,i  #aagth ,,congress  #ast ,session    
,h4 ,r4 #cjhe  ,,in ,,the ,,house ,,of  
,,representatives  ,may #aa1 #bjba,ms4  
,blunt ,rochester 7for herself1 ,ms4    
,herrera ,beutler1 ,mr4 ,curtis1 ,mr4   
,smith of ,new ,jersey1 and ,ms4        
,waters7 introduced the following bill2 
which was referred to the ,committee on 
,energy and ,commerce  ,a ,,bill  ,to   
amend the ,public ,health ,service ,act 
to improve the diversity of participants
 in research on ,alzheimer's disease1   
and for other purposes4  #a4 ,short     
title ,this ,act may be cited as the    
,equity in ,neuroscience and            
,alzheimer's ,clinical ,trials ,act of  
#bjba or the ,,enact ,act of #bjba4  #b4
 ,incentives1 improvements1 and outreach
 to increase diversity in ,alzheimer's  
disease research  7a7 ,improving access 
for and outreach to underrepresented    
populations  7#a7 ,expanding access to  
,alzheimer's research centers  7,a7 ,in 
general ,section #dde7;a77#a7 of the    
,public ,health ,service ,act 7#db      

,u4,s4,c4 #bhe;e-#b7;a77#a77 is         
amended-- 7i7 by striking 7a77#a7 ,the  
,director of the ,institute may and     
inserting the following3  7a7 7#a7 ,the 
,director of the ,institute-- 7,a7 may  
2  7ii7 by striking disease4 and        
inserting disease2 and2 and  7iii7 by   
adding at the end the following3  7,b7  
beginning ,january #a1 #bjbb1 shall     
enter into cooperative agreements and   
make grants to public or private        
nonprofit entities under this subsection
 for the planning1 establishment1 and   
operation of new such centers that are  
located in areas with a higher          
concentration of minority groups 7as    
determined under section                
#ddd7;d77#c77;,d771 such as entities    
that are historically ,black colleges   
and universities1 ,hispanic-serving     
institutions1 ,tribal colleges and      
universities1 or centers of excellence  
for other minority populations4  4  7,b7
 ,use of funding for clinics to operate 
clinical trials ,section #dde7;b7 of the

 ,public ,health ,service ,act 7#db     
,u4,s4,c4 #bhe;e-#b7;b77 is amended by  
adding at the end the following3  7#c7  
,federal payments made under a          
cooperative agreement or grant under    
subsection 7a7 from funds made available
 under section #b7;g7 of the ,,enact    
,act of #bjba shall1 with respect to    
,alzheimer's disease1 be used in part to
 establish and operate diagnostic and   
treatment clinics designed-- 7,a7 to    
meet the special needs of minority and  
rural populations and other underserved 
populations2 and  7,b7 to operate       
clinical trials  4  7#b7 ,outreach  7,a7
 ,alzheimer's disease centers ,section  
#dde7;b7 of the ,public ,health ,service
 ,act 7#db ,u4,s4,c4 #bhe;e-#b7;b771 as 
amended by paragraph 7#a77;,b71 is      
further amended by adding at the end the
 following new paragraph3  7#d7 ,federal
 payments made under a cooperative      
agreement or grant under subsection 7a7 
shall be used to establish engagement   
centers to carry out public outreach1   

education efforts1 and dissemination of 
information for members of minority     
groups about clinical trial             
participation4 ,activities funded       
pursuant to the preceding sentence shall
 include-- 7,a7 using established       
mechanisms to encourage members of      
minority groups to participate in       
clinical trials on ,alzheimer's disease2
  7,b7 expanding education efforts to   
make members of minority groups aware of
 ongoing clinical trials2  7,c7 working 
with trial sponsors to increase the     
number of recruitment events for members
 of minority groups2  7,d7 conducting   
outreach to national1 ,state1 and local 
physician professional organizations1   
especially for members of such          
organizations who are primary care      
physicians or physicians who specialize 
in dementia1 to increase awareness of   
clinical research opportunities for     
members of minority groups2 and  7,e7   
using community-based participatory     
research methodologies to engage with   

minority populations4  4  7,b7 ,resource
 centers for minority aging research    
,section #ddd7;c7 of the ,public ,health
 ,service ,act 7#db ,u4,s4,c4           
#bhe;e-#a7;c77 is amended-- 7i7 by      
striking 7c7 and inserting 7c77#a7 2 and
  7ii7 by adding at the end the         
following new paragraph3  7#b7 ,the     
,director1 acting through the ,resource 
,centers for ,minority ,aging ,research 
of the ,institute1 shall carry out      
public outreach1 education efforts1 and 
dissemination of information for members
 of minority groups about participation 
in clinical research on ,alzheimer's    
disease carried out or supported under  
this subpart4  4  7b7 ,incentives to    
increase diversity in ,alzheimer's      
disease research through principal      
investigators and researchers from      
underrepresented populations  7#a7      
,alzheimer's clinical research and      
training awards ,section #dde;,i of the 
,public ,health ,service ,act 7#db      
,u4,s4,c4 #bhe;e-#aj;a7 is amended by   

adding at the end the following new     
subsection3  7d7 ,enhancing the         
participation of principal investigators
 and researchers who are members of     
underrepresented populations  7#a7 ,in  
general ,the ,director shall enhance    
diversity in the conduct or support of  
clinical research on ,alzheimer's       
disease under this subpart by           
encouraging the participation of        
individuals from groups that are        
underrepresented in the biomedical1     
clinical1 behavioral1 and social        
sciences as principal investigators of  
such clinical research1 as researchers  
for such clinical research1 or both4    
7#b7 ,training for principal            
investigators ,the ,director of the     
,institute shall provide training for   
principal investigators who are members 
of a minority group with respect to     
skills for-- 7,a7 the design and conduct
 of clinical research and clinical      
protocols2  7,b7 applying for grants for
 clinical research2 and  7,c7 such other

 areas as the ,director determines to be
 appropriate4  4  7#b7 ,senior          
researcher awards ,section #dde;,b7a7 of
 the ,public ,health ,service ,act 7#db 
,u4,s4,c4 #bhe;e-#d7;a77 is amended by  
inserting 1 including senior researchers
 who are members of a minority group    
before the period at the end of the     
first sentence4  7c7 ,incentives to     
increase diversity in ,alzheimer's      
disease research through trial sites    
,section #ddd7;d7 of the ,public ,health
 ,service ,act 7#db ,u4,s4,c4           
#bhe;e-#a7;d77 is amended-- 7#a7 by     
striking 7d7 and inserting 7d77#a7 2 and
  7#b7 by adding at the end the         
following new paragraphs3  7#b7 ,in     
conducting or supporting clinical       
research on ,alzheimer's disease for    
purposes of this subpart1 in addition to
 requirements otherwise imposed under   
this title1 including under section     
#dib;,b1 the ,director of the ,institute
 shall increase the participation of    
members of minority groups in such      

clinical research through one or more of
 the activities described in paragraph  
7#c74  7#c7 7,a7 ,the ,director of the  
,institute shall provide incentives for 
the support of clinical research on     
,alzheimer's disease with clinical trial
 sites established in areas with a      
higher concentration of minority groups1
 including rural areas if practicable4  
7,b7 ,in determining whether to conduct 
or support clinical research on         
,alzheimer's disease1 the ,director of  
the ,institute shall encourage the      
conduct of clinical research with       
clinical trial sites in areas described 
in subparagraph 7,a7 as a higher-level  
priority criterion among the criteria   
established to evaluate whether to      
conduct or support clinical research4   
7,c7 ,in determining the amount of      
funding to be provided for the conduct  
or support of such clinical research1   
the ,director of the ,institute shall   
provide additional funding for the      
conduct of such clinical research with  

clinical trial sites in areas described 
in subparagraph 7,a74  7,d7 ,in         
determining whether an area is an area  
with a higher concentration of minority 
groups1 the ,director of the            
,institute-- 7i7 shall consider the most
 recent data collected by the ,bureau of
 the ,census2 and  7ii7 may also        
consider-- 7,i7 data from the ,centers  
for ,medicare  ,medicaid ,services on   
the incidence of ,alzheimer's disease in
 the ,united ,states by region2 and     
7,,ii7 such other data as the ,director 
determines appropriate4  7#d7 ,in order 
to facilitate the participation of      
members of minority groups in clinical  
research supported under this subpart1  
in addition to activities described in  
paragraph 7#c71 the ,director of the    
,institute shall-- 7,a7 ensure that such
 clinical research uses community-based 
participatory research methodologies2   
and  7,b7 encourage the use of remote   
health technologies1 including          
telehealth1 remote patient monitoring1  

and mobile technologies1 that reduce or 
eliminate barriers to participation of  
members of minority groups in such      
clinical research4  7#e7 7,a7 ,clinical 
research on ,alzheimer's disease        
conducted or supported under this       
subpart shall ensure that such research 
includes outreach activities designed to
 increase the participation of members  
of minority groups in such research4    
7,b7 7i7 ,each applicant for a grant    
under this subpart for clinical research
 on ,alzheimer's disease shall submit to
 the ,director of the ,institute in the 
application for such grant-- 7,i7 a     
budget for outreach activities to       
members of minority populations with    
respect to participation in such        
clinical research2 and  7,,ii7 a        
description of the plan to conduct such 
outreach4  7ii7 ,the ,director of the   
,institute shall encourage applicants   
for1 and recipients of1 grants under    
this subpart to conduct clinical        
research on ,alzheimer's disease to     

engage with community-based             
organizations to increase participation 
of minority populations in such         
research4  7#f7 ,for purposes of this   
subpart3 7,a7 ,the term clinical        
research includes a clinical trial4     
7,b7 ,the term minority group has the   
meaning given such term by reason of    
section #dib;,b7g74  4  7d7 ,participant
 eligibility criteria ,section #dde;,i  
of the ,public ,health ,service ,act    
7#db ,u4,s4,c4 #bhe;e-#aj;a71 as amended
 by subsection 7b77#a71 is further      
amended by adding at the end the        
following new subsection3  7e7          
,participant eligibility criteria ,the  
,director of the ,institute shall take  
such actions as are necessary to ensure 
that clinical research on ,alzheimer's  
disease conducted or supported under    
this subpart is designed with           
eligibility criteria that ensure the    
clinical trial population reflects the  
diversity of the prospective patient    
population4 ,such actions may include   

the following3 7#a7 ,examination of     
criteria  7,a7 ,in general ,an          
examination of each exclusion criterion 
to determine if the criterion is        
necessary to ensure the safety of trial 
participants or to achieve the study    
objectives4  7,b7 ,modification of      
criteria ,in the case of an exclusion   
criterion that is not necessary to      
ensure the safety of trial participants 
or to achieve the study objectives-- 7i7
 encouraging the modification or        
elimination of the criterion2 or  7ii7  
encouraging tailoring the criterion as  
narrowly as possible to avoid           
unnecessary limits to the population of 
the clinical study4  7#b7 ,requirement  
for strong justification for exclusion  
,a review of each exclusion criterion to
 ensure that populations are included in
 clinical trials1 such as older adults1 
individuals with a mild form of disease1
 individuals at the extremes of the     
weight range1 or children1 unless there 
is a strong clinical or scientific      

justification to exclude them4  7#c7    
,use of adaptive design ,encouraging the
 use of an adaptive clinical trial      
design that-- 7,a7 starts with a defined
 population where there are concerns    
about safety2 and  7,b7 may expand to a 
broader population based on initial data
 from the trial and external data4  4   
7e7 ,resource center for successful     
strategies to increase participation of 
underrepresented populations in         
,alzheimer's disease clinical research  
,section #ddd of the ,public ,health    
,service ,act 7#db ,u4,s4,c4 #bhe;e-#a7 
is amended by adding at the end the     
following new subsection3  7e7 7#a7     
,acting through the ,office of ,special 
,populations and in consultation with   
the ,division of ,extramural            
,activities1 the ,director of the       
,institute shall support resource       
information and technical assistance to 
grantees under section #dde 7relating to
 ,alzheimer's disease centers71 other   
grantees1 and prospective grantees1     

designed to increase the participation  
of minority populations in clinical     
research on ,alzheimer's disease        
conducted or supported under this       
subpart4  7#b7 ,the resource information
 and technical assistance provided under
 paragraph 7#a7 shall include the       
maintenance of a central resource       
library in order to collect1 prepare1   
analyze1 and disseminate information    
relating to strategies and best         
practices used by recipients of grants  
under this subpart and other researchers
 in the development of the clinical     
research designed to increase the       
participation of minority populations in
 such clinical research4  4  7f7 ,annual
 reports ,section #ddd of the ,public   
,health ,service ,act 7#db ,u4,s4,c4    
#bhe;e-#a71 as amended by subsection    
7e71 is further amended by adding at the
 end the following new subsection3  7f7 
7#a7 7,a7 ,the ,director of the         
,institute shall submit annual reports  
to the ,congress on the impact of the   

amendments made to this subpart by the  
,,enact ,act of #bjba4  7,b7 ,the       
,secretary shall transmit a copy of each
 such report to the ,advisory ,council  
on ,alzheimer's ,research1 ,care1 and   
,services established under section     
#b7;e7 of the ,national ,alzheimer's    
,project ,act 7,public ,law #aaa-cge74  
7#b7 ,in each report under paragraph    
7#a71 the ,director of the ,institute   
shall include information and data on   
the following matters with respect to   
clinical trials on ,alzheimer's disease 
conducted during the preceding year3    
7,a7 ,the number of participants who are
 members of a minority group in such    
clinical trials4  7,b7 ,the number of   
such clinical trials for which          
incentives under subsection 7d77#c7 were
 made available1 the nature of such     
incentives1 the amount of increased     
funding 7if any7 made available for     
research on ,alzheimer's disease1 and   
the training provided to principal      
investigators who are members of a      

minority group and the amount of funding
 7if any7 for such training4  7,c7 ,the 
number of such clinical trials for which
 the principal investigator is a member 
of a minority group4  7,d7 ,the number  
of such clinical trials for which a     
significant percentage of researchers   
are members of a minority group4  7,e7  
,modifications to patient eligibility   
criteria in clinical trial designs under
 section #dde;,i7e74  7,f7 ,outreach and
 education efforts conducted under      
section #dde7;b77#c74  7#c7 ,the        
,director of the ,institute shall make  
each report under paragraph 7#a7        
available to the public1 including      
through posting on the appropriate      
website of the ,department of ,health   
and ,human ,services4  4  7g7           
,authorization of appropriations ,for   
each of fiscal years #bjbb through      
#bjbf1 there is authorized to be        
appropriated to the ,secretary of       
,health and ,human ,services #fj1jjj1jjj
 to carry out the amendments made by    

this section1 to remain available until 
expended4