,,ii  #aag? ,,congress  #a/ ,session    
,s4 #bgjf  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,augu/ #aj1 #bjba,mr4  
,m55dez 7= himself & ,mr4 ,scott ( ,s\? 
,c>ol9a7 introduc$ ! foll[+ bill2 :i* 0 
read twice & ref]r$ to ! ,committee on  
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to improve div]sity 9       
cl9ical trials & data collection =      
,,covid-#ai & future public heal? ?reats
 to address social det]m9ants ( heal?4  
#a4 ,%ort title ,?is ,act may be cit$ z 
! ,div]sify+ ,inve/igations ,via        
,equitable ,rese>* ,/udies = ,ev]yone   
,trials ,act or ! ,,div]se ,trials ,act4
  #b4 ,guidance on dec5traliz$ cl9ical  
trials  7a7 ,def9itions ,9 ?is section1 
! t]m dec5traliz$ cl9ical trials        
includes cl9ical trials t are execut$   
?r\gh a broad spectrum ( options1 su* z 
telem$ic9e or o!r mobile or digital     
te*nologies1 to all[ = ! remote         
collection & assessm5t ( cl9ical trial  
data f p>ticipants1 includ+ 9 ! home or 
(fice sett+4  7b7 ,guidance ,n lat] ?an 

#f mon?s aft] ! date ( enactm5t ( ?is   
,act1 ! ,secret>y ( ,heal? & ,human     
,s]vices 7ref]r$ to 9 ?is ,act z !      
,secret>y71 act+ ?r\gh ! ,commission] ( 
,food & ,drugs 7ref]r$ to 9 ?is ,act z !
 ,commission]71 %all issue a draft      
guidance t addresses h[ to conduct      
dec5traliz$ cl9ical trials ) mean+ful   
demographic div]sity1 includ+ racial1   
e?nic1 age1 g5d]1 & geographic div]sity 
9 pati5t engagem5t1 enrollm5t1 &        
p>ticipation1 includ+ h[ to             
appropriately use digital heal?         
te*nologies or o!r remote assessm5t     
options1 su* z telem$ic9e1 to support   
su* trials4 ,n lat] ?an #f mon?s aft] ! 
date ! public comm5t p]iod = ! draft    
guidance ends1 ! ,secret>y %all issue a 
f9al guidance4  7c7 ,cont5t ( guidance  
,! guidance "u subsection 7b7 %all      
address ! foll[+3 7#a7 ,/rategies to    
engage ) prospective cl9ical trial      
p>ticipants & community p>tn]s1 su* z   
pati5t advocacy gr\ps ) div]se          
repres5tation1 to incorporate input (   

su* pati5ts & p>tn]s into ! design (    
dec5traliz$ cl9ical trials4  7#b7       
,recomm5dations =-- 7,a7 protocol design
 approa*es2  7,b7 appropriate cl9ical   
endpo9ts2  7,c7 in/itutional review bo>d
 composition & ensur+ t su* bo>ds       
include memb]s ) exp]tise 9 dec5traliz$ 
cl9ical trials2  7,d7 delegation (      
cl9ical rese>* organization             
responsibilities & suitable proxies =   
cl9ical rese>* organizations2 &  7,e7   
simplify+ in=m$ cons5t4  7#c7           
,recomm5dations = h[ digital heal?      
te*nology or o!r remote assessm5t       
options1 su* z telem$ic9e1 c\ld support 
dec5traliz$ cl9ical trials1 includ+     
guidance on appropriate te*nological    
plat=ms & m$iums1 data collection & use1
 data integrity1 & communication to /udy
 p>ticipants ?r\gh digital te*nology4   
7#d7 ,recomm5dations = appropriate      
me?ods ( pati5t recruitm5t & ret5tion1  
includ+ in/itutional review bo>d        
ov]sight1 pati5t communication1 & ! role
 ( /udy p>ticipants & community p>tn]s z

 advocates to facilitate cl9ical trial  
recruitm5t1 p>ticul>ly ) respect to     
und]repres5t$ populations4  7#e7        
,in=mation reg>d+ :5 & h[ a /udy sponsor
 may solicit a meet+ ) ! ,secret>y      
reg>d+ ! issues describ$ 9 p>agraphs    
7#a7 ?r\gh 7#d74  7d7 ,int]national     
,h>monization ,aft] issu+ ! f9al        
guidance "u subsection 7b71 ! ,secret>y1
 act+ ?r\gh ! ,commission]1 may "w )    
=eign regulators pursuant to exi/+      
memor&a ( und]/&+ gov]n+ ex*ange (      
in=mation to facilitate int]national    
h>monization ( ! regulation (           
dec5traliz$ cl9ical trials & use (      
digital heal? te*nology or o!r remote   
assessm5t options4  #c4 ,enc\ragem5t (  
cl9ical trial enrollm5t by racially &   
e?nically div]se populations  7a7 ,no   
co/ provision ( digital heal?           
te*nologies ,! free provision ( digital 
heal? te*nologies by drug or device     
manufactur]s to _! cl9ical trial        
p>ticipants %all n be consid]$ a        
violation ( section #aabh;,a ( ! ,social

 ,security ,act 7commonly kn[n z !      
,civil ,monet>y ,p5alties ,law7 7#db    
,u4,s4,c4 #acbj;a-#g;a71 section        
#aabh;,b ( ! ,social ,security ,act 7#db
 ,u4,s4,c4 #acbj;a-#g;b71 or sections   
#cgbi ?r\gh #cgcc ( title #ca1 ,unit$   
,/ates ,code1 7commonly kn[n z ! ,false 
,claims ,act71 provid$ t-- 7#a7 ! use ( 
digital heal? te*nologies w facilitate 9
 any phase ( cl9ical developm5t !       
inclusion ( div]sity ( pati5t           
populations1 su* z und]repres5t$ racial 
& e?nic m9orities1 l[-income            
populations1 & ! eld]ly2  7#b7 ! digital
 heal? te*nologies w facilitate         
individuals p>ticipation1 or are        
necess>y to su* p>ticipation2  7#c7 all 
features ( ! digital heal? te*nologies t
 are unrelat$ to use 9 ! cl9ical trial  
are disabl$ or only all[$ to rema9      
activat$ to model real-_w usage ( !     
digital te*nology2 &  7#d7 ! cl9ical    
trial sponsor requires p>ticipants to   
return1 pur*ase1 or disable ! digital   
heal? te*nologies by ! conclusion ( !   

trial4  7b7 ,grants & contracts  7#a7 ,9
 g5]al ,! ,secret>y may issue grants to 
& ent] into contracts ) entities to     
support community education1 outrea*1 & 
recruitm5t activities = cl9ical trials )
 respect to drugs1 includ+ vacc9es =    
diseases or conditions :i* h a          
disproportionate impact on und]repres5t$
 populations 7includ+ on racial & e?nic 
m9ority populations71 includ+ = !       
diagnosis1 prev5tion1 or treatm5t (     
,,covid-#ai4 ,su* activities may        
include-- 7,a7 work+ ) community cl9ical
 trial sites1 includ+ community heal?   
c5t]s1 academic heal? c5t]s1 & o!r      
facilities2  7,b7 tra9+ heal? c>e       
p]sonnel includ+ pot5tial cl9ical trial 
inve/igators1 ) a focus on significantly
 increas+ ! numb] ( und]repres5t$ racial
 & e?nic m9ority heal?c>e p]sonnel :o   
are cl9ical trial inve/igators at !     
community sites = ongo+ cl9ical trials2 
7,c7 engag+ community /akehold]s to     
enc\rage p>ticipation 9 cl9ical trials1 
especially 9 und]repres5t$ racial &     

e?nic m9ority communities2 &  7,d7 fo/]+
 p>tn]%ips ) community-bas$             
organizations s]v+ und]repres5t$ racial 
& e?nical m9ority populations1 includ+  
employee unions & frontl9e heal? c>e    
work]s4  7#b7 ,priority = grant &       
contract aw>ds ,9 aw>d+ grants &        
contracts "u ?is subsection1 ! ,secret>y
 %all prioritize entities t-- 7,a7      
develop educational1 recruitm5t1 & tra9+
 mat]ials 9 multiple languages2 or  7,b7
 und]take cl9ical trial outrea* ef=ts 9 
m div]se racial & e?nic communities t   
are traditionally und]repres5t$ 9       
cl9ical trials1 su* z tribal areas4     
7#c7 ,au?orization ( appropriations ,!re
 is au?oriz$ to be appropriat$ = fiscal 
ye>s #bjbj & #bjba su* sums z may be    
necess>y to c>ry out ?is subsection4    
#d4 ,enhancem5t ( ,,covid-#ai data      
collection to address demographic data  
gaps & social det]m9ants ( heal?  7a7   
,data collection ,to address demographic
 data gaps  7#a7 ,9 g5]al ,! ,secret>y  
%all require laboratories t are subject 

to ! report+ requirem5ts "u section     
#ahaae7;a7 ( ! ,coronavirus ,aid1       
,relief1 & ,economic ,security ,act     
7,public ,law #aaf-acf71 to include )   
reports made "u su* section #ahaae7;a7  
in=mation to enhance su* exi/+          
,,covid-#ai data collection activities &
 to advance policies to address social  
det]m9ants ( heal?1 includ+ additional  
id5tifi]s1 su* z ^? id5tifi$ by !       
,commission]1 includ+ build+ on guidance
 exi/+ on ! date ( enactm5t ( ?is ,act1 
= ! collection ( race & e?nicity data 9 
cl9ical trials1 z det]m9$ appropriate by
 ! ,secret>y4  7#b7 ,additional use (   
data ,! data collect$ "u p>agraph 7#a7  
may be us$ to in=m-- 7,a7 cl9ical trial 
recruitm5t2  7,b7 res\rce allocations2  
7,c7 treatm5t /rategies2 &  7,d7 o!r    
public heal? activities4  7#c7          
,collection via grants or contracts     
7,a7 ,9 g5]al ,! ,secret>y may issue    
grants to1 & ent] into contracts )1     
,/ates1 local public heal? dep>tm5ts1 or
 o!r entities supply+ data to !         

,secret>y z requir$ "u ?is subsection1  
to support ! activities "u ?is          
subsection4  7,b7 ,guidance = use (     
funds ,9 issu+ grants or contracts "u   
subp>agraph 7,a71 ! ,secret>y may issue 
guidance reg>d+ be/ practices = collect+
 data pursuant to p>agraph 7#a7 & track 
! p]=mance ( entities receiv+ grants or 
contracts4  7#d7 ,use & disclosure =    
public heal? activities ,! submission & 
use ( data collect$ pursuant to ?is     
subsection %all be consid]$ a p]mitt$   
disclosure & use = public heal?         
activities z set =? 9 section           
#afd4eab7;b77#a77;i7 ( #de1 ,code (     
,f$]al ,regulations 7or any successor   
regulations74  7b7 ,data collection     
reg>d+ enhanc$ risk = ,,covid-#ai ,!    
,secret>y %all-- 7#a7 conduct a /udy on 
be/ practices = laboratories t are      
subject to ! report+ requirem5ts "u     
section #ahaae7;a7 ( ! ,coronavirus     
,aid1 ,relief1 & ,economic ,security    
,act 7,public ,law #aaf-acf7 to aid su* 
laboratories 9 collect+ data elem5ts    

relat$ to enhanc$ risk = ,,covid-#ai1   
su* z data1 ) respect to a pati5t1      
reg>d+ income1 education1 employm5t1    
disability1 community res\rces1 & social
 support2  7#b7 consid] :i* gov]nm5tal  
entities 7includ+ ,f$]al1 ,/ate1 & local
 gov]nm5tal entities7 w\ld be be/ suit$ 
to aid+ 9 collect+ su* data elem5ts 9   
coord9ation ) su* laboratories2 &  7#c7 
issue guidance on su* be/ practices4    
#e4 ,cl>ification t c]ta9 remun]ation   
relat$ to p>ticipation 9 cl9ical trials 
does n con/itute remun]ation "u ! ,f$]al
 civil money p5alties law  7a7 ,9 g5]al 
,section #aabh;,a7i77#f77;,f7 ( !       
,social ,security ,act 7#db ,u4,s4,c4   
#acbj;a-#g;a7i77#f77;,f77 is am5d$ by   
ins]t+ 7includ+ remun]ation (f]$ or     
transf]r$ to an individual to promote ! 
p>ticipation 9 an approv$ cl9ical trial1
 z def9$ 9 subsection 7d7 ( ! fir/      
section #bgji ( ! ,public ,heal? ,s]vice
 ,act1 t is regi/]$ ) ! database (      
cl9ical trials ma9ta9$ by ! ,national   
,libr>y ( ,m$ic9e 7or any successor     

database71 s long z su* remun]ation     
facilitates equitable inclusion (       
pati5ts f all relevant demographic &    
socioeconomic populations & is relat$ to
 pati5t p>ticipation 9 ! approv$ cl9ical
 trial7 aft] promotes access to c>e4    
7b7 ,effective date ,! am5dm5t made by  
subsection 7a7 %all apply to remun]ation
 provid$ on or aft] ! date ( ! enactm5t 
( ?is ,act4  #f4 ,national academy (    
m$ic9e /udy  7a7 ,9 g5]al ,! ,secret>y  
%all ent] into an arrangem5t ) !        
,national ,academy ( ,m$ic9e "u :i* !   
,national ,academy agrees to /udy &     
propose a design = a national           
int]op]able data plat=m to improve      
access to heal? data1 & o!r relevant    
data ne$s1 dur+ public heal? em]g5cies4 
7b7 ,report ,! arrangem5t "u subsection 
7a7 %all provide = submission by !      
,national ,academy ( ,m$ic9e to !       
,secret>y & ,congress1 n lat] ?an #abj  
days aft] ! date ( enactm5t ( ?is ,act1 
( a report on ! results ( ! /udy "u     
subsection 7a7 & ! design propos$ bas$  

on su* /udy4