Why Information Integrity Is an Moral Obligation, Not Only a Scientific One

Biomedical research is entering a new era—one in which human biology is no longer treated as the final validation step but as the foundation for the entire process. Advances in access to human tissue, improved integration of clinical data, and new experimental human models are accelerating the field’s ability to study disease in systems that more directly reflect the human condition.

Regulators are reinforcing this shift. The US Food & Drug Administration (FDA), National Institutes of Health (NIH), and international agencies have increasingly emphasized the need for human-relevant evidence and translational rigor. This shift reflects a broader recognition that many of the costliest failures in drug development stem from a familiar root cause, which is preclinical models that fail to predict human outcomes. This momentum is reshaping how biomedical data is generated. But it also raises a more fundamental question: What does ethical stewardship require when science is built on altruistically donated human tissue and data?

When human-derived samples and data become the backbone of biomedical progress, the ethical responsibility of the scientific community expands. Informed consent and ethical sourcing remain essential, but they are no longer sufficient. The field must also take responsibility for what happens after consent, because the implicit promise of donation is not simply that tissue will be used, but that it will be converted into enduring biological knowledge that profoundly advances medicine.

That promise can only be fulfilled if the resulting data are captured, structured, and preserved with rigor. Without strong data integrity, even ethically sourced human material can produce findings that are irreproducible, uninterpretable, or unusable downstream, limiting its ability to drive transformative clinical progress. That is why data integrity must be understood not only as a scientific requirement, but as an ethical obligation.

Human-Centered Science Is Built on Altruistic Trust

Human-centered science depends on living patients who contribute tissue and clinical data and who volunteer their time and bodies to research studies. It also depends on deceased donors and on the families who, in moments of grief, choose donation at the end of life because they want that loss to be more than suffering and to create lasting impact by helping advance medicine for others. These contributions are not transactional. They are gifts.

The impact of altruistic donation is not hypothetical. Donated human tissue and biospecimens have shaped biomedical research for decades. The molecular profiling of tumors, made possible through patient-derived samples, enabled the identification of clinically actionable subtypes such as HER2-positive breast cancer and helped usher in the era of targeted therapies.^1,2 In hematology, the study of donated blood and patient-derived stem cells laid the foundation for breakthroughs in β-thalassemia and sickle cell disease, culminating in recent CRISPR-based therapies that directly target its underlying genetic cause.³ Similarly, the discovery and characterization of hepatitis C, and the development of curative antiviral regimens, depended on patient-derived samples that made it possible to understand the virus and track disease progression in humans.⁴

This is what gives human-centered science its ethical gravity. It is not simply a new way to study biology. It is a model of progress built on a relationship between science and the public.

When patients and families donate, they are not simply providing material. They are trusting that their gift will not be wasted.

That promise is the backbone of human-centered science.

Stewardship Is the Ethical Frame That Sustains That Trust

Ethical sourcing and informed consent are essential, but consent only establishes whether a sample or dataset may be used at all. It does not determine whether that use ultimately honors the gift that made it possible. Stewardship provides the broader ethical frame. It recognizes that human-derived data carries ongoing responsibility across its entire lifecycle, from collection to analysis to long-term reuse. Scientists are not merely authorized users of these materials. They are custodians of something finite, personal, and irreplaceable.

Stewardship shifts the ethical question from permission to care. Not simply whether samples and data were collected appropriately, but whether they were handled in a way that preserved their meaning and fully realized potential.

If human samples are the foundation of innovation, then the systems that use those samples must be designed to preserve traceability, context, and transparency. A gift given in trust should not disappear into a black box of disconnected datasets and irreproducible findings. Stewardship demands that human contributions remain intelligible and usable, not only for the originating study, but for the downstream scientific ecosystem that donation was meant to serve.

The ethical responsibility of stewardship becomes even more urgent when we confront the reality of how human data is actually generated.

The Reality of Human Data Generation

Human-derived samples and data typically do not originate in a well-controlled experimental environment. They are collected in real clinical care settings—during surgery, during acute inpatient care, and during routine diagnostic evaluations—where the primary objective is patient wellbeing, not research optimization.

As a result, the generation of human data is shaped by variability that is both inevitable and appropriate. There will be differences in timing, documentation practices, clinical priorities, and sample handling conditions. These constraints are not failures of intent. They are structural realities of human-centered science.

But reality has consequences. When systems are not designed to support high-fidelity data capture in these environments, meaning begins to erode at the point of origin. Context is lost. Provenance weakens. Subtle but critical details never enter the dataset.

In practice, this can take many forms: a tissue sample without precise ischemic time recorded, incomplete information about medication exposure, unclear documentation of handling temperature or a processing delay, and missing clinical context that determines whether a molecular signature reflects underlying disease biology or an acute clinical intervention. These gaps are rarely malicious, and they are often unavoidable in care-first environments. But they can dramatically alter downstream interpretation.

The intent of donation still exists, but its capacity to become enduring biological truth begins to diminish.

How Infrastructure Supports Stewardship

These challenges are easy to dismiss as operational friction—inevitable complexity at the boundary between clinical care and research. But in human-centered science, they carry deeper consequences.

Without infrastructure designed for human-derived data, stewardship becomes dependent on individual effort. Clinicians and scientists compensate as best they can, patching gaps with manual workarounds to preserve context and continuity. But good intent cannot overcome structural misalignment. If the ecosystem is not built to support human donation and human data, then the ethical promise embedded in altruistic trust will be weakened, not through negligence, but through design failure.

This is why data integrity must be understood differently in human-centered science.

Data integrity is often defined as accuracy, reproducibility, and compliance. Those standards are necessary but insufficient. In human-centered science, integrity is also about preserving meaning and ensuring that provenance, clinical context, and interpretability survive beyond a single study, team, or technology platform.

A dataset may be technically correct and still ethically thin if it cannot be responsibly interpreted or reused outside its original setting. Integrity is what allows a donated sample to retain value over time, supporting new questions, new analyses, and new translational decisions. It is how human contribution avoids becoming stranded in isolated datasets and instead becomes part of a durable scientific record.

Ultimately, data integrity is what allows human donation to translate into enduring real-world impact.

Stewardship Is How Human Contribution Becomes Legacy

At its best, human-centered science transforms individual pain and loss into enduring biological truth with the power to create lasting and transformative benefits for humanity. But that transformation is not automatic. It depends on adopting a stewardship mindset and on data practices that are designed to preserve meaning, enable integration, and support enduring impact. Consent opens the door. Stewardship determines what follows.

Data integrity, then, is not just a scientific requirement. It is how science keeps faith with the people who make it possible. It is how human contribution becomes legacy and how the promise at the heart of human-centered science is ultimately fulfilled.