Many biobanks in the U.S. consent thousands of contributors of biospecimens and health information. There is growing interest in the efficiency of electronic consenting (e-consent) given the scale of these efforts. However, e-consent tools also need to promote diverse users’ understanding and trust, and demonstrate their effectiveness in comparison to traditional methods such as face-to-face (F2F) consenting. For e-consent to be successful, biobanks require well-designed e-consent tools that meet diverse user needs and preferences. Thus, empirical research on the design and effectiveness of e-consent is critical for biobank stakeholders to determine whether and how to implement e-consent processes.
The long-term objective of this three-year (R01) study is to improve the efficiency and effectiveness of informed consent through use of systematically developed e-consent tools. The immediate objective is to develop and test an interactive, multimedia (IM) e-consent tool based on theories of cognition and learning, resulting in guidelines for biobanks to develop their own e-consent processes. The specific aims of the study are to systematically (1) refine and evaluate a model process for developing IM e-consent tools for biobanking and (2) compare the effectiveness and efficiency of IM to standard F2F consent processes for biobanking.
For Aim 1, a prototype IM consent module, including a Spanish language version, will be developed with iterative feedback from biobank staff, IRBs, IT experts, and prospective users at three genetic biobank operations in the East, South, and Midwest. Focus groups and interviews will be conducted with stakeholders at each biobank, to generate insights into the utility of stakeholder engagement in the module development process. This aim of the study will generate essential guidance for biobanks and other research entities wanting to transition to e-consent. It will also provide three IM modules with which the study’s partner biobanks can begin consenting electronically.
In Aim 2, a multisite randomized trial will be conducted with a total of 700 participants at the study’s three partnering biobanks, including one site with a simplified (2-page) consent document and Spanish-language version. The trial will test the hypotheses that 1) individuals who use the IM multimedia consent tool will have better understanding and confidence in their understanding, higher trust in biobank research and higher satisfaction compared to individuals who complete the biobanks’ standard, F2F consents, when controlling for age, gender, race/ethnicity, education, computer self-efficacy and income; and 2) staff will spend less time in the IM consent process, compared to time spent in the biobanks’ standard, F2F consents. Significant numbers of traditionally underrepresented minorities will be enrolled in the trial. This aim of the study will provide empirical evidence for IRBs and the broader genomic research community to decide whether to move forward with electronic, IM consenting. Overall, the study is expected to contribute to ethical, cost-effective consenting efforts through in-depth empirical knowledge of IM e-consent technology.