Regulatory & Compliance Oversight |
The NIH recently reclassified BESH studies as non-clinical trials, reducing registration and reporting burdens, while simultaneously aligning its “intervention” definition with the 2018 Common Rule, expanding the scope of clinical trials. These conflicting decisions highlight the tension between administrative burden and research transparency amid growing expectations for research accountability.
After prolonged debate, in January of 2026, the NIH announced it would no longer classify basic experimental studies involving humans (“BESH”) as meeting the definition of a “clinical trial,” effectively reducing the scope of NIH-funded research subject to ClinicalTrials.gov registration and results reporting requirements. (NIH, January 2026). Three months later, the NIH harmonized its definition of an “intervention” with the 2018 Common Rule, broadening the types of research that meet NIH’s definition of a “clinical trial.” (NIH, March 2026). These policy changes reflect conflicting priorities: in an era marked by declining public trust in the research enterprise, should advancing research transparency take precedence over reducing administrative burden?
The NIH established the definition of a “clinical trial” in 2014 to increase transparency and accountability in research (NIH, 2014). Since then, the definition has undergone multiple policy reinterpretations that have altered the scope of research subject to registration and reporting requirements. BESH research has been a long-standing issue, with the agency issuing multiple notices over the last eight years on whether such studies meet the definition of a “clinical trial” requiring registration and reporting. (NIH, 2018; NIH, 2025).
After May 25, 2026, NIH grant applications for BESH research will no longer be classified as a “clinical trial.” (NIH, January 2026). While this decision reduces administrative burden by simplifying grant writing and reporting, it runs counter to modern expectations for research transparency by the global research community. Under the NIH Policy on Dissemination of NIH-Funded Clinical Trial Information, NIH-funded BESH research will no longer be required to register and report results. (NIH, 2016). However, many BESH studies still meet the International Committee of Medical Journal Editors (ICMJE) definition of a clinical trial, which requires prospective registration of eligible studies as a condition for publication in ICMJE-affiliated journals. (ICMJE, n.d.). Additionally, the World Medical Association’s Declaration of Helsinki, revised in October 2024, mandates the registration of all research involving human subjects, including BESH. (WMA, 2024).
The NIH’s recent harmonization with the 2018 Common Rule’s definition of “intervention” introduces ambiguity to NIH’s current approach to policymaking. Under the new definition of “intervention,” which expands the scope to include both physical procedures for gathering information or biospecimens and manipulations of the subject or the subject's environment, more NIH-funded research is subject to registration and reporting requirements. (NIH, March 2026). This update aligns with recent efforts to standardize federal human subjects research requirements but seemingly runs counter to NIH’s recent notice on BESH. Taken together, these changes signal conflicting priorities at the NIH, with reducing administrative burden and promoting research transparency concurrently shaping policy decisions.
Recent public health emergencies, such as the COVID-19 pandemic, have had a complex and lasting impact on public trust in the research enterprise, with misinformation often outpacing scientific communication. As a result, calls for greater transparency, timely data sharing, and clear communication with the public have intensified across the research community. One prominent example is the International Council for Harmonisation Good Clinical Practice (ICH-GCP) E6 Revision 3 update in January 2025, which introduced stronger expectations around transparency and public disclosure of trial results. (International Council for Harmonisation, 2025). As research transparency expectations continue to rise, the NIH must proactively adapt its policies and reporting frameworks to remain aligned with the evolving research enterprise landscape. Prioritizing research transparency over administrative burden in policymaking restores public trust, shifting the focus towards accountability and ethical research conduct. Notably, to maintain public trust, the NIH will need to remain clear and consistent in its messaging and policy implementation. Aligning with evolving research transparency expectations and consistent policy frameworks will foster meaningful discourse going forward.
Takeaway: How Can Institutions and Researchers Remain Compliant?
As clinical trial and transparency boundaries shift, institutions and researchers must remain compliant to secure and maintain government funding, adhere to ethical requirements, and prevent reputational harm. Institutions can support researchers by creating clear guidelines on clinical trial registration and results reporting through local policy. These guidelines should not be static; as the research transparency landscape evolves, the policy must evolve to ensure continued compliance.
Institutions should also provide tailored messaging and training to researchers as compliance expectations change. Institutional action alone will not be sufficient to maintain compliance; researchers must also foster a culture of compliance and accountability. Early planning for clinical trial registration and results reporting embeds compliance into the study lifecycle and provides a buffer to ensure all requirements are met in a timely manner. Researchers should also engage their institution’s ClinicalTrials.gov administrators early in the study lifecycle to stay up to date on evolving requirements. Study teams would also benefit from developing standardized processes, such as internal SOPs and checklists, to reduce the risk of non-compliance. Ultimately, a coordinated effort among institutions and researchers is essential to maintain proactive alignment with evolving research transparency requirements.