Challenges in creating an opt-in biobank with a registrar-based consent process and a commercial EHR.

Journal Article (Journal Article)

Residual clinical samples represent a very appealing source of biomaterial for translational and clinical research. We describe the implementation of an opt-in biobank, with consent being obtained at the time of registration and the decision stored in our electronic health record, Epic. Information on that decision, along with laboratory data, is transferred to an application that signals to biobank staff whether a given sample can be kept for research. Investigators can search for samples using our i2b2 data warehouse. Patient participation has been overwhelmingly positive and much higher than anticipated. Over 86% of patients provided consent and almost 83% requested to be notified of any incidental research findings. In 6 months, we obtained decisions from over 18 000 patients and processed 8000 blood samples for storage in our research biobank. However, commercial electronic health records like Epic lack key functionality required by a registrar-based consent process, although workarounds exist.

Full Text

Duke Authors

Cited Authors

  • Marsolo, K; Corsmo, J; Barnes, MG; Pollick, C; Chalfin, J; Nix, J; Smith, C; Ganta, R

Published Date

  • November 2012

Published In

Volume / Issue

  • 19 / 6

Start / End Page

  • 1115 - 1118

PubMed ID

  • 22878682

Pubmed Central ID

  • PMC3486732

Electronic International Standard Serial Number (EISSN)

  • 1527-974X

Digital Object Identifier (DOI)

  • 10.1136/amiajnl-2012-000960


  • eng

Conference Location

  • England