Overview
At Stanford iGEM, we recognize that developing novel therapeutics for complex diseases requires rigorous ethical foundations alongside scientific innovation. Our LiRA (Logic Integrated RADAR) system represents a programmable RNA platform designed to deliver targeted immunotherapy for hepatitis B-associated hepatocellular carcinoma. As we advance this technology toward potential clinical application, we maintain unwavering commitment to conducting research that is scientifically sound, ethically responsible, and accessible to the communities who need it most.
Human Ethics
Patient perspectives have fundamentally shaped LiRA's development trajectory from our earliest design decisions. Through extensive interviews with advocates like Dr. Chari Cohen of the Hepatitis B Foundation and Dr. Jacki Chen, who brings both clinical expertise and lived experience as a chronic HBV patient, we learned that liver cancer represents a primary fear among people living with hepatitis B. This insight directly influenced our pivot from diagnostic-only approaches to therapeutic intervention. Similarly, we have documented every stakeholder interaction with explicit consent and adapted our science based on patient priorities. Moving forward, we're committed to expanding our community partnerships to include diverse linguistic and cultural perspectives, especially from Asia, the Pacific Islands, and Africa.
Informed Consent
When developing experimental RNA therapeutics for patients with life-threatening diseases, it is essential to prioritize a clear consent process. These patients often face limited treatment options, which can make them especially vulnerable to coercion. Before collecting any information, we ensure that participants are fully informed about the purpose of our research, the potential risks and benefits associated with LiRA's experimental nature, and how their data will be used to improve novel therapeutic outcomes. This process is designed to respect the autonomy of participants, promote transparency, and support ethical decision-making. Explicit consent is obtained for all responses and participants are able to withdraw at any time.
Data Privacy and Security
Privacy protection carries particular significance when researching diseases associated with social stigma and potential discrimination. Our comprehensive security protocols include encryption, anonymization, and restricted access measures designed to protect participants from potential professional or social harm that could result from their involvement in hepatitis B research. We maintain transparent policies about data collection, storage, and sharing while implementing safeguards that exceed standard research requirements to address the specific vulnerabilities of stigmatized populations. As our international outreach expands, we remain committed to upholding these rigorous privacy standards across diverse regulatory environments and cultural contexts, ensuring all participants are equally protected.
Environmental Ethics
Our laboratory practices adhere to comprehensive environmental responsibility standards, including proper sterilization and disposal of biological materials such as HEK293T and Hep3B cells through certified medical waste systems. We minimize environmental impact through recycling programs for laboratory consumables and sustainable research practices. As we consider potential large-scale therapeutic deployment, we evaluate manufacturing approaches that balance therapeutic effectiveness with environmental sustainability, including energy-efficient production processes and distribution strategies that reduce carbon footprint.
Therapeutic Safety and Responsibility
LiRA's dual-biomarker AND-gate design reflects our prioritization of therapeutic specificity and patient safety. Our approach requires both HBV integration markers and cancer-associated biomarkers for therapeutic activation, significantly reducing off-target effects compared to single-marker targeting strategies. Our selection of IL-2 as the therapeutic output followed extensive expert consultation, selecting a well-characterized immune stimulator with established clinical profiles over experimental alternatives with unknown safety profiles. We are committed to rigorous safety evaluation as LiRA progresses toward clinical translation. This includes dose-response evaluation and long-term monitoring protocols designed for RNA therapeutics.
Equity and Access
We believe that the benefits of our research should be accessible to everyone. Regions hit hardest by HBV-related liver cancer often lack the healthcare infrastructure and economic resources to access advanced therapies. We recognize that the high development and manufacturing costs of RNA-based treatments could limit their availability further. Our modular platform design facilitates adaptation for different biomarker combinations, supporting cost-effective personalized approaches that can serve diverse patient populations. We are committed to exploring differential pricing strategies that reflect local economic conditions and building collaborations with health organizations that prioritize global access to these therapies.
Ethical Oversight
Our research adheres to all relevant institutional, state, and national guidelines governing synthetic biology and therapeutic development. We maintain regular consultations with ethics boards, participate in professional development activities addressing emerging ethical challenges in RNA therapeutics, and implement comprehensive documentation and peer review processes. Our commitment includes transparent reporting of both research successes and limitations while protecting participant privacy and preventing potential misuse of platform technologies. We are dedicated to improving our practices as ethical challenges arise, ensuring that our research remains responsible, accountable, and aligned with the highest ethical standard.
Future Commitments
As LiRA progresses toward clinical application, we commit to establishing formal patient advisory councils with diverse community representation, developing measurable accountability mechanisms for our equity commitments, and maintaining ongoing responsiveness to emerging ethical challenges in programmable therapeutics. Our long-term vision extends beyond technical innovation to include meaningful partnerships with global health organizations and sustained impact on communities affected by hepatitis B and liver cancer worldwide, ensuring that scientific advancement adheres to ethical standards and achieves health equity goals.
Social Implications and Innovation
LiRA's development as a programmable platform represents a new approach to precision medicine that could influence broader therapeutic development for underserved populations. We are mindful of our responsibility to establish positive precedents for community engagement, cultural competency, and equitable access in synthetic biology applications. Our approach encompasses supporting informed discourse about RNA therapeutic technologies and their implications for healthcare systems, patient communities, and public attitudes in genetic interventions.