Future-use consent and human virome research: ethical challenges

Ethical frameworks and community engagement in HIV cure-related research at the end of life: looking back, moving forward.

PURPOSE OF REVIEW HIV cure-related research at the end-of-life has created a rare opportunity to study viral persistence in tissues that cannot be safely or repeatedly sampled during life. This review examines ethical frameworks and community engagement approaches in this field from 2016 to 2026, with attention to potential new scientific directions and implementation across diverse settings. RECENT FINDINGS The literature has developed important recommendations on informed consent, autonomy, dignity, altruism, patient-participant-centeredness, next-of-kin/loved one involvement, staff coordination, rapid research autopsy, and tissue stewardship. Much of this work has emerged from the Last Gift program and related studies in the United States, with growing documented evidence from Canada and emerging biospecimen infrastructure work in Brazil. As the field expands toward novel approaches, such as organoids, organ-on-chip systems, ex vivo models, and possible in vivo testing of HIV cure-related research strategies, ethical questions increasingly extend to tissue transformation, future use, commercialization, acceptable risk, oversight, and long-term governance. SUMMARY HIV cure-related research at the end-of-life has been ethically deliberate from the outset. The next task is to define the practices, safeguards, and engagement processes needed to conduct this work responsibly across more diverse cultural, legal, clinical, and community settings as scientific innovations evolve.

When does broad consent expire? A temporal validity framework for biobank samples in induced pluripotent stem cell research

Background. Induced pluripotent stem cell (iPSC) research increasingly draws on biobank samples collected years or decades earlier under broad consent for future unspecified use. We previously reported that the time elapsed between original sample collection and a proposed new use shaped whether community members and bioethicists regard the original broad consent as still sufficient, and identified this association as a novel finding, but we did not translate it into an operational standard. We address that gap in this paper. Methods. We conducted and analyzed key informant interviews with six Community Advisory Board (CAB) members and five bioethicists, and two focus group discussions with twenty community members, from a study of the YRI HapMap community in Ibadan, Nigeria. We coded the transcripts against two a priori axes - duration since original consent, and novelty of the proposed technology relative to what the original consent anticipated - supplemented by inductive codes. Reporting follows the COREQ-32 guidance. Results. Participants treated broad consent as durable but conditional rather than open-ended. Duration thresholds recurred across independent groups: renewal “at 5-year intervals,” a fixed “time limit… like 20 years,” and, at the permissive extreme, validity “to 50, 100 years.” Duration and technological novelty operated jointly rather than separately; several participants tied renewal explicitly to technology “changing,” and bioethicists distinguished elapsed time from the separate problem that the original consent language never contemplated iPSC-type uses. Anonymity of the original donors and continuity of the CAB shaped how participants resolved the two constraints, and several proposed the CAB as a surrogate re-authorizing body once individual re-contact was no longer feasible. We translate these findings into a four-state framework - presumptively valid, requires community reaffirmation, requires new authorization, and requires de novo consent - defined by elapsed-time bands crossed with a technology-novelty category. Conclusions. Elapsed time is not, by itself, an expiration date for broad consent. It is one input, alongside technological novelty and the persistence of trust infrastructure such as CAB continuity and community reporting, into a graded governance decision. The framework gives biobanks and research ethics committees a reproducible way to decide when broad consent for a sample collection still holds, when it needs reaffirmation, and when it does not.

The oriGen case and Mexico's regulatory blind spots in genomic biobanking.

The oriGen project represents a pioneering but institutionally anchored response to Mexico's regulatory gap. Yet, viewed through the lens of contemporary scholarship, its model-private university ownership, broad individual consent, and external sequencing partnerships-stands in tension with emerging global norms for equitable, transparent, and democratically governed genomic research.

Biotechnology’s Ethical and Reproducibility Crisis: Beyond the Hype

Modern biotechnology promises to cure diseases, feed the world, and address major ecological challenges. Yet a critical examination reveals that the field also faces significant ethical, reproducibility, and governance challenges that deserve rigorous scrutiny. Drawing on documented cases from gene therapy pricing controversies, CRISPR-based ecological interventions, and the biomedical replication crisis, this commentary argues that biotechnology’s most pressing challenge is not technical but ethical and structural. We identify systemic drivers including venture capital incentives, flawed publication norms, and regulatory gaps, and we propose concrete governance reforms. Importantly, we also highlight exemplary successes demonstrating that when properly governed, biotechnology can deliver transformative, equitable outcomes. The commentary concludes that sustainable progress requires measuring outcomes in lives improved rather than patents filed, and rewarding rigorous, reproducible science over speculative claims.

Deliberate infection in research: ethical perspective of controlled human infection studies.

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

BACKGROUND Biobank 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. METHODS This 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. RESULTS Patients 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. CONCLUSIONS These 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.