title: Biobanking, consent, and commercialization in international genetics research: the Type 1 Diabetes Genetics Consortium.
abstract: BACKGROUND
  and
  
  
  OBJECTIVE
  This article describes several ethical, legal, and social issues typical of international genetics biobanking, as encountered in the Type 1 Diabetes Genetics Consortium (T1DGC).
  
  
  METHODS
  By studying the examples set and lessons learned from other international biobanking studies and by devoting considerable time and resources to identifying, addressing, and continually monitoring ethical and regulatory concerns, T1DGC was able to minimize the problems reported by some earlier studies.
  
  
  CONCLUSIONS
  Several important conclusions can be drawn based on the experience in this study: (1) Basic international standards for research ethics review and informed consent are broadly consistent across developed countries. (2) When consent forms are adapted locally and translated into different languages, discrepancies are inevitable and therefore require prompt central review and resolution before research is initiated. (3) Providing separate 'check-box' consent for different elements of a study creates confusion and may not be essential. (4) Creating immortalized cell lines to aid future research is broadly acceptable, both in the US and internationally. (5) Imposing some limits on the use of stored samples aids in obtaining ethics approvals worldwide. (6) Allowing potential commercial uses of donated samples is controversial in some Asian countries. (7) Obtaining government approvals can be labor-intensive and time-consuming, and can require legal and diplomatic skills.
authors.affiliation: Division of Public Health Sciences, Wake Forest University Health Sciences, Winston-Salem, NC 27157, USA. mhall@wfubmc.edu
authors.forename: Mark A
authors.initials: MA
authors.lastname: Hall
authors.forename: Nancy M P
authors.initials: NM
authors.lastname: King
authors.forename: Letitia H
authors.initials: LH
authors.lastname: Perdue
authors.forename: Joan E
authors.initials: JE
authors.lastname: Hilner
authors.forename: Beena
authors.initials: B
authors.lastname: Akolkar
authors.forename: Carla J
authors.initials: CJ
authors.lastname: Greenbaum
authors.forename: Catherine
authors.initials: C
authors.lastname: McKeon
mesh_terms: D035843:Biomedical Research / Q000941:ethics*; D002460:Cell Line; D003625:Data Collection / Q000941:ethics; D003922:Diabetes Mellitus, Type 1 / Q000235:genetics*; D032984:Ethics, Research; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D038622:Internationality; D014015:Tissue Banks / Q000941:ethics*