OBJECTIVE: To characterize the participatory and democratic creation of the Brazilian guidelines for biorepositories and biobanks of human biological material with the purpose of research based on the ethical principles of human dignity, autonomy, beneficence, justice, and precaution. METHODS: An interdisciplinary work group was constituted to prepare the document, considering the following criteria: experience in biobank operation, regional representation, type of stored biological material, and bioethics specialists. Members of the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária - ANVISA), also participated due to their regulatory competence. Members from the National Commission on Ethics in Research (Comissão Nacional de Ética em Pesquisa - Conep) participated as the social control organization. RESULTS: The document, based on ethical, legal, and technical guidelines, presents the concepts, activities, purposes, and differences between biorepositories and biobanks; forms of consent on the part of the subject; in addition to other aspects permeated by concerns regarding the appropriate use of information. The Brazilian guidelines for biorepository and biobank of human biological material with the purpose of research contains 39 articles, which are distributed in five chapters. CONCLUSION: The importance of legislation arises from the ethical concern, considering morals and taking into account the legal aspects, which translate into a document that does not end in itself. The dynamics of science always leads to changes in paradigms, which can go beyond the existing laws.
Bioethics; Biobanks; Biorepositories; Guidelines