Reforming Biobank Consent Policy: A Necessary Move Away from Broad Consent Toward Dynamic Consent

Abstract

The field of genomic-based medicine has power in numbers. With the increasing ability of new technology infrastructures to allow streamlined data sharing, there is a rising potential for networks of data to accelerate genomicbased translational research. Networks of registries and biobanks are being formed that allow researchers access to more specimens and samples that further allow for studies of greater statistical significance (Kaye et al., 2012). The summer of 2013 saw a call from the Patient Centered Outcomes Research Institute for ‘‘patient-powered research networks’’ and ‘‘clinical data research networks’’ with the hope that they will be woven into a national clinical research network. This increase in data sharing intensifies long-held concerns about what is traditionally described as privacy and effective informed consent. A shift from the current biobank (and its associated registry; however, for the sake of this article, we will limit our comments to biobanks) paradigm of broad consent to a digitally based system of dynamic consent can help alleviate concerns attached to open databases of information and effectively involve participants in the research process and trial results. Attaining broad consent from individuals who participate in biobanks is the current norm (Steinsbekk et al., 2013). It is difficult for biobanks to achieve fully informed consent because the nature of future research is often unknown or widely variable (Kaye et al., 2011; Kaye et al., 2012). Therefore, until recently, it appeared that broad consent, in which donors consent to a range of experiments before participating in a biobank (Hofmann, 2009), was the only solution. Broad consent assumes that there is minimal risk to an individual donor and therefore that the benefit to research as a whole outweighs the risk an individual incurs by donating samples. Some argue that broad consent is ethical on the basis that consent can be revoked at any time, and in the event protocol changes, an ethics review board will make an informed decision of whether participants must be reconsented. Ethics review boards can decide, for example, that the use of deidentified information is sufficient to allow sample use without reconsent from the participant (Kaye et al., 2011). The argument for broad consent is sprinkled with a priori assumptions. First, the notion that there is minimal risk to the individual is no longer true in an age where even de-identified information can be traced back to an individual using public databases (Gymrek et al., 2013). Depositing a sample in a biobank does not have the same risks as physically participating in a clinical trial, but the ‘‘informational’’ risk is still of concern and can have unknown future adverse effects. Second, even if the option to revoke consent is available, donors cannot possibly revoke consent if they are not aware that their data are being used or for what they are used. Information sharing between biobanks and participants can somewhat alleviate this problem, but in cases where data or samples are already distributed, of course the individual cannot withdraw from that analysis. Third, ethics review boards are not always fully equipped to assess the safety of an individual’s information because of the unknown downstream affects of open, individual genetic information (Hofmann, 2009). The aforementioned pitfalls of broad consent could justifiably be overlooked in a previous era of limited communication between participants and biobank custodians, an era in which reconsenting for new research purposes would be costly and difficult, and would hinder the advancement of said research (Hofmann, 2009). However, in a highly digitized age with social media, electronic medical records, and advances in health information technology, it is time to reevaluate the process of broad consent and look to the paradigm of dynamic consent. United Kingdom academics and companies are testing dynamic consent as part of the EnCoRe (Ensuring Consent and Revocation) project (Wee, 2013). Dynamic consent is based on a patient-centric information technology system that allows individuals to set specific preferences for the use of their data. The system also allows participants to modify, change, or revoke their preferences over time. Participants can also track and audit changes made to their privacy settings. In addition, participants are able to choose when and how they would prefer to be contacted for future studies or for the reporting of results (Wee, 2013). The dynamic consent model is oriented around the participant and involves ongoing communication between the biobank, donor, and researchers. Ongoing communication fosters a culture of respect between participants and researchers and