title: Sharing individual level data from observational studies and clinical trials: a perspective from NHLBI.
abstract: There are numerous benefits to the research community from data sharing, and yet the open sharing of participant level data is not without potential pitfalls. In addition to the scientific community, the interests of study participants who volunteered their data must be considered, along with the interests of study investigators who expend a substantial amount of effort into the design, conduct, and analytical plans for the study. The National Heart, Lung, and Blood Institute (NHLBI) has developed a data-sharing protocol focused on balancing the interests of study participants, study investigators, and the research community with independent oversight by the NHLBI IRB. The data repository presently includes individual level data on more than 560,000 participants from 100 Institute-supported clinical trials and observational studies.
authors.affiliation: Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 10200, Bethesda, MD 20892, USA. coadys@nhlbi.nih.gov
authors.forename: Sean A
authors.initials: SA
authors.lastname: Coady
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Wagner
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards; D003299:Cooperative Behavior; D003628:Database Management Systems; D016208:Databases, Factual / Q000592:standards; D017408:Guidelines as Topic; D006801:Humans; D033181:Information Dissemination; D054555:National Heart, Lung, and Blood Institute (U.S.) / Q000592:standards; D028701:Patient Rights; D012107:Research Design / Q000592:standards; D012108:Research Personnel; D035842:Research Subjects; D013997:Time Factors; D014481:United States