title: Using EHRs to integrate research with patient care: promises and challenges.
abstract: Clinical research is the foundation for advancing the practice of medicine. However, the lack of seamless integration between clinical research and patient care workflow impedes recruitment efficiency, escalates research costs, and hence threatens the entire clinical research enterprise. Increased use of electronic health records (EHRs) holds promise for facilitating this integration but must surmount regulatory obstacles. Among the unintended consequences of current research oversight are barriers to accessing patient information for prescreening and recruitment, coordinating scheduling of clinical and research visits, and reconciling information about clinical and research drugs. We conclude that the EHR alone cannot overcome barriers in conducting clinical trials and comparative effectiveness research. Patient privacy and human subject protection policies should be clarified at the local level to exploit optimally the full potential of EHRs, while continuing to ensure participant safety. Increased alignment of policies that regulate the clinical and research use of EHRs could help fulfill the vision of more efficiently obtaining clinical research evidence to improve human health.
authors.affiliation: Department of Biomedical Informatics, Columbia University, New York, New York 10032, USA. cw2384@columbia.edu
authors.forename: Chunhua
authors.initials: C
authors.lastname: Weng
authors.forename: Paul
authors.initials: P
authors.lastname: Appelbaum
authors.forename: George
authors.initials: G
authors.lastname: Hripcsak
authors.forename: Ian
authors.initials: I
authors.lastname: Kronish
authors.forename: Linda
authors.initials: L
authors.lastname: Busacca
authors.forename: Karina W
authors.initials: KW
authors.lastname: Davidson
authors.forename: J Thomas
authors.initials: JT
authors.lastname: Bigger
mesh_terms: D022126:Access to Information; D035843:Biomedical Research / Q000458:organization & administration*; D057186:Comparative Effectiveness Research; D003219:Confidentiality / Q000331:legislation & jurisprudence*; D057286:Electronic Health Records; D028744:Ethics Committees, Research; D020408:Health Insurance Portability and Accountability Act; D006801:Humans; D018579:Patient Selection; D035842:Research Subjects / Q000331:legislation & jurisprudence*; D014481:United States