2015 INTEL ISEF Rules and Guidelines (2)

7/25/2019 2015 INTEL ISEF Rules and Guidelines (2)

1/67

INTERNATIONALINTERNATIONAL

SCIENCE ANDSCIENCE AND

ENGINEERING FAIRENGINEERING FAIR

Rules andRules and

GuidelinesGuidelines

2015


2/67

Adult roles andAdult roles and

responsibilitiesresponsibilities

Adult SponsorAdult Sponsor

uali!ed S"ientistuali!ed S"ientist

Desi#nated Super$isorDesi#nated Super$isor

Institutional Re$ie% &oard 'IR&(Institutional Re$ie% &oard 'IR&(

S"ienti!" Re$ie% Co))itteeS"ienti!" Re$ie% Co))ittee'SRC('SRC(


3/67

AdultAdult sponsorsponsor

O$ersees pro*e"t to )a+e sure t,atO$ersees pro*e"t to )a+e sure t,at

studentstudent

is in-or)ed o- ISEF Rules and Guidelinesis in-or)ed o- ISEF Rules and Guidelines is a%are o- ris+s asso"iated %it, pro*e"tis a%are o- ris+s asso"iated %it, pro*e"t

is a%are o- -or)s re.uired -or pro*e"tis a%are o- -or)s re.uired -or pro*e"t

%ill pro$ide proper super$ision durin#%ill pro$ide proper super$ision durin#

e/peri)entatione/peri)entation i- re.uired sub)its pro*e"t to IR& or SRCi- re.uired sub)its pro*e"t to IR& or SRC

Tea",er usuall ser$es as Adult SponsorTea",er usuall ser$es as Adult Sponsor


4/67

uali!ed S"ientistuali!ed S"ientist

Re.uired -orRe.uired -or so)eso)epro*e"tspro*e"ts

S,ould ,a$e a do"toralpro-essionalS,ould ,a$e a do"toralpro-essional

de#ree related to student resear",de#ree related to student resear",OrOr

3a$e appli"able e/perien"e and3a$e appli"able e/perien"e and

e/pertise %it, re$ie% and appro$ale/pertise %it, re$ie% and appro$alb t,e SRCb t,e SRC

Co)pletes For) 2 4 S For)Co)pletes For) 2 4 S For)


5/67


Ani)al Care Super$isor -or $ertebrateAni)al Care Super$isor -or $ertebrate

ani)al pro*e"tsani)al pro*e"ts

Super$ises pro*e"ts in$ol$in#Super$ises pro*e"ts in$ol$in#,aardous ",e)i"als a"ti$ities or,aardous ",e)i"als a"ti$ities or

de$i"esde$i"es

Super$ises pro*e"ts re.uirin# aSuper$ises pro*e"ts re.uirin# a

uali!ed S"ientist %,en t,e uali!eduali!ed S"ientist %,en t,e uali!ed

S"ientist "annot dire"tl super$ise t,eS"ientist "annot dire"tl super$ise t,e

studentstudent


6/67


7/67

IR&IR& 'Institutional Re$ie%'Institutional Re$ie%

&oard(&oard( Re$ie%s ,u)an parti"ipants studiesRe$ie%s ,u)an parti"ipants studies 6e)bers,ip )ust in"lude76e)bers,ip )ust in"lude7

an edu"atoran edu"ator a s",ool ad)inistratora s",ool ad)inistrator so)eone +no%led#eable aboutso)eone +no%led#eable about

e$aluatin# p,si"al andore$aluatin# p,si"al andor

ps",olo#i"al ris+7 6D 8A RNps",olo#i"al ris+7 6D 8A RNps",olo#ist li"ensed so"ial %or+er orps",olo#ist li"ensed so"ial %or+er orli"ensed "lini"al pro-essional "ounselorli"ensed "lini"al pro-essional "ounselor


8/67

SRCSRC 'S"ienti!" Re$ie%'S"ienti!" Re$ie%

Co))itteeCo))ittee(( Re$ie%sRe$ie%s so)eso)epro*e"ts be-orepro*e"ts be-ore

e/peri)entatione/peri)entation

Re$ie%sRe$ie%s allallpro*e"ts *ust prior topro*e"ts *ust prior to"o)petition"o)petition

6e)bers,ip )ust in"lude76e)bers,ip )ust in"lude7 a bio)edi"al s"ientist '8,9D9 69D9a bio)edi"al s"ientist '8,9D9 69D9

D9:969 D9D9S9 8,ar)D9 D9O9(D9:969 D9D9S9 8,ar)D9 D9O9( an edu"atoran edu"ator one ot,er )e)berone ot,er )e)ber


9/67

Co)bined IR&SRCCo)bined IR&SRC

a bio)edi"al s"ientist '8,9D9 69D9a bio)edi"al s"ientist '8,9D9 69D9D9:969 D9D9S9 8,ar)D9 D9O9(D9:969 D9D9S9 8,ar)D9 D9O9(

a s",ool ad)inistratora s",ool ad)inistrator an edu"atoran edu"ator so)eone +no%led#eable aboutso)eone +no%led#eable about

e$aluatin# p,si"al andore$aluatin# p,si"al andor

ps",olo#i"al ris+7 6D 8A RNps",olo#i"al ris+7 6D 8A RNps",olo#ist li"ensed so"ial %or+erps",olo#ist li"ensed so"ial %or+eror li"ensed "lini"al pro-essionalor li"ensed "lini"al pro-essional"ounselor"ounselor


10/67

For)s re.uired -or allFor)s re.uired -or all

pro*e"tspro*e"ts


11/67


12/67


13/67

Resear", 8lan8ro*e"tResear", 8lan8ro*e"t

Su))arSu))ar Re.uired -or all pro*e"tsRe.uired -or all pro*e"ts

S,ould in"orporate all o- t,eS,ould in"orporate all o- t,e

rele$ant topi"s listed in t,erele$ant topi"s listed in t,e

Instru"tionsInstru"tions

S,ould su))arie %,at %asS,ould su))arie %,at %as

a"tuall done in t,e pro*e"ta"tuall done in t,e pro*e"t


14/67


15/67


16/67

Studies "ondu"ted at aStudies "ondu"ted at a

resear", institutionresear", institution

industrial settin# or anindustrial settin# or an%or+ site ot,er t,an ,o)e%or+ site ot,er t,an ,o)e

s",ool or !eld re.uire For)s",ool or !eld re.uire For)

1C1C


17/67


18/67

ContinuationResear",ContinuationResear",

8ro#ression Studies8ro#ression Studies 8ro*e"t based on prior resear", in8ro*e"t based on prior resear", in

t,e sa)e !eld o- studt,e sa)e !eld o- stud

Lon#itudinal studies areLon#itudinal studies areper)ittedper)itted 6ulti;ear stud6ulti;ear stud

Studies ti)e;based ",an#eStudies ti)e;based ",an#e

Re.uire -or)


19/67


20/67

3=6AN 8ARTICI8ANTS3=6AN 8ARTICI8ANTS


21/67

>,at are ,u)an>,at are ,u)an

parti"ipants studies?parti"ipants studies?3u)an parti"ipants studies in$ol$e3u)an parti"ipants studies in$ol$e

li$in# indi$iduals %,ere t,ere isli$in# indi$iduals %,ere t,ere is

Inter$ention or intera"tion %it,Inter$ention or intera"tion %it,

parti"ipantsparti"ipants

and/orand/or Colle"tion o- identi!able pri$ateColle"tion o- identi!able pri$ate

in-or)ationin-or)ation


22/67

E/e)ptE/e)ptstudies 4 do notstudies 4 do not

re.uire IR& re$ie% norre.uire IR& re$ie% nor

,u)an parti"ipants -or)s,u)an parti"ipants -or)sTestin# o- a student in$entionTestin# o- a student in$ention

pro#ra) "on"ept et"9pro#ra) "on"ept et"9 Student resear",er is onl one doin# t,eStudent resear",er is onl one doin# t,e

testin#testin#

No ,ealt, ,aardsNo ,ealt, ,aards

No personal data "olle"tedNo personal data "olle"ted

Feedba"+ dire"tl related to produ"tFeedba"+ dire"tl related to produ"t

Studies usin# pre;e/istin# publi"lStudies usin# pre;e/istin# publi"l

a$ailable ,u)an dataa$ailable ,u)an data


23/67

Additional e/e)pt studiesAdditional e/e)pt studies

&e,a$ioral obser$ations in&e,a$ioral obser$ations in

unrestri"ted publi" settin#sunrestri"ted publi" settin#s No intera"tionNo intera"tion

No )anipulation o- en$iron)entNo )anipulation o- en$iron)ent

No re"ordin# o- an personalNo re"ordin# o- an personalidenti!ersidenti!ers

Studies usin# "erti!ed de;Studies usin# "erti!ed de;

identi!ed anon)ous dataidenti!ed anon)ous data


24/67

3u)an parti"ipants3u)an parti"ipants

resear",resear",T,e IR& )ust re$ie% and appro$eT,e IR& )ust re$ie% and appro$et,e resear", plant,e resear", plan be-orebe-oree/peri)entation be#inse/peri)entation be#ins

Resear", parti"ipants 1@ ears o-Resear", parti"ipants 1@ ears o-a#e or older )ust #i$ea#e or older )ust #i$e informedinformedconsentconsent

Resear", parti"ipants under 1@Resear", parti"ipants under 1@)ust #i$e)ust #i$e assentassentand t,eirand t,eirparents )a be re.uired to #i$eparents )a be re.uired to #i$ewritten permissionwritten permission


25/67

3u)an3u)an parti"ipants resear",parti"ipants resear",

"ontd"ontdT,e IR& e$aluates t,e pro*e"t andT,e IR& e$aluates t,e pro*e"t and

deter)inesdeter)ines Ris+ le$elRis+ le$el Re.uire)ent -or uali!ed S"ientistRe.uire)ent -or uali!ed S"ientist

Re.uire)ent -or %ritten in-or)edRe.uire)ent -or %ritten in-or)ed

"onsentassentparental per)ission"onsentassentparental per)ission


26/67

Ris+ e$aluationRis+ e$aluation

No )ore t,an )ini)al ris+No )ore t,an )ini)al ris+Anti"ipated ,ar) and dis"o)-ort notAnti"ipated ,ar) and dis"o)-ort not

#reater t,an en"ountered in dail li-e#reater t,an en"ountered in dail li-e

6ore t,an )ini)al ris+6ore t,an )ini)al ris+Anti"ipated ,ar) or dis"o)-ort isAnti"ipated ,ar) or dis"o)-ort is

#reater t,an en"ountered in dail li-e#reater t,an en"ountered in dail li-e

6ore t,an )ini)al ris+ studies s,ould6ore t,an )ini)al ris+ studies s,ould

re.uirere.uire %ritten%ritten"onsentassent and"onsentassent andparental per)ission9 Final deter)inationparental per)ission9 Final deter)ination-or t,is re.uire)ent )ade b t,e IR&-or t,is re.uire)ent )ade b t,e IR&


27/67

Tpes o- Ris+Tpes o- Ris+

8,si"al ris+s8,si"al ris+s E/er"iseE/er"ise

In#estion tastin# s)ellin# appli"ation o-In#estion tastin# s)ellin# appli"ation o-

substan"essubstan"es E/posure to potentiall ,aardous )aterialE/posure to potentiall ,aardous )aterial

8s",olo#i"al ris+s8s",olo#i"al ris+s

In$asion o- pri$a"In$asion o- pri$a" 8arti"ipant is a )e)ber o- an at;8arti"ipant is a )e)ber o- an at;

ris+ #roupris+ #roup


28/67

E/pedited Re$ie%E/pedited Re$ie%

IR& )a ele"t to do an e/peditedIR& )a ele"t to do an e/pedited

'one )e)ber( re$ie%'one )e)ber( re$ie%

Can onl be used -or pro*e"ts %,ereCan onl be used -or pro*e"ts %,ere 3u)an parti"ipants test t,e -un"tionalit o- a3u)an parti"ipants test t,e -un"tionalit o- astudent;desi#ned in$ention pro#ra) et"9student;desi#ned in$ention pro#ra) et"9

%it, no ,ealt, o- sa-et ,aards%it, no ,ealt, o- sa-et ,aards

T,e student resear",er is t,e onl sub*e"t o-T,e student resear",er is t,e onl sub*e"t o-

t,e resear", t,at in$ol$es no )ore t,ant,e resear", t,at in$ol$es no )ore t,an

)ini)al ris+)ini)al ris+


29/67

IR& de"isions areIR& de"isions aredo"u)ented on For) Bdo"u)ented on For) B


30/67


31/67

I- IR& deter)ines t,at %rittenin-or)ed "onsentassent or

parental per)ission isre.uired do"u)entation isobtained on an in-or)ed

"onsent do"u)ent


32/67


33/67

:ERTE&RATE ANI6ALS:ERTE&RATE ANI6ALS


34/67

>,at is a $ertebrate>,at is a $ertebrate

ani)al?ani)al? Li$e non,u)an $ertebrateLi$e non,u)an $ertebrate

)a))alian e)bros or -etuses)a))alian e)bros or -etuses

&ird and reptile e##s %it,in das&ird and reptile e##s %it,in daso- ,at",in#o- ,at",in#

All ot,er non,u)an $ertebratesAll ot,er non,u)an $ertebrates'in"ludin# !s,( at ,at",in# or birt,'in"ludin# !s,( at ,at",in# or birt,

ebra!s, e)bros < das '1@ebra!s, e)bros < das '1@,ours( post -ertiliation,ours( post -ertiliation


35/67

8ro,ibited studies8ro,ibited studies

Indu"ed to/i"it studies in$ol$in#Indu"ed to/i"it studies in$ol$in#+no%n to/i" substan"es t,at "ould+no%n to/i" substan"es t,at "ouldi)pair ,ealt, or destro li-ei)pair ,ealt, or destro li-e

&e,a$ioral e/peri)ents %it,&e,a$ioral e/peri)ents %it, Conditionin# usin# a$ersi$e sti)uliConditionin# usin# a$ersi$e sti)uli 6ot,erin-ant separation6ot,erin-ant separation Indu"edlearned ,elplessnessIndu"edlearned ,elplessness

Studies o- painStudies o- pain 8redator$ertebrate pre8redator$ertebrate pre

e/peri)entse/peri)ents


36/67

No $ertebrate ani)al deat,s dueNo $ertebrate ani)al deat,s due

to t,e e/peri)ental pro"eduresto t,e e/peri)ental pro"edures

are per)ittedare per)itted Studies desi#ned or anti"ipatedStudies desi#ned or anti"ipatedto "ause $ertebrate ani)al deat,to "ause $ertebrate ani)al deat,are pro,ibited9are pro,ibited9

An deat,s )ust be in$esti#atedAn deat,s )ust be in$esti#atedb a .uali!ed indi$idualb a .uali!ed indi$idual

I- deat, %as t,e result o-I- deat, %as t,e result o-

e/peri)ental pro"edure t,ee/peri)ental pro"edure t,estud )ust be ter)inated andstud )ust be ter)inated andt,e stud %ill not .uali- -ort,e stud %ill not .uali- -or"o)petition9"o)petition9

& , i l b i -


37/67

&e,a$ioral obser$ations o-&e,a$ioral obser$ations o-

ani)als are e/e)pt -ro) SRCani)als are e/e)pt -ro) SRC

re$ie% i-re$ie% i-T,ere is no intera"tion %it, t,eT,ere is no intera"tion %it, t,e

ani)alsani)als

andandT,ere is no )anipulation o- t,eT,ere is no )anipulation o- t,e

en$iron)enten$iron)ent

andand All -ederal or state !s, #a)e andAll -ederal or state !s, #a)e and

%ildli-e re#ulations are -ollo%ed%ildli-e re#ulations are -ollo%ed


38/67

Resear", sitesResear", sites

S",ool3o)eFieldS",ool3o)eField

Re#ulated Resear", InstitutionRe#ulated Resear", Institution'')ust)ust,a$e an IAC=C re$ie% and appro$al,a$e an IAC=C re$ie% and appro$alpro"ess(pro"ess(

=ni$ersities=ni$ersities

Go$ern)ent resear", a#en"iesGo$ern)ent resear", a#en"ies

8ri$ate resear", laboratories8ri$ate resear", laboratories


39/67

Re.uire)ents -or studies atRe.uire)ents -or studies at

s",ool,o)e!elds",ool,o)e!eld A#ri"ultural be,a$ioral obser$ational orA#ri"ultural be,a$ioral obser$ational or

supple)ental nutritional studiessupple)ental nutritional studiesandand

Non;in$asi$e and non;intrusi$e %it, no ne#ati$eNon;in$asi$e and non;intrusi$e %it, no ne#ati$eeHe"t on ani)als ,ealt, or %ell;bein#eHe"t on ani)als ,ealt, or %ell;bein#

andand

Re.uire SRC pre;re$ie% and appro$alRe.uire SRC pre;re$ie% and appro$al


40/67


41/67



42/67


re#ulated resear",re#ulated resear",

institutionsinstitutions 6ust be appro$ed b IAC=C6ust be appro$ed b IAC=C

'Institutional Ani)al Care and =se'Institutional Ani)al Care and =se

Co))ittee(Co))ittee( Lo"al SRC s,ould re$ie% pro*e"t be-oreLo"al SRC s,ould re$ie% pro*e"t be-ore

e/peri)entatione/peri)entation

E/peri)entation )ust -ollo% ISEF rulesE/peri)entation )ust -ollo% ISEF rules

S "o)pletes For) 5& %,i", in"ludesS "o)pletes For) 5& %,i", in"ludes

do"u)entation o- IAC=C appro$aldo"u)entation o- IAC=C appro$al


43/67


44/67

8OTENTIALL 3AARDO=S8OTENTIALL 3AARDO=S

&IOLOGICAL AGENTS&IOLOGICAL AGENTS


45/67

8otentiall ,aardous8otentiall ,aardous

biolo#i"al a#ents in"ludebiolo#i"al a#ents in"lude 6i"roor#anis)s 'in"ludin#6i"roor#anis)s 'in"ludin#

ba"teria $iruses -un#i et"9(ba"teria $iruses -un#i et"9(

Re"o)binant DNARe"o)binant DNA 3u)an or ani)al -res,-roen3u)an or ani)al -res,-roen

tissues blood or bod Juidstissues blood or bod Juids

All studies in$ol$in#All studies in$ol$in#


46/67

All studies in$ol$in#All studies in$ol$in#

potentiall ,aardouspotentiall ,aardous

biolo#i"al a#entsbiolo#i"al a#ents Studies )ust ,a$e prior appro$al bStudies )ust ,a$e prior appro$al b

SRCIAC=CI&CSRCIAC=CI&C

6ost studies are pro,ibited in a ,o)e6ost studies are pro,ibited in a ,o)een$iron)enten$iron)ent Studies intended to #eneti"allStudies intended to #eneti"all

en#ineer ba"teria %it, )ultipleen#ineer ba"teria %it, )ultipleantibioti" resistan"e are pro,ibitedantibioti" resistan"e are pro,ibited

Lab studies utiliin# 6RSA :RE andLab studies utiliin# 6RSA :RE andK8C )ust be "ondu"ted in a Re#ulatedK8C )ust be "ondu"ted in a Re#ulatedResear", Institution under do"u)entedResear", Institution under do"u)entedI&C re$ie% and appro$al9 Students areI&C re$ie% and appro$al9 Students are

pro,ibited -ro) "ulturin# CRE9pro,ibited -ro) "ulturin# CRE9


47/67

Ris+ assess)entRis+ assess)ent

Re.uired o- all 83&A pro*e"tsRe.uired o- all 83&A pro*e"ts De!nes potential le$el o- ,ar)De!nes potential le$el o- ,ar)

in*ur or disease to plantsin*ur or disease to plants

ani)als or ,u)ansani)als or ,u)ans In$ol$esIn$ol$es

Assi#n)ent o- biolo#i"al a#ent toAssi#n)ent o- biolo#i"al a#ent toris+ #roupris+ #roup

Deter)ination o- le$el o- biolo#i"alDeter)ination o- le$el o- biolo#i"al"ontain)ent"ontain)ent

Assess)ent o- e/pertise o- adult's(Assess)ent o- e/pertise o- adult's( Assi#n)ent o- !nal biosa-et le$elAssi#n)ent o- !nal biosa-et le$el


48/67

Ris+ assess)ent "ontdRis+ assess)ent "ontd

&SL 1 studies "an usuall be "ondu"ted&SL 1 studies "an usuall be "ondu"ted

in a ,i#, s",ool or "olle#e tea",in#in a ,i#, s",ool or "olle#e tea",in#

laborator9laborator9

&SL 2 studies are usuall "ondu"ted in a&SL 2 studies are usuall "ondu"ted in are#ulated resear", institutionre#ulated resear", institution

&SL and &SL B studies are pro,ibited&SL and &SL B studies are pro,ibited

-or ISEF pro*e"ts-or ISEF pro*e"ts

For) A '8otentiall 3aardous &iolo#i"alFor) A '8otentiall 3aardous &iolo#i"alA#ents -or)( re.uired -or )ost pro*e"tsA#ents -or)( re.uired -or )ost pro*e"ts

in$ol$in# )i"roor#anis)s and -or allin$ol$in# )i"roor#anis)s and -or all

pro*e"ts in$ol$in# rDNA and -res, ,u)anpro*e"ts in$ol$in# rDNA and -res, ,u)an

and $ertebrate ani)al tissuesand $ertebrate ani)al tissues


49/67

Studies e/e)pt -ro) priortu es e/e)pt ro) pr or


50/67

Studies e/e)pt -ro) priortu es e/e)pt ro) pr orSRC re$ie% and noSRC re$ie% and no

additional 83&A -or)sadditional 83&A -or)sre.uiredre.uired

Studies usin# ba+ers and bre%ers east 'e/"eptStudies usin# ba+ers and bre%ers east 'e/"eptrDNA studies(rDNA studies(

Studies usin# La"toba"illus nitro#en;!/in#Studies usin# La"toba"illus nitro#en;!/in#ba"teria &9t,urin#inensis oil;eatin# ba"teria andba"teria &9t,urin#inensis oil;eatin# ba"teria andal#ae;eatin# ba"teria in natural en$iron)ent9 Notal#ae;eatin# ba"teria in natural en$iron)ent9 Note/e)pt i- "ultured in a petri dis, en$iron)ente/e)pt i- "ultured in a petri dis, en$iron)ent

Studies o- )old #ro%t, on -ood ite)s i-Studies o- )old #ro%t, on -ood ite)s i-

e/peri)ent ter)inated at !rst si#n o- )olde/peri)ent ter)inated at !rst si#n o- )old Studies in$ol$in# %ater or soil not "on"entrated inStudies in$ol$in# %ater or soil not "on"entrated in

)edia "ondu"i$e to #ro%t,)edia "ondu"i$e to #ro%t, Studies o- )us,roo)s and sli)e )oldStudies o- )us,roo)s and sli)e )old

Studies e/e)pt -ro) priorStudies e/e)pt -ro) prior


51/67

Studies e/e)pt -ro) priorStudies e/e)pt -ro) prior

SRC re$ie% t,at re.uireSRC re$ie% t,at re.uire

For) For) Studies in$ol$in# protists ar",ae and si)ilarStudies in$ol$in# protists ar",ae and si)ilar

)i"roor#anis)s)i"roor#anis)s

Resear", usin# )anure -or "o)postin# -uelResear", usin# )anure -or "o)postin# -uelprodu"tion or ot,er non;"ulturin#produ"tion or ot,er non;"ulturin#

e/peri)entse/peri)ents

Studies usin# "o))er"iall a$ailable "olorStudies usin# "o))er"iall a$ailable "olor

",an#e "oli-or) %ater test +its",an#e "oli-or) %ater test +its

Studies in$ol$in# de"o)position o-Studies in$ol$in# de"o)position o-

$ertebrate or#anis)s '-orensi" studies($ertebrate or#anis)s '-orensi" studies(

Studies %it, )i"robial -uel "ellsStudies %it, )i"robial -uel "ells

S di i l i +


52/67

Studies in$ol$in# un+no%Studies in$ol$in# un+no%

)i"roor#anis)s)i"roor#anis)s

&SL 1 i-&SL 1 i- Or#anis)s "ultured in plasti" petriOr#anis)s "ultured in plasti" petri

dis,dis, Culture dis, re)ains sealedCulture dis, re)ains sealed

t,rou#,out e/peri)entt,rou#,out e/peri)ent

Culture dis, disposed o- inCulture dis, disposed o- inappropriate )annerappropriate )anner

&SL 2 i- petri dis, is opened&SL 2 i- petri dis, is opened


53/67

rDNA te",nolo#iesrDNA te",nolo#ies

E/peri)ents %it,E/peri)ents %it, &SL 1&SL 1or#anis)s "an be done in &SL 1or#anis)s "an be done in &SL 1

lab %it, a S or trained DSlab %it, a S or trained DS E/peri)ents %it,E/peri)ents %it, &SL 2&SL 2

or#anis)s )ust be done in aor#anis)s )ust be done in a

re#ulated resear", institutionre#ulated resear", institution%it, a S%it, a S


54/67

TissuesTissues

I- ani)al is eut,anied solel -orI- ani)al is eut,anied solel -or

student pro*e"t 4 $ertebratestudent pro*e"t 4 $ertebrate

ani)al stud %,i", re.uiresani)al stud %,i", re.uiresIAC=C appro$alIAC=C appro$al

I- ani)al is eut,anied -or aI- ani)al is eut,anied -or a

purpose ot,er t,an studentpurpose ot,er t,an studentpro*e"t 4 tissue studpro*e"t 4 tissue stud


55/67

Classi!"ation as &SL 1 or 2 basedClassi!"ation as &SL 1 or 2 basedon sour"e o- tissue and possibiliton sour"e o- tissue and possibilit

o- "ontainin# in-e"tious a#entso- "ontainin# in-e"tious a#ents

All studies %it, ,u)an or %ildAll studies %it, ,u)an or %ildani)al blood are &SL 29 Studiesani)al blood are &SL 29 Studies

%it, do)esti" ani)al blood are%it, do)esti" ani)al blood are

&SL 19&SL 19

Studies %it, ,u)an bod JuidsStudies %it, ,u)an bod Juids

%,i", "an be asso"iated %it, a%,i", "an be asso"iated %it, a

person )ust ,a$e IR& appro$alperson )ust ,a$e IR& appro$al


56/67

E/e)pt as 83&A tissuesE/e)pt as 83&A tissues

8lant tissues8lant tissues 8lant and non;pri)ate establis,ed "ell8lant and non;pri)ate establis,ed "ell

and tissue "ulturesand tissue "ultures

Fres, or -roen )eat )eat b;produ"tsFres, or -roen )eat )eat b;produ"tspasteuried )il+ e##s 4 -ro) #ro"erpasteuried )il+ e##s 4 -ro) #ro"erstores restaurants pa"+in# ,ousesstores restaurants pa"+in# ,ouses

3air3air

Sterilied teet,Sterilied teet, Fossilied tissuear",eolo#i"al spe"i)ensFossilied tissuear",eolo#i"al spe"i)ens 8repared !/ed tissue slides8repared !/ed tissue slides


57/67

For) &For) &

Re.uired -or all pro*e"ts usin#Re.uired -or all pro*e"ts usin# Fres,-roen tissueFres,-roen tissue

8ri)ar "ell "ultures8ri)ar "ell "ultures 3u)an and ot,er pri)ate3u)an and ot,er pri)ate

establis,ed "ell lines and tissueestablis,ed "ell lines and tissue

"ultures"ultures

&lood and blood produ"ts&lood and blood produ"ts

&od Juids&od Juids


58/67


59/67

3AARDO=S C3E6ICALS3AARDO=S C3E6ICALS

ACTI:ITIES OR DE:ICESACTI:ITIES OR DE:ICES


60/67

3aardous ",e)i"als3aardous ",e)i"als

a"ti$ities or de$i"es in"ludea"ti$ities or de$i"es in"lude C,e)i"alsC,e)i"als

E.uip)entE.uip)ent

DEA;Controlled Substan"esDEA;Controlled Substan"es 8res"ription Dru#s8res"ription Dru#s

Al"o,ol and Toba""oAl"o,ol and Toba""o

Firear)s and E/plosi$esFirear)s and E/plosi$es

RadiationRadiation


61/67

General RulesGeneral Rules

Studies do not re.uire prior SRCStudies do not re.uire prior SRCre$ie% and appro$alre$ie% and appro$al

All studies re.uire a Ris+All studies re.uire a Ris+Assess)ent do"u)ented on For) Assess)ent do"u)ented on For) DEA ; "ontrolled substan"es re.uireDEA ; "ontrolled substan"es re.uire

a uali!ed S"ientista uali!ed S"ientist All ot,er studies re.uire aAll ot,er studies re.uire a



62/67

DEA;Controlled Substan"esDEA;Controlled Substan"es Consult DEA list o- "ontrolledConsult DEA list o- "ontrolled

substan"essubstan"es All studies re.uire uali!ed S"ientistAll studies re.uire uali!ed S"ientist

Controlled substan"es on S",edule 1Controlled substan"es on S",edule 1

re.uire DEA proto"ol re$ie%re.uire DEA proto"ol re$ie%

Firear)s and E/plosi$esFirear)s and E/plosi$es 6ust ad,ere to lo"al trainin# and6ust ad,ere to lo"al trainin# and

"erti!"ation re.uire)ents"erti!"ation re.uire)ents


63/67

Al"o,ol and Toba""oAl"o,ol and Toba""o

Students )ust ad,ere to =9S9 re#ulationsStudents )ust ad,ere to =9S9 re#ulations

as %ell as lo"al and "ountr la%sas %ell as lo"al and "ountr la%s

8rodu"tion o- %ine or beer b adults is8rodu"tion o- %ine or beer b adults is

allo%able9 8arents )ust dire"tlallo%able9 8arents )ust dire"tl

super$ise an student resear", in$ol$in#super$ise an student resear", in$ol$in#

le#al ,o)e produ"tionle#al ,o)e produ"tion

Al"o,ol distillation -or -uel produ"tion orAl"o,ol distillation -or -uel produ"tion or

ot,er non "onsu)able produ"ts an beot,er non "onsu)able produ"ts an be

"ondu"ted at s",ool %it, TT& per)it"ondu"ted at s",ool %it, TT& per)it

obtained b s",ool o"ialsobtained b s",ool o"ials


64/67

8res"ription Dru#s8res"ription Dru#s Cannot be ad)inistered to ,u)anCannot be ad)inistered to ,u)an

sub*e"tssub*e"ts

Ani)al ad)inistration )ust -ollo% ISEFAni)al ad)inistration )ust -ollo% ISEF

$ertebrate ani)al #uidelines$ertebrate ani)al #uidelines

3aardous C,e)i"als3aardous C,e)i"alsRe-er to 6SDS S,eets -or sa-et and disposalRe-er to 6SDS S,eets -or sa-et and disposal

in-or)ationin-or)ation

3aardous De$i"es3aardous De$i"es In$ol$e le$el o- ris+ beond t,atIn$ol$e le$el o- ris+ beond t,at

en"ountered in students e$erda li-een"ountered in students e$erda li-e

Follo% ,andlin# #uidelinesFollo% ,andlin# #uidelines


65/67

RadiationRadiation Studies usin# non;ioniin# radiation and studiesStudies usin# non;ioniin# radiation and studies

o- ioniin# radiation usin# $olta#e M 10 +$oltso- ioniin# radiation usin# $olta#e M 10 +$oltsre.uire a do"u)ented ris+ assess)ent on For) re.uire a do"u)ented ris+ assess)ent on For)

Studies o- ioniin# radiation usin# $olta#eStudies o- ioniin# radiation usin# $olta#e

bet%een 10 and 25 +$olts )ust be preappro$edbet%een 10 and 25 +$olts )ust be preappro$edb t,e SRC and ,a$e a do"u)ented ris+b t,e SRC and ,a$e a do"u)ented ris+

assess)entassess)ent

Studies o- ioniin# radiation usin# $olta#eStudies o- ioniin# radiation usin# $olta#e

e/"eedin# 25 +$olts )ust be "ondu"ted in a sitee/"eedin# 25 +$olts )ust be "ondu"ted in a site%it, a Li"ensed Radiation 8ro#ra) and%it, a Li"ensed Radiation 8ro#ra) and

preappro$ed b t,e institutionpreappro$ed b t,e institution


66/67

For) For)

Re.uired -or all pro*e"ts in$ol$in#Re.uired -or all pro*e"ts in$ol$in# DEA;Controlled Substan"esDEA;Controlled Substan"es

8res"ription Dru#s8res"ription Dru#s Al"o,ol and Toba""oAl"o,ol and Toba""o 3aardous C,e)i"als3aardous C,e)i"als 3aardous De$i"es3aardous De$i"es 3aardous A"ti$ities3aardous A"ti$ities RadiationRadiation


67/67

2015 INTEL ISEF Rules and Guidelines (2)

Documents