[Regulatory requirements; What steps must be taken before starting a biomedical research study?]

Studies of research with human beings, their biological specimens, or their personal data in the field of biomedicine have been subject to regulation since the middle of the last century. Initially a regulation based on recommendations such as the Nuremberg Code, the Belmont Report or the first versions of the Declaration of Helsinki. All of them documents in which the principles (autonomy, beneficence, non-maleficence, and justice) were conceptualized, and that all researchers had to follow in the development of their research. This first phase is known as a period of self-regulation, because it is considered that the researchers themselves could, by following these recommendations, carry out their investigations without further control. Subsequently, it went through a clearly regulatory period in which the premises of these recommendations were progressively incorporated into the legal system of the different countries, and with this, arose the external control of the investigation by the administrations and other bodies, such as the Research Ethics Committees. The purpose of this article is to serve as a guide to professionals whose main activity is care in the field of Primary Care and who, in turn, are interested in initiating research studies to respond to uncertainties in the context of their daily activity that may arise.