title: Precise definition of anonymization in genetic polymorphism studies.
abstract: Anonymization is an essential tool to protect privacy of participants in epidemiological studies. This paper classifies types of anonymization in genetic polymorphism studies, providing precise definitions. They are: 1) unlinkable anonymization at enrollment without a participant list; 2) unlinkable anonymization before genotyping with a participant list; 3) linkable anonymization; 4) unlinkable anonymization for outsiders; and 5) linkable anonymization for outsiders. The classification in view of accessibility to a table including genotype data with directly identifiable data such as names is important; if such tables exist, staff may obtain genotype information about participants. The first three modes are defined here as anonymization unaccessible to genotype data with directly identifiable information for research staff. Anonymization with a key code held by participants is possible with any of the above anonymization modes, by which participants can access to their own genotypes through telephone or internet. A guideline issued on March 29, 2001 with collaboration of three Ministries in Japan defines "anonymization in a linkable fashion" and "anonymization in an unlinkable fashion", "for the purpose of preventing the personal information from being divulged externally in violation of law, the present guidelines or a research protocol", but the contents are not clear in practice. The proposed definitions will be useful when we describe and discuss the preferable mode of anonymization for a given polymorphism study.
authors.affiliation: Department of Preventive Medicine/Biostatistics and Medical Decision Making, Nagoya University Graduate School of Medicine, Nagoya 466-8550 Japan. nhamajim@med.nagoya-u.ac.jp
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Hamajima
authors.forename: Yoshiko
authors.initials: Y
authors.lastname: Atsuta
authors.forename: Yoshimitsu
authors.initials: Y
authors.lastname: Niwa
authors.forename: Kazuko
authors.initials: K
authors.lastname: Nishio
authors.forename: Daisuke
authors.initials: D
authors.lastname: Tanaka
authors.forename: Kazuhito
authors.initials: K
authors.lastname: Yamamoto
authors.forename: Akiko
authors.initials: A
authors.lastname: Tamakoshi
mesh_terms: D035041:Anonymous Testing / Q000941:ethics*; D035843:Biomedical Research / Q000941:ethics; D003219:Confidentiality / Q000941:ethics*; D016021:Epidemiologic Studies; D005838:Genotype; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D007564:Japan; D011110:Polymorphism, Genetic; D011640:Public Policy; D009626:Terminology as Topic