title: Brazilian guidelines for biorepositories and biobanks of human biological material.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors: National Commission on Research Ethics (CONEP), National Health Council, Department of Science and Technology (DECIT), Secretariat of Science, Technology and Strategic Inputs (SCTIE), Ministry of Health, Brasília, DF, Brazil. gabriela.marodin@gmail.com
authors: Gabriela
authors: G
authors: Marodin
authors: Jennifer Braathen
authors: JB
authors: Salgueiro
authors: Márcia da Luz
authors: Mda L
authors: Motta
authors: Leonor Maria Pacheco
authors: LM
authors: Santos
mesh_terms: D018070:Biological Specimen Banks / Q000941:ethics / Q000331:legislation & jurisprudence; D035843:Biomedical Research / Q000941:ethics*; D001938:Brazil; D006801:Humans; D007258:Informed Consent / Q000941:ethics