Module232025

07/05/2025

How many participants are in the trial? (2)

• Is the foetus a “participant” in the trial? The definition of a participant in cluster randomised trials is “an individual whose interests may be compromised as a result of interventions in a research study”. In a cluster randomised trial pre-existing groups, called clusters, are randomly assigned to different treatment arms instead of individual participants If the foetus appears to be responding adversely to or following the IMP, it seems likely that the Investigator would take steps or discuss with the pregnant woman the need to take steps to manage the situation - just as would happen in any other clinical trial. • European Court of Human Rights has steadfastly refused to answer the question of whether an unborn child is a ‘person’. • Data are likely to be collected from and regarding the foetus in any trial.

• The answer, legally, appears to be “not one but not two”.

• Under 21 CFR §46.204 (e) Research involving pregnant women or fetuses, if the research holds out the prospect of direct benefit solely to the foetus then the consent of the pregnant woman and the father is required, as would be the case if a child was involved – so 3 “participants”.

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Paternal “rights” or “interests”

• Negated by maternal autonomy in most countries Lead UK case: Paton v British Pregnancy Advisory Service Trustees [1978] • Exception is research intended to benefit the foetus, rather than the mother (21 CFR §46.204 (e)) – permission of both parents required. This exception is US-specific – not reflected in other NA or EMEA regulations. • Paternal interests prevail when women lack autonomy. most likely in some Shari’ah law countries : husband must give permission for wife to enter trial, father must give permission for daughter to marry (or sometimes work), in the absence of the father, a male relative, e.g., son, may give permission for a woman, e.g., mother, to enrol.

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