,i #aai? ,,congress #a/ ,session ,h4 ,r4 #fehc ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,decemb] #aj1 #bjbe,mr4 ,murphy introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,vet]ans' ,affairs ,a ,,bill ,to am5d title #ch1 ,unit$ ,/ates ,code1 to e/abli% a c5traliz$ rese>* data sy/em = ! ,dep>tm5t ( ,vet]ans ,affairs & to make c]ta9 improvem5ts to processes applicable to major rese>* projects ( ! ,dep>tm5t1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,,va ,rese>* ,re=m ,act ( #bjbe4 #b4 ,e/abli%m5t ( ,c5traliz$ ,,va ,rese>* ,data ,sy/em2 /&>ds ) respect to major rese>* programs ( ! ,dep>tm5t ,sub*apt] ,v ( *apt] #gc ( title #ch1 ,unit$ ,/ates ,code1 is am5d$ by add+ at ! end ! foll[+ new sections 7& con=m+ ! table ( sections at ! beg9n+ ( su* *apt] accord+ly73 #gchc4 ,,va ,c5traliz$ ,rese>* ,data ,sy/em 7a7 ,e/abli%m5t ,! ,secret>y %all e/abli% & ma9ta9 a c5traliz$ rese>* data sy/em = ! ,dep>tm5t 7to be kn[n z ! ,,va ,c5traliz$ ,rese>* ,data ,sy/em71 to collect & manage in=mation on all rese>* activities ( ! ,dep>tm5t4 ,su* sy/em %all include data ) respect to all programs ( m$ical rese>* conduct$ "u section #gcjc ( ?is title1 includ+ biom$ical rese>*1 cl9ical rese>*1 m5tal heal? rese>*1 heal? s]vices & policy rese>*1 & any o!r category ( rese>* support$ by ! ,dep>tm5t4 7b7 ,elem5ts ( sy/em ,! ,,va ,c5traliz$ ,rese>* ,data ,sy/em %all include1 = ea* rese>* project conduct$ by or support$ by ! ,dep>tm5t ! foll[+ in=mation3 7#a7 ,a summ>y ( ! objectives1 scope1 & /udy design ( ! project4 7#b7 ,an id5tification ( ,dep>tm5t fund+1 & any non-,dep>tm5t fund+1 support+ ! project1 includ+ am\nts & fund+ me*anisms4 7#c7 ,! "n & affiliation ( ! pr9cipal inve/igator & key /aff or collaborators involv$ 9 ! rese>*4 7#d7 ,! /atus & dates ( all requir$ approvals1 includ+ in/itutional review bo>d approvals or exemptions1 o!r regulatory approvals 7includ+ safety or e?ical reviews71 & associat$ assurances ( compliance4 7#e7 ,p]iodic updates on ! progress ( ! project1 includ+-- 7,a7 ! initiation date2 7,b7 ! completion ( key mile/ones or phases2 & 7,c7 ! anticipat$ & actual completion dates ( ! rese>*4 7#f7 ,! results & products ( ! rese>*1 includ+ any f9d+s1 publications 9 pe]-review$ j\rnals1 pres5tations1 pat5ts or inv5tions1 & not$ impacts on cl9ical c>e or policy aris+ f ! project4 7c7 ,use & integration ,! ,secret>y %all ensure t ! ,,va ,c5traliz$ ,rese>* ,data ,sy/em is-- 7#a7 us$ to facilitate ov]sight & coord9ation ( ,dep>tm5t rese>*2 7#b7 design$ to-- 7,a7 all[ au?oriz$ p]sonnel ( ! ,dep>tm5t1 includ+ ! ,(fice ( ,rese>* & ,developm5t & (ficials at ,vet]ans ,heal? ,adm9i/ration facilities1 to track rese>* progress & outcomes1 avoid unnecess>y duplication ( rese>* ef=ts1 & id5tify opportunities = translat+ rese>* f9d+s into cl9ical practice2 & 7,b7 protect p]sonally id5tifiable in=mation1 9 accordance ) applicable laws & regulations2 & 7#c7 compatible ) ! electronic heal? record sy/em ( ! ,dep>tm5t4 7d7 ,regulations ,n lat] ?an #ahj days aft] ! date ( ! enactm5t ( ?is section1 ! ,secret>y %all prescribe su* regulations or guidance z ! ,secret>y det]m9es necess>y to implem5t ?is section1 includ+-- 7#a7 policies = ! submission ( in=mation by inve/igators into ! ,c5traliz$ ,rese>* ,data ,sy/em2 & 7#b7 protocols = ma9ta9+ ! accuracy & security ( data 9 ! sy/em4 #gchd4 ,rese>* proposal review & approval processes 7a7 ,ti]$ review bas$ on risk & impact ,! ,secret>y %all develop & implem5t a ti]$ sy/em = ! e?ical & sci5tific review & approval ( rese>* proposals conduct$ by ! ,dep>tm5t or us+ ,dep>tm5t facilities1 data1 or res\rces4 ,"u su* sy/em1 ! level ( review & applicable requirem5ts %all be comm5surate ) ! project$ risk to human subjects 7or to animal subjects1 z applicable7 & ! expect$ effect or significance ( ! rese>*4 7b7 ,level ( review 7#a7 ,"u ! ti]$ sy/em requir$ by subsection 7a71 ! ,secret>y %all ensure t rese>* proposals ! ,secret>y det]m9es pose-- 7,a7 a m9imal risk 7z def9$ by ,secret>y 9 regulations7 to subjects or are ( a small scope or %ort duration are eligible = an exp$it$ or abbreviat$ review process t is consi/5t ) ! protection ( human subjects & s\nd rese>* practice2 & 7,b7 a great] ?an m9imal risk to subjects1 involve invasive proc$ures1 or h broad pot5tial impact 7includ+ z l>ge cl9ical trials or multi-site /udies7 und]go a full review process4 7#b7 ,! ,secret>y may e/abli% int]m$iate levels ( review =-- 7,a7 categories ( rese>* ! ,secret>y det]m9es fall betwe5 m9imal risk & high risk2 or 7,b7 projects deem$ ( high sci5tific importance1 to ensure appropriate scrut9y )\t unnecess>y delay4 7c7 ,/&>diz$ national timel9es ,= ea* ti] ( rese>* review "u subsection 7b71 ! ,secret>y %all e/abli% /&>diz$1 ,dep>tm5t-wide t>get timel9es = completion ( ! review & approval or disapproval ( rese>* proposals4 ,su* timel9es %all be design$ to exp$ite ! initiation ( valuable rese>* :ile ma9ta9+ /&>ds = safety & e?ics4 ,! ,secret>y %all ensure t ^! review processes & timel9es are appli$ uni=mly across all facilities ( ! ,vet]ans ,heal? ,adm9i/ration1 not)/&+ any local policies4 7d7 ,(fice ( rese>* & developm5t ov]ride au?ority 7#a7 ,! ,"u ,secret>y = ,heal?1 act+ ?r\gh ! ,*ief ,rese>* & ,developm5t ,(fic] ( ! ,(fice ( ,rese>* & ,developm5t e/abli%$ "u section #gcha ( ?is title1 %all monitor ! rese>* proposal review process nationwide to id5tify any undue delays or b>ri]s to timely approval4 ,if a rese>* proposal subject to ,dep>tm5t review is n approv$1 conditionally approv$1 or disapprov$ )9 ! applicable timel9e e/abli%$ "u subsection 7c71 ! ,"u ,secret>y1 ?r\gh ! ,(fice ( ,rese>* & ,developm5t1 may int]v5e to ensure a timely decision ) respect to ! rese>* proposal4 7#b7 7,a7 ,9 ex]cis+ ! au?ority "u p>agraph 7#a71 ! ,"u ,secret>y = ,heal? may1 z appropriate-- 7i7 assume responsibility = or reassign ! review ( ! proposal to an alt]native duly con/itut$ in/itutional review bo>d or o!r rese>* review body t meets applicable /&>ds2 or 7ii7 issue an approval or disapproval ( ! proposal aft] su* additional exp$it$ review z ! ,"u ,secret>y det]m9es necess>y4 7,b7 ,! ,"u ,secret>y %all notify ! *ief rese>* (fic] ( ! affect$ facility & ! ,(fice ( ,rese>* ,ov]sight "u section #gcjg ( ?is title ( any int]v5tion "u subp>agraph 7,a7 & ! rationale = su* int]v5tion4 7,c7 ,any action by ! ,"u ,secret>y "u ?is subsection %all ensure t all requisite e?ical & safety reviews are complet$4 7#c7 ,no?+ 9 ?is subsection %all be con/ru$ to waive or ov]ride any law or regulation protect+ human subjects1 animal welf>e1 or rese>* integrity4 7e7 ,guidance & ov]sight ,! ,secret>y %all-- 7#a7 issue policies or guidance to implem5t ! ti]$ review sy/em "u ?is section1 includ+-- 7,a7 def9itions ( risk & impact categories2 7,b7 specific timeframes = review at ea* ti]2 & 7,c7 proc$ures = c5traliz$ monitor+ ( compliance ) ^! timel9es2 7#b7 ov]see adh]5ce to ^! processes ?r\gh ! ,(fice ( ,rese>* & ,developm5t2 & 7#c7 provide tra9+ to memb]s ( in/itutional review bo>ds & o!r rese>* review committees on ! new requirem5ts to ensure consi/5t application4 7f7 ,annual review ( timel9ess ,! ,secret>y %all track ! p]=mance ( ! ,dep>tm5t's rese>* approval processes & include 9 ! annual report "u section #gchh ( ?is title an analysis ( ! timel9ess ( rese>* proposal reviews1 id5tify+ any sy/emic bottl5ecks & /eps tak5 to improve ! effici5cy ( rese>* approvals4 #gche4 ,implem5tation ( high-impact rese>* f9d+s 7a7 ,fund+ allocation requirem5t ,( ! am\nts appropriat$ or o!rwise made available to ! ,dep>tm5t ea* fiscal ye> = ! m$ical & pro/hetic rese>* program au?oriz$ "u section #gcjc ( ?is title1 ! ,secret>y %all ensure t funds are allocat$ = activities to implem5t ! f9d+s ( su* rese>* program to improve ! deliv]y ( c>e & s]vices to vet]ans4 7b7 ,use ( funds2 high-impact rese>* 7#a7 ,9 c>ry+ out subsection 7a71 ! ,secret>y1 act+ ?r\gh ! ,*ief ,rese>* & ,developm5t ,(fic] ( ! ,(fice ( ,rese>* & ,developm5t "u section #gcha ( ?is title1 %all id5tify complet$ or ongo+ rese>* projects t h produc$1 or are likely to produce1 evid5ce or innovations ) high pot5tial to improve vet]an heal? c>e or quality ( life 79 ?is section ref]r$ to z high-impact rese>*74 7#b7 ,! ,secret>y %all utilize funds allocat$ pursuant to subsection 7a7 to accel]ate ! transf] ( su* high-impact rese>* f9d+s into cl9ical practice1 sy/ems ( c>e1 or programmatic improvem5ts4 7#c7 ,activities fund$ ) su* am\nts may include-- 7,a7 implem5tation & dissem9ation /udies2 7,b7 ! developm5t or updat+ ( cl9ical practice guidel9es2 7,c7 tra9+ ( heal? c>e provid]s 9 new evid5ce-bas$ practices2 7,d7 modification ( heal? in=mation te*nology or equipm5t to accommodate new treatm5ts or diagno/ic2 7,e7 pati5t outrea* & education reg>d+ new /&>ds ( c>e2 & 7,f7 o!r actions necess>y to integrate rese>* discov]ies into r\t9e vet]ans c>e4 7c7 ,coord9ation & avoidance ( duplication 7#a7 ,! ,secret>y %all ensure t ! allocation & use ( funds = implem5tation activities "u ?is section are coord9at$ ) o!r ,dep>tm5t initiatives 9 implem5tation sci5ce & quality improvem5t1 includ+ ! ,quality ,enhancem5t ,rese>* ,initiative & o!r translational rese>* programs )9 ! ,dep>tm5t to lev]age exi/+ exp]tise & avoid duplicative ef=ts4 7#b7 ,! ,(fice ( ,rese>* & ,developm5t %all consult regul>ly ) ,vet]ans ,heal? ,adm9i/ration program (fices responsible = cl9ical op]ations to id5tify priority areas :]e rese>* f9d+s are ready to be adopt$ on a wid] scale )9 ! ,dep>tm5t4 7d7 ,acc\ntability ,! ,secret>y %all include1 9 ! annual report requir$ by section #gchh ( ?is title-- 7#a7 ! am\nt ( rese>* fund+ devot$ to implem5tation activities & ! outcomes ( su* inve/m5ts2 & 7#b7 an analysis ( compliance ) ! fund+ allocation 9 subsection 7a7 & a description ( major implem5tation projects und]tak51 ! /atus ( su* projects1 & ! effect ( su* projects on heal? c>e = vet]ans4 #gchf4 ,vet]an impact =eca/ & translation plan = major rese>* projects requir$ 7a7 ,requirem5t = major rese>* projects ,! ,secret>y %all ensure t any major rese>* project ( ! ,dep>tm5t includes1 z "p ( ! rese>* protocol & application = fund+ submitt$ to ! ,secret>y-- 7#a7 a vet]an impact =eca/ describ$ 9 subsection 7b72 & 7#b7 a translation plan describ$ 9 subsection 7c74 7b7 ,vet]an impact =eca/ ,a vet]an impact =eca/ describ$ 9 ?is subsection is a writt5 assessm5t1 prep>$ by ! inve/igators or sponsors ( a major rese>* project at ! "t ( proposal1 t describes ! anticipat$ b5efits & outcomes ( ! rese>* = vet]ans & ! heal? c>e sy/em ( ! ,dep>tm5t4 ,! vet]an impact =eca/ %all1 to ! maximum ext5t practicable1 quantify or describe ! foll[+3 7#a7 ,h[ ! f9d+s or results ( successful rese>* is successful are expect$ to improve heal? outcomes among vet]ans1 includ+-- 7,a7 r$uctions 9 morbidity or mortality2 7,b7 improvem5ts to functional /atus2 & 7,c7 enhancem5ts to ! quality ( life = vet]ans f ! condition or conditions subject to ! rese>*4 7#b7 ,! ways 9 :i* ! rese>* results c\ld-- 7,a7 be integrat$ into ! cl9ical practice ( ! ,vet]ans ,heal? ,adm9i/ration2 or 7,b7 lead to *anges 9 heal? c>e policy or programs = vet]ans 7includ+ adoption ( new treatm5ts1 diagno/ics1 prev5tive measures1 or c>e deliv]y models7 & an e/imate ( ! magnitude ( ! vet]an population likely to be affect$ by su* *anges4 7#c7 ,an explanation ( ! urg5cy ( ! rese>* "q = vet]ans & an e/imate ( ! "t frame )9 :i* positive f9d+s c\ld be implem5t$ into cl9ical practice1 giv5 ! nature ( ! /udy design & any necess>y regulatory approvals4 7c7 ,translation plan ,a translation plan describ$ 9 ?is subsection is a proactive plan = h[ positive f9d+s f ! rese>* w be dissem9at$ & implem5t$ 9 ! ,dep>tm5t to b5efit vet]ans t includes ! foll[+3 7#a7 ,an id5tification ( /eps & res\rces ne$$ to move any successful outcomes ( ! rese>* into g5]al ,dep>tm5t use4 7#b7 ,a description ( h[ & to :om ! rese>* results w be communicat$ ^u completion1 includ+ id5tification ( ! relevant entities t %\ld be in=m$ ( su* results1 includ+-- 7,a7 program (fices2 7,b7 cl9ical practice lead]s2 7,c7 policymak]s )9 ! ,dep>tm5t 9 a position to act on su* results2 7,d7 ext]nal p>tn]s 7includ+ academic affiliates72 & 7,e7 ! heads ( relevant ,f$]al ag5cies4 7#c7 ,specific actions to be tak5 if ! /udy yields positive results1 includ+-- 7,a7 ! developm5t or revision ( cl9ical protocols & guidel9es2 7,b7 pursu+ regulatory approvals = new !rapies1 if applicable2 7,c7 tra9+ cl9icians 9 new practices2 7,d7 updat+ heal? in=mation te*nology sy/ems or decision support tools2 or 7,e7 initiat+ pilot programs to implem5t ! f9d+s 9 "o or m m$ical c5t]s ( ! ,dep>tm5t4 7#d7 ,an id5tification ( pot5tial ob/acles to implem5tation1 includ+ res\rce ne$s1 tra9+ gaps1 or int]op]ability issues4 7#e7 ,a description ( h[ ! inve/igators or ! ,dep>tm5t might address su* ob/acles to facilitate timely translation ( ! rese>* into practice4 7#f7 ,z appropriate1 to ensure t ! translation ( f9d+s is feasible & su/a9able )9 ! ,dep>tm5t1 plans = engag+ relevant /akehold]s 9 ! implem5tation process1 includ+-- 7,a7 ! ,"u ,secret>y = ,heal?2 7,b7 vet]ans :o w\ld be affect$ by ! *ange2 7,c7 c>egiv]s2 or 7,d7 ext]nal regulatory bodies4 7d7 ,incorporation into approval & fund+ 7#a7 ,! ,secret>y %all ensure t no major rese>* project is approv$ or fund$ by ! ,dep>tm5t unless ! proposal includes a vet]an impact =eca/ & translation plan meet+ ! requirem5ts ( ?is section4 7#b7 ,! ,(fice ( ,rese>* & ,developm5t %all review ! adequacy ( ! vet]an impact =eca/ & translation plan dur+ ! sci5tific review or fund+ decision process1 & may provide fe$back or require modifications z necess>y to /r5g!n ! likelihood t ! rese>*1 if successful1 c be readily appli$ to improve c>e = vet]ans4 7e7 ,guidance & waiv] 7#a7 ,! ,secret>y1 ?r\gh ! ,(fice ( ,rese>* & ,developm5t1 %all issue guidance def9+ ! classes ( rese>* projects subject to ! requirem5ts ( ?is section & detail+ ! =mat & cont5t expectations = vet]an impact =eca/s & translation plans4 7#b7 ,! ,secret>y may exempt a p>ticul> project or class ( projects f "o or bo? ( ^! requirem5ts only if ! ,secret>y det]m9es t su* project is ( a nature = :i* ^! plann+ docum5ts w\ld n be practicable or mean+ful4 ,any su* exemption %all be docum5t$ 9 writ+ ) a ju/ification & submitt$ to ! ,committees on ,vet]ans' ,affairs ( ! ,h\se ( ,repres5tatives & ! ,s5ate z "p ( ! annual report "u section #gchh ( ?is title4 7f7 ,updates & po/-,/udy review 7#a7 ,! ,secret>y %all e/abli% a me*anism to revisit & update ! translation plan z necess>y dur+ ! c\rse ( ! rese>* project & imm$iately foll[+ its completion1 9 light ( ! actual f9d+s4 ,inve/igators conduct+ a cov]$ project %all1 at ! conclusion ( ! project1 report on h[ ! f9d+s comp>e to ! vet]an impact =eca/ & propose any adju/m5ts to ! actions 9 ! translation plan4 7#b7 ,! ,(fice ( ,rese>* & ,developm5t1 9 conjunction ) relevant cl9ical op]ations (ficials1 %all evaluate ^! po/-/udy reports to det]m9e :at implem5tation /eps w be tak5 by ! ,dep>tm5t & %all track ! outcomes ( major rese>* projects 9 t]ms ( uptake into cl9ical practice or policy4 7g7 ,major rese>* project def9$ ,9 ?is section1 a major rese>* project means-- 7#a7 a rese>* /udy or program1 includ+ a cl9ical trial or multisite /udy1 t meets crit]ia indicat+ sub/antial size1 scope1 or significance1 z %all be def9$ by ! ,secret>y2 & 7#b7 includes-- 7,a7 rese>* projects ) project$ ,dep>tm5t fund+ above a ?re%old am\nt set by ! ,secret>y2 & 7,b7 any o!r rese>* initiatives designat$ by ! ,(fice ( ,rese>* & ,developm5t z hav+ high pot5tial impact on vet]ans heal? or heal? c>e sy/ems4 #gchg4 ,dep>tm5t ( ,vet]ans ,affairs regional rese>* hubs 7a7 ,e/abli%m5t 7#a7 ,! ,secret>y %all e/abli% a sy/em ( regional rese>* hubs ( ! ,dep>tm5t 79 ?is section ref]r$ to z rese>* hubs7 )9 ! ,vet]ans ,heal? ,adm9i/ration to support & coord9ate ! rese>* activities ( ! ,dep>tm5t across multiple m$ical c5t]s & cl9ics4 ,! numb] & locations ( su* rese>* hubs %all be det]m9$ by ! ,secret>y to ensure t all m$ical facilities ( ! ,dep>tm5t ) active rese>* programs may access ! s]vices ( a rese>* hub4 ,9 e/abli%+ rese>* hubs pursuant to ?is section1 ! ,secret>y may consid] ,vet]an ,integrat$ ,s]vices ,networks1 or o!r appropriate regional gr\p+s ( facilities4 7#b7 ,ea* rese>* hub %all be organizationally e/abli%$ "u ! ,(fice ( ,rese>* & ,developm5t1 & %all op]ate "u ! direction ( a ,regional ,rese>* ,hub ,director appo9t$ by ! ,"u ,secret>y = ,heal?1 or a designee ( ! ,"u ,secret>y4 ,! ,director ( ea* rese>* hub %all be an individual ) exp]i5ce 9 manag+ biom$ical or heal? s]vices rese>* & k ( regulatory compliance1 :o %all report to ! ,(fice ( ,rese>* & ,developm5t ) respect to activities ( ! hub4 7b7 ,functions ,ea* rese>* hub %all1 9 coord9ation ) ! ,(fice ( ,rese>* & ,developm5t1 c>ry out ! foll[+ functions 9 support ( ,dep>tm5t rese>* )9 ! applicable area ( geographic responsibility3 7#a7 ,facilitat+ ! effici5t & timely review ( rese>* protocols by coord9at+ in/itutional review bo>d approvals = multi-site /udies1 includ+-- 7,a7 e/abli%+ or utiliz+ regional or c5tral in/itutional review bo>ds to s]ve multiple facilities2 7,b7 h>moniz+ in/itutional review bo>d submission requirem5ts2 & 7,c7 ensur+ t a s+le in/itutional review bo>d ( record c be us$ = multi-site projects :5 feasible & 9 accordance ) applicable regulations4 7#b7 ,provid+ te*nical assi/ance & support to inve/igators & rese>* /aff at facilities 9 ! region4 ,su* support %all include-- 7,a7 guidance on rese>* proposal developm5t2 7,b7 /udy design & me?odology consultation2 7,c7 assi/ance ) regulatory compliance1 includ+ human subjects protections1 animal c>e1 & safety regulations2 & 7,d7 tra9+ or education programs = new inve/igators & rese>* coord9ators to build rese>* capacity4 7#c7 ,coord9at+ rese>* ef=ts among ! ,dep>tm5t facilities 9 ! region & ) affiliat$ academic in/itutions or o!r p>tn]s4 ,su* rese>* ef=ts %all id5tify opportunities = multi-site rese>* projects1 promote %>+ ( res\rces 7includ+ rese>* equipm5t1 specializ$ laboratories1 or data res\rces71 & enc\rage collaboration on /udies t address vet]an heal? priorities4 ,pursuant to su* rese>* ef=ts1 ! rese>* hub may organize regul> regional rese>* meet+s or consortia to fo/] in=mation ex*ange & p>tn]%ip among inve/igators & cl9icians4 7#d7 ,assi/+ inve/igators 9 develop+ /rategies = recruitm5t & enrollm5t ( vet]an p>ticipants 9 rese>* /udies1 especially = multi-site cl9ical trials or /udies requir+ l>ge sample sizes4 ,! hub %all facilitate outrea* to vet]ans 9 ! region :o might be eligible = ongo+ /udies1 9 accordance ) privacy rules1 & coord9ate ) local cl9ical /aff to improve aw>5ess & engagem5t 9 rese>* opportunities4 7#e7 ,(f]+ c5traliz$ adm9i/rative support = rese>* projects1 su* z budget & grant managem5t assi/ance1 data managem5t & bio/ati/ical support1 & guidance on us+ ,dep>tm5t data sy/ems1 includ+ ! ,,va ,c5traliz$ ,rese>* ,data ,sy/em "u section #gchc ( ?is title & o!r in=mation tools1 = rese>* purposes4 7#f7 ,p]=m+ su* o!r rese>*-support+ functions consi/5t ) ! goal ( enhanc+ ! productivity1 effici5cy1 & effects ( ! rese>* ent]prise ( ! ,dep>tm5t 9 s]vice ( vet]ans1 z ! ,secret>y or ,"u ,secret>y = ,heal? det]m9e appropriate4 7c7 ,evaluation & ov]sight 7#a7 ,! ,*ief ,rese>* & ,developm5t ,(fic] ( ! ,(fice ( ,rese>* & ,developm5t ( ! ,dep>tm5t %all ov]see ! p]=mance ( ! rese>* hubs & ensure su* rese>* hubs are meet+ ! ne$s ( ! respective regions 9 :i* su* rese>* hubs are locat$4 7#b7 ,! ,"u ,secret>y = ,heal? %all e/abli% metrics & goals = ! hubs1 includ+ metrics relat$ to in/itutional review bo>d review times1 numb] ( multi-site /udies support$1 tra9+ activities conduct$1 & improvem5ts 9 vet]an rese>* enrollm5t4 7#c7 ,! ,"u ,secret>y %all-- 7,a7 require ea* rese>* hub to submit p]iodic reports to ! ,"u ,secret>y ) respect to ! activities c>ri$ out by ! rese>* hub & ! outcomes ( su* activities2 & 7,b7 include su* p]iodic reports into ! annual report "u section #gchh ( ?is title4 7d7 ,consultation & p>tn]%ips ,9 e/abli%+ & op]at+ ! rese>* hubs1 ! ,secret>y may collaborate ) ,f$]al p>tn]s1 includ+ ! ,dep>tm5t ( ,def5se & ! ,national ,in/itutes ( ,heal?1 & academic affiliates to co-locate or jo9tly support res\rces t b5efit bo? ,dep>tm5t & non-,dep>tm5t rese>* endeavors4 ,! ,secret>y may also seek input f inve/igators1 vet]ans1 & o!r /akehold]s 9 ea* region 9 :i* a rese>* hub is locat$ ) respect to ! rese>* priorities & support ne$s ! rese>* hubs %\ld address4 #gchh4 ,rese>* p]=mance metrics2 annual report 7a7 ,e/abli%m5t ( metrics2 b5*m>k+ program ,! ,secret>y %all develop & implem5t a /&>diz$ program ( metrics to assess ! p]=mance1 productivity1 & impact ( rese>* activities at ea* facility ( ! ,vet]ans ,heal? ,adm9i/ration 7includ+ ,dep>tm5t m$ical c5t]s & affiliat$ cl9ics7 t conducts rese>*4 ,su* metrics %all be us$ to b5*m>k ,vet]ans ,heal? ,adm9i/ration facilities aga9/ ea* o!r & aga9/ ,dep>tm5tal goals to id5tify be/ practices & areas = improvem5t4 ,at a m9imum1 su* metrics %all include measures ( ! foll[+3 7#a7 ,! volume ( rese>* projects und]tak5 & complet$1 & ! effici5cy ( rese>* processes at ! facility1 includ+-- 7,a7 ! numb] ( rese>* proposals submitt$1 approv$1 & initiat$ ea* ye>2 7,b7 ! av]age or m$ian "t f proposal submission to in/itutional review bo>d approval & project />t2 & 7,c7 ! numb] ( /udies complet$ or publications produc$ p] ye>1 normaliz$ to ! rese>* /aff or fund+ level4 7#b7 ,! ext5t ( vet]an engagem5t 9 rese>* at ! facility1 includ+-- 7,a7 ! total numb] ( vet]an p>ticipants enroll$ 9 cl9ical trials or o!r rese>* /udies2 7,b7 & ! p]c5tage ( ! facility's pati5t population or eligible population involv$ 9 rese>*4 7#c7 ,! degree to :i* rese>* f9d+s are implem5t$ into cl9ical c>e or in=m improvem5ts to heal? c>e deliv]y at ! facility4 ,?is may include-- 7,a7 ! numb] ( evid5ce-bas$ int]v5tions or new cl9ical practices adopt$ by ! facility t orig9at$ f rese>* 7:e!r ,dep>tm5t-fund$ or ext]nal rese>*72 7,b7 ! p]iod ( "t betwe5 rese>* discov]y & implem5tation at ! facility2 & 7,c7 qualitative examples ( significant *anges 9 pati5t c>e driv5 by rese>* f9d+s4 7#d7 ,if det]m9$ relevant by ! ,secret>y-- 7,a7 ! level ( collaboration & ext]nal support1 includ+ ! numb] ( p>tn]%ips ) academic or indu/ry rese>*]s2 7,b7 ! am\nt ( non-,dep>tm5t rese>* fund+ 7includ+ grants f ! ,national ,in/itutes ( ,heal? or ! ,dep>tm5t ( ,def5se7 manag$ ?r\gh ! facility2 & 7,c7 ! ext5t ( p>ticipation 9 multi-site or nationwide /udies4 7#e7 ,any o!r quantifiable measure t ! ,secret>y consid]s appropriate to evaluate rese>* program effectiv5ess1 includ+-- 7,a7 compliance ) rese>* safety & e?ics requirem5ts2 7,b7 tra9+ & c>e] developm5t ( rese>*]s2 & 7,c7 innovation 9 rese>* op]ations4 7b7 ,annual report 7#a7 ,n lat] ?an #ahj days aft] ! end ( ea* fiscal ye>1 & on an annual basis !reaft]1 ! ,secret>y %all submit to ! ,committees on ,vet]ans' ,affairs ( ! ,h\se ( ,repres5tatives & ! ,s5ate a report on ! p]=mance ( ! rese>* program ( ! ,dep>tm5t1 ) specific emphasis on ! facility-level metrics describ$ 9 subsection 7a74 ,! report %all include1 = ! fiscal ye> dur+ :i* ! report is submitt$1 ! foll[+3 7,a7 ,a table or summ>y display+ ea* m$ical c5t] ( ! ,dep>tm5t1 & any o!r major rese>* site1 & values ( su* rese>* site = ea* ( ! p]=mance metrics 9 subsection 7a7 = ! fiscal ye> &1 = context1 = at lea/ "o prior ye>4 7,b7 ,an analysis by ! ,secret>y id5tify+ :i* facilities repres5t ! highe/ p]=m]s 9 v>i\s categories 7includ+ %orte/ rese>* approval times1 highe/ vet]an p>ticipation rates1 mo/ implem5tations ( f9d+s1 & :i* facilities are lagg+ beh9d b5*m>ks or av]ages74 ,! analysis %\ld discuss factors contribut+ to /rong p]=mance1 z well z *all5ges fac$ by l[]-p]=m+ sites4 7,c7 ,a description ( ef=ts ( ! ,dep>tm5t to improve rese>* p]=mance & address any id5tifi$ defici5cies4 ,?is %\ld include any initiatives to %>e be/ practices f high-p]=m+ facilities1 t>get$ support or corrective actions = "u-p]=m+ facilities1 & progress updates on any ongo+ ,dep>tm5t-wide rese>* improvem5t ef=ts4 7,d7 ,highlights ( significant rese>* accompli%m5ts f ! ye>1 especially in/ances :]e rese>* conduct$ by ! ,dep>tm5t l$ to improvem5ts 9 vet]an c>e1 new treatm5ts or te*nologies1 or notable sci5tific publications1 z well z recognition ( any rese>*]s or teams = exceptional contributions4 7#b7 ,! fir/ annual report "u ?is subsection %all be submitt$ n lat] ?an #ah mon?s aft] ! date ( ! enactm5t ( ?is section4 7c7 ,public availability 7#a7 ,! ,secret>y %all make ea* annual report "u subsection 7b7 publicly available on an int]net website ( ! ,dep>tm5t1 9 a =mat t is readily accessible to vet]ans1 rese>*]s1 & o!r /akehold]s4 7#b7 ,! publicly releas$ v]sion ( ! report may aggregate or anonymize data z ! ,secret>y det]m9es necess>y to protect p]sonal privacy & to safegu>d confid5tial rese>* project details4 7#c7 ,! ,secret>y is enc\rag$ to include on ! website us]-fri5dly visualizations or da%bo>ds t illu/rate ! p]=mance ( ! applicable rese>* program on key metrics ov] "t & by facility4 7d7 ,sunset or modification ( metrics 7#a7 ,! ,secret>y %all cont9u\sly evaluate ! relevance & effectiv5ess ( ! p]=mance metrics e/abli%$ "u subsection 7a74 ,! ,secret>y may modify ! metrics or b5*m>k+ me?ods "u subsection 7a71 z ! ,secret>y det]m9es appropriate1 to bett] measure rese>* impact & effici5cy4 7#b7 ,any su* modifications %all be describ$ 9 ! annual report "u subsection 7b74 #gchi4 ,integration ( rese>* data & int]ag5cy collaboration 7a7 ,improvem5t ( data %>+ = rese>* 7#a7 ,! ,secret>y may include1 9 ! plan requir$ "u section #ajh7;a77#a7 ( ! ,s5ator ,elizabe? ,dole #ba/ ,c5tury ,vet]ans ,heal?c>e & ,b5efits ,improvem5t ,act 7,public ,law #aah-baj2 #ch ,u4,s4,c4 note prec4 #egja71 su* actions z may be necess>y to facilitate ! secure integration & %>+ ( data = rese>* purposes betwe5 ! ,dep>tm5t & key rese>* p>tn]s1 includ+ o!r ,f$]al ag5cies & academic in/itutions4 7#b7 ,= purposes ( ?is subsection1 ! ,secret>y %all ensure t any data 9 ! cu/ody1 possession1 or control ( ! ,dep>tm5t1 7)\t reg>d to ! orig9al own]%ip ( su* data71 may be %>$ to ! ext5t p]mitt$ "u applicable privacy1 security1 & e?ical /&>ds4 7#c7 ,! ,secret>y may include a description ( any actions tak5 pursuant to ?is subsection 9 ! reports requir$ "u subsection 7c77#b7 ( su* section4 7#d7 ,9 c>ry+ out ?is subsection1 ! ,secret>y %all seek to improve int]op]ability ( data sy/ems & ease ( collaboration ) ! foll[+3 7,a7 ,! ,dep>tm5t ( ,def5se1 to-- 7i7 facilitate rese>* on-- 7,i7 memb]s ( ! ,arm$ ,=ces assign$ to active duty2 & 7,,ii7 vet]ans across ! cont9uum ( milit>y s]vice & po/-s]vice life2 & 7ii7 support jo9t rese>* initiatives ( ! ,dep>tm5t & ! ,dep>tm5t ( ,def5se4 7,b7 ,! ,dep>tm5t ( ,heal? & ,human ,s]vices1 includ+ ! ,national ,in/itutes ( ,heal? & o!r compon5ts engag$ 9 biom$ical & heal? s]vices rese>*1 to facilitate-- 7i7 mutually b5eficial %>+ ( heal? data & rese>* results2 & 7ii7 p>ticipation ( ! ,dep>tm5t 9 national rese>* ef=ts1 su* z cl9ical trials networks & obs]vational /udy consortia4 7,c7 ,affiliat$ univ]sities & o!r academic rese>* in/itutions t p>tn] ) ! ,dep>tm5t or receive rese>* fund+ f ! ,dep>tm5t1 to ensure t rese>*]s c collaborate effectively :ile ma9ta9+ appropriate data security & pati5t privacy4 7,d7 ,o!r public or private rese>* entities z det]m9$ appropriate by ! ,secret>y1 includ+ nonpr(it rese>* organizations or indu/ry p>tn]s1 especially 9 contexts :]e coop]ation c accel]ate ! developm5t ( treatm5ts or te*nologies = ! b5efit ( vet]ans4 7c7 ,privacy & security 7#a7 ,all activities "u ?is section %all be c>ri$ out 9 compliance ) applicable ,f$]al privacy laws1 includ+ ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 7,,hipaa1 ,public ,law #ajd-aia2 #aaj ,/at4 #aicf7 & ! ,privacy ,act ( #aigd 7#e ,u4,s4,c4 #eeb;a71 & ) regulations gov]n+ human subjects rese>* confid5tiality4 7#b7 ,9 c>ry+ out ?is section1 ! ,secret>y %all ensure t robu/ safegu>ds are 9 place to protect p]sonally id5tifiable in=mation & p]sonal heal? in=mation ( vet]ans4 ,su* safegu>ds %all include us] au!ntication1 role-bas$ access controls1 encryption ( data 9 transit & at re/1 cont9u\s monitor+ = unau?oriz$ access or anomalies1 & regul> cyb]security audits4 7#c7 ,:5 %>+ data ) ! ,dep>tm5t ( ,def5se or o!r ag5cies1 ! ,secret>y %all1 to ! maximum ext5t practicable1 use secure ,f$]al heal? data ex*ange frameworks & reciprocal data access agreem5ts t uphold ! same or high] /&>ds ( privacy & security z ^? us$ )9 ! ,dep>tm5t4 7d7 ,consultation ,9 c>ry+ out ! provisions ( ?is section1 ! ,secret>y %all consult ) relevant ,f$]al (ficials & outside exp]ts1 includ+ ! ,*ief ,in=mation ,(fic] ( ! ,dep>tm5t ( ,def5se or designee1 ! ,director ( ! ,national ,in/itutes ( ,heal? or designee1 & repres5tatives ( academic in/itutions ) exp]tise 9 heal? in=mation tools & data %>+4 4