Introduction to Bioethics: The Boundary Between Research and Clinical Practice

Numerous documents referred to the protection of people and especially those in vulnerable situations in biomedical research have been published. More than 70 years ago the “Nuremberg Code” (1947) laid the groundwork for regulations on human experimentation [4]. Three basic elements became the foundation for subsequent codes of ethics and research regulations: voluntary informed consent, favorable risk-benefit analysis, and the right to withdraw without repercussions [5]. A year later the “Universal Declaration of Human Rights” (1948) [6] was announced, expressing acknowledge of the inherent dignity and the equal and inalienable rights of all members of the human family. However, after the publication of both documents, numerous events in clinical research affected the life, rights, or well-being of participants [7]. These events led to the publication and updating of new recommendations, such as the “Declaration of Helsinki” of 1964, adopted by the World Medical Association, in an attempt to formulate a more specific international code of ethics [8]. As biomedical research efforts expanded, the Declaration has required nine subsequent updates, the last in 2013. The amended version of 1975 stated that research p ro jec t s s h o u l d b e su b m i tted to an independent research ethics committee for a p p ro b at i o n a n d s u p e r v i s i o n . T h i s committee must review the scientific quality of the research proposal and its conformity w ith nat ional law, being i ts g uiding framework for the protection, welfare, and safety of participants [9]. Therefore, these commissions have a central role in the r e s e a r c h p r o c e s s b y i m p r o v i n g t h e truthfulness and quality of clinical research [10]. The translation of new insights provided by basic biomedical research into innovative methods of diagnosis and therapy requires a strict safety and efficacy evaluation before it is being approved as a routine validated inter vention [2]. All these promising advances also posed some troubling ethical questions [3].