FDA sends warn­ing let­ter to com­mu­ni­ty hos­pi­tal re­view board over re­search con­cerns

An in­sti­tu­tion­al re­view board (IRB) for a hos­pi­tal in South Flori­da has been hit with a warn­ing let­ter from the FDA over con­cerns raised dur­ing an in­spec­tion late in 2021.

The let­ter, sent ear­li­er this month to Sima Marzban, the VP of re­search and aca­d­e­m­ic af­fairs for the Larkin Com­mu­ni­ty Hos­pi­tal In­sti­tu­tion­al Re­view Board, states that an in­spec­tion was con­duct­ed in No­vem­ber to see if the hos­pi­tal’s hu­man stud­ies com­plied with FDA re­quire­ments. The site was is­sued a Form ‘483, how­ev­er, in­ves­ti­ga­tors no­ticed af­ter re­view­ing the IRB’s re­sponse that it “did not ad­here to ap­plic­a­ble statu­to­ry re­quire­ments” that gov­ern the pro­tec­tion of hu­man sub­jects.

Specif­i­cal­ly, in­ves­ti­ga­tors took is­sue with how the IRB re­viewed pro­posed re­search. The agency ac­cused the IRB of re­view­ing and ap­prov­ing re­search at meet­ings in which a ma­jor­i­ty of mem­bers (in­clud­ing one “non­sci­en­tist”) were not present, go­ing against re­quire­ments. In the re­sponse to the FDA, the IRB promised it would take steps to cor­rect this, but the agency wasn’t com­plete­ly sat­is­fied.

“We are un­able to per­form an in­formed eval­u­a­tion of the IRB’s writ­ten re­sponse be­cause you did not pro­vide a cor­rec­tive ac­tion plan that, if prop­er­ly car­ried out, would pre­vent the re­cur­rence of this type of vi­o­la­tion in the fu­ture. Specif­i­cal­ly, you did not pro­vide suf­fi­cient de­tails on the pro­ce­dures you are ini­ti­at­ing and how you will en­sure that a ma­jor­i­ty of the IRB mem­bers, in­clud­ing at least one mem­ber whose pri­ma­ry con­cerns are in non­sci­en­tif­ic ar­eas, will be present at con­vened meet­ings when pro­posed FDA-reg­u­lat­ed re­search is un­der re­view,” the let­ter said.

The let­ter al­so said that the IRB did not main­tain doc­u­men­ta­tion of its ac­tiv­i­ties, in­clud­ing a list of cur­rent mem­bers, and that it had failed to en­sure its process for pro­vid­ing pa­tients with in­for­ma­tion as a part of in­formed con­sent was up to code.

More specif­i­cal­ly, in­ves­ti­ga­tors ac­cused the IRB of  fail­ing to make sure that the in­formed con­sent doc­u­ments for two clin­i­cal tri­als con­tained a state­ment no­ti­fy­ing the pa­tient that their tri­al in­for­ma­tion “has been or will be sub­mit­ted for in­clud­ing in the clin­i­cal tri­al reg­istry data­bank.”

The re­sponse to the FDA did note that “ac­tions were in mo­tion to es­tab­lish best prac­tices” and that fu­ture tri­al doc­u­ments would in­clude the state­ment. How­ev­er, the let­ter notes that the re­sponse did not in­clude an ac­tion plan for pre­vent­ing the re­cur­rence of this vi­o­la­tion in the fu­ture.

“Specif­i­cal­ly, you did not pro­vide suf­fi­cient de­tails on the best prac­tices you are es­tab­lish­ing and how you will en­sure that the ICDs will con­tain the state­ment,” the let­ter said.

End­points News reached out to Larkin Com­mu­ni­ty Hos­pi­tal, but did not re­ceive a re­sponse by press time.

Illustration: Assistant Editor Kathy Wong for Endpoints News

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