A guide to the WIA-BIO-018 standard
Where the rules of human-subjects research came from, what the principles behind them actually demand, and how WIA-BIO-018 tries to turn those principles into records a machine can check.
Every rule an ethics office enforces today has a history, and most of those histories begin with harm. Consent forms, independent review boards, extra protections for children and prisoners, the insistence that a study be scientifically sound before anyone is enrolled: each was written in response to research that injured people who had not agreed to it, did not understand it, or could not refuse it. This chapter traces that history, sets out the principles that grew out of it, and then shows how the WIA-BIO-018 standard (version 1.0.0, published 2025-12-26) attempts to express those principles as data structures, scores and validation rules.
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