Doctors and nurses working on ethical issues within Healthcare. Image by Getty Images Signature via Canva.
Guadalupe Hayes-Mota is director, bioethics at the Markkula Center for Applied Ethics. Views are his own.
This article, "Using the CARES Framework to Build Ethical Biotech Startups" , originally appeared on Forbes.com and is reprinted with permission.
In my experience, launching a biotech startup is one of the most thrilling and consequential ventures a person can undertake. It combines the drive of entrepreneurship with the weight of human health. But when I founded my own healthcare company, I quickly realized that the hardest challenges weren’t only scientific or financial—they were ethical.
Every decision—from which disease to target to how data is used—has moral implications. Yet ethics is too often treated as a compliance box to check rather than a source of innovation and trust. Building an ethical business from day one can be a strategic advantage that attracts partners, talent and investors who care about long-term impact.
Drawing from my experience leading in both biotechnology and artificial intelligence, I developed a practical model for founders who want to integrate ethics into their company’s DNA: the CARES Framework. While my last article covered this model in relation to ethical AI usage, this one will focus more broadly on why and how biotech founders can use the five principles of the CARES Framework to implement ethics at their core.
1. Clinical Accuracy
Every biotech founder starts with a hypothesis. In my experience, ethical entrepreneurship demands that we have humility about uncertainty. Clinical accuracy means committing to rigorous validation and transparency about what your product can and cannot do. Too often, early-stage companies rush to make bold claims to attract funding. The temptation is understandable, but exaggerating results or cutting corners in validation can have devastating consequences for patients and investors alike.
I recommend implementing an internal “truth audit” to review every claim and algorithmic output before communicating externally. My company found that this reduced regulatory risk and built credibility. Ask yourself and your team, "Are our scientific claims reproducible? Are we transparent about limitations?" Truth is important for building trust, and trust is one of biotechnology’s core currencies.
2. Accessibility And Equity
Another element of ethical design involves asking who benefits—and who might be left behind. To be truly effective, accessibility and equity should be built into your product and system design, not added later as PR gestures. For example, an AI diagnostic tool trained on one population risks misdiagnosing others. Likewise, pricing strategies that make lifesaving therapies unaffordable betray the purpose of biotech innovation.
Track inclusion metrics alongside your technical milestones. This might look like taking extra steps to ensure your algorithms include data from underserved regions, or partnering with clinics in low-resource settings. This isn't always easy, but I've seen how transformative it can be: Designing for inclusion can expand your market, strengthen trust and align your company with the movement toward health equity by design.
3. Responsibility And Oversight
Startups grow fast, and so do ethical risks. Founders often think about oversight only after a funding round or regulatory audit, but I've found that true responsibility requires proactive governance. Creating an internal ethics committee, even a lightweight one, can help prevent blind spots and reinforce accountability. For example, consider forming a small advisory board that meets quarterly to review ethically significant decisions.
From my time in global pharmaceutical operations, I've learned that oversight doesn’t slow innovation—it strengthens it. Teams tend to make better decisions when someone asks, “Is this responsible?” before major milestones. What's more, many investors favor startups that show ethical foresight. Responsibility is not a constraint; it’s a framework for sustainable growth.
4. Ethics In Data Privacy
I expect that the next wave of biotech innovation will depend on rebuilding public trust in data. AI and biotech intersect through data—genomic, clinical, behavioral—but behind every dataset is a person. Patients deserve agency in how their data is used, shared and monetized.
Go beyond mere HIPAA or GDPR compliance and allow privacy to evolve into partnership. This can look like transparent consent, opt-out options and clear communication with your clients about their benefits. For example, when training AI models on de-identified clinical data, my company built explainability dashboards showing where predictions came from. This transparency deepened our collaboration with hospitals and helped us reassure patients that their information served a collective good.
5. Social Accountability
The final pillar—social accountability—anchors what I believe should be the ethical purpose of any business: improving lives. If a startup focuses solely on valuation, they're likely to miss broader measures of success.
Social accountability looks like connecting company growth to public benefit, tracking your impact regularly, ensuring environmental responsibility in lab operations and fostering community partnerships to reach those most in need. In my startup, our guiding question was simple: "Does our technology move the needle on equitable access to medicine?" That question has helped shape our product design, partnerships and employee incentives, turning ethics into measurable outcomes.
Considering how you can track metrics such as how many lives your projects improve, how much waste is reduced or how many underserved patients are reached. These are not “soft” metrics; they help define ethical biotechnology.
The Ethical Startup Flywheel
Practiced together, the CARES principles can create a self-reinforcing cycle—a flywheel of ethical growth.
• Accuracy earns trust.
• Equity expands markets.
• Responsibility helps ensure resilience.
• Ethical data use protects reputation.
• Social accountability fuels loyalty and purpose.
This flywheel can allow you to build a community of employees, investors and patients aligned by shared values. In biotech, where products literally touch human life, I have found that ethics need to be more than just an accessory—they should be our operating system.
Putting It Into Practice
How can founders bring this to life? Here are some small but intentional steps to get you started:
• Write an ethical charter alongside your business plan.
• Conduct an ethics risk map. Where could harm occur?
• Create an advisory circle of scientists, ethicists and patients.
• Publish equity and impact metrics.
• Train your team to discuss ethical dilemmas openly.
Ethical entrepreneurship isn’t about perfection; it’s about reflection and accountability. Mistakes will happen. What matters is building systems that can identify them early and help you course-correct transparently.
Conclusion
When I look back on my career, from managing global supply chains to founding a healthcare startup, the common thread has been purpose. The question isn’t "Can we build it?" but "Should we build it—and for whom?"
Biotechnology can cure, extend and transform life. But based on my experiences, its full potential can only be realized when innovation and ethics advance together. To every scientist-founder at the edge of discovery: How can your business plan not only explain how you’ll succeed, but also why your success should exist?