,,ii  #aah? ,,congress  #a/ ,session    
,s4 #agja  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,may #ah1 #bjbc,mr4    
,m55dez 7= himself & ,ms4 ,coll9s7      
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,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      
,div]sity ,act ( #bjbc4  #b4 ,div]sity  
goals = cl9ical trials fund$ by !       
,national ,in/itutes ( ,heal?  7a7      
,applications ,beg9n+ on ! 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 require t a rese>*     
organization or entity fund$ by !       
,national ,in/itutes ( ,heal? 7ref]r$ to

 9 ?is section z an ,,nih-fund$ rese>*  
organization or entity7 seek+ to conduct
 a cl9ical trial inve/igat+ a drug or   
device 7z ^? t]ms are def9$ 9 section   
#bja ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#ba ,u4,s4,c4 #cba77 or 
a biological product 7z def9$ 9 section 
#cea7;i7 ( ! ,public ,heal? ,s]vice ,act
 7#db ,u4,s4,c4 #bfb7;i777 t is fund$ by
 ! ,national ,in/itutes ( ,heal? or a   
behavioral int]v5tion1 ! protocol = :i* 
is approv$ by ! ,national ,in/itutes (  
,heal?1 submit an application 7or r5ewal
 !re(7 = su* fund+ or 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$2 or  7,b7 z             
sci5tifically or e?ically ju/ifi$ &     
appropriate1 ! 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      
det]m9e ! 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 h[ ! trial w recruit a /udy        
population t is-- 7i7 sci5tifically &   
e?ically appropriate 9 t]ms ( !         
sci5tific objectives & propos$ /udy     
design2 &  7ii7 9 suffici5t numb]s to   
obta9 cl9ically & /ati/ically mean+ful  
det]m9ations ( ! safety & effectiv5ess (
 ! drug1 device1 or behavioral          
int]v5tion be+ /udi$ 9 ! respective     
race1 e?nicity1 age1 & sex gr\ps2 &     
7#d7 ! ,,nih-fund$ rese>* organization  
or entity's plan = implem5t+1 or an     

explanation ( :y ! ,,nih-fund$ rese>*   
organization or entity _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 appropriately
 qualifi$ /aff 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$ic9e visits2  7,g7 use ( we>able  
te*nology to record key heal? p>amet]s2 
&  7,h7 use ( alt]nate labs or imag+    
c5t]s1 :i* may be clos] to ! resid5ce ( 
! pati5ts p>ticipat+ 9 ! trial4  7b7    
,t]ms  7#a7 ,9 g5]al ,z a condition on !
 receipt ( fund+ ?r\gh ! ,national      
,in/itutes ( ,heal?1 z describ$ 9       
subsection 7a71 ) respect to a cl9ical  
trial1 ! ,,nih-fund$ rese>* organization
 or entity ( ! 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 ! 
,,nih-fund$ rese>* organization or      
entity submits to ! program (fic] &     
grants managem5t speciali/ ( ! specific 
in/itute1 c5t]1 or (fice ( ! ,national  
,in/itutes ( ,heal?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 ! cl9ical trial rese>*]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$]al privacy laws & by ,national   
,in/itutes ( ,heal? policy4  7c7        
,exception ,9 lieu ( submitt+ an        
application "u subsection 7a7 &         
docum5tation ( goals z requir$ 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   
#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?1 %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$]al ,regulations 7or successor    
regulations71 & section #aabh;,b ( !    
,social ,security ,act 7commonly ref]r$ 
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]vices 7ref]r$ to 9   
?is section z ! ,secret>y71 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;,a77i7 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 & ) ! public4  7c7 ,heal?  
disp>ities ,9 develop+ ! national       
campaign "u subsection 7a71 ! ,secret>y 
%all recognize & address-- 7#a7 heal?   
disp>ities 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 ( ! ,food & ,drug  
,adm9i/ration1 ! ,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 #bjbd ?r\gh #bjbg4  #e4     
,def9ition ,9 ?is ,act1 ! 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