,,ii  #aah? ,,congress  #a/ ,session    
,s4 #cbf  ,,9 ,,! ,,s5ate ,,( ,,!       
,,unit$ ,,/ates  ,febru>y #i1 #bjbc,mr4 
,te/] 7= himself & ,mr4 ,sullivan7      
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,vet]ans' ,affairs  ,a ,,bill  ,to      
direct ! ,secret>y ( ,vet]ans ,affairs  
to c>ry out a /udy & cl9ical trials on !
 effects ( cannabis on c]ta9 heal?      
outcomes ( vet]ans ) *ronic pa9 &       
po/-traumatic /ress disord]1 & = o!r    
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,,va ,m$ic9al ,cannabis    
,rese>* ,act ( #bjbc4  #b4 ,def9itions  
,9 ?is ,act3 7#a7 ,cov]$ vet]an ,! t]m  
cov]$ vet]an means a vet]an :o is       
enroll$ 9 ! pati5t enrollm5t sy/em ( !  
,dep>tm5t ( ,vet]ans ,affairs e/abli%$ &
 op]at$ "u section #agje7;a7 ( title    
#ch1 ,unit$ ,/ates ,code4  7#b7         
,secret>y ,! t]m ,secret>y means !      
,secret>y ( ,vet]ans ,affairs4  #c4     
,dep>tm5t ( ,vet]ans ,affairs           
l>ge-scale1 mix$ me?ods1 retrospective  

qualitative /udy on ! effects ( cannabis
 on c]ta9 heal? outcomes ( vet]ans )    
*ronic pa9 & po/-traumatic /ress disord]
  7a7 ,/udy requir$  7#a7 ,9 g5]al ,!   
,secret>y1 ?r\gh ! ,(fice ( ,rese>* &   
,developm5t ( ! ,dep>tm5t ( ,vet]ans    
,affairs1 %all c>ry out a l>ge-scale1   
mix$ me?ods1 retrospective1 &           
qualitative /udy on ! effects ( cannabis
 on ! heal? outcomes ( cov]$ vet]ans    
diagnos$ ) *ronic pa9 & cov]$ vet]ans   
diagnos$ ) po/-traumatic /ress disord]4 
7#b7 ,obs]vational /udy ,! /udy requir$ 
by p>agraph 7#a7 %all be conduct$ z an  
obs]vational /udy on ! effects (        
cannabis use on ! heal? ( cov]$ vet]ans4
  7#c7 ,elem5ts  7,a7 ,9 g5]al ,! /udy  
requir$ by p>agraph 7#a7 %all-- 7i7     
triangulate a range ( data s\rces2  7ii7
 comp>e ! positive & negative heal?     
outcomes ( cov]$ vet]ans :o use         
cannabis1 utiliz+ outcomes t c be       
measur$ 9 an electronic heal? record ( !
 ,dep>tm5t & ?r\gh data sets ( !        
,dep>tm5t relat+ to claims = b5efits "u 

! laws adm9i/]$ by ! ,secret>y2  7iii7  
elicit ! positive & negative outcomes ( 
cannabis use = cov]$ vet]ans ?r\gh      
semi-/ructur$ int]views2  7iv7 e/imate  
curr5t & future heal? sy/em ne$s to     
address positive & negative outcomes (  
cannabis use = cov]$ vet]ans2  7v7      
include a qualitative1 op5-end$ survey  
provid$ to cov]$ vet]ans :o h s\ght c>e 
f ! ,dep>tm5t = *ronic pa9 or           
po/-traumatic /ress disord] dur+ !      
five-ye> p]iod prec$+ ! survey2 &  7vi7 
include an assessm5t (-- 7,i7 all       
records )9 ! ,vet]ans ,heal?            
,adm9i/ration = cov]$ vet]ans p>ticipat+
 9 ! /udy2 &  7,,ii7 all records )9 !   
,vet]ans ,b5efits ,adm9i/ration = cov]$ 
vet]ans p>ticipat+ 9 ! /udy4  7,b7      
,heal? outcomes ,a comp>ison ( heal?    
outcomes "u subp>agraph 7,a77ii7 %all   
include an assessm5t ( ! foll[+3 7i7 ,! 
r$uction or increase 9 opiate use or    
dosage4  7ii7 ,! r$uction or increase 9 
b5zodiazep9e use or dosage4  7iii7 ,!   
r$uction or *ange 9 use ( o!r types (   

m$ication4  7iv7 ,! r$uction or increase
 9 alcohol use4  7v7 ,! r$uction or     
increase 9 ! preval5ce ( sub/ance abuse 
disord]s4  7vi7 ,sleep quality4  7vii7  
,o/eopa?ic pa9 7includ+ pa9 int5sity &  
pa9-relat$ outcomes74  7viii7           
,agitation4  7ix7 ,quality ( life4  7x7 
,mortality & morbidity4  7xi7 ,hospital 
readmissions4  7xii7 ,any newly develop$
 or exac]bat$ heal? conditions1 includ+ 
m5tal heal? conditions4  7b7            
,implem5tation ,n lat] ?an #ahj days    
aft] ! date ( ! enactm5t ( ?is ,act1 !  
,secret>y %all comm5ce ! implem5tation (
 ! /udy requir$ by subsection 7a77#a74  
7c7 ,duration ( /udy ,! /udy requir$ by 
subsection 7a77#a7 %all be c>ri$ out =  
an #ah-mon? p]iod4  7d7 ,report  7#a7 ,9
 g5]al ,n lat] ?an #ij days aft] !      
completion ( ! /udy requir$ by          
subsection 7a77#a71 ! ,secret>y %all    
submit to ! ,committee on ,vet]ans'     
,affairs ( ! ,s5ate & ! ,committee on   
,vet]ans' ,affairs ( ! ,h\se (          
,repres5tatives a report on ! /udy4     

7#b7 ,ability to conduct cl9ical trials 
,! ,secret>y %all include 9 ! report    
requir$ by p>agraph 7#a7 an assessm5t ( 
:e!r ! ,secret>y is able to meet !      
crit]ia necess>y to conduct ! cl9ical   
trials requir$ "u section #d1 includ+   
consid]ation ( subsection 7e77#a7 ( su* 
section4  #d4 ,dep>tm5t ( ,vet]ans      
,affairs cl9ical trials on ! effects (  
cannabis on c]ta9 heal? outcomes (      
vet]ans ) *ronic pa9 & po/-traumatic    
/ress disord]  7a7 ,cl9ical trials      
requir$  7#a7 ,9 g5]al ,if ! ,secret>y  
indicates 9 ! report requir$ by section 
#c7;d7 t ! ,secret>y is able to meet !  
crit]ia necess>y to proce$ to cl9ical   
trials1 comm5c+ n lat] ?an #ahj days    
aft] ! submittal ( t report1 ! ,secret>y
 %all c>ry out a s]ies ( cl9ical trials 
on ! effects ( cannabis appropriate =   
inve/igational use1 z det]m9$ by ! ,food
 & ,drug ,adm9i/ration "u section       
#eje7;i7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i771
 on ! heal? outcomes ( cov]$ vet]ans    

diagnos$ ) *ronic pa9 & cov]$ vet]ans   
diagnos$ ) po/-traumatic /ress disord]4 
7#b7 ,consid]ations ,! cl9ical trials   
requir$ by p>agraph 7#a7 %all include1 z
 appropriate1 an evaluation ( key       
symptoms1 cl9ical outcomes1 & conditions
 associat$ ) *ronic pa9 & po/-traumatic 
/ress disord]1 :i* may include-- 7,a7 ) 
respect to cov]$ vet]ans diagnos$ )     
*ronic pa91 an evaluation ( ! effects ( 
! use ( cannabis on-- 7i7 o/eopa?ic pa9 
7includ+ pa9 int5sity & pa9-relat$      
outcomes72  7ii7 ! r$uction or increase 
9 opioid use or dosage2  7iii7 !        
r$uction or increase 9 b5zodiazep9e use 
or dosage2  7iv7 ! r$uction or increase 
9 alcohol use2  7v7 ! r$uction or       
increase 9 ! preval5ce ( sub/ance use   
disord]s2  7vi7 inflammation2  7vii7    
sleep quality2  7viii7 agitation2  7ix7 
quality ( life2  7x7 exac]bat$ or new   
m5tal heal? conditions2 &  7xi7 suicidal
 ideation4  7,b7 ) respect to cov]$     
vet]ans diagnos$ ) po/-traumatic /ress  
disord]1 an evaluation ( ! effects ( !  

use ( cannabis on-- 7i7 ! symptoms (    
po/-traumatic /ress disord] 7,,ptsd7 z  
e/abli%$ by or d]iv$ f ! cl9ician       
adm9i/]$ ,,ptsd scale1 ! ,,ptsd *eckli/1
 ! ,,ptsd symptom scale1 ! po/-traumatic
 diagno/ic scale1 & o!r applicable      
me?ods ( evaluat+ symptoms (            
po/-traumatic /ress disord]2  7ii7 !    
r$uction or increase 9 b5zodiazep9e use 
or dosage2  7iii7 ! r$uction or increase
 9 alcohol use2  7iv7 ! r$uction or     
increase 9 ! preval5ce ( sub/ance use   
disord]s2  7v7 mood2  7vi7 anxiety2     
7vii7 social function+2  7viii7         
agitation2  7ix7 suicidal ideation2 &   
7x7 sleep quality1 includ+ frequ5cy (   
nightm>es & night t]rors4  7#c7         
,optional elem5ts ,! cl9ical trials     
requir$ by p>agraph 7#a7 may include1 z 
appropriate1 an evaluation ( ! effects (
 ! use ( cannabis to treat *ronic pa9 & 
po/-traumatic /ress disord] on o!r      
symptoms1 cl9ical outcomes1 & conditions
 n cov]$ by p>agraph 7#b71 :i* may      
include-- 7,a7 pulmon>y function2  7,b7 

c>diovascul> ev5ts2  7,c7 head1 neck1 & 
oral canc]2  7,d7 te/icul> canc]2  7,e7 
ov>ian canc]2  7,f7 transitional cell   
canc]2  7,g7 inte/9al inflammation2     
7,h7 motor vehicle accid5ts2 or  7,i7   
spa/icity4  7b7 ,long-,t]m obs]vational 
/udy ,! ,secret>y may c>ry out a        
long-t]m obs]vational /udy ( !          
p>ticipants 9 ! cl9ical trials requir$  
by subsection 7a74  7c7 ,type ( cannabis
  7#a7 ,9 g5]al ,9 c>ry+ out ! cl9ical  
trials requir$ by subsection 7a71 !     
,secret>y %all /udy v>y+ =ms ( cannabis1
 includ+ :ole plant raw mat]ial &       
extracts1 & may /udy v>y+ r\tes (       
adm9i/ration4  7#b7 ,plant cultiv>s ,( !
 v>y+ =ms ( cannabis requir$ "u p>agraph
 7#a71 ! ,secret>y %all /udy plant      
cultiv>s ) v>y+ ratios (                
tetrahydrocannab9ol to cannabidiol4  7d7
 ,implem5tation ,n lat] ?an #ah mon?s   
aft] ! date ( ! enactm5t ( ?is ,act1 !  
,secret>y %all-- 7#a7 develop a plan to 
implem5t ?is section & submit su* plan  
to ! ,committee on ,vet]ans' ,affairs ( 

! ,s5ate & ! ,committee on ,vet]ans'    
,affairs ( ! ,h\se ( ,repres5tatives2 & 
7#b7 issue any reque/s = proposals !    
,secret>y det]m9es appropriate = su*    
implem5tation4  7e7 ,t]m9ation ( cl9ical
 trials  7#a7 ,cl9ical guidel9e         
requirem5ts or excessive risk ,!        
,secret>y may t]m9ate ! cl9ical trials  
requir$ by subsection 7a7 if ! ,secret>y
 det]m9es t ! ,dep>tm5t ( ,vet]ans      
,affairs is unable to meet cl9ical      
guidel9e requirem5ts necess>y to conduct
 su* trials or ! cl9ical trials w\ld    
create excessive risk to p>ticipants4   
7#b7 ,completion ^u submittal ( f9al    
report ,! ,secret>y may t]m9ate !       
cl9ical trials requir$ by subsection 7a7
 ^u submittal ( ! f9al report requir$ "u
 subsection 7f77#b74  7f7 ,reports  7#a7
 ,p]iodic reports ,dur+ ! five-ye> p]iod
 beg9n+ on ! date ( ! comm5cem5t (      
cl9ical trials requir$ by subsection    
7a71 ! ,secret>y %all submit            
p]iodically1 b n less frequ5tly ?an     
annually1 to ! ,committee on ,vet]ans'  

,affairs ( ! ,s5ate & ! ,committee on   
,vet]ans' ,affairs ( ! ,h\se (          
,repres5tatives reports on !            
implem5tation ( ?is section4  7#b7 ,f9al
 report ,n lat] ?an "o ye> aft] !       
completion ( ! five-ye> p]iod specifi$ 9
 p>agraph 7#a71 ! ,secret>y %all submit 
to ! ,committee on ,vet]ans' ,affairs ( 
! ,s5ate & ! ,committee on ,vet]ans'    
,affairs ( ! ,h\se ( ,repres5tatives a  
f9al report on ! implem5tation ( ?is    
section4  #e4 ,adm9i/ration ( /udy &    
cl9ical trials  7a7 ,demographic        
repres5tation ,9 c>ry+ out ! /udy       
requir$ by section #c & ! cl9ical trials
 requir$ by section #d1 ! ,secret>y %all
 ensure repres5tation 9 su* /udy &      
trials ( demographics t repres5t !      
population ( vet]ans 9 ! ,unit$ ,/ates1 
z det]m9$ by ! mo/ rec5tly available    
data f ! ,am]ican ,community ,survey ( !
 ,bureau ( ! ,c5sus4  7b7 ,data         
pres]vation ,! ,secret>y %all ensure t !
 /udy requir$ by section #c & ! cl9ical 
trials requir$ by section #d include a  

me*anism to ensure-- 7#a7 ! pres]vation 
( all data1 includ+ all data sets &     
survey results1 collect$ or us$ =       
purposes ( su* /udy & trials 9 a mann] t
 w facilitate fur!r rese>*2 &  7#b7     
regi/ration ( su* data 9 ! database (   
privately & publicly fund$ cl9ical      
/udies ma9ta9$ by ! ,national ,libr>y ( 
,m$ic9e 7or successor database74  7c7   
,anonym\s data ,! ,secret>y %all ensure 
t data relat+ to any /udy or cl9ical    
trial conduct$ "u ?is ,act is anonymiz$ 
& _c be trac$ back to an individual     
pati5t4  7d7 ,effect on o!r b5efits ,!  
eligibility or entitlem5t ( a cov]$     
vet]an to any o!r b5efit "u ! laws      
adm9i/]$ by ! ,secret>y or any o!r      
provision ( law %all n be affect$ by !  
p>ticipation ( ! cov]$ vet]an 9 ! /udy  
"u section #c1 a cl9ical trial "u       
section #d7;a71 or a /udy "u section    
#d7;b74  7e7 ,effect on o!r laws ,no?+ 9
 ?is ,act %all affect or modify-- 7#a7 !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cja et seq472  7#b7     

section #cea ( ! ,public ,heal? ,s]vice 
,act 7#db ,u4,s4,c4 #bfb72 or  7#c7 !   
au?ority ( ! ,commission] ( ,food &     
,drugs & ! ,secret>y ( ,heal? & ,human  
,s]vices-- 7,a7 "u-- 7i7 ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 
#cja et seq472 or  7ii7 section #cea ( !
 ,public ,heal? ,s]vice ,act 7#db       
,u4,s4,c4 #bfb72 or  7,b7 to promulgate 
,f$]al regulations & guidel9es p]ta9+ to
 cannabidiol1 m>ijuana1 or o!r subject  
matt] address$ 9 ?is ,act4