%0 Journal Article
%T Autonomous Translational Pharmacology Requires Human-Defined Experiment Rights, Evidence Thresholds, Escalation Rules, and Irreversible Stop Conditions for High-Consequence Decisions
%A Lucas Meyer
%A Anna Schmid
%A Stefan Braun
%A Laura Keller
%J International Journal of Pharmaceutical Research and Allied Sciences
%@ 2277-3657
%D 2026
%V 15
%N 2
%R 10.51847/uGYERdBsld
%P 1-9
%X Autonomous experimental systems are progressing from isolated automation toward integrated platforms capable of proposing hypotheses, selecting tools, executing computational or physical procedures, interpreting observations, and modifying subsequent actions. In translational pharmacology, these capabilities create governance problems that cannot be resolved by model accuracy, conventional laboratory safety controls, general human oversight, or reporting requirements alone. This Original Autonomous-Governance Theory Article proposes a Governance Constitution for Autonomous Translational Pharmacology in which experimental capability remains subordinate to human-defined scientific purposes, enumerated experiment rights, consequence-sensitive evidence thresholds, escalation rules, meaningful intervention authority, and non-overridable stop conditions. The proposed Experiment-Rights Ledger specifies the data, materials, instruments, operations, scale, duration, reversibility, and evidence state within which an autonomous system may act. Evidence gates distinguish hypothesis generation and sandboxed computation from restricted physical experimentation, adaptive closed-loop activity, and translationally consequential action. Escalation is required when novelty, uncertainty, distribution shift, conflicting observations, protocol deviation, tool substitution, cumulative risk, or loss of provenance exceeds the authorized envelope. Irreversible stop conditions prohibit actions involving unauthorized biological targets, harmful optimization, containment failure, unapproved scale expansion, non-reconstructable activity, or patient-affecting decisions without explicit authorization. Append-only logging, independent replay, dissent recording, and challenge procedures make autonomous activity contestable rather than merely observable. Governance stress tests are proposed to examine adversarial manipulation, false evidence maturity, stop circumvention, automation bias, and interactions among models, tools, instruments, and human organizations. The framework is an original conceptual synthesis that requires prospective technical, experimental, human-factors, translational, and institutional validation. It does not establish clinical utility, regulatory acceptability, universal thresholds, legal responsibility, or deployment readiness. 
%U https://ijpras.com/article/autonomous-translational-pharmacology-requires-human-defined-experiment-rights-evidence-thresholds-ootflwhu7eefbrw