FDA’s New Draft Guidance on Tissue Biopsies: Strengthening Ethical and Scientific Standards in Clinical Trials
Insight into the FDA’s 2025 draft guidance on tissue biopsies in clinical trials—highlighting ethical standards, patient safety, and evolving regulatory oversight.
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1/6/20251 min read
FDA’s New Draft Guidance on Tissue Biopsies: Strengthening Ethical and Scientific Standards in Clinical Trials
The U.S. Food and Drug Administration (FDA), in collaboration with the Office for Human Research Protections (OHRP), has released a new draft guidance (January 2025) that underscores a crucial aspect of modern clinical research the inclusion of tissue biopsies in clinical trials.
As regulatory professionals, we recognize that such guidance plays a pivotal role in shaping how investigational medical products are evaluated, especially when participant safety and ethical transparency are at stake. The FDA’s latest draft aims to help sponsors, investigators, and Institutional Review Boards (IRBs) better understand the balance between scientific necessity and ethical responsibility when performing tissue biopsies in adults and children.
Tissue biopsies are often essential for determining participant eligibility, confirming disease targets, or analyzing key endpoints within oncology and precision-medicine trials. However, the FDA emphasizes that each biopsy procedure carries inherent risk and therefore, the decision to make a biopsy required or optional must be guided by clear scientific justification and ethical oversight.
This guidance not only defines how biopsy procedures should be integrated into study protocols but also reinforces the principles of informed consent, especially in pediatric studies. It requires transparency about risks, benefits, and the specific role biopsies play in the research objectives.
By strengthening ethical and procedural clarity, the FDA continues its mission to foster patient-centered innovation while ensuring data integrity and regulatory compliance a balance that lies at the heart of every regulatory affairs professional’s role.
As someone engaged in the regulatory landscape, I view this guidance as a reflection of how harmonized oversight, robust documentation, and clinical ethics continue to evolve together. Staying informed about such updates not only aligns with global GCP standards but also enhances our ability to support compliant, evidence-driven product development from the earliest stages of clinical research.
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