The Michigan BioTrust for Health is a unique biobank that, upon its incorporation in 2010, brought a staggering four million residual dried blood spots (DBSs) derived from newborn health screening to the scientific community for research purposes. This included contemporary DBSs with intact parental consent and retrospective DBSs collected without written consent (1984–2010). This leaves the BioTrust with a dual consent policy: opt-in parental-proxy for new specimens and opt-out for retrospective participants.
Even clear consent policies engender ethical dilemmas. Opt-out procedures maximize access to samples but minimize full participant autonomy, since individuals may be unaware the specimens exist. Moreover, ethicists question whether a participant’s agreement can ever be truly informed when opting into future research with unknown specifics.
To evaluate options for addressing these concerns, Thiel et al.1 recently simulated an online, dynamic instrument intended to educate and elicit tiered consent for the BioTrust. They assessed user experiences to determine the tool’s reception, accessibility and overall function.
Working with another company, the team developed an online consent portal and an educational website to recruit pilot testers. They created two test groups: one drawn from the general community via community meetings and promotional materials (92 participants) and one pulled from the student population of the University of Michigan, Ann Arbor (95 participants). Both pilot groups were well-balanced in terms of gender but differed in other factors such as race/ethnicity, education and age.
The reported overall user experience with the online portal was largely positive or neutral. 64.3% of the community pilot group and 68.7% of the student pilot group recorded the experience as “somewhat” or “very” positive. Other indicators of user experience included the following:
Perceived time for completion (~15–20 minutes)
| Community pilot | Student pilot | |
| Less time than anticipated | 42.9% | 17.4% |
| Right amount of time | 35.7% | 44.2% |
| More time than anticipated, but worthwhile | 16.1% | 17.4% |
| More time than anticipated, too long | 5.4% | 20.9% |
Ease of use
| Community pilot | Student pilot | |
| Easy to use | 82.1% | 89.5% |
| Some easy parts, some difficult parts | 10.7% | 8.1% |
| Difficult to use | 7.1% | 2.4% |
Willingness to recommend to others
| Community pilot | Student pilot | |
| Likely to recommend | 82.2% | 77.9% |
| Unlikely to recommend | 17.9% | 22.1% |
One particularly intriguing aspect of the portal addressed longitudinal consent. When asked if the participant preferred notification for consent purposes each time the BioTrust flagged an individual DBS for research, the results were mixed:
Permission each time DBS would be used
| Community pilot | Student pilot | |
| Agree | 85.7% | 58.1% |
| Disagree | 14.3% | 41.9% |
Thiel et al. report that the response to the online portal was largely positive, indicating its promise for real-world applications. They note that the time requirement and general ease of navigation elicited a positive response from most participants. The major challenge lies in ensuring privacy and security without overburdening the user or making the user uncomfortable with the process. Overall, this online tool could serve as a public access point for the BioTrust and similar entities, offering education and communication opportunities in an ever-evolving health information economy.
Reference
1 Thiel, D.B., et al. (2014) “Testing an online, dynamic consent portal for large population biobank research,” Public Health Genomics, doi: 10.1159/000366128.
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