Patient and IRB perspectives on biobank consent models: implications for international policy from Taiwan.

backgroundBiobank consent models are contested globally. The EU's GDPR Article 89, the US revised Common Rule (2018), and international guidelines offer divergent approaches to balancing participant autonomy and research efficiency. Despite ongoing policy debate, empirical evidence comparing research ethics oversight bodies (IRBs) with potential participants remains limited, particularly in Asia, where rapid biobank development has proceeded with limited stakeholder input. Taiwan's Human Biobank Management Act provides an opportunity to examine whether governance frameworks adequately address diverse stakeholder concerns.

methodsThis cross-sectional survey compared the perspectives of 154 patients and 147 institutional review board (IRB) members in Taiwan regarding biospecimen consent preferences, privacy concerns, governance-related attitudes, and willingness to provide biospecimens. Participants completed a questionnaire including a single item assessing willingness to provide biospecimens, a 6-item privacy concern scale, and a 4-item governance-related confidence/expectations index derived from governance-related items in the original questionnaire, as well as items on consent model preferences. Multivariable logistic regression was used to identify independent predictors of willingness to provide biospecimens.

resultsPatients more frequently endorsed tiered consent (61.0% vs. 45.6%, p = 0.012) and were more willing to provide biospecimens (61.7% vs. 47.6%, p = 0.014) than IRB members. Privacy concerns did not differ significantly between groups (p > 0.05), and governance-related index scores were also similar across groups. In the multivariable analysis, IRB membership was independently associated with lower willingness to provide biospecimens (adjusted odds ratio AOR = 0.52, p = 0.010), whereas higher governance-related index scores were associated with greater willingness (AOR = 2.08, p = 0.010). Other variables, including age, sex, marital status, education level, prior research participation, and high privacy concern, were not significant predictors.

conclusionsThese findings suggest that willingness to participate in biobank research is shaped by stakeholder role and governance-related attitudes, not by consent model preferences alone. Consent models should therefore be considered one component of a broader governance framework that also includes transparency, oversight, and privacy protections. Because the governance-related index likely captures multiple related dimensions, including governance expectations, support for regulatory safeguards, and confidence in oversight mechanisms, rather than trust alone, the observed associations should be interpreted cautiously. Future research using psychometrically validated measures of trust, governance literacy, and risk perception will be important for disentangling these constructs and confirming the nature of the observed relationships.