title: Global requirements for DNA sample collections: results of a survey of 204 ethics committees in 40 countries.
abstract: The Industry Pharmacogenomics Working Group has an interest in attaining a better understanding of global requirements for sample collections intended for pharmacogenetics research. To have adequately powered pharmacogenetics studies representative of the clinical trial population, it is important to collect DNA samples from a majority of consenting study participants under many institutional review board/ethics committee (IRB/EC) jurisdictions. A survey was distributed to gather information from local and central IRBs/ECs. The survey included questions related to the approval of pharmacogenetics studies, collection and banking of samples, and return of data to subjects. A total of 204 responses were received from global IRBs/ECs with pharmacogenetic experience. The data show that requirements for approval of pharmacogenetic research differ between IRBs/ECs within and between countries but not between regions of the United States. A better understanding of differing requirements should facilitate global sample collection of DNA for pharmacogenetics research and may provide the basis for harmonized regulations for collection of genetic samples in the future.
authors.affiliation: Johnson & Johnson Pharmaceutical Research and Development, Raritan, New Jersey, USA. dricci@its.jnj.com
authors.forename: D S
authors.initials: DS
authors.lastname: Ricci
authors.forename: E D
authors.initials: ED
authors.lastname: Broderick
authors.forename: A
authors.initials: A
authors.lastname: Tchelet
authors.forename: F
authors.initials: F
authors.lastname: Hong
authors.forename: S
authors.initials: S
authors.lastname: Mayevsky
authors.forename: D M
authors.initials: DM
authors.lastname: Mohr
authors.forename: M E
authors.initials: ME
authors.lastname: Schaffer
authors.forename: A W
authors.initials: AW
authors.lastname: Warner
authors.forename: P
authors.initials: P
authors.lastname: Hakkulinen
authors.forename: A
authors.initials: A
authors.lastname: Snapir
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods; D004247:DNA / Q000032:analysis*; D003625:Data Collection; D015195:Drug Design; D028744:Ethics Committees, Research / Q000706:statistics & numerical data*; D006801:Humans; D010597:Pharmacogenetics / Q000379:methods*; D013048:Specimen Handling / Q000379:methods
chemical_list: D004247:DNA