FDA di­rects spon­sors to keep in­formed con­sent in­fo con­cise, tai­lored to par­tic­i­pants

The FDA is aim­ing to make it eas­i­er for clin­i­cal tri­al par­tic­i­pants to un­der­stand in­formed con­sent, of­fer­ing tri­al spon­sors rec­om­men­da­tions for clar­i­fy­ing key in­for­ma­tion, as part of draft guid­ance pub­lished Fri­day.

The 19-page draft di­rects spon­sors, in­ves­ti­ga­tors and in­sti­tu­tion­al re­view boards to clear­ly present par­tic­i­pants with in­for­ma­tion on the re­search and to do so in a way that is un­der­stand­able to the them. This can in­clude in­for­ma­tion about the goals of the re­search, the length of the project and the risks and ben­e­fits of par­tic­i­pa­tion.

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