Ethical Considerations in Biopsy-based Research and Precision Oncology Trials

Anaissie Dijke^*
*Correspondence: Anaissie Dijke, Department of Pharmacy, China Medical University, Taichung 406040, Taiwan, Email:

Introduction

The advent of precision oncology has ushered in a new era of personalized cancer care, where treatment decisions are guided by the molecular and genetic characteristics of individual tumors. Central to this approach is the increasing reliance on tumor biopsies-either at baseline or serially-to provide real-time insights into tumor biology, monitor disease progression, and evaluate treatment efficacy. Biopsy-based research has therefore become a cornerstone of clinical trials aiming to identify biomarkers, validate therapeutic targets, and develop individualized therapeutic regimens [1].

However, the integration of invasive tissue sampling into research protocols presents a host of ethical challenges. Unlike routine biopsies performed for diagnostic purposes, research biopsies often provide no direct benefit to the patient and may expose individuals to unnecessary risks. In precision oncology trials, where biopsies may determine eligibility or stratify treatment arms, concerns regarding informed consent, participant autonomy, data privacy, and therapeutic misconception become increasingly complex. Ethical tensions also arise around equitable access, the commercialization of biospecimens, and the potential for incidental findings with psychosocial implications [2].

Description

Participants must be clearly informed that research biopsies may not provide direct clinical benefit. Risks such as pain, bleeding, infection, or pneumothorax (in lung biopsies) must be transparently communicated, alongside the possibility of repeated procedures. The voluntary nature of participation should be emphasized, especially in trials where biopsies are a prerequisite. Patients may conflate research procedures with standard care, mistakenly believing that research biopsies will influence their treatment. This "therapeutic misconception" undermines informed decision-making. Investigators must clearly delineate the investigational purpose of biopsies and distinguish between clinical and research components. Consent forms should address the potential generation of complex molecular data, which may be difficult for participants to interpret. Clarity about which results, if any, will be shared with participants is essential. In some cases, findings may be clinically actionable; in others, they may be uncertain or of no immediate relevance [3].

Participants should retain the right to withdraw from the trial or decline further biopsies without penalty. However, in biomarker-driven studies, withdrawal may affect treatment eligibility, which must be disclosed during consent. Ethical research must have a sound scientific rationale. Biopsy-based procedures must be justified by a clearly defined research question and an evidence-based likelihood that the samples will contribute meaningfully to scientific knowledge or therapeutic development. Ethically, the potential benefits of knowledge gained must outweigh the risks posed to participants. Trials should minimize unnecessary biopsies by employing robust study designs, leveraging archival tissue when appropriate, or incorporating non-invasive alternatives [4].

Patients in rural or underserved areas may face logistical challenges in accessing trial centers capable of performing image-guided biopsies. Financial burdens related to travel, lodging, or missed work can deter participation, leading to underrepresentation of marginalized groups. Trials that require recent biopsies for enrollment may exclude patients with inaccessible tumors or those unable to undergo invasive procedures due to comorbidities. This can introduce bias and limit the generalizability of trial results. In low- and middle-income countries, the infrastructure for advanced biopsy techniques and molecular testing may be lacking, restricting participation in precision oncology trials and access to cutting-edge therapies [5].

Conclusion

Biopsy-based research and precision oncology trials represent the frontier of personalized cancer care. They promise tailored therapies, improved outcomes, and deeper insights into tumor biology. Yet, with this promise comes a host of ethical responsibilities. The act of obtaining tissue from a living patient for research-particularly when not clinically indicated-requires careful ethical consideration rooted in respect for autonomy, minimization of harm, and fairness in research participation. To uphold these values, ethical biopsy-based research must prioritize transparent informed consent, minimize procedural risks, justify scientific necessity, and ensure equitable access to trial participation. Ongoing engagement with patients, communities, regulators, and ethicists is essential in navigating the evolving challenges posed by genomic medicine and biopsy-driven trials. Ultimately, ethics must evolve alongside science, ensuring that the pursuit of personalized oncology remains not only precise in its biology but principled in its humanity. Only then can the full potential of precision medicine be realized-delivering hope, healing, and innovation grounded in ethical care.

Acknowledgement

None.

Conflict of Interest

None.

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