The reflexivity deficit in human subjects review: normative anchor drift and the case for proportional re-engagement

U.S. human-subjects review has shifted from calibrated protection toward compliance criteria insufficiently traceable to its normative anchor. The paper develops two linked constructs: normative anchor drift, the widening gap betweecn founding norms and institutional practice as operational criteria proliferate without documented justification and reflexivity deficit, the failure of formal responsiveness to correct drift when governance bodies' incentives remain unchanged. Analysis of the 1991 and 2018 Common Rule, IRB burden evidence and institutional history identifies layering, conversion and drift as modes of change. Comparison with Canadian ethics governance and socio-technical integration identifies structural alternatives. The paper proposes re-anchoring, proportionate tiering, and reflexive re-engagement as a non-deregulatory reform agenda. Unlike the 2018 revision, it shifts determinations toward investigators, replaces routine ex ante submission with post-hoc audit, and separates novel-methods reflexivity from IRB compliance. It differs from gain-of-function deregulation and First Amendment challenges to review licensing.