Pre-Authorised Protocol Branching: The Release Valve Model and Contextual Consent Decoupling
Year: 2026
Type: preprint
Abstract: Many clinical trial protocols still organise participation around a single dominant, predefined pathway, with limited prospectively authorised mechanisms for reducing data-collection burden once a participant begins to struggle. This paper proposes two related structural responses. The Release Valve Model introduces a prospectively specified lower-burden data-collection pathway that a designated Intermediary may activate once protocol-defined burden criteria are met, with the alternative pathway's statistical and regulatory consequences addressed at the design stage rather than improvised after disengagement begins. Contextual Consent Decoupling applies the same pre-authorisation logic to the environment and operational delivery of trial participation, particularly for neurodivergent adults whose barriers may arise from executive or sensory load rather than impaired comprehension. Both proposals draw on ICH E9(R1) and ICH E6(R3) while extending that logic into a governance question neither guideline directly addresses, and remain untested.
Author: Koroma, Martha Wuya
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7210293882
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