IRB-004B 6/08

Proposal ID No.:_____________ ( Assigned by IRB !"#N$DD-%$R&# &'(($!$

!)ynedd *alley+ Pennsyl,ania

Request for Expedited Review Da-e s.b/i--ed:_____________________ 0. 1i-le o2 Resear34 Proposal: In2or/a-ion and De3ision %a5ing 6. Prin3ipal In,es-iga-or: 7a3.l-y Ad,isor (i2 s-.den- proposal :

8-ep4anie 8.ggs 8.ggs.s9g/3.ed.

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Rebe33a !.llan+ P4.D g.llan.r9g/3.ed.

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&er-ain -ypes o2 resear34 /ay be re,ie)ed and appro,ed -4ro.g4 an e:pedi-ed pro3ess. 14e pri/ary 3ri-erion 2or e:pedi-ed re,ie) is -4a- -4e resear34 be o2 /ini/al ris5 -o 4./an s.b;e3-s. In addi-ion+ -4e p.rpose o2 -4e resear34 /.s- 2i- )i-4in a se- o2 3a-egories s-ip.la-ed by 7DA and D<<8 reg.la-ions. $:pedi-ed re,ie) re2ers -o a re,ie) /e-4od ra-4er -4an -o an abbre,ia-ed or si/pli2ied pro-o3ol s.b/ission. 14e 2irs- s-ep in re=.es-ing an e:pedi-ed re,ie) is -o 3o/ple-e -4e pro-o3ol appli3a-ion in 2.ll. In addi-ion+ -4e resear34er /.s- s.b/i- -4is 2or/. Dire3-ions: De-ails o2 -4e Resear34 Design /.s- indi3a-e -4a- -4e resear34 2.l2ills bo-4 re=.ire/en-s A and B and one o2 -4e 3a-egories .nder &. Please re,ie) A+ B+ and & belo) and indi3a-e by /eans o2 a 34e35 /ar5 -4a- -4e resear34 /ee-s -4e 3ri-eria:

A. 14is resear34 a3-i,i-y poses no grea-er -4a- /ini/al ris5 -o s.b;e3-s> and B. 14e iden-i2i3a-ion o2 s.b;e3-s and/or -4eir responses )o.ld no- ne3essarily pla3e -4e s.b;e3- a- ris5 o2 3ri/inal or 3i,il liabili-y or be da/aging -o -4e s.b;e3-?s 2inan3ial s-anding+ e/ployabili-y+ ins.rabili-y+ rep.-a-ion+ or be s-ig/a-i@ing+ .nless reasonable and appropria-e pro-e3-ions )ill be i/ple/en-ed so -4a- -4e ris5s rela-ed -o in,asion o2 pri,a3y and brea34 o2 3on2iden-iali-y are no- grea-er -4a- /ini/al> and &. 14e pro;e3- 2alls .nder one or /ore o2 -4e e:pedi-ed 3a-egories belo). Please 34e35 all -4a- apply. &a-egory 0. &lini3al s-.dies o2 dr.gs and /edi3al de,i3es only )4en 3ondi-ion (A or (B is /e-.
a. Resear34 on dr.gs 2or )4i34 an in,es-iga-ional ne) dr.g appli3a-ion is no- re=.ired. b. Resear34 on /ar5e-ed dr.gs -4a- signi2i3an-ly in3reases -4e ris5s or de3reases -4e a33ep-abili-y o2 ris5s asso3ia-ed )i-4 -4e pro;e3- is no- eligible 2or e:pedi-ed re,ie). 3. Resear34 on /edi3al de,i3es 2or )4i34 an in,es-iga-ional de,i3e e:e/p-ion is no- re=.ired+ or -4e /edi3al de,i3e is 3leared/appro,ed 2or /ar5e-ing and -4e /edi3al de,i3e is being .sed in a33ordan3e )i-4 i-s 3leared/appro,ed labeling.

&a-egory 6. &olle3-ion o2 blood sa/ples by 2inger s-i35+ 4eel s-i35+ ear s-i35+ or ,enip.n3-.re as 2ollo)s:
a. 2ro/ 4eal-4y+ non-pregnan- ad.l-s )4o )eig4 a- leas- 000 po.nds. 7or -4ese s.b;e3-s -4e a/o.n- dra)n /ay no- e:3eed AA0 /l. in an 8 )ee5 period and 3olle3-ion /ay no- o33.r /ore 2re=.en-ly -4an 6 -i/es per )ee5> or b. 2ro/ o-4er ad.l-s and 34ildren+ 3onsidering -4e age+ )eig4-+ and 4eal-4 o2 -4e s.b;e3-s+ -4e 3olle3-ion pro3ed.re+ -4e a/o.n- o2 blood -o be 3olle3-ed+ and -4e 2re=.en3y )i-4 )4i34 i- )ill

IRB-004B 6/08 be 3olle3-ed. 7or -4ese s.b;e3-s+ -4e a/o.n- dra)n /ay no- e:3eed -4e lesser o2 A0 /l. or B/l. per 5g. in an 8 )ee5 period+ and 3olle3-ion /ay no- o33.r /ore 2re=.en-ly -4an 6 -i/es per )ee5.

&a-egory B. Prospe3-i,e 3olle3-ion o2 biologi3al spe3i/ens 2or resear34 p.rposes by nonin,asi,e /eans.
$:a/ples: a 4air and nail 3lippings in a non-dis2ig.ring /anner> b de3id.o.s -ee-4 a- -i/e o2 e:2olia-ion or i2 ro.-ine pa-ien- 3are indi3a-es a need 2or e:-ra3-ion> 3 per/anen- -ee-4 i2 ro.-ine pa-ien- 3are indi3a-es a need 2or e:-ra3-ion> d e:3re-a and e:-ernal se3re-ions (in3l.ding s)ea- > e .n3ann.la-ed sali,a 3olle3-ed ei-4er in an .ns-i/.la-ed 2as4ion or s-i/.la-ed by 34e)ing g./ base or )a: or by applying a dil.-e 3i-ri3 sol.-ion -o -4e -ong.e> 2 pla3en-a re/o,ed a- deli,ery> g a/nio-i3 2l.id ob-ained a- -4e -i/e o2 r.p-.re o2 -4e /e/brane prior -o or d.ring labor> 4 s.pra- and s.bgingi,al den-al pla=.e and 3al3.l.s+ pro,ided -4e 3olle3-ion pro3ed.re is no- /ore in,asi,e -4an ro.-ine prop4yla3-i3 s3aling o2 -4e -ee-4 and -4e pro3ess is a33o/plis4ed in a33ordan3e )i-4 a33ep-ed prop4yla3-i3 -e34ni=.es> i /.3osal and s5in 3ells 3olle3-ed by b.33al s3raping or s)ab+ s5in s)ab+ or /o.-4 )as4ings> ; sp.-./ 3olle3-ed a2-er saline /is- neb.li@a-ion.

&a-egory 4. &olle3-ion o2 da-a -4ro.g4 nonin,asi,e pro3ed.res (no- in,ol,ing general anes-4esia or seda-ion ro.-inely e/ployed in 3lini3al pra3-i3e+ e:3l.ding pro3ed.res in,ol,ing :rays or /i3ro)a,es. "4ere /edi3al de,i3es are e/ployed+ -4ey /.s- be 3leared/appro,ed 2or /ar5e-ing. (8-.dies in-ended -o e,al.a-e -4e sa2e-y and e22e3-i,eness o2 -4e /edi3al de,i3e are no- generally eligible 2or e:pedi-ed re,ie)+ in3l.ding s-.dies o2 3leared /edi3al de,i3es 2or ne) indi3a-ions.
$:a/ples: a p4ysi3al sensors -4a- are applied ei-4er -o -4e s.r2a3e o2 -4e body or a- a dis-an3e and do no- in,ol,e inp.- o2 signi2i3an- a/o.n-s o2 energy in-o -4e s.b;e3- or an in,asion o2 -4e s.b;e3-?s pri,a3y> b )eig4ing or -es-ing sensory a3.i-y> 3 /agne-i3 resonan3e i/aging> d ele3-ro3ardiograp4y+ .l-raso.nd+ diagnos-i3 in2rared i/aging+ Doppler blood 2lo)+ and e34o3ardiograp4y> e /odera-e e:er3ise+ /.s3.lar s-reng-4 -es-ing+ body 3o/posi-ion assess/en-+ and 2le:ibili-y -es-ing )4ere appropria-e gi,e -4e age+ )eig4-+ and 4eal-4 o2 -4e indi,id.al. ( No-e: %RI in,ol,ing in-rod.3-ion o2 a 3on-ras- /edi./ or dye is no- eligible 2or e:pedi-ed re,ie).

&a-egory A. Resear34 in,ol,ing /a-erials (da-a+ do3./en-s+ re3ords+ or spe3i/ens -4a- 4a,e been 3olle3-ed+ or )ill be 3olle3-ed solely 2or non-resear34 p.rposes (s.34 as /edi3al -rea-/en- or diagnosis . (No-e: 8o/e resear34 in -4is 3a-egory /ay be e:e/p2ro/ -4e D<<8 reg.la-ions 2or -4e pro-e3-ion o2 4./an s.b;e3-s.

&a-egory 6. &olle3-ion o2 da-a 2ro/ ,oi3e+ ,ideo+ digi-al+ or i/age re3ordings /ade 2or resear34 p.rposes. &a-egory C. Resear34 on indi,id.al or gro.p 34ara3-eris-i3s or be4a,ior (in3l.ding b.- no- li/i-ed -o resear34 on per3ep-ion+ 3ogni-ion+ /o-i,a-ion+ iden-i-y+ lang.age+ 3o//.ni3a-ion+ 3.l-.ral belie2s or pra3-i3es+ and so3ial be4a,ior or resear34 e/ploying s.r,ey+ in-er,ie)+ oral 4is-ory+ 2o3.s gro.p+ progra/ e,al.a-ion+ 4./an 2a3-ors e,al.a-ion+ or =.ali-y ass.ran3e /e-4odologies. (No-e: 8o/e resear34 in -4is
3a-egory /ay be e:e/p- 2ro/ D<<8 reg.la-ions 2or -4e pro-e3-ion o2 4./an s.b;e3-s.

&a-egory 8. Resear34 in,ol,es 3on-in.ing re,ie) o2 resear34 pre,io.sly appro,ed by -4e IRB )4ere no ne) s.b;e3-s are enrolled+ all resear34-rela-ed in-er,en-ions 4a,e been 3o/ple-ed+ and -4e resear34 re/ains a3-i,e only 2or -4e long--er/ 2ollo) .p o2 s.b;e3-s or -4e re/aining resear34 a3-i,i-ies are li/i-ed -o da-a analysis &a-egory D. Resear34 in,ol,es /inor 34anges -o pre,io.sly appro,ed resear34 d.ring -4e 06 /on-4 period 2or )4i34 appro,al is a.-4ori@ed. A %inor 34ange is de2ined as a 34ange -4a- does no- a22e3- ris5 and bene2i-s.

IRB-004B 6/08

Please re,ie) -4e 2ollo)ing s-a-e/en-s and indi3a-e -4a- yo. 4a,e read -4e/ by signing belo): A. I .nders-and -4a- -4e resear34 pro;e3- /ay no- be ini-ia-ed .n-il e:pedi-ed re,ie) is 3o/ple-ed and )ri--en per/ission is re3ei,ed 2ro/ -4e IRB. B. I2 -4is resear34 proposal 34anges in s.34 a )ay -4a- i- no longer 3on2or/s -o -4e 3ri-eria 2or e:pedi-ed re,ie)+ a ne) re=.es- 2or a 2.ll re,ie) )ill be s.b/i--ed. &. I2 an e:pedi-ed re,ie) is no- appro,ed+ -4e proposal )ill be s.b;e3- -o a 2.ll re,ie). 14e in,es-iga-or )ill se3.re )ri--en appro,al 2ro/ -4e IRB prior -o ini-ia-ing -4e resear34 pro;e3-. ___________________________________ 8igna-.re o2 Prin3ipal In,es-iga-or ___________________________________ Da-e _____________________________________ 8igna-.re o2 7a3.l-y Ad,isor (i2 s-.den- proposal ________________________ Da-e