Testing an Online, Dynamic Consent Portal for Large Population Biobank Research

Abstract

Background: Michigan's BioTrust for Health, a public health research biobank comprised of residual dried bloodspot (DBS) cards from newborn screening contains over 4 million samples collected without written consent. Participant-centric initiatives are IT tools that hold great promise to address the consent challenges in biobank research. Methods: Working with Private Access™ Inc., a pioneer in patient-centric web solutions, we created and pilot tested a dynamic informed consent simulation, paired with an educational website, focusing on consent for research utilizing DBSs in Michigan's BioTrust for Health. Results: Out of 187 pilot testers recruited in 2 groups, 137 completed the consent simulation and exit survey. Over 50% indicated their willingness to set up an account if the simulation went live and to recommend it to others. Participants raised concerns about the process of identity verification and appeared to have little experience with sharing health information online. Conclusions: Applying online, dynamic approaches to address the consent challenges raised by biobanks with legacy sample collections should be explored, given the positive reaction to our pilot test and the strong preference for active consent. Balancing security and privacy with accessibility and ease of use will continue to be a challenge.

Dynamic Consent: a potential solution to some of the challenges of modern biomedical research

“…The technology to gather and securely store Dynamic Consent records can be developed so that it is durable despite rapid software advances and meets security expectations similar to requirements for electronic health records [60]. For instance, online consent may be valid only if provided with an official e-identity or unique user name and password given by public services [30]. In principle, the Dynamic Consent platform can also be linked to other information systems such as Laboratory Information Management Systems in biobanks [24] and electronic patient records [33].…”

Use of Archived Neonatal Bloodspots for Examining Associations between Prenatal Exposure to Potentially Traumatic or Stressful Life Events, Maternal Herpesvirus Infection and Lifetime History of Generalized Anxiety Disorder in Offspring

“…While 78.3% of women who completed the interview portion of the pilot study were willing to be mailed consent materials for participation in the bloodspot portion of our study, only 44.4% returned the consent form to study staff. It is possible that alternative processes for obtaining individual consent for use of bloodspot samples archived in the MNB, such as a recently proposed web-based portal (Thiel et al, 2015), could both serve as a more effective medium for providing participants information about consent options and increase participation rates in future studies by lowering participant burden.…”

Dwarna: a blockchain solution for dynamic consent in biobanking

“…Although transparency is dependent on the biobank's functioning, laws and regulations like the GDPR heap responsibility on entities within the European Union to protect research partners' personal data. Nevertheless, the technological solutions that host dynamic consent evoke concerns of privacy [39,40] and security [39]. In healthcare, the blockchain model is emerging as one solution to these issues by contributing transparency and accountability [41].…”