Declaração de Helsinki: relativismo e vulnerabilidade

Abstract

The Helsinki Declaration is a crucial ethical landmark for clinical research involving human beings. Since the Declaration was issued, a series of revisions and modifications have been introduced into the original text, but they have not altered its humanist approach or its international force for regulating clinical research. A proposal for an extensive revision of the Declaration's underlying ethical principles has been debated for the past four years. If the proposal is approved, international clinical research involving human beings will be modified, further increasing the vulnerability of certain social groups. This article discusses the historical process involved in passing the Helsinki Declaration and the most recent debate on the new draft. The article analyzes the new text's social implications for underdeveloped countries, arguing for a political approach to the vulnerability concept.

Conceitos de vulnerabilidade humana e integridade individual para a bioética

“…That is, they reduce the requirements of internationally accepted ethical standards in conducting clinical studies and, consequently, the costs of research, claiming urgency of cure 29,30 . Therefore, populations of peripheral countries are in situations of vulnerability, not necessarily through biological but by economic factors, since poverty and inequities in low-income countries make them attractive for research.…”

Clinical research monitoring: scenarios and challenges

“…Research volunteers have different socioeconomic conditions that directly impact their ability to consent to participate, and they are protected by legal frameworks that vary across countries and states. This vulnerability has been the subject of concern for more than five decades and the subject of discussion in the Declaration of Helsinki, a document that enshrines the basic principles of protection for study participants [7][8][9][10][11] . The challenge of conducting biomedical research in a variety of scenarios is directly related to the need for universal ethical principles in a multicultural world that exhibits multiplicities of health care systems with significant differences in healthcare standards [12][13] .…”

Vulnerabilidade e vida nua: bioética e biopolítica na atualidade

“…In this study, the author selected 50 reports on ethically questionable research on human beings that had been published in scientifi c journals, from which he revealed 22 examples conducted among patients in charity hospitals, children, mentally defi cient adults, prisoners and newborns. These individuals had not been given enough information or explanations about the objective or about the fact that research was being conducted, thereby making them mere experimental objects (Diniz & Corrêa, 13 2001).…”

“…One of the most signifi cant historical markers in the genealogy of the discipline was the publication of the book "Bioethics: bridge to the future", by Van Rensselaer Potter 21 (1971). However, André Hellegers, 13 at the University of Georgetown, was the fi rst to institute the term, with the objective of designating a new fi eld of activity, which gave rise to the so-called principlist school (Diniz & Guilhem,12 p.11). Within this school, bioethical refl ection was systematized by drawing up four principles: 1) autonomy, which starts from the presupposition that, to exercise freedom, an individual needs to be autonomous, i.e.…”

“…Much has already been said about the proposal to modify the Declaration of Helsinki, which was suggested by the World Medical Association in 1999, concerning the questions raised by the debate on standards of treatment and clinical trials (Diniz & Corrêa, 13 2001; Garrafa & Prado, 16 2001). This discussion originated in analyses of studies on prophylactic therapy aimed at preventing HIV transmission from mother to child, with placebo controls, which were sponsored by various international institutions and carried out in certain "developing" countries, particularly in Africa.…”