Implementation of Electronic Consent at a Biobank: An Opportunity for Precision Medicine Research

Abstract

The purpose of this study is to characterize the potential benefits and challenges of electronic informed consent (eIC) as a strategy for rapidly expanding the reach of large biobanks while reducing costs and potentially enhancing participant engagement. The Partners HealthCare Biobank (Partners Biobank) implemented eIC tools and processes to complement traditional recruitment strategies in June 2014. Since then, the Partners Biobank has rigorously collected and tracked a variety of metrics relating to this novel recruitment method. From June 2014 through January 2016, the Partners Biobank sent email invitations to 184,387 patients at Massachusetts General Hospital and Brigham and Women’s Hospital. During the same time period, 7078 patients provided their consent via eIC. The rate of consent of emailed patients was 3.5%, and the rate of consent of patients who log into the eIC website at Partners Biobank was 30%. Banking of biospecimens linked to electronic health records has become a critical element of genomic research and a foundation for the NIH’s Precision Medicine Initiative (PMI). eIC is a feasible and potentially game-changing strategy for these large research studies that depend on patient recruitment.

The use of electronic health records for psychiatric phenotyping and genomics

“…sun exposure, family history, and sleep habits) [Karlson and others 2016]. At this writing more than 60,000 patients have enrolled using face-to-face and electronic web-based informed consent [Boutin and others 2016] with approximately 2000 added monthly at Partners hospitals including Massachusetts General Hospital, Brigham and Women’s Hospital, and McLean Hospital. In addition to phenotypic data from the full longitudinal EHR (spanning approximately 20 years), we have used a method of unbiased automated feature extraction to build NLP-derived phenotypic algorithms that have been trained and validated by clinician chart review.…”

Patients’ experiences and preferences for opt‐in models and health professional involvement in biobanking consent: A cross‐sectional survey of Australian cancer outpatients

“…The act of processing, storing and distributing human‐biospecimens with associated clinical data for research purposes, otherwise known as biobanking, provides researchers with a powerful resource to examine longitudinal patient outcomes and the biomechanics of disease . By reducing the time and funds needed by individual researchers to collect, store and curate samples, these centralized repositories can help to facilitate the timely translation of research findings into improved patient outcomes …”

“…Biobanks are dependent upon high patient consent rates to provide sufficient numbers of samples, but also to ensure broad coverage of rarer cancers and varying patient and tumor characteristics . There are several options for the way in which individuals may provide consent and be recruited to donate biospecimens .…”

Online Education and e-Consent for GeneScreen, a Preventive Genomic Screening Study

“…In contrast, online education and consent (sometimes referred to as “econsent”) is likely to reach more people at a faster rate and let participants proceed at their own pace. It also may permit participants to choose how much information they review about a study and in what order, offering them more freedom to investigate elements of a study they deem most important [3]. …”