Policy Perspective

Reducing Regulatory and Institutional Burden Associated with Animal Research: June 2017 Meeting

The document provides a thorough overview of ongoing efforts and recommendations to alleviate regulatory and institutional burdens associated with animal research in the United States, highlighting concerns from academic institutions, federal agencies, and advisory bodies. Key initiatives include the NIH's efforts to collaborate with major regulatory bodies (OPRR, USDA, AAALAC) to streamline policy interpretation and reduce redundant reviews and inspections, as well as endeavors to create unified reporting formats and risk-based protocols. The 21st Century Cures Act, signed into law in 2016, mandates a review of laboratory animal care regulations by NIH, USDA, and FDA to reduce unnecessary administrative tasks while maintaining ethical standards.

Workshops and surveys documented widespread recognition that current requirements place a significant, sometimes excessive, administrative burden on researchers and institutions—often without proportionate benefits to animal welfare. Various recommendations advocate for consolidation of oversight under a single federal entity, greater reliance on risk-based and tiered review systems, and reduction of duplicative or low-impact processes such as protocol congruency checks and mandatory literature searches for non-essential categories. Survey data show diverse institutional responses to existing regulations, with variations in protocol review frequency, literature search requirements, and implementation of administrative streamlining. Advisory committees and educational organizations, such as COGR, continue to identify practical steps institutions can take to reduce self-imposed compliance burdens. The environment appears conducive to regulatory reform, driven by legislative mandates and an executive focus, with avenues for both legislative and administrative improvements being actively explored. The overarching aim remains to balance efficient administrative practices with robust animal welfare protections and scientific integrity.

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