To support next-generation genomic research and science, many biobanks in the U.S. consent thousands of contributors of biospecimens and health information. Traditional paper-based consenting methods are inefficient given this scale of recruitment. For this reason, biobanks are expressing strong interest in electronic consent (i.e., e-consent), which is expected to be more efficient at enrolling patients (i.e., require less staff time), more reliable at delivering and documenting consent, and better aligned with the computer-use preferences of younger patients. For e-consent to be implemented among biobanks nationally, two major challenges must be addressed. First, there is the challenge of creating a high-quality e-consent process. Addressing this challenge will require systematic, multi-stakeholder input into the design and development of e-consent. Second, there is the challenge of showing that e-consent is at least as effective at promoting individuals’ understanding of a biobank’s informed consent document as compared to traditional paper-based consenting methods, given the importance placed on informed consent understanding in the ethics of research recruitment. By addressing these two challenges, this project aims to improve informed consent for the banking of human DNA and tissue through electronic technology. The immediate objective of the project is to develop and test an interactive, multimedia informed consent module for biobanking, following theories of cognition, learning and instructional design. The specific aims of the study are: 1. to systematically refine and evaluate a user-centered approach to the design and development of interactive, multimedia informed consent for biobanking, and 2. to systematically compare interactive, multimedia to standard, face-to-face consent processes at three U.S. biobanks (located in the East, South, and Midwest). In Aim 1, User-Centered Design theory and methods will be used to develop three interactive, multimedia consent modules. Focus groups and interviews with biobank staff, IRBs, IT experts, and lay persons will be conducted at three academic-based biobanks (located in the East, South, and Midwest) to identify preferences for the design and usability of the consent module prototypes. To evaluate the utility of this process, iterative changes to the design of the consent modules, based on stakeholder input, will be documented. This component of the study is expected to result in a widely usable approach with known utility for purposes of designing and developing e-consent processes. In Aim 2, a national, multisite, randomized trial will be conducted to test the hypotheses that 1) individuals who use an interactive, multimedia consent module will have better understanding, more confidence in their understanding of the consent information, and higher trust and satisfaction compared to individuals who complete each biobank’s standard, face-to-face consent, when controlling for age, gender, race/ethnicity, education, computer efficacy and income; and 2) biobank consenters will spend less time in the delivery of the interactive, multimedia consent module, compared to time spent in the biobanks’ standard, face-to-face consents. This component of the study is expected to result in evidence of the effectiveness and efficiency of interactive, multimedia consent across organizational settings and populations, thus providing a basis for biobanks nationally to move forward with efforts to electronically consent contributors of biospecimens and health information.
|Effective start/end date||8/10/15 → 5/31/19|
- University of Iowa (1001514516//5R01HG008348-03)
- National Human Genome Research Institute (1001514516//5R01HG008348-03)
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