dilemmas identified. Especially important were the translation of clinical trials principles for a behavioral intervention trial, strategies for ensuring confidentiality and informed consent, dilemmas relating to partner notification of sexually transmitted infections including HIV, minimizing the risks of social harm, establishing community partnerships, ensuring equity among United States and in-country principal investigators, and building capacity for additional research. CONCLUSION: We document our processes and decisions, and their underlying rationales, and hope they contribute to the development of further thinking and practice regarding the ethics of social and behavioral HIV and STD prevention trials in resource-poor settings.

Responsabilidad del patrocinador después de un ensayo clínico / Responsability of sponsors after clinical trials are finished

Este artículo describe algunos problemas éticos derivados de los estudios multicéntricos en países en desarrollo, particularmente los referidos al rol de los patrocinadores luego de concluido un ensayo clínico. Luego de pasar revista a algunas normativas internacionales, propone un conjunto de obligaciones éticas para los patrocinadores de estos ensayos. Las evidencias mostradas hacia el final sugieren más bien pesimismo respecto de su cumplimiento.

This paper describes some ethical problems derived from multi center studies in developing countries, specifically those referred to the role of sponsors after the clinical trial is concluded. After reviewing some international norms, it proposes several ethical obligations fro sponsors of these trials. Finally, the evidence shows pessimism with respect to fulfilling them.

Este artigo descreve alguns problemas éticos derivados dos estudos muticêntricos nos países em desenvolvimento, particularmente os relacionados com o papel dos patrocinadores logo após a conclusão de um ensaio clínico. Após análise de algumas normas interaccionáis, propõe um conjunto de obrigações éticas para os patrocinadores destes ensaios. As evidências indicam um certo pessimismo quanto ao seu cumprimento.