NIH is proposing updates to its Data and Safety Monitoring Policy to reflect the evolving clinical research landscape while maintaining its commitment to participant safety and the quality and integrity of research data.
NIH is releasing a Draft Updated Policy for Data and Safety Monitoring for public comment. The proposed updates aim to:
- Harmonize data and safety monitoring requirements across NIH.
- Reduce administrative burden that is not commensurate with research risk.
- Establish meaningful expectations to ensure robust, reliable data and sound scientific conclusions.
The draft policy was informed by feedback received through NIH’s initial stakeholder engagement efforts.
Submit Your Comments
NIH invites stakeholders and the public to review the draft policy and provide feedback. Comments must be submitted through the NIH Public Comment Form by January 6, 2027.
Questions may be sent to [email protected].
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