Bioethics of biomedical risks

Abstract

Informed consent (IC) for medical procedures and research protocols bases on a benefit/risk evaluation. Sophisticated therapeutic procedures and advanced biomedical investigations may entail considerable risks, even if benefits for participants are marginal or nonexistent, especially in non-therapeutic studies. To facilitate participants’ recruitment, it has been proposed to stress non-specific medical benefits or vaguely appealing to common good that, thus, would foster what stimulates false therapeutic expectations. Information on risks is incomplete, mitigating the magnitude or possibility of negative effects, and by resorting to minimal riskcs doctrine to recruit both autonomous people and those with impaired mental competence. Cultural and socioeconomic barriers between researchers and the population from poor nations, which host the studies, have promoted the idea of vulnerable ones, defined as the incapacity to look after their own interests that unduly establishes paternalistic relationships, approaching to colonialism. Ethics committees should be stringent in their evaluations to protect those who are incorporated into procedures of uncertain benefits and unknow risks or higher than informed.