Skip to main content

Protocol Negation

Meaning

Protocol Negation refers to the formal and definitive rejection or invalidation of a proposed therapeutic plan, clinical trial design, or standard operating procedure, often occurring during the rigorous review phase by an Institutional Review Board (IRB) or regulatory authority. This negation is triggered when the protocol demonstrates an unacceptable risk-benefit ratio, contains methodological flaws that compromise data integrity, or fails to align with established ethical and scientific standards in endocrinology or pharmaceutical research. It functions as a critical safety mechanism, preventing the deployment of potentially harmful or scientifically unsound interventions.