Module232025

07/05/2025

Beneficence (doing good) ≠ non-maleficence (not doing bad)

Clinical equipoise: genuine uncertainty must exist regarding which treatment is better (? safer), otherwise study is unethical

(Non-)maleficence

Beneficence

• Blinding –investigator cannot access some (safety) data • Placebo-control, when approved treatment exists

• Additional hospital visits (invasive or intrusive) tests, blood samples • Closer monitoring – better patient care • Baseline assessments – responding to incidental findings

• Investigational drug may not work

The Organisation for Professionals in Regulatory Affairs

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The notion of supererogation

A class of actions which go “beyond the call of duty” 7 Acts which are morally good although not (strictly) required Behaviour beyond the “duty” to participate in / contribute to research Is trial participation supererogatory? What do trial subjects know / need to know / want to know / want NOT to know? What does the investigator know / not know? Placebo control – knowingly foregoing a treatment option Do we owe trial subjects more information than regular patients? Remember we state in consent documents that participants’ legal rights are not affected Are children capable of supererogatory behaviour?

The Organisation for Professionals in Regulatory Affairs

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