nsabb report: preliminary findings and draft recommendations about gof research (samuel stanley)
TRANSCRIPT
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8/19/2019 NSABB Report: Preliminary Findings and Draft Recommendations about GOF Research (Samuel Stanley)
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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
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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=)
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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
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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>
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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/
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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
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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
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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.
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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
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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>
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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.
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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
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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
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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.
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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.
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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
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@aoomlts ta; lshddBan.lif.jav
X]MP^IALP EAT E]T^FMT@ALPINMTH^IAL