FDA fi­nal­izes 2014 guid­ance on in­formed con­sent in tri­als, with more up­dates com­ing soon

The FDA on Tues­day fi­nal­ized guid­ance from 2014 to help spon­sors, IRBs and in­ves­ti­ga­tors meet all of their in­formed con­sent re­quire­ments when it comes to clin­i­cal tri­als. But the agency still needs to har­mo­nize this guid­ance with HHS’ Com­mon Rule on gov­ern­ment-fund­ed tri­als from 2018.

The 61-page guid­ance cov­ers every­thing from con­sid­er­a­tions for en­rolling chil­dren in tri­als to ob­tain­ing in­formed con­sent via elec­tron­ic meth­ods.

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