Dis­clo­sure and Du­al­i­ty of In­ter­est Man­age­ment

All mem­bers of the ex­pert pan­el (the PPC mem­bers, ad hoc mem­bers, and sub­ject mat­ter ex­perts) and ADA staff are re­quired to com­ply with the ADA pol­i­cy on du­al­i­ty of in­ter­est, which re­quires dis­clo­sure of any finan­cial, in­tel­lec­tu­al, or oth­er in­ter­ests that might be con­strued as con­sti­tut­ing an ac­tu­al, po­ten­tial, or ap­par­ent conflict, re­gard­less of rel­e­van­cy to the guide­line top­ic. For transparency, ADA re­quires full dis­clo­sure of all re­la­tion­ships. Full dis­clo­sure state­ments from all com­mit­tee mem­bers are so­licit­ed and re­viewed dur­ing the ap­point­ment pro­cess. Dis­clo­sures are then up­dat­ed through­out the guide­line de­vel­op­ment pro­cess (specifical­ly be­fore the start of ev­ery meet­ing), and dis­clo­sure state­ments are sub­mit­ted by ev­ery Stan­dards of Care au­thor upon sub­mis­sion of the re­vised Stan­dards of Care sec­tion. Mem­bers are re­quired to dis­close for a time frame that in­cludes 1 year pri­or to ini­ti­a­tion of the com­mit­tee ap­point­ment pro­cess un­til pub­li­ca­tion of that year’s Stan­dards of Care. Po­ten­tial du­al­i­ties of in­ter­est are eval­u­at­ed by a des­ig­nat­ed re­view group and, if nec­es­sary, the Le­gal Af­fairs Di­vi­sion of the ADA. The du­al­i­ty of in­ter­est as­sess­ment is based on the rel­a­tive weight of the finan­cial re­la­tion­ship (i.e., the mon­e­tary amount) and the rel­e­vance of the re­la­tion­ship (i.e., the de­gree to which an in­de­pen­dent ob­serv­er might rea­son­ably in­ter­pret an as­so­ci­a­tion as re­lat­ed to the top­ic or rec­om­men­da­tion of con­sid­er­a­tion). In ad­di­tion, the ADA ad­heres to Sec­tion 7 of the Coun­cil for Med­i­cal Spe­cial­ty So­ci­eties “Code for In­ter­ac­tions with Com­pa­nies” (3). The du­al­i­ty of in­ter­est re­view group also en­sures the ma­jor­i­ty of the PPC and the PPC chair are with­out po­ten­tial conflict rel­e­vant to the sub­ject area. Fur­ther­more, the PPC chair is re­quired to re­main un­conflict­ed for 1 year af­ter the pub­li­ca­tion of the Stan­dards of Care. Mem­bers of the com­mit­tee who dis­close a po­ten­tial du­al­i­ty of in­ter­est per­ti­nent to any specific rec­om­men­da­tion are pro­hib­it­ed from par­tic­i­pat­ing in dis­cus­sions re­lat­ed to those rec­om­men­da­tions. No ex­pert pan­el mem­bers were em­ploy­ees of any phar­ma­ceu­ti­cal or med­i­cal de­vice com­pa­ny dur­ing the de­vel­op­ment of the 2023 Stan­dards of Care. Mem­bers of the PPC, their em­ploy­ers, and their dis­closed po­ten­tial du­al­i­ties of in­ter­est are list­ed in the sec­tion “Dis­clo­sures: Stan­dards of Med­i­cal Care in Di­a­betes—2023.“ The ADA funds the de­vel­op­ment of the Stan­dards of Care from gen­er­al rev­enue and does not use in­dus­try sup­port for this pur­pose.