Gain-of-function research oversight has no enforcement mechanism beyond voluntary compliance

After the COVID-19 lab leak debate, the US updated its policy on enhanced potential pandemic pathogen (ePPP) research in 2024, but compliance relies entirely on researchers self-reporting whether their work meets the ePPP definition. No federal agency audits lab notebooks, reviews experimental protocols, or independently assesses whether research meets the gain-of-function threshold. A researcher who believes their work is exempt simply does not report it. This persists because the enforcement framework treats biosafety as a researcher ethics issue rather than a regulatory compliance issue, and the NIH funding mechanism provides no budget for independent lab auditing.