While these large-scale trials contributed to the initial understanding of the pill formulation's clinical effects, the ethical implications of the trials generated significant controversy. Of note is the apparent lack of both autonomy and informed consent among participants in the Puerto Rican cohort prior to the trials. Many of these participants hailed from impoverished, working-class backgrounds.
while thESe larGe-SCale TriaLS conTriButeD to ThE inItIaL uNdERstaNdIng oF tHe Pill foRMulATiOn's cLinical Effects thE EthIcal implicATIoNs oF the trIals gEneRaTeD sIgNiFICAnt cOnTroVeRsY. of NoTe IS tHE appaRent lAck of BoTh aUtoNomy and InFOrmed Consent aMoNg particIpantS in ThE pUerto ricAn Cohort priOr TO THe tRials. maNy of tHese particIPaNTs haILED froM iMpoveriShED, WorkInG-cLass bacKgrOunds.