Analysis of ethical guidelines for epidemiological studies and biomedical research

Introduction. As biomedical researches on human subjects are including interactions or interventions with a living person occur, they are inherently controversial. Epidemiological studies encompass a wide range of research ranging from research into the causes of disease in the population, using molecular biology tools, to assessing health services, and analyzing social factors, establishing health and disease, to major studies of new public health and interventions to prevent disease. Shameful examples of dishonest behavior in research have been the result of the establishment of ethical rules and norms. Special considerations epidemiological researchers should have for maximize potential benefits of studies to research participants and community and to minimize potential harm, avoiding and disclosing conflicts of interests and protecting privacy and confidentiality. Objectives. The specific objectives of this research were: (i) to display and analyze basic ethical norms that are used as guides in conducting biomedical and epidemiological research; (ii) to analyze the similarities and differences in the requirements of ethical guides used in biomedical and epidemiological research; Materials and methods. In this research, the following methods were used to achieve the research objectives: documentary analysis of secondary data sources and comparative analysis. Secondary sources of data were used, documents of an international character and which are the leading guidelines for ethical assessment when dealing with epidemiological and biomedical research. Those are: (1) Declaration of Helsinki, (DoH) 2013; (2) International Ethical Guidelines for Health-Related Research Involving Humans, 2016; and (3) International Ethical Guidelines for Epidemiological Studies, 2009. Results. An analysis of the content of selected ethical guides related to epidemiological and biomedical surveys was done through a thematic analysis that focuses on the interpretation of meanings in order to demonstrate the basic ethical principles. Five main categories were identified, each divided into several relevant subcategories. Information policy (8); Protection of subjects (11); Particularly sensitive categories in research (4); Formal and operational requirements (9); Types of study (15). The results point to the compliance of these guides, but also to some inaccuracies and shortcomings. The fundamental principles of securing the ethics of research are: respect for autonomy, the principle of non-maleficence, justice and beneficence. Conclusion. The existence of ethical nominatives or guidelines, certainly introduces some rules in research, however, their existence does not ensure respect for ethical principles and norms in practice. Guidelines deal with ethical issues, but do not give instructions on how to implement a solution in practice, leaving space for researchers to different interpretations of a particular ethical question.