,i #aai? ,,congress #a/ ,session ,h4 ,r4 #fhfg ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,decemb] #ah1 #bjbe,ms4 ,kelly ( ,ill9ois 7= h]self & ,mr4 ,fitzpatrick7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to direct ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,director ( ! ,national ,in/itutes ( ,heal?1 to take c]ta9 /eps to increase cl9ical trial div]sity1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,,nih ,cl9ical ,trial ,integrity ,act4 #b4 ,div]sity goals = cl9ical trials 7a7 ,applications ,beg9n+ on ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,director ( ! ,national ,in/itutes ( ,heal? 79 ?is section ref]r$ to z ! ,secret>y71 %all require t a sponsor seek+ to conduct a cl9ical trial inve/igat+ a drug1 device 7z ^? t]ms are def9$ 9 section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba et seq4771 biological product 7z def9$ 9 section #cea7;i7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;i7771 or behavioral int]v5tion1 ! protocol = :i* is approv$ by ! ,national ,in/itutes ( ,heal?1 to submit an application 7or r5ewal !re(7 = su* approval t includes-- 7#a7 cle> & measurable goals = ! recruitm5t & ret5tion ( p>ticipants t reflect-- 7,a7 ! race1 e?nicity1 age1 & sex ( pati5ts ) ! disease or condition be+ inve/igat$2 or 7,b7 ! race1 e?nicity1 age1 & sex ( ! g5]al population ( ! ,unit$ ,/ates if ! preval5ce ( ! disease or condition is n kn[n2 7#b7 a rationale = ! goals specifi$ "u p>agraph 7#a7 t specifies-- 7,a7 h[ inve/igators w calculate ! numb] ( p>ticipants = ea* population category t reflect ! population gr\ps specifi$ 9 p>agraph 7#a72 or 7,b7 /rategies t w be us$ to enroll & reta9 p>ticipants across ! diff]5t race1 e?nicity1 age1 & sex categories2 7#c7 a detail$ plan = h[ ! cl9ical trial w a*ieve ! goals specifi$ "u p>agraph 7#a7 t specifies-- 7,a7 ! requirem5ts = rese>*]s1 9 conduct+ ! trial1 to analyze ! population gr\ps specifi$ 9 p>agraph 7#a7 sep>ately2 7,b7 ! role ( community p>tn]s or community in/itutional review bo>ds 9 review+ ! plans2 & 7,c7 h[ ! trial w recruit a /udy population t is-- 7i7 9 proportion to ! preval5ce ( ! disease or condition 9 su* gr\ps relative to ! preval5ce ( ! disease or condition 9 ! ov]all population ( ! ,unit$ ,/ates2 7ii7 9 suffici5t numb]s to obta9 cl9ically & /ati/ically mean+ful det]m9ations ( ! safety & effectiv5ess ( ! drug1 device1 biological product1 or behavioral int]v5tion be+ /udi$ 9 ! respective race1 e?nicity1 age1 & sex gr\ps2 & 7iii7 consi/5t ) ! guidance "u section #eje7;b77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77#a77 & guidance issu$ by ! ,national ,in/itutes ( ,heal? on ! inclusion ( wom5 & m9orities 9 cl9ical trials2 7#d7 ! sponsor's plan = implem5t+1 or an explanation ( :y ! sponsor _c implem5t1 alt]native cl9ical trial foll[-up requirem5ts t are less burd5some = trial p>ticipants1 su* z-- 7,a7 requir+ few] foll[-up visits2 7,b7 all[+ phone foll[-up or home visits by nurse trial coord9ators 79 lieu ( 9-p]son visits by pati5ts72 7,c7 all[+ = onl9e foll[-up options2 7,d7 p]mitt+ ! pati5t's prim>y c>e provid] to p]=m "s ( ! foll[-up visit requirem5ts2 7,e7 all[+ = ev5+ & week5d h\rs = requir$ foll[-up visits2 7,f7 all[+ virtual or telem$ic9e visits2 7,g7 use ( we>able te*nology to record key heal? p>amet]s2 & 7,h7 use ( alt]nate labs or imag+ c5t]s1 :i* may be clos] to ! resid5ce ( ! pati5ts p>ticipat+ 9 ! trial2 & 7#e7 ! sponsor's education & tra9+ requirem5ts = rese>*]s & o!r individuals conduct+ or support+ ! cl9ical trial ) respect to div]sity & heal? inequities 91 & ! developm5t (1 curricula = heal?c>e pr(essionals on h[ to p>ticipate 9 cl9ical trials z an inve/igator & h[ !y c enroll pati5ts 9 trials1 :i* may include consultation )1 & ! review ( mat]ials made available by1 su* committees1 task =ces1 work+ gr\ps1 & o!r entities ! ,director det]m9es are appropriate1 includ+ ! foll[+3 7,a7 ,! ,equity ,committee ( ! ,national ,in/itutes ( ,heal?4 7,b7 ,! ,national ,advisory ,c\ncil on ,m9ority ,heal? & ,heal? ,disp>ities4 7,c7 ,! ,advisory ,committee on ,rese>* on ,wom5's ,heal?4 7,d7 ,! ,tribal ,heal? ,rese>* ,coord9at+ ,committee ( ! ,national ,in/itutes ( ,heal?4 7b7 ,t]ms 7#a7 ,9 g5]al ,z a condition on ! approval ( a protocol to conduct a cl9ical trial by ! ,national ,in/itutes ( ,heal?1 z describ$ 9 subsection 7a71 ! sponsor ( ! cl9ical trial %all agree to t]ms requir+ t-- 7,a7 ! aggregate demographic in=mation ( trial p>ticipants be %>$ on an annual basis ) ! ,secret>y :ile p>ticipant recruitm5t & data collection 9 su* trial is ongo+1 & t su* in=mation is provid$ ) respect to-- 7i7 und]repres5t$ populations1 includ+ populations gr\p$ by race1 e?nicity1 age1 & sex2 & 7ii7 su* populations t reflect ! preval5ce ( ! disease or condition t is ! subject ( ! cl9ical trial involv$ 7z available & z appropriate to ! sci5tific objective = ! /udy1 z det]m9$ by ! ,director ( ! ,national ,in/itutes ( ,heal?72 7,b7 ! sponsor submits to ! program (fic] & grants managem5t speciali/ ( ! specific ,national ,in/itutes ( ,heal? national rese>* in/itute or national c5t]1 annually or z frequ5tly z su* (fic] or speciali/ det]m9es necess>y1 ! ret5tion rate ( p>ticipants 9 ! cl9ical trial1 disaggregat$ by race1 e?nicity1 age1 & sex2 7,c7 bo? ! cl9ical trial rese>*]s & ! applicant review]s complete education & tra9+ programs on div]sity 9 cl9ical trials2 & 7,d7 at ! conclusion ( ! trial1 ! sponsor submits to ! ,secret>y ! numb] ( p>ticipants 9 ! trial1 disaggregat$ by race1 e?nicity1 age1 & sex4 7#b7 ,privacy protections ,any data %>$ "u p>agraph 7#a7 may n include any individually id5tifiable in=mation or protect$ heal? in=mation ) respect to cl9ical trial p>ticipants & %all only be disclos$ to ! ext5t all[$ "u ,f$]al privacy laws4 7c7 ,exception ,9 lieu ( submitt+ an application "u subsection 7a7 & docum5tation ( goals z requir$ by p>agraph 7#a7 ( su* subsection1 an applicant may provide reason+ = :y ! recruitm5t ( ea* ( ! population gr\ps specifi$ 9 p>agraph 7#a7 ( subsection 7a7 is n necess>y & :y su* recruitm5t is n sci5tifically ju/ifi$ or possible4 7d7 ,publication ,! ,secret>y %all-- 7#a7 publi% on a public website ( ! ,national ,in/itutes ( ,heal?1 ^u receipt ( an application to :i* subsection 7a7 applies-- 7,a7 a summ>y ( ! disease be+ t>get$ 9 ! cl9ical trial t is ! subject ( ! application & ! preval5ce ( su* disease across race1 e?nicity1 age1 sex1 & ! cl9ical trial repres5tation 9 ea* su* category2 7,b7 ! goals specifi$ 9 su* application1 z requir$ by subsection 7a77#a72 or 7,c7 ! reason+ describ$ 9 subsection 7c72 & 7#b7 ensure t1 9 publi%+ in=mation relat+ to an application "u p>agraph 7#a71 ! design ( ! /udy involv$ is n disclos$4 7e7 ,rem$iation 7#a7 ,9 g5]al ,9 ! case ( a cl9ical trial subject to subsection 7a7 t fails to meet ! condition specifi$ pursuant to subsection 7a7 by su* date z may be agre$ ^u by ! sponsor ( ! trial & ! program (fic] & grants managem5t speciali/ ( ! specific ,national ,in/itutes ( ,heal? national rese>* in/itute or national c5t]1 ! ,secret>y %all require ! sponsor ( t cl9ical trial1 n lat] ?an #ij days aft] su* date occurs-- 7,a7 to develop1 9 consultation ) ! ,secret>y & advocacy & community-bas$ organizations repres5t+ individuals :o are memb]s ( relevant demographic gr\ps specifi$ 9 subsection 7a77#a71 a /rategic plan to increase p>ticipation 9 su* cl9ical trial ( su* individuals2 & 7,b7 to submit to ! ,secret>y su* /rategic plan4 7#b7 ,publication ,! ,secret>y %all make publicly available on ! website ( ! ,national ,in/itutes ( ,heal?1 ! /rategic plan receiv$ "u p>agraph 7#a7 z soon z possible aft] receipt4 ,! ,secret>y %all ensure t1 9 publi%+ su* plan "u ! prec$+ s5t5ce1 ! design ( ! /udy involv$ is n disclos$4 7#c7 ,implem5tation ,! sponsor ( ! cl9ical trial t is ! subject ( ! /rategic plan publi%$ "u p>agraph 7#b71 %all1 n lat] ?an #ij days aft] su* date z may be agre$ ^u by ! sponsor ( ! trial & ! appropriate program (fic] & grants managem5t speciali/ ( ! ,national ,in/itutes ( ,heal?1 implem5t ! /rategic plan4 7#d7 ,te*nical assi/ance ,! ,secret>y may provide te*nical assi/ance to a sponsor ( a cl9ical trial1 z necess>y = ! sponsor to meet ! requirem5ts ( p>agraph 7#c74 7f7 ,waiv] = c]ta9 cl9ical trials 7#a7 ,9 g5]al ,9 ! case ( a cl9ical trial t receiv$ fund+ ?r\gh ! ,national ,in/itutes ( ,heal? & is ongo+ z ( ! date ( ! enactm5t ( ?is ,act1 ! sponsor ( su* cl9ical trial is exempt f ! requirem5ts ( 7& associat$ p5alties impos$ by7 ?is ,act4 7#b7 ,report ,! ,secret>y %all include 9 ! tri5nial report requir$ to be submitt$ "u section #djc ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhc71 a li/ ( all cl9ical trials receiv+ fund+ ?r\gh ! ,national ,in/itutes ( ,heal? t reque/$ & receiv$ waiv]s "u ?is section4 7g7 ,/udy 7#a7 ,9 g5]al ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy t-- 7,a7 exam9es :i* actions ,f$]al ag5cies h tak5 to address b>ri]s to p>ticipation 9 f$]ally fund$ cl9ical trials by ! demographic gr\ps specifi$ 9 subsection 7a77#a72 & 7,b7 id5tifies *all5ges1 if any1 9 implem5t+ su* actions4 7#b7 ,report ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ,congress a report on ! f9d+s ( ! /udy conduct$ "u p>agraph 7#a74 7h7 ,nondiscrim9ation ,section #aeeg ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahaaf7 %all apply ) respect to a cl9ical trial subject to subsection 7a74 #c4 ,elim9at+ co/ b>ri]s ,n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,director ( ! ,national ,in/itutes ( ,heal? 7ref]r$ to 9 ?is section z ! ,secret>y71 %all conduct & complete a /udy on-- 7#a7 ! ne$ = review ( human subject regulations specifi$ 9 "p #df ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations71 & relat$ guidance2 7#b7 ! mod]nization ( su* regulations & guidance to e/abli% updat$ guidel9es = reimbursem5t ( out-(-pocket exp5ses ( human subjects1 comp5sation ( human subjects = "t sp5t p>ticipat+ 9 ! cl9ical trial1 & inc5tives = recruitm5t ( human subjects2 & 7#c7 ! ne$ = updat$ safe h>bor rules "u section #ajja4ieb ( title #db1 ,code ( ,f$]al ,regulations 7or successor regulations7 & section #aabh;,b ( ! ,social ,security ,act 7commonly ref]r$ to z ! ,f$]al ,anti-,kickback ,/atute 7#db ,u4,s4,c4 #acbj;a-#g;b77 ) respect to ! assi/ance provid$ "u ?is section4 #d4 ,public aw>5ess & education campaign 7a7 ,national campaign ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,director ( ! ,national ,in/itutes ( ,heal? & ! ,commission] ( ,food & ,drugs 7ref]r$ to 9 ?is section z ! ,secret>y7 & 9 consultation ) ! /akehold]s specifi$ 9 subsection 7e71 %all c>ry out a national campaign to increase ! aw>5ess & k ( individuals 9 ! ,unit$ ,/ates1 includ+ heal?c>e pr(essionals1 pati5ts1 & o!rs1 ) respect to ! ne$ = div]se cl9ical trials among ! demographic gr\ps id5tifi$ pursuant to section #b7;a77#a74 7b7 ,requirem5ts ,! national campaign conduct$ "u ?is section %all include-- 7#a7 7,a7 ! developm5t & di/ribution ( writt5 educational mat]ials2 7,b7 ! developm5t & plac+ ( public s]vice ann\ncem5ts t are int5d$ to enc\rage individuals :o are memb]s ( ! demographic gr\ps id5tifi$ pursuant to section #b7;b77#a77;,a77,i7 to seek to p>ticipate 9 cl9ical trials2 & 7,c7 ! developm5t ( curricula = heal? c>e pr(essionals on-- 7i7 h[ to p>ticipate 9 cl9ical trials z an inve/igator2 & 7ii7 h[ su* pr(essionals c enroll pati5ts 9 trials2 7#b7 su* ef=ts z are reasonable & necess>y to ensure mean+ful access by consum]s ) limit$ ,engli% pr(ici5cy2 7#c7 ! developm5t & di/ribution ( be/ practices & tra9+ = recruit+ und]repres5t$ /udy populations1 includ+ a me?od = %>+ su* be/ practices among cl9ical trial sponsors1 provid]s1 community-bas$ organizations :o assi/ ) recruitm5t1 & ) ! public2 & 7#d7 ! conduct ( focus gr\ps to bett] und]/& ! conc]ns & fe>s ( c]ta9 und]repres5t$ gr\ps :o may be reluctant to p>ticipate 9 cl9ical trials4 7c7 ,heal? inequities ,9 develop+ ! national campaign "u subsection 7a71 ! ,secret>y %all recognize & address-- 7#a7 heal? inequities among individuals :o are memb]s ( ! population gr\ps specifi$ 9 section #b7;b77#a77;,a7 ) respect to access to c>e & p>ticipation 9 cl9ical trials2 & 7#b7 any b>ri]s 9 access to c>e & p>ticipation 9 cl9ical trials t are specific to individuals :o are memb]s ( su* gr\ps4 7d7 ,grants ,! ,secret>y %all e/abli% a program to aw>d grants to nonpr(it private entities 7includ+ community bas$ organizations & fai? communities1 in/itutions ( high] education eligible to receive funds "u section #cga ( ! ,high] ,education ,act ( #aife 7#bj ,u4,s4,c4 #ajfgq71 national organizations t s]ve und]repres5t$ populations1 & community ph>macies7 to enable su* entities-- 7#a7 to te/ alt]native outrea* & education /rategies to increase ! aw>5ess & k ( individuals 9 ! ,unit$ ,/ates1 ) respect to ! ne$ = div]se cl9ical trials t reflect ! race1 e?nicity1 age1 & sex ( pati5ts ) ! disease or condition be+ inve/igat$2 & 7#b7 to cov] adm9i/rative co/s ( su* entities 9 assi/+ 9 div]sify+ cl9ical trials subject to section #b4 7e7 ,/akehold]s specifi$ ,! /akehold]s specifi$ 9 ?is subsection are ! foll[+3 7#a7 ,repres5tatives ( ! ,heal? ,res\rces ,s]vices ,adm9i/ration1 ! ,(fice on ,m9ority ,heal? ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,c5t]s = ,disease ,control & ,prev5tion1 & ! ,national ,in/itutes ( ,heal?4 7#b7 ,community-bas$ res\rces & advocates4 7f7 ,au?orization ( ,appropriations ,!re is au?oriz$ to be appropriat$ to c>ry out ?is section #aj1jjj1jjj = ea* ( fiscal ye>s #bjbg ?r\gh #bjcj4 #e4 ,def9itions ,9 ?is ,act3 7#a7 ,cl9ical trial ,! t]m cl9ical trial means a rese>* /udy 9 :i* "o or m human subjects are prospectively assign$ to "o or m int]v5tions 7:i* may include placebo or o!r control7 to evaluate ! effects ( ^? int]v5tions on heal?-relat$ biom$ical or behavioral outcomes4 7#b7 ,sponsor ,! t]m sponsor has ! mean+ giv5 su* t]m 9 section #ej4c ( title #ba1 ,code ( ,f$]al ,regulations 7or successor regulations74