,i  #aaith ,,congress  #ast ,session    
,h4 ,r4 #fhfg  ,,in ,,the ,,house ,,of  
,,representatives  ,december #ah1       
#bjbe,ms4 ,kelly of ,illinois 7for      
herself and ,mr4 ,fitzpatrick7          
introduced the following bill2 which was
 referred to the ,committee on ,energy  
and ,commerce  ,a ,,bill  ,to direct the
 ,secretary of ,health and ,human       
,services1 acting through the ,director 
of the ,national ,institutes of ,health1
 to take certain steps to increase      
clinical trial diversity1 and for other 
purposes4  #a4 ,short title ,this ,act  
may be cited as the ,,nih ,clinical     
,trial ,integrity ,act4  #b4 ,diversity 
goals for clinical trials  7a7          
,applications ,beginning on the date of 
the enactment of this ,act1 the         
,secretary of ,health and ,human        
,services1 acting through the ,director 
of the ,national ,institutes of ,health 
7in this section referred to as the     
,secretary71 shall require that a       
sponsor seeking to conduct a clinical   

trial investigating a drug1 device 7as  
those terms are defined in section #bja 
of the ,federal ,food1 ,drug1 and       
,cosmetic ,act 7#ba ,u4,s4,c4 #cba et   
seq4771 biological product 7as defined  
in section #cea7;i7 of the ,public      
,health ,service ,act 7#db ,u4,s4,c4    
#bfb7;i7771 or behavioral intervention1 
the protocol for which is approved by   
the ,national ,institutes of ,health1 to
 submit an application 7or renewal      
thereof7 for such approval that         
includes--  7#a7 clear and measurable   
goals for the recruitment and retention 
of participants that reflect-- 7,a7 the 
race1 ethnicity1 age1 and sex of        
patients with the disease or condition  
being investigated2 or  7,b7 the race1  
ethnicity1 age1 and sex of the general  
population of the ,united ,states if the
 prevalence of the disease or condition 
is not known2  7#b7 a rationale for the 
goals specified under paragraph 7#a7    
that specifies--  7,a7 how investigators
 will calculate the number of           

participants for each population        
category that reflect the population    
groups specified in paragraph 7#a72 or  
7,b7 strategies that will be used to    
enroll and retain participants across   
the different race1 ethnicity1 age1 and 
sex categories2  7#c7 a detailed plan   
for how the clinical trial will achieve 
the goals specified under paragraph 7#a7
 that specifies-- 7,a7 the requirements 
for researchers1 in conducting the      
trial1 to analyze the population groups 
specified in paragraph 7#a7 separately2 
7,b7 the role of community partners or  
community institutional review boards in
 reviewing the plans2 and  7,c7 how the 
trial will recruit a study population   
that is--  7i7 in proportion to the     
prevalence of the disease or condition  
in such groups relative to the          
prevalence of the disease or condition  
in the overall population of the ,united
 ,states2  7ii7 in sufficient numbers to
 obtain clinically and statistically    
meaningful determinations of the safety 

and effectiveness of the drug1 device1  
biological product1 or behavioral       
intervention being studied in the       
respective race1 ethnicity1 age1 and sex
 groups2 and  7iii7 consistent with the 
guidance under section #eje7;b77#a7 of  
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act 7#ba ,u4,s4,c4 #cee7;b77#a77 and  
guidance issued by the ,national        
,institutes of ,health on the inclusion 
of women and minorities in clinical     
trials2  7#d7 the sponsor's plan for    
implementing1 or an explanation of why  
the sponsor cannot implement1           
alternative clinical trial follow-up    
requirements that are less burdensome   
for trial participants1 such as--  7,a7 
requiring fewer follow-up visits2  7,b7 
allowing phone follow-up or home visits 
by nurse trial coordinators 7in lieu of 
in-person visits by patients72  7,c7    
allowing for online follow-up options2  
7,d7 permitting the patient's primary   
care provider to perform some of the    
follow-up visit requirements2  7,e7     

allowing for evening and weekend hours  
for required follow-up visits2  7,f7    
allowing virtual or telemedicine visits2
  7,g7 use of wearable technology to    
record key health parameters2 and  7,h7 
use of alternate labs or imaging        
centers1 which may be closer to the     
residence of the patients participating 
in the trial2 and  7#e7 the sponsor's   
education and training requirements for 
researchers and other individuals       
conducting or supporting the clinical   
trial with respect to diversity and     
health inequities in1 and the           
development of1 curricula for healthcare
 professionals on how to participate in 
clinical trials as an investigator and  
how they can enroll patients in trials1 
which may include consultation with1 and
 the review of materials made available 
by1 such committees1 task forces1       
working groups1 and other entities the  
,director determines are appropriate1   
including the following3 7,a7 ,the      
,equity ,committee of the ,national     

,institutes of ,health4  7,b7 ,the      
,national ,advisory ,council on         
,minority ,health and ,health           
,disparities4  7,c7 ,the ,advisory      
,committee on ,research on ,women's     
,health4  7,d7 ,the ,tribal ,health     
,research ,coordinating ,committee of   
the ,national ,institutes of ,health4   
7b7 ,terms  7#a7 ,in general ,as a      
condition on the approval of a protocol 
to conduct a clinical trial by the      
,national ,institutes of ,health1 as    
described in subsection 7a71 the sponsor
 of the clinical trial shall agree to   
terms requiring that--  7,a7 the        
aggregate demographic information of    
trial participants be shared on an      
annual basis with the ,secretary while  
participant recruitment and data        
collection in such trial is ongoing1 and
 that such information is provided with 
respect to-- 7i7 underrepresented       
populations1 including populations      
grouped by race1 ethnicity1 age1 and    
sex2 and  7ii7 such populations that    

reflect the prevalence of the disease or
 condition that is the subject of the   
clinical trial involved 7as available   
and as appropriate to the scientific    
objective for the study1 as determined  
by the ,director of the ,national       
,institutes of ,health72  7,b7 the      
sponsor submits to the program officer  
and grants management specialist of the 
specific ,national ,institutes of       
,health national research institute or  
national center1 annually or as         
frequently as such officer or specialist
 determines necessary1 the retention    
rate of participants in the clinical    
trial1 disaggregated by race1 ethnicity1
 age1 and sex2  7,c7 both the clinical  
trial researchers and the applicant     
reviewers complete education and        
training programs on diversity in       
clinical trials2 and  7,d7 at the       
conclusion of the trial1 the sponsor    
submits to the ,secretary the number of 
participants in the trial1 disaggregated
 by race1 ethnicity1 age1 and sex4  7#b7

 ,privacy protections ,any data shared  
under paragraph 7#a7 may not include any
 individually identifiable information  
or protected health information with    
respect to clinical trial participants  
and shall only be disclosed to the      
extent allowed under ,federal privacy   
laws4  7c7 ,exception ,in lieu of       
submitting an application under         
subsection 7a7 and documentation of     
goals as required by paragraph 7#a7 of  
such subsection1 an applicant may       
provide reasoning for why the           
recruitment of each of the population   
groups specified in paragraph 7#a7 of   
subsection 7a7 is not necessary and why 
such recruitment is not scientifically  
justified or possible4  7d7 ,publication
 ,the ,secretary shall-- 7#a7 publish on
 a public website of the ,national      
,institutes of ,health1 upon receipt of 
an application to which subsection 7a7  
applies--  7,a7 a summary of the disease
 being targeted in the clinical trial   
that is the subject of the application  

and the prevalence of such disease      
across race1 ethnicity1 age1 sex1 and   
the clinical trial representation in    
each such category2  7,b7 the goals     
specified in such application1 as       
required by subsection 7a77#a72 or  7,c7
 the reasoning described in subsection  
7c72 and  7#b7 ensure that1 in          
publishing information relating to an   
application under paragraph 7#a71 the   
design of the study involved is not     
disclosed4  7e7 ,remediation  7#a7 ,in  
general ,in the case of a clinical trial
 subject to subsection 7a7 that fails to
 meet the condition specified pursuant  
to subsection 7a7 by such date as may be
 agreed upon by the sponsor of the trial
 and the program officer and grants     
management specialist of the specific   
,national ,institutes of ,health        
national research institute or national 
center1 the ,secretary shall require the
 sponsor of that clinical trial1 not    
later than #ij days after such date     
occurs-- 7,a7 to develop1 in            

consultation with the ,secretary and    
advocacy and community-based            
organizations representing individuals  
who are members of relevant demographic 
groups specified in subsection 7a77#a71 
a strategic plan to increase            
participation in such clinical trial of 
such individuals2 and  7,b7 to submit to
 the ,secretary such strategic plan4    
7#b7 ,publication ,the ,secretary shall 
make publicly available on the website  
of the ,national ,institutes of ,health1
 the strategic plan received under      
paragraph 7#a7 as soon as possible after
 receipt4 ,the ,secretary shall ensure  
that1 in publishing such plan under the 
preceding sentence1 the design of the   
study involved is not disclosed4  7#c7  
,implementation ,the sponsor of the     
clinical trial that is the subject of   
the strategic plan published under      
paragraph 7#b71 shall1 not later than   
#ij days after such date as may be      
agreed upon by the sponsor of the trial 
and the appropriate program officer and 

grants management specialist of the     
,national ,institutes of ,health1       
implement the strategic plan4  7#d7     
,technical assistance ,the ,secretary   
may provide technical assistance to a   
sponsor of a clinical trial1 as         
necessary for the sponsor to meet the   
requirements of paragraph 7#c74  7f7    
,waiver for certain clinical trials     
7#a7 ,in general ,in the case of a      
clinical trial that received funding    
through the ,national ,institutes of    
,health and is ongoing as of the date of
 the enactment of this ,act1 the sponsor
 of such clinical trial is exempt from  
the requirements of 7and associated     
penalties imposed by7 this ,act4  7#b7  
,report ,the ,secretary shall include in
 the triennial report required to be    
submitted under section #djc of the     
,public ,health ,service ,act 7#db      
,u4,s4,c4 #bhc71 a list of all clinical 
trials receiving funding through the    
,national ,institutes of ,health that   
requested and received waivers under    

this section4  7g7 ,study  7#a7 ,in     
general ,the ,comptroller ,general of   
the ,united ,states shall conduct a     
study that-- 7,a7 examines which actions
 ,federal agencies have taken to address
 barriers to participation in federally 
funded clinical trials by the           
demographic groups specified in         
subsection 7a77#a72 and  7,b7 identifies
 challenges1 if any1 in implementing    
such actions4  7#b7 ,report ,not later  
than #a year after the date of the      
enactment of this ,act1 the ,comptroller
 ,general of the ,united ,states shall  
submit to ,congress a report on the     
findings of the study conducted under   
paragraph 7#a74  7h7 ,nondiscrimination 
,section #aeeg of the ,patient          
,protection and ,affordable ,care ,act  
7#db ,u4,s4,c4 #ahaaf7 shall apply with 
respect to a clinical trial subject to  
subsection 7a74  #c4 ,eliminating cost  
barriers ,not later than #b years after 
the date of the enactment of this ,act1 
the ,secretary of ,health and ,human    

,services1 acting through the ,director 
of the ,national ,institutes of ,health 
7referred to in this section as the     
,secretary71 shall conduct and complete 
a study on--  7#a7 the need for review  
of human subject regulations specified  
in part #df of title #de1 ,code of      
,federal ,regulations 7or successor     
regulations71 and related guidance2     
7#b7 the modernization of such          
regulations and guidance to establish   
updated guidelines for reimbursement of 
out-of-pocket expenses of human         
subjects1 compensation of human subjects
 for time spent participating in the    
clinical trial1 and incentives for      
recruitment of human subjects2 and  7#c7
 the need for updated safe harbor rules 
under section #ajja4ieb of title #db1   
,code of ,federal ,regulations 7or      
successor regulations7 and section      
#aabh;,b of the ,social ,security ,act  
7commonly referred to as the ,federal   
,anti-,kickback ,statute 7#db ,u4,s4,c4 
#acbj;a-#g;b77 with respect to the      

assistance provided under this section4 
#d4 ,public awareness and education     
campaign  7a7 ,national campaign ,the   
,secretary of ,health and ,human        
,services1 acting through the ,director 
of the ,national ,institutes of ,health 
and the ,commissioner of ,food and      
,drugs 7referred to in this section as  
the ,secretary7 and in consultation with
 the stakeholders specified in          
subsection 7e71 shall carry out a       
national campaign to increase the       
awareness and knowledge of individuals  
in the ,united ,states1 including       
healthcare professionals1 patients1 and 
others1 with respect to the need for    
diverse clinical trials among the       
demographic groups identified pursuant  
to section #b7;a77#a74  7b7             
,requirements ,the national campaign    
conducted under this section shall      
include-- 7#a7 7,a7 the development and 
distribution of written educational     
materials2  7,b7 the development and    
placing of public service announcements 

that are intended to encourage          
individuals who are members of the      
demographic groups identified pursuant  
to section #b7;b77#a77;,a77,i7 to seek  
to participate in clinical trials2 and  
7,c7 the development of curricula for   
health care professionals on--  7i7 how 
to participate in clinical trials as an 
investigator2 and  7ii7 how such        
professionals can enroll patients in    
trials2  7#b7 such efforts as are       
reasonable and necessary to ensure      
meaningful access by consumers with     
limited ,english proficiency2  7#c7 the 
development and distribution of best    
practices and training for recruiting   
underrepresented study populations1     
including a method for sharing such best
 practices among clinical trial         
sponsors1 providers1 community-based    
organizations who assist with           
recruitment1 and with the public2 and   
7#d7 the conduct of focus groups to     
better understand the concerns and fears
 of certain underrepresented groups who 

may be reluctant to participate in      
clinical trials4  7c7 ,health inequities
 ,in developing the national campaign   
under subsection 7a71 the ,secretary    
shall recognize and address--  7#a7     
health inequities among individuals who 
are members of the population groups    
specified in section #b7;b77#a77;,a7    
with respect to access to care and      
participation in clinical trials2 and   
7#b7 any barriers in access to care and 
participation in clinical trials that   
are specific to individuals who are     
members of such groups4  7d7 ,grants    
,the ,secretary shall establish a       
program to award grants to nonprofit    
private entities 7including community   
based organizations and faith           
communities1 institutions of higher     
education eligible to receive funds     
under section #cga of the ,higher       
,education ,act of #aife 7#bj ,u4,s4,c4 
#ajfgq71 national organizations that    
serve underrepresented populations1 and 
community pharmacies7 to enable such    

entities-- 7#a7 to test alternative     
outreach and education strategies to    
increase the awareness and knowledge of 
individuals in the ,united ,states1 with
 respect to the need for diverse        
clinical trials that reflect the race1  
ethnicity1 age1 and sex of patients with
 the disease or condition being         
investigated2 and  7#b7 to cover        
administrative costs of such entities in
 assisting in diversifying clinical     
trials subject to section #b4  7e7      
,stakeholders specified ,the            
stakeholders specified in this          
subsection are the following3  7#a7     
,representatives of the ,health         
,resources ,services ,administration1   
the ,office on ,minority ,health of the 
,department of ,health and ,human       
,services1 the ,centers for ,disease    
,control and ,prevention1 and the       
,national ,institutes of ,health4  7#b7 
,community-based resources and          
advocates4  7f7 ,authorization of       
,appropriations ,there is authorized to 

be appropriated to carry out this       
section #aj1jjj1jjj for each of fiscal  
years #bjbg through #bjcj4  #e4         
,definitions ,in this ,act3  7#a7       
,clinical trial ,the term clinical trial
 means a research study in which one or 
more human subjects are prospectively   
assigned to one or more interventions   
7which may include placebo or other     
control7 to evaluate the effects of     
those interventions on health-related   
biomedical or behavioral outcomes4  7#b7
 ,sponsor ,the term sponsor has the     
meaning given such term in section #ej4c
 of title #ba1 ,code of ,federal        
,regulations 7or successor regulations74