Re­port calls for im­proved pro­tec­tion in hu­man re­search

Modern Healthcare - - LATE NEWS -

The U.S. pro­vides ad­e­quate pro­tec­tion for hu­man vol­un­teers in fed­er­ally spon­sored re­search projects but fur­ther steps can be taken to im­prove the process, ac­cord­ing to a re­view of re­search stan­dards re­leased by the Pres­i­den­tial Com­mis­sion for the Study of Bioeth­i­cal Is­sues. For in­stance, fed­eral de­part­ments and agen­cies should work to in­crease trans­parency by de­vel­op­ing a gov­ern­men­twide, uni­fied data­base of in­for­ma­tion, the com­mis­sion said in the re­port. Hu­man sub­jects who are in­jured while par­tic­i­pat­ing in re­search stud­ies should also not have to pay for their own treat­ment, the com­mis­sion said, adding that “most other de­vel­oped na­tions have in­sti­tuted poli­cies to re­quire re­searchers or spon­sors to pro­vide treat­ment, or com­pen­sa­tion for treat­ment, for in­juries suf­fered by re­search sub­jects.” The re­port was prompted by ev­i­dence that sur­faced in 2010 show­ing that the U.S. Pub­lic Health Ser­vice had sup­ported re­search that in­ten­tion­ally ex­posed “thou­sands of Gu­atemalans to sex­u­ally trans­mit­ted dis­eases with­out their con­sent,” ac­cord­ing to a news re­lease from the com­mis­sion. “The com­mis­sion is con­fi­dent that what hap­pened in Gu­atemala in the 1940s could not hap­pen to­day,” Amy Gut­mann, com­mis­sion chair, said in the re­lease. “How­ever, it is also clear that im­prove­ments can be made to pro­tect hu­man sub­jects go­ing for­ward.”

The re­port calls for a uni­fied data­base of hu­man re­search in­for­ma­tion.

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