Ethical Planning in Conducting a Research Project

Abstract

Countries that still do not have a national normative document on research ethics, like most African and Latin American countries, have taken the Declaration of Helsinki as a reference for ethical guidance to researchers and members of ethics committees. However, the literature has shown that the latest revisions of this declaration have tended to favor the interests of central countries and their industries, mainly through the more flexible acceptance of greater risks and smaller benefits. Even when there are norms adequate to the reality of each country, the ethical planning of a research goes far beyond the simple bureaucratic fulfillment of the norms that guide the presentation of a protocol and a consent term to a research ethics committee. It presupposes an in-depth reflection on the methodological procedures themselves that will involve the participants and on the ways in which they interact with the socioeconomic and cultural contexts of these participants' daily lives. In developing countries, consideration of social vulnerability, especially with regard to poverty and low levels of education, is a central element in this planning. I intend to discuss this planning taking the three classic axes of research subject protection: obtaining consent, minimizing risks and maximizing benefits in their relationship with contexts of social vulnerability in three modalities of health research: those that handle information from identifiable subjects, such as clinical protocols; those using interviews and questionnaires; and clinical trials for new drugs.