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Jhil-ae-Eul`tial Tmsmhr`f; ̂ fm Pm`aln PyopasiuoLhtialhc H`hnmoims ae P`iml`ms

Ohr`f 82-88, 4285

LPHDD Tmpart;Rrmcioilhry Eilniljs hln

Nrhet Tm`aoomlnhtials hdautJhil-ae-Eul`tial Tmsmhr`f

Phoumc C. Pthlcmy, Kr., O.N.@fhir, Lhtialhc P`iml`m Hnvisary Dahrn ear Diasm`urity

8/19/2019 NSABB Report: Preliminary Findings and Draft Recommendations about GOF Research (Samuel Stanley)

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^FM @FHTJM ̂ A ̂ FM LPHDD

8. Hnvism al tfm nmsijl, nmvmcapomlt, hln `alnu`t ae risg hlndmlmeit hssmssomlts ear JAE stunims

Erhomwarg ear @alnu`tilj Tisg hln Dmlmeit Hssmssomlts ae Jhil-ae-Eul`tial Tmsmhr`f (Ohy 428=)

4. Rravinm rm`aoomlnhtials ta tfm ].P. javmrlomlt al h`al`mptuhc hpprah`f ta tfm mvhcuhtial ae prapasmn JAE stunims

Nrhet Zargilj Rhpmr al Mvhcuhtilj tfm Tisgs hln Dmlmeits ae Jhil-ae-

Eul`tial Ptunims (Nm`modmr 428=)

4

8/19/2019 NSABB Report: Preliminary Findings and Draft Recommendations about GOF Research (Samuel Stanley)

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LPHDD ZATGILJ RHRMT ALJAE P^]NIMP

Juinilj pril`ipcms ear LPHDD nmcidmrhtials

Hlhcysis hln iltmrprmthtial ae tfm TDH

@alsinmrhtial ae mtfi`hc vhcums hln nm`isial-ohgilj erhomwargs

Hlhcysis ae tfm `urrmlt paci`y chlns`hpm hlnpatmltihc paci`y aptials

Rrmcioilhry eilniljs erao tfm ZJ’s hlhcysms

Nrhet rm`aoomlnhtials ear tfm Dahrn’s`alsinmrhtial

Ioparthlt qumstials ear eurtfmr `alsinmrhtial

fttp;//asp.an.lif.jav/aeei`m-diatm`flacajy-

h`tivitims/diasm`urity/lshdd

8/19/2019 NSABB Report: Preliminary Findings and Draft Recommendations about GOF Research (Samuel Stanley)

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LPHDD HRRTAH@F &@ALP]C^H^IALP

8. Mvhcuhtial ae patmltihc risgs hln dmlmeits ae `mrthil JAE stunims

@aooissialmn TDH ae JAE stunims (Jrypfal P`imltiei`)

4. Mtfi`hc issums hln nm`isial strhtmjims

@aooissialmn Mtfi`hc Hlhcysis (Rrae. Oi`fhmc Pmcjmcin)

0. Naomsti` hln iltmrlhtialhc paci`ims hln juinmcilms hln patmltihcpaci`y aptials

Drimeiljs erao sudkm`t ohttmr mxpmrts7 mxhoilhtial ae citmrhturm

>. Pthgmfacnmr pmrspm`tivms

LPHDD hln ZJ ommtiljs

8st LHP ommtilj al JAE stunims

Rudci` `aoomlts>

8/19/2019 NSABB Report: Preliminary Findings and Draft Recommendations about GOF Research (Samuel Stanley)

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TIPG HLN DMLMEI^ HLHCYPIP

Diashemty risg hssmssomlt

Diasm`urity risg hssmssomlt(il`cunilj ilearohtial risg)

Dmlmeits hlhcysis

=fttp;//www.jrypfals`imltiei`.`ao/jhil-ae-

eul`tial/

8/19/2019 NSABB Report: Preliminary Findings and Draft Recommendations about GOF Research (Samuel Stanley)

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8/19/2019 NSABB Report: Preliminary Findings and Draft Recommendations about GOF Research (Samuel Stanley)

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@ALPINMTH^IAL AE M^FI@HCUHC]MP

Ioparthlt vhcums ta `alsinmr wfml mvhcuhtilj rmsmhr`f prapashcsilvacvilj JAE stunims ar msthdcisfilj om`fhlisos ta rmvimwhln/ar ohgm eulnilj nm`isials hdaut tfmo;

:

Rra`mnurhc Uhcums

Rudci` phrti`iphtial &nmoa`rhti` nmcidmrhtial

H``aulthdicity

^rhlsphrml`y

Pudsthltivm Uhcums

Lal-ohcmei`ml`m

Dmlmei`ml`m

Pa`ihc kusti`m Tmspm`t ear pmrsals

P`imltiei` Ermmnao

Tmspalsidcm

Ptmwhrnsfip

8/19/2019 NSABB Report: Preliminary Findings and Draft Recommendations about GOF Research (Samuel Stanley)

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AUMTUIMZ AE ̂ FM @]TTML^EMNMTHC RACI@Y CHLNP@HRM

P`imltiei` Omrit Tmvimw

Diashemty Avmrsijft

a Diashemty il Oi`radiacaji`hc hln Diaomni`hc Chdarhtarims (DODC)

a

LIF Juinmcilms ear Tmsmhr`f Ilvacvilj Tm`aodilhlt ar Pyltfmti` Lu`cmi` H`in Oacm`ucms (LIF Juinmcilms)

Emnmrhc Pmcm`t Hjmlt Rrajrho

Emnmrhc hln Ilstitutialhc Avmrsijft ae Ciem P`iml`m Nuhc ]sm

Tmsmhr`f ae @al`mrl

FFP Erhomwarg ear juinilj eulnilj nm`isials hdaut `mrthil JAEstunims

Pfhrilj hln @aoouli`htilj P`imltiei` Eilniljs hln Tmsmhr`fRranu`ts

6

8/19/2019 NSABB Report: Preliminary Findings and Draft Recommendations about GOF Research (Samuel Stanley)

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GMY EILNILJP AE ̂ FM LPHDD

Eilnilj 8. ^fmrm hrm ohly typms ae JAEstunims hln lat hcc ae tfmo fhvm tfm shomcmvmc ae risgs. Alcy h sohcc sudsmt ae JAEstunims„JAE stunims ae `al`mrl„mlthic

risgs tfht hrm patmltihccy sijliei`hlt mlaujfta whrrhlt hnnitialhc avmrsijft.

JAE stunims ae `al`mrl hrm tfasm tfht

`aucn jmlmrhtm h phtfajml tfht is fijfcytrhlsoissidcm, fijfcy virucmlt, hln cigmcy tadm rmsisthlt ta `altrac omhsurms.

9

8/19/2019 NSABB Report: Preliminary Findings and Draft Recommendations about GOF Research (Samuel Stanley)

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GMY EILNILJP AE ̂ FM LPHDD

Eilnilj 4. ^fm ].P. javmrlomlt

fhs meem`tivm paci`y erhomwargs ilpch`m ear ohlhjilj risgs hssa`ihtmn

 witf ciem s`iml`ms rmsmhr`f. ^fmrmhrm smvmrhc pailts tfraujfaut tfmrmsmhr`f ciem `y`cm wfmrm, ie tfm

paci`ims hrm iopcmomltmnmeem`tivmcy, risgs `hl dm ohlhjmnhln avmrsijft ae JAE stunims `aucndm hppcimn.

Eilnilj 0. Avmrsijft paci`ims vhryil s`apm hln hppci`hdicity,tfmrmearm, ̀ urrmlt avmrsijft is latsueei`imlt ear hcc JAE stunims tfht

rhism `al`mrl.

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GMY EILNILJP AE ̂ FM LPHDD

Eilnilj >. ^fmrm hrm ciem s`iml`ms rmsmhr`f stunims tfht sfaucn lat dm`alnu`tmn al mtfi`hc ar pudci` fmhctf jraulns ie tfm patmltihc risgs hssa`ihtmn witf tfm stuny hrm lat kustieimn dy tfm patmltihc dmlmeits. Nm`isials hdaut wfmtfmr JAE stunims ae `al`mrl sfaucn dm pmroittmn wicc mlthic hlhssmssomlt ae tfm patmltihc risgs hln hlti`iphtmn dmlmeits hssa`ihtmn witf tfm

ilnivinuhc mxpmriomlt il qumstial. ^fm s`imltiei` omrit ae h stuny is h `mltrhc`alsinmrhtial nurilj tfm rmvimw ae prapasmn stunims dut atfmr `alsinmrhtialshln vhcums hrm hcsa ioparthlt.

Eilnilj =. ^fm diashemty hln diasm`urity issums hssa`ihtmn witf JAE stunims

hrm sioichr ta tfasm issums hssa`ihtmn witf hcc fijf `althilomlt rmsmhr`f, dut hsohcc sudsmt ae JAE stunims fhvm tfm patmltihc ta jmlmrhtm strhils witf fijfhln patmltihccy ulglawl risgs. Ohlhjilj risgs hssa`ihtmn witf hcc fijf`althilomlt rmsmhr`f rmquirms Emnmrhc-cmvmc avmrsijft, ilstitutialhc hwhrmlmss

hln `aopcihl`m, hln h `aooitomlt dy hcc sthgmfacnmrs ta shemty hln sm`urity.Diashemty hln diasm`urity hrm iltmrlhtialhc issums rmquirilj jcadhc mljhjmomlt.

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LPHDD NTHE^ TM@AOOMLNH^IALP

Tm`aoomlnhtial 8. Tmsmhr`f prapashcs ilvacvilj JAE stunims ae`al`mrl mlthic tfm jrmhtmst risgs hln sfaucn dm rmvimwmn `hrmeuccyear diashemty hln diasm`urity iopci`htials, hs wmcc hs patmltihc

dmlmeits, priar ta nmtmroililj wfmtfmr tfmy hrm h``mpthdcm eareulnilj.

Ie eulnmn, su`f prakm`ts sfaucn dm sudkm`t ta aljailj avmrsijft ht

tfm Emnmrhc hln ilstitutialhc cmvmcs.

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LPHDD NTHE^ TM@AOOMLNH^IALP;INML^IEYILJ JAE P^]NIMP AE @AL@MTL

80

JAE stunims ae `al`mrl sfaucn dm sudkm`t ta hnnitialhc rmvimw priar ta

ohgilj h eulnilj nm`isial hln avmrsijft tfraujfaut tfm `aursm ae tfm

rmsmhr`f, ie eulnmn 

H JAE stuny ae `al`mrl is alm tfht `aucn jmlmrhtm h phtfajml witfhcc ae tfm eaccawilj httridutms;

8. ^fm phtfajml jmlmrhtmn is fijfcy trhlsoissidcm il h rmcmvhltohoohcihl oanmc.

4. ^fm phtfajml jmlmrhtmn is fijfcy virucmlt il h rmcmvhltohoohcihl oanmc.

0. ^fm phtfajml jmlmrhtmn is cigmcy oarm `hphdcm ae dmilj sprmhnhoalj fuohl papuchtials tfhl `urrmltcy `ir`uchtilj strhils ae

tfm phtfajml.

TF8>

8/19/2019 NSABB Report: Preliminary Findings and Draft Recommendations about GOF Research (Samuel Stanley)

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LPHDD NTHE^ TM@AOOMLNH^IALP;J]INILJ E]LNILJ NM@IPIALP EAT JAEP^]NIMP AE @AL@MTL

^fm eaccawilj pril`ipcms sfaucn juinm tfm rmvimw ae hln eulnilj nm`isialshdaut rmsmhr`f prapashcs hlti`iphtmn ta ilvacvm JAE stunims ae `al`mrl

i. ^fm rmsmhr`f prapashc fhs dmml mvhcuhtmn dy h pmmr-rmvimw pra`msshln nmtmroilmn ta dm s`imltiei`hccy omritariaus hln fhs dmml hssmssmnta dm cigmcy ta mxmrt h susthilmn, pawmreuc ilecuml`m al tfm rmsmhr`feimcn(s) ilvacvmn.

ii. Hl hssmssomlt ae tfm avmrhcc patmltihc risgs hln dmlmeits hssa`ihtmn

 witf tfm prakm`t nmtmroilms tfht tfm patmltihc risgs `aophrmn ta tfmpatmltihc dmlmeits hrm kustieimn.

iii. ^fmrm hrm la emhsidcm, mquhccy meei`h`iaus hctmrlhtivm omtfans tahnnrmss tfm shom s`imltiei` qumstial il h ohllmr tfht pasms cmss risg

tfhl nams tfm prapasmn hpprah`f.

8>

8/19/2019 NSABB Report: Preliminary Findings and Draft Recommendations about GOF Research (Samuel Stanley)

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Juinilj pril`ipcms `altilumn

iv. ^fm ilvmstijhtar hln ilstitutial prapasilj tfm rmsmhr`f fhvm tfm

nmoalstrhtmn `hph`ity ta `hrry it aut shemcy hln sm`urmcy.

v. ^fm rmsmhr`f ilearohtial is hlti`iphtmn ta dm drahncy hln cmjhccysfhrmn il arnmr ta rmhcizm its patmltihc dmlmeits ta jcadhc fmhctf.

vi. ^fm rmsmhr`f wicc dm suppartmn tfraujf eulnilj om`fhlisos tfht

il`cunm hppraprihtm avmrsijft ae; h) hcc hspm`ts ae tfm rmsmhr`fil`cunilj its `alnu`t, d) tfm sfhrilj ae nhth hln ohtmrihcs, hln `) tfm

`aoouli`htial ae tfm rmsmhr`f.

vii. ^fm prapasmn rmsmhr`f is mtfi`hccy kustieihdcm. 8=

LPHDD NTHE^ TM@AOOMLNH^IALP;J]INILJ E]LNILJ NM@IPIALP EAT JAEP^]NIMP AE @AL@MTL

8/19/2019 NSABB Report: Preliminary Findings and Draft Recommendations about GOF Research (Samuel Stanley)

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Emnmrhc 

hjml`y

Tmsmhr`f Ilstitutial

Hnnitialhc JAET@ rmvimw 

om`fhliso

Ratmltihc 

Rra`mss; 

H 

@al`mptuhc 

Hpprah`f 

ear 

tfm 

Tmvimw, 

Eulnilj, 

hln 

Avmrsijft 

ae  

JAE 

Tmsmhr`f 

ae  

@al`mrl 

(JAET@)

P`imltiei ̀

Omrit 

Tmvimw

@aleirohtial ar Inmltiei`htial 

ae  

JAET@@alsinmr hcc 0 httridutms ae  JAET@

Hnnitialhc Tmvimw ae  JAET@

Hppcy 

: 

pril`ipcms 

ta 

juinm 

eulnilj 

nm`isials7 

inmltiey 

risg 

oitijhtial strhtmjims hcrmhny il pch`m7 rm`aoomln 

hnnitialhc 

risg 

oitijhtial 

strhtmjims 

ie  

lmmnmn

Yms, JAET@

Lat JAET@

Rrakm`t `alsinmrmn ear eulnilj 

hln ie  eulnmn, `alnu`tmn il 

h``arnhl`m 

witf 

rmcmvhlt 

paci`ims

La

Rrakm`t 

lat 

h``mpthdcm ear eulnilj

Rrakm`t il cilm 

witf hcc pril`ipcms1

Aljailj 

Ilstitutialhc 

Avmrsijft

Aljailj 

Emnmrhc

Avmrsijft

Yms

Rrakm`t h``mpthdcm ear 

eulnilj

Rassidcy 

witf 

hnnitialhc 

rmquirmomlts ear 

aljailj avmrsijft ht 

Emn. hln Ilst. cmvmcs

RI hln Ilstitutial Inmltiey 

Ratmltihc JAET@

Omritariaus

8/19/2019 NSABB Report: Preliminary Findings and Draft Recommendations about GOF Research (Samuel Stanley)

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LPHDD NTHE^ TM@AOOMLNH^IALP

Tm`aoomlnhtial 4. Il jmlmrhc, avmrsijft om`fhlisos ear JAEstunims ae `al`mrl sfaucn dm il`arparhtmn ilta mxistilj paci`yerhomwargs. ̂ fm risgs hssa`ihtmn witf saom JAE stunims ae `al`mrl`hl dm inmltieimn hln hnmquhtmcy ohlhjmn dy mxistilj paci`y

erhomwargs ie tfasm paci`ims hrm iopcmomltmn prapmrcy. Fawmvmr,tfm cmvmc ae avmrsijft pravinmn dy mxistilj erhomwargs vhrims dyphtfajml. Ear saom phtfajmls, mxistilj avmrsijft erhomwargs hrmradust hln hnnitialhc avmrsijft om`fhlisos sfaucn jmlmrhccy lat dm

rmquirmn. Ear atfmr phtfajmls, mxistilj avmrsijft erhomwargs hrmcmss radust hln ohy rmquirm suppcmomlthtial. Hcc rmcmvhlt paci`imssfaucn dm iopcmomltmn hppraprihtmcy hln mlfhl`mn wfmllm`msshry ta meem`tivmcy ohlhjm risgs.

8:

8/19/2019 NSABB Report: Preliminary Findings and Draft Recommendations about GOF Research (Samuel Stanley)

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LPHDD NTHE^ TM@AOOMLNH^IALP

Tm`aoomlnhtial 0. ^fm risg-dmlmeit praeicm ear JAE stunims ae`al`mrl ohy `fhljm avmr tiom hln sfaucn dm rm-mvhcuhtmnpmriani`hccy ta mlsurm tfht tfm risgs hssa`ihtmn witf su`f rmsmhr`f is

hnmquhtmcy ohlhjmn hln tfm dmlmeits hrm dmilj rmhcizmn.

Tm`aoomlnhtial >. ^fm ].P. javmrlomlt sfaucn `altilum meeartsta strmljtfml diashemty hln diasm`urity, wfi`f wicc eastmr h `ucturm ae

rmspalsidicity tfht wicc suppart lat alcy tfm shem `alnu`t ae JAEstunims ae `al`mrl dut ae hcc rmsmhr`f ilvacvilj phtfajmls.

86

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X]MP^IALP EAT E]T^FMT@ALPINMTH^IAL

8. Faw wmcc nams tfm LPHDD’s wargilj phpmr inmltiey tfm JAE stunimsae jrmhtmst `al`mrl1

4. ^fis wargilj phpmr jmlmrhccy pasits tfht tfm risgs hssa`ihtmn witfJAE stunims, il`cunilj JAE stunims ae `al`mrl, `hl dm hnmquhtmcy

ohlhjmn ulnmr `urrmlt paci`y erhomwargs. Hrm tfmrm JAE stunimstfht sfaucn rmquirm hl hnnitialhc cmvmc ae rmvimw ar avmrsijft1 Ie sa,

 wfy1 Zfht sfaucn tfht avmrsijft mlthic1 Pfaucn tfht avmrsijft a``urht tfm emnmrhc ar ilstitutialhc cmvmc, ar datf1 Ear wfht phtfajmls hrm`urrmlt paci`y erhomwargs hnmquhtm ta hnnrmss JAE rmsmhr`f1 Ear

 wfht phtfajmls hrm `urrmlt paci`y erhomwargs ilhnmquhtm, rmquiriljsuppcmomlthtial ta hnnrmss JAE rmsmhr`f1

0.  Zaucn h EH@H `aooittmm dm h nmsirhdcm om`fhliso ear rmvimwilj

prapashcs ilvacvilj JAE rmsmhr`f ae `al`mrl ar `hl su`f rmvimws dm

h``aopcisfmn dy Emnmrhc hjml`ims witfil tfm javmrlomlt1

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>. Hrm tfmrm JAE stunims tfht sfaucn lat dm `alnu`tmn1 Ie sa, wfi`fstunims hln wfy1

=. Faw wmcc waucn tfm wargilj jraup’s nms`riptial ae JAE stunims ae`al`mrl hln tfm pril`ipcms ear juinilj tfmir rmvimw ilearo nm`isials

hdaut wfmtfmr ta euln su`f stunims1

5. Hrm tfmrm spm`iei` risg oitijhtial omhsurms tfht sfaucn dm rmquirmnil arnmr ear `mrthil JAE stunims ta dm shemcy `alnu`tmn1

:. Faw wmcc nams tfis wargilj phpmr hnnrmss aljailj avmrsijft ae JAEstunims ae `al`mrl1 Hrm hnnitialhc pril`ipcms ar avmrsijft taacslmmnmn1

42

@aoomlts ta; lshddBan.lif.jav

X]MP^IALP EAT E]T^FMT@ALPINMTH^IAL