Overview
The National Institutes of Health (NIH) is seeking public comment on a proposed update to its longstanding Policy for Data and Safety Monitoring. The draft policy would significantly broaden NIH data and safety monitoring expectations by extending them beyond clinical trials to all NIH-supported clinical research.
Released November 2, 2026, under NIH Notice NOT-OD-27-006, the proposal aims to modernize the agency’s data and safety monitoring framework, established in 1998. Comments are due January 6, 2027. [grants.nih.gov], [osp.od.nih.gov]
Why NIH Is Proposing an Update
NIH developed its current data and safety monitoring policy nearly three decades ago, primarily around clinical trials. Since then, clinical research has expanded to include a wider range of approaches, including real-world data research, implementation science, machine learning, genomics, decentralized studies, adaptive designs, and other emerging methods.
NIH also notes that almost two-thirds of its clinical research portfolio consists of studies that are not clinical trials. According to the agency, expanding the policy would support a more consistent approach to participant safety and the quality and integrity of data across its broader clinical research portfolio.
The proposed approach centers on risk-based monitoring, with the nature and extent of oversight proportionate to the risks associated with a particular study.
What Would Change?
The draft would significantly expand the policy’s scope. The 1998 policy established NIH data and safety monitoring requirements for clinical trials. The draft policy would extend those expectations across NIH-supported clinical research, including clinical trials, patient-oriented research, epidemiological and behavioral studies, and outcomes and health services research.
Under the proposed policy, covered studies would need an NIH Institute, Center, or Office-approved data and safety monitoring plan based on an assessment of the study’s risks. The initial plan would need approval before human subject activities begin.
The proposal also outlines required elements for monitoring plans, including:
- The results of a study risk assessment and identification of critical risks
- Activities and methods used to monitor those risks
- Processes for addressing identified critical risks
- Reasons that could warrant temporary suspension or premature study discontinuation
- Procedures for communicating and reviewing monitoring reports
- Methods for documenting monitoring activities
The draft encourages investigators to develop, where appropriate, a single monitoring plan that can satisfy NIH, IRB, and other applicable regulatory requirements, including FDA requirements, while remaining consistent with Good Clinical Practice.
A More Flexible Approach to Independent Monitoring
The draft also proposes a more risk-based approach to independent monitoring. Instead of requiring Data and Safety Monitoring Boards for all Phase 3 or multi-site clinical trials, the proposal would make independent monitoring decisions based on the study’s risk assessment. NIH states that independent monitoring may be appropriate when additional expertise or independence could reduce bias, increase rigor, or mitigate conflicts of interest or undue influence.
If independent monitoring is required, the relevant NIH Institute, Center, or Office would need to identify in writing why it is necessary. This represents an important shift in emphasis from monitoring requirements largely driven by study categories toward study-specific oversight based on risk.
What Would This Mean for Research Institutions?
If finalized, the updated policy could affect institutions and investigators conducting a broad range of NIH-supported human subjects research, not only those conducting clinical trials. Recipient institutions and investigators would be responsible for developing and implementing monitoring plans, assessing study risks, responding to monitoring findings, and updating plans when necessary. They would also provide monitoring reports and relevant study documents to appropriate parties.
NIH Institutes, Centers, and Offices would have separate responsibilities for reviewing plans and monitoring reports and overseeing compliance. Importantly, these requirements are still proposed. The final policy may change following NIH’s consideration of public comments.
If adopted, NIH states that the policy would take effect for applicable applications submitted six months after publication of the final policy.
NIH Is Asking the Research Community for Feedback
NIH is specifically seeking input on whether the proposed policy appropriately supports risk-based oversight of participant safety and data quality and integrity. The agency is also asking which areas may need clarification and what resources could make implementation more effective without creating unnecessary administrative burden.
Potential supplemental resources could include guidance documents, templates, model monitoring plans, risk-assessment tools, educational materials, and other implementation resources. NIH is also requesting input regarding monitoring considerations involving large language models and other emerging technologies.
Organizations involved in NIH-supported clinical research may want to review the draft with stakeholders across research administration, human research protections, clinical research operations, research compliance, investigators, and other teams involved in research oversight.
How to Submit Comments
Comments on NOT-OD-27-006 are due January 6, 2027. Responses are voluntary and may be submitted anonymously. NIH notes that submitted responses may later be posted publicly without redaction and advises respondents not to include proprietary, classified, confidential, sensitive, or other information they do not wish to make public.
Comments can be submitted through the NIH Office of Science Policy comment form. The full proposal is available in NIH Notice NOT-OD-27-006.
