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.