The ELSI (Ethical, Legal and Social Implications) Program of the NIH/NHGRI has a history of supporting research to guide and improve informed consent policy and practice for genomics research and testing (McEwen et al. 2014). New models for simplifying genomic consent documents and processes are being developed (e.g., Beskow et al. 2010). Yet efforts to improve individuals’ understanding of research participation have proved challenging, including video and other media interventions (Flory & Emanuel 2004, Nishimura et al. 2013). While some multimedia interventions have been successful at impacting understanding (e.g., Dunn et al. 2001; Karunaratne et al. 2010), others have not. Few studies of electronic consent, however, have been theory-driven and carefully controlled with respect to interactivity and multimedia (IM).
Our efforts focus on IM as a vehicle for electronic consent. Our recent work (Klein & Schartz 2012; Klein, Schartz & Simon 2014) and that of others (e.g., Mahnke et al. 2014; Rowbotham et al. 2013) suggest that informed consent understanding can be improved by combining interactivity with multimedia, and indirectly by involving lay and expert stakeholders in the design and development process. These efforts align with survey work showing that many people would like to consent electronically to research. McCormick (2014) found that patients in a hypothetical study at the Mayo Clinic were highly receptive to electronic consenting, regardless of whether they participated in the paper-based or electronic consent condition of the study. In another study (Brink 2006), individuals presented with a Phase II cancer trial consent document in multimedia and paper formats reported that the multimedia version was “easier to read and understand, more interesting and exciting, [and] more informative and effective in getting points across.” Web-based tools are also being recommended as a means to keep research participants informed and to give them management options with respect to research participation (e.g., Holm & Taylor 2012; Tabor et al. 2012).
Apart from improving understanding and aligning with people’s preferences, e-consent also offers a potentially more efficient way to obtain consent. Many biobanks are seeking cost-saving infrastructures (Bowton et al. 2014). U.S. biobanks average almost a half a million (461,396) biospecimens, with a median of 8,000 (Henderson et al. 2013). Even with a ratio of 5 or fewer specimens for each contributor, this means that many biobanks approach thousands of individuals. On this scale, traditional consenting methods require significant personnel support, which can be costly, even prohibitively so, for large-scale operations (Ahmed 2011). IM technology may allow staff to reduce their time conveying basic information, while still being available to address participants’ questions or concerns. This may help reduce costs for biobanks, promote understanding, and minimize misunderstanding on the part of informed consent participants. Yet, while it is often assumed that e-consent will translate into improved efficiency, data are needed to establish more firmly how electronic consenting methods will affect staff time in the consent process.
Significance Summary: The proposed research is significant, in our opinion, in that it addresses a growing demand for pragmatic solutions to the challenges of informed consent for large-scale genetic, genomic and other (e.g., clinical, pragmatic and community-based) research studies. Yet two major challenges need to be addressed before e-consent can be widely and successfully implemented. First, guidance is needed on how best to design and develop high-quality (i.e., efficient and effective) e-consent tools. This study will document the utility of stakeholder engagement in the development of IM tools, with the goal of ensuring that these tools reflect contextual preferences and needs, and are more usable as a result. Thus, Aim 1 of the study will contribute to the national literature a model process for effective e-consent tool design and development. The other major need currently is for evidence of both the effectiveness and efficiency of IM consent tools in diverse populations. The study will address this need by conducting a multisite randomized trial comparing an IM consent process to a standard F2F process, which includes a Spanish language version and a 2-page simplified consent document. The results of this trial will provide empirical data on the effectiveness (i.e., capacity to promote understanding) and efficiency (i.e., staff time in the consent process) of IM consent for biobanking. It may also be possible to adapt the IM approach developed in this study to consent processes for clinical genomic testing, where concerns about consent efficiency (e.g., Berg et al. 2011) and effectiveness (e.g., Sharp 2011) are also emerging. Thus, the impact of this study is expected to be highly significant for the potential to advance genomic research and medicine in general through pragmatic and ethical electronic consenting.