title: Designing and implementing sample and data collection for an international genetics study: the Type 1 Diabetes Genetics Consortium (T1DGC).
abstract: OBJECTIVE
  The Type 1 Diabetes Genetics Consortium (T1DGC) is an international project whose primary aims are to: (a) discover genes that modify type 1 diabetes risk; and (b) expand upon the existing genetic resources for type 1 diabetes research. The initial goal was to collect 2500 affected sibling pair (ASP) families worldwide.
  
  
  METHODS
  T1DGC was organized into four regional networks (Asia-Pacific, Europe, North America, and the United Kingdom) and a Coordinating Center. A Steering Committee, with representatives from each network, the Coordinating Center, and the funding organizations, was responsible for T1DGC operations. The Coordinating Center, with regional network representatives, developed study documents and data systems. Each network established laboratories for: DNA extraction and cell line production; human leukocyte antigen genotyping; and autoantibody measurement. Samples were tracked from the point of collection, processed at network laboratories and stored for deposit at National Institute for Diabetes and Digestive and Kidney Diseases (NIDDK) Central Repositories. Phenotypic data were collected and entered into the study database maintained by the Coordinating Center.
  
  
  RESULTS
  T1DGC achieved its original ASP recruitment goal. In response to research design changes, the T1DGC infrastructure also recruited trios, cases, and controls. Results of genetic analyses have identified many novel regions that affect susceptibility to type 1 diabetes. T1DGC created a resource of data and samples that is accessible to the research community.
  
  
  CONCLUSIONS
  Participation in T1DGC was declined by some countries due to study requirements for the processing of samples at network laboratories and/or final deposition of samples in NIDDK Central Repositories. Re-contact of participants was not included in informed consent templates, preventing collection of additional samples for functional studies.
  
  
  CONCLUSIONS
  T1DGC implemented a distributed, regional network structure to reach ASP recruitment targets. The infrastructure proved robust and flexible enough to accommodate additional recruitment. T1DGC has established significant resources that provide a basis for future discovery in the study of type 1 diabetes genetics.
authors.affiliation: Department of Biostatistics, School of Public Health, University of Alabama at Birmingham, Birmingham, AL 35294-0022, USA. jhilner@ms.soph.uab.edu
authors.forename: Joan E
authors.initials: JE
authors.lastname: Hilner
authors.forename: Letitia H
authors.initials: LH
authors.lastname: Perdue
authors.forename: Elizabeth G
authors.initials: EG
authors.lastname: Sides
authors.forename: June J
authors.initials: JJ
authors.lastname: Pierce
authors.forename: Ana M
authors.initials: AM
authors.lastname: Wägner
authors.forename: Alan
authors.initials: A
authors.lastname: Aldrich
authors.forename: Amanda
authors.initials: A
authors.lastname: Loth
authors.forename: Lotte
authors.initials: L
authors.lastname: Albret
authors.forename: Lynne E
authors.initials: LE
authors.lastname: Wagenknecht
authors.forename: Concepcion
authors.initials: C
authors.lastname: Nierras
authors.forename: Beena
authors.initials: B
authors.lastname: Akolkar
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D003625:Data Collection / Q000379:methods*; D003922:Diabetes Mellitus, Type 1 / Q000453:epidemiology / Q000235:genetics*; D005260:Female; D005838:Genotype; D033161:Government Regulation; D006801:Humans; D038622:Internationality; D008297:Male; D016730:Program Development; D011786:Quality Control; D012107:Research Design; D012307:Risk Factors; D055815:Young Adult