,,ii  #aahth ,,congress  #ast ,session  
,s4 #cbf  ,,in ,,the ,,senate ,,of ,,the
 ,,united ,,states  ,february #i1       
#bjbc,mr4 ,tester 7for himself and ,mr4 
,sullivan7 introduced the following     
bill2 which was read twice and referred 
to the ,committee on ,veterans' ,affairs
  ,a ,,bill  ,to direct the ,secretary  
of ,veterans ,affairs to carry out a    
study and clinical trials on the effects
 of cannabis on certain health outcomes 
of veterans with chronic pain and       
post-traumatic stress disorder1 and for 
other purposes4  #a4 ,short title ,this 
,act may be cited as the ,,va ,medicinal
 ,cannabis ,research ,act of #bjbc4  #b4
 ,definitions ,in this ,act3 7#a7       
,covered veteran ,the term covered      
veteran means a veteran who is enrolled 
in the patient enrollment system of the 
,department of ,veterans ,affairs       
established and operated under section  
#agje7;a7 of title #ch1 ,united ,states 
,code4  7#b7 ,secretary ,the term       
,secretary means the ,secretary of      

,veterans ,affairs4  #c4 ,department of 
,veterans ,affairs large-scale1 mixed   
methods1 retrospective qualitative study
 on the effects of cannabis on certain  
health outcomes of veterans with chronic
 pain and post-traumatic stress disorder
  7a7 ,study required  7#a7 ,in general 
,the ,secretary1 through the ,office of 
,research and ,development of the       
,department of ,veterans ,affairs1 shall
 carry out a large-scale1 mixed methods1
 retrospective1 and qualitative study on
 the effects of cannabis on the health  
outcomes of covered veterans diagnosed  
with chronic pain and covered veterans  
diagnosed with post-traumatic stress    
disorder4  7#b7 ,observational study    
,the study required by paragraph 7#a7   
shall be conducted as an observational  
study on the effects of cannabis use on 
the health of covered veterans4  7#c7   
,elements  7,a7 ,in general ,the study  
required by paragraph 7#a7 shall-- 7i7  
triangulate a range of data sources2    
7ii7 compare the positive and negative  

health outcomes of covered veterans who 
use cannabis1 utilizing outcomes that   
can be measured in an electronic health 
record of the ,department and through   
data sets of the ,department relating to
 claims for benefits under the laws     
administered by the ,secretary2  7iii7  
elicit the positive and negative        
outcomes of cannabis use for covered    
veterans through semi-structured        
interviews2  7iv7 estimate current and  
future health system needs to address   
positive and negative outcomes of       
cannabis use for covered veterans2  7v7 
include a qualitative1 open-ended survey
 provided to covered veterans who have  
sought care from the ,department for    
chronic pain or post-traumatic stress   
disorder during the five-year period    
preceding the survey2 and  7vi7 include 
an assessment of-- 7,i7 all records     
within the ,veterans ,health            
,administration for covered veterans    
participating in the study2 and  7,,ii7 
all records within the ,veterans        

,benefits ,administration for covered   
veterans participating in the study4    
7,b7 ,health outcomes ,a comparison of  
health outcomes under subparagraph      
7,a77ii7 shall include an assessment of 
the following3 7i7 ,the reduction or    
increase in opiate use or dosage4  7ii7 
,the reduction or increase in           
benzodiazepine use or dosage4  7iii7    
,the reduction or change in use of other
 types of medication4  7iv7 ,the        
reduction or increase in alcohol use4   
7v7 ,the reduction or increase in the   
prevalence of substance abuse disorders4
  7vi7 ,sleep quality4  7vii7           
,osteopathic pain 7including pain       
intensity and pain-related outcomes74   
7viii7 ,agitation4  7ix7 ,quality of    
life4  7x7 ,mortality and morbidity4    
7xi7 ,hospital readmissions4  7xii7 ,any
 newly developed or exacerbated health  
conditions1 including mental health     
conditions4  7b7 ,implementation ,not   
later than #ahj days after the date of  
the enactment of this ,act1 the         

,secretary shall commence the           
implementation of the study required by 
subsection 7a77#a74  7c7 ,duration of   
study ,the study required by subsection 
7a77#a7 shall be carried out for an     
#ah-month period4  7d7 ,report  7#a7 ,in
 general ,not later than #ij days after 
the completion of the study required by 
subsection 7a77#a71 the ,secretary shall
 submit to the ,committee on ,veterans' 
,affairs of the ,senate and the         
,committee on ,veterans' ,affairs of the
 ,house of ,representatives a report on 
the study4  7#b7 ,ability to conduct    
clinical trials ,the ,secretary shall   
include in the report required by       
paragraph 7#a7 an assessment of whether 
the ,secretary is able to meet the      
criteria necessary to conduct the       
clinical trials required under section  
#d1 including consideration of          
subsection 7e77#a7 of such section4  #d4
 ,department of ,veterans ,affairs      
clinical trials on the effects of       
cannabis on certain health outcomes of  

veterans with chronic pain and          
post-traumatic stress disorder  7a7     
,clinical trials required  7#a7 ,in     
general ,if the ,secretary indicates in 
the report required by section #c7;d7   
that the ,secretary is able to meet the 
criteria necessary to proceed to        
clinical trials1 commencing not later   
than #ahj days after the submittal of   
that report1 the ,secretary shall carry 
out a series of clinical trials on the  
effects of cannabis appropriate for     
investigational use1 as determined by   
the ,food and ,drug ,administration     
under section #eje7;i7 of the ,federal  
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cee7;i771 on the health      
outcomes of covered veterans diagnosed  
with chronic pain and covered veterans  
diagnosed with post-traumatic stress    
disorder4  7#b7 ,considerations ,the    
clinical trials required by paragraph   
7#a7 shall include1 as appropriate1 an  
evaluation of key symptoms1 clinical    
outcomes1 and conditions associated with

 chronic pain and post-traumatic stress 
disorder1 which may include-- 7,a7 with 
respect to covered veterans diagnosed   
with chronic pain1 an evaluation of the 
effects of the use of cannabis on-- 7i7 
osteopathic pain 7including pain        
intensity and pain-related outcomes72   
7ii7 the reduction or increase in opioid
 use or dosage2  7iii7 the reduction or 
increase in benzodiazepine use or       
dosage2  7iv7 the reduction or increase 
in alcohol use2  7v7 the reduction or   
increase in the prevalence of substance 
use disorders2  7vi7 inflammation2      
7vii7 sleep quality2  7viii7 agitation2 
7ix7 quality of life2  7x7 exacerbated  
or new mental health conditions2 and    
7xi7 suicidal ideation4  7,b7 with      
respect to covered veterans diagnosed   
with post-traumatic stress disorder1 an 
evaluation of the effects of the use of 
cannabis on-- 7i7 the symptoms of       
post-traumatic stress disorder 7,,ptsd7 
as established by or derived from the   
clinician administered ,,ptsd scale1 the

 ,,ptsd checklist1 the ,,ptsd symptom   
scale1 the post-traumatic diagnostic    
scale1 and other applicable methods of  
evaluating symptoms of post-traumatic   
stress disorder2  7ii7 the reduction or 
increase in benzodiazepine use or       
dosage2  7iii7 the reduction or increase
 in alcohol use2  7iv7 the reduction or 
increase in the prevalence of substance 
use disorders2  7v7 mood2  7vi7 anxiety2
  7vii7 social functioning2  7viii7     
agitation2  7ix7 suicidal ideation2 and 
7x7 sleep quality1 including frequency  
of nightmares and night terrors4  7#c7  
,optional elements ,the clinical trials 
required by paragraph 7#a7 may include1 
as appropriate1 an evaluation of the    
effects of the use of cannabis to treat 
chronic pain and post-traumatic stress  
disorder on other symptoms1 clinical    
outcomes1 and conditions not covered by 
paragraph 7#b71 which may include-- 7,a7
 pulmonary function2  7,b7              
cardiovascular events2  7,c7 head1 neck1
 and oral cancer2  7,d7 testicular      

cancer2  7,e7 ovarian cancer2  7,f7     
transitional cell cancer2  7,g7         
intestinal inflammation2  7,h7 motor    
vehicle accidents2 or  7,i7 spasticity4 
7b7 ,long-,term observational study ,the
 ,secretary may carry out a long-term   
observational study of the participants 
in the clinical trials required by      
subsection 7a74  7c7 ,type of cannabis  
7#a7 ,in general ,in carrying out the   
clinical trials required by subsection  
7a71 the ,secretary shall study varying 
forms of cannabis1 including whole plant
 raw material and extracts1 and may     
study varying routes of administration4 
7#b7 ,plant cultivars ,of the varying   
forms of cannabis required under        
paragraph 7#a71 the ,secretary shall    
study plant cultivars with varying      
ratios of tetrahydrocannabinol to       
cannabidiol4  7d7 ,implementation ,not  
later than #ah months after the date of 
the enactment of this ,act1 the         
,secretary shall-- 7#a7 develop a plan  
to implement this section and submit    

such plan to the ,committee on          
,veterans' ,affairs of the ,senate and  
the ,committee on ,veterans' ,affairs of
 the ,house of ,representatives2 and    
7#b7 issue any requests for proposals   
the ,secretary determines appropriate   
for such implementation4  7e7           
,termination of clinical trials  7#a7   
,clinical guideline requirements or     
excessive risk ,the ,secretary may      
terminate the clinical trials required  
by subsection 7a7 if the ,secretary     
determines that the ,department of      
,veterans ,affairs is unable to meet    
clinical guideline requirements         
necessary to conduct such trials or the 
clinical trials would create excessive  
risk to participants4  7#b7 ,completion 
upon submittal of final report ,the     
,secretary may terminate the clinical   
trials required by subsection 7a7 upon  
submittal of the final report required  
under subsection 7f77#b74  7f7 ,reports 
7#a7 ,periodic reports ,during the      
five-year period beginning on the date  

of the commencement of clinical trials  
required by subsection 7a71 the         
,secretary shall submit periodically1   
but not less frequently than annually1  
to the ,committee on ,veterans' ,affairs
 of the ,senate and the ,committee on   
,veterans' ,affairs of the ,house of    
,representatives reports on the         
implementation of this section4  7#b7   
,final report ,not later than one year  
after the completion of the five-year   
period specified in paragraph 7#a71 the 
,secretary shall submit to the          
,committee on ,veterans' ,affairs of the
 ,senate and the ,committee on          
,veterans' ,affairs of the ,house of    
,representatives a final report on the  
implementation of this section4  #e4    
,administration of study and clinical   
trials  7a7 ,demographic representation 
,in carrying out the study required by  
section #c and the clinical trials      
required by section #d1 the ,secretary  
shall ensure representation in such     
study and trials of demographics that   

represent the population of veterans in 
the ,united ,states1 as determined by   
the most recently available data from   
the ,american ,community ,survey of the 
,bureau of the ,census4  7b7 ,data      
preservation ,the ,secretary shall      
ensure that the study required by       
section #c and the clinical trials      
required by section #d include a        
mechanism to ensure-- 7#a7 the          
preservation of all data1 including all 
data sets and survey results1 collected 
or used for purposes of such study and  
trials in a manner that will facilitate 
further research2 and  7#b7 registration
 of such data in the database of        
privately and publicly funded clinical  
studies maintained by the ,national     
,library of ,medicine 7or successor     
database74  7c7 ,anonymous data ,the    
,secretary shall ensure that data       
relating to any study or clinical trial 
conducted under this ,act is anonymized 
and cannot be traced back to an         
individual patient4  7d7 ,effect on     

other benefits ,the eligibility or      
entitlement of a covered veteran to any 
other benefit under the laws            
administered by the ,secretary or any   
other provision of law shall not be     
affected by the participation of the    
covered veteran in the study under      
section #c1 a clinical trial under      
section #d7;a71 or a study under section
 #d7;b74  7e7 ,effect on other laws     
,nothing in this ,act shall affect or   
modify-- 7#a7 the ,federal ,food1 ,drug1
 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja 
et seq472  7#b7 section #cea of the     
,public ,health ,service ,act 7#db      
,u4,s4,c4 #bfb72 or  7#c7 the authority 
of the ,commissioner of ,food and ,drugs
 and the ,secretary of ,health and      
,human ,services-- 7,a7 under-- 7i7 the 
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cja et seq472 or   
7ii7 section #cea of the ,public ,health
 ,service ,act 7#db ,u4,s4,c4 #bfb72 or 
7,b7 to promulgate ,federal regulations 
and guidelines pertaining to            

cannabidiol1 marijuana1 or other subject
 matter addressed in this ,act4