Revising the declaration of Helsinki: ethics vs economics or the fallacy of urgency

Constant vigilance is required to ensure that the rights of volunteers in clinical trials are protected, particularly in developing countries. In this presentation to the XIII International AIDS Conference (abstract ThOrE651), Dirceu B Greco, of the Federal University of Minas Gerais in Brazil, describes the debate that has raged over the proposed changes to the Declaration of Helsinki, particularly with respect to access to medical care for trial volunteers and to the use of placebos in the control arms of the trials. The presentation argues: (1) that all trial volunteers should have access to the best diagnostic, preventive, and therapeutic methods, regardless of the standard of care in the countries where the trials are taking place; (2) that large efficacy trials of vaccines and drugs should be done first in countries where the best diagnostic, preventive, and therapeutic methods are available; and (3) that the costs of providing care and prevention services should be considered an integral part of the cost of the trials. The presentation explains how a partnership between activists, scientists, ethicists, and medical associations was effective in resisting pressures to lower the ethical standards for clinic trials. The presentation concludes that the gains made by this partnership constitute an important step in the struggle to provide universal access to education and health.