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{\title                                                                                                                               }{\author Larry Niemoeller}{\operator Sandra A. Buckler}{\creatim\yr2006\mo1\dy26\hr10\min30}
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\ql \li0\ri0\nowidctlpar\faauto\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs16\insrsid2651942                                            
                                                                                                                                                                                        OMB No. 0990-0263
\par                                                                                                                                                                                                          Approved for use through }{
\fs16\insrsid15622052\charrsid15622052 11/30/2008}{\fs16\insrsid2651942 
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\par }\pard \qc \li0\ri0\nowidctlpar\intbl\faauto\rin0\lin0 {\b\f1\insrsid2651942 Protection of Human Subjects
\par Assurance Identification/IRB Certification/Declaration of Exemption}{\f1\insrsid2651942  
\par }\pard \qc \li0\ri0\sa58\nowidctlpar\intbl\faauto\rin0\lin0 {\b\f1\fs20\insrsid2651942 (Common Rule)}{\f1\insrsid2651942 \cell }\pard \ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\f1\insrsid2651942 \trowd \irow0\irowband0
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}\trowd \irow1\irowband1\lastrow \ts11\trgaph81\trleft90\trftsWidth1\trpaddl81\trpaddr81\trpaddfl3\trpaddfr3 \clvertalt\clbrdrt\brdrs\brdrw15\brdrcf1 \clbrdrl\brdrnone \clbrdrb\brdrs\brdrw15\brdrcf1 \clbrdrr\brdrnone 
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\par }\pard \qj \li0\ri0\sa58\nowidctlpar\intbl\faauto\rin0\lin0 {\i\f37\fs16\insrsid2651942 Policy}{\f37\fs16\insrsid2651942 
: Research activities involving human subjects may not be conducted or supported by the Departments and Agencies adopting the Common Rule (56FR28003, June
 18, 1991) unless the activities are exempt from or approved in accordance with the Common Rule. See section 101(b) of the Common Rule for exemptions. Institutions submitting applications or proposals for support must submit certification of appropriate I
nstitutional Review Board (IRB) review and approval to the Department or Agency in accordance with the Common Rule. \cell }\pard \ql \li0\ri0\sl-57\slmult0\nowidctlpar\intbl\faauto\rin0\lin0 {\f37\fs16\insrsid2651942 
\par }\pard \qj \li0\ri0\sa58\nowidctlpar\intbl\faauto\rin0\lin0 {\f37\fs16\insrsid2651942 Institutions must have an assurance of compliance that applies to the research to be conducted and should submit certification of IRB revie
w and approval with each application or proposal unless otherwise advised by the Department or Agency.}{\insrsid2651942 \cell }\pard \ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\insrsid2651942 
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\par }\pard \ql \li0\ri0\nowidctlpar\intbl\faauto\rin0\lin0 {\fs16\insrsid2651942 1. Request Type}{\insrsid2651942 
\par }{\f38\fs20\insrsid2651942  [ ]  ORIGINAL}{\insrsid2651942 
\par }{\f38\fs20\insrsid2651942  [ ]  CONTINUATION}{\insrsid2651942 
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\par }{\f38\fs20\insrsid2651942  [ ]  GRANT    [ ]  CONTRACT    [ ]  FELLOWSHIP
\par  [ ]  COOPERATIVE AGREEMENT
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\par }\pard \ql \li0\ri0\nowidctlpar\intbl\faauto\rin0\lin0 {\f1\fs16\insrsid2651942 3. Name of Federal Department or Agency and, if known, Application or Proposal Identification No.
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\par }\pard \ql \li0\ri0\sa58\nowidctlpar\intbl\faauto\rin0\lin0 {\f1\fs16\insrsid2651942 4. Title of Application or Activity \cell }\pard \ql \li0\ri0\sl-28\slmult0\nowidctlpar\intbl\faauto\rin0\lin0 {\f1\fs16\insrsid2651942 
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\f1\fs16\insrsid2651942 
\par  6. Assurance Status of this Project}{\i\f1\fs16\insrsid2651942  (Respond to one of the following)}{\f1\fs16\insrsid2651942 
\par 
\par  }{\f1\fs20\insrsid2651942 [ ]}{\f1\fs16\insrsid2651942  This Assurance, on file with Department of Health and Human Services, covers this activity: 
\par        }{\field{\*\fldinst {\f1\fs16\insrsid2651942 ADVANCE \\u2}}{\fldrslt }}{\f1\fs16\insrsid2651942 Assurance Identification No.}{\f1\fs16\ul\insrsid2651942                                                   }{\f1\fs16\insrsid2651942 
, the expiration date}{\f1\fs16\ul\insrsid2651942                           }{\f1\fs16\insrsid2651942    IRB Registration No.  ____________________ }{\f1\insrsid2651942 
\par 
\par }{\f1\fs16\insrsid2651942  }{\f1\fs20\insrsid2651942 [ ]}{\f1\fs16\insrsid2651942  This Assurance, on file with }{\i\f1\fs16\insrsid2651942 (agency/dept)}{\f1\fs16\insrsid2651942 
____________________________________________________________________, covers this activity. 
\par        Assurance No._____________________, the expiration date_}{\f1\fs16\ul\insrsid2651942               __    }{\f1\fs16\insrsid2651942  IRB Registration/Identification No.__________________}{\i\f1\fs16\insrsid2651942 (if applicable) }{
\f1\fs16\insrsid2651942 
\par 
\par  }{\f1\fs20\insrsid2651942 [ ]}{\f1\fs16\insrsid2651942  No assurance has been filed for this institution. This institution declares that it will provide an Assurance and Certification of IRB review and                       approval upon request. 
\par 
\par  }{\f1\fs20\insrsid2651942 [ ]}{\f1\fs16\insrsid2651942  Exemption Status: Human subjects are involved, but this activity qualifies for exemption under Section 101(b), paragraph___________. 
\par }{\f1\insrsid2651942 
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\par }\pard \ql \li0\ri0\nowidctlpar\intbl\faauto\rin0\lin0 {\f1\fs16\insrsid2651942 7. Certification of IRB Review (Respond to one of the following IF you have an Assurance on file) 
\par 
\par  }{\f1\fs20\insrsid2651942 [ ]}{\f1\fs16\insrsid2651942  This activity has been reviewed and approved by the IRB in accordance with the Common Rule and any other governing regulations. 
\par         by:     }{\f1\fs20\insrsid2651942 [ ]}{\f1\fs16\insrsid2651942  }{\fs16\insrsid2651942 Full IRB Review on (date of IRB meeting) }{\fs16\ul\insrsid2651942            _____                    }{\fs16\insrsid2651942  }{\f1\fs16\insrsid2651942 or   }{
\f1\fs20\insrsid2651942 [ ]}{\insrsid2651942  }{\f1\fs16\insrsid2651942 Expedited Review on (date) }{\f1\fs16\ul\insrsid2651942                                     }{\f1\fs16\insrsid2651942 
\par                      }{\f1\fs20\insrsid2651942 [ ]}{\f1\fs16\insrsid2651942  If less than one year approval, provide expiration date _____________________
\par  }{\f1\fs20\insrsid2651942 [ ]}{\f1\fs16\insrsid2651942  This activity contains multiple projects, some of which have not been reviewed. The IRB has granted approval on condition that all projects
\par }\pard \ql \li0\ri0\sa58\nowidctlpar\intbl\faauto\rin0\lin0 {\f1\fs16\insrsid2651942        covered by the Common Rule will be reviewed and approved before they are initiated and that appropriate further certification will be submitted.}{
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\par }\pard \ql \li0\ri0\nowidctlpar\intbl\faauto\rin0\lin0 {\f1\fs16\insrsid2651942 8. Comments
\par 
\par 
\par 
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}\pard \ql \li0\ri0\nowidctlpar\faauto\rin0\lin0\itap0 {\v\f1\fs16\insrsid2651942 
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\par }\pard \ql \li0\ri0\sa58\nowidctlpar\intbl\faauto\rin0\lin0 {\f1\fs16\insrsid2651942 
9. The official signing below certifies that the information provided above is correct and that, as required, future reviews will be performed until study closure and certification will be provided.\cell }\pard \ql \li0\ri0\sl-43\slmult0
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\par }\pard \ql \li0\ri0\sa58\nowidctlpar\intbl\faauto\rin0\lin0 {\f1\fs16\insrsid2651942 10. Name and Address of Institution \cell }\pard \ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\f1\fs16\insrsid2651942 
\trowd \irow0\irowband0\ts11\trgaph43\trleft0\trkeep\trftsWidth1\trpaddl43\trpaddr43\trpaddfl3\trpaddfr3 \clvertalt\clbrdrt\brdrnone \clbrdrl\brdrnone \clbrdrb\brdrs\brdrw15\brdrcf1 \clbrdrr\brdrs\brdrw15\brdrcf1 
\cltxlrtb\clftsWidth3\clwWidth5400\clshdrawnil \cellx5400\clvmgf\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15\brdrcf1 \clbrdrb\brdrnone \clbrdrr\brdrnone \cltxlrtb\clftsWidth3\clwWidth5400\clshdrawnil \cellx10800\row }\trowd \irow1\irowband1
\ts11\trgaph43\trleft0\trkeep\trftsWidth1\trpaddl43\trpaddr43\trpaddfl3\trpaddfr3 \clvertalt\clbrdrt\brdrs\brdrw15\brdrcf1 \clbrdrl\brdrnone \clbrdrb\brdrs\brdrw15\brdrcf1 \clbrdrr\brdrnone \cltxlrtb\clftsWidth3\clwWidth2700\clshdrawnil \cellx2700
\clvertalt\clbrdrt\brdrs\brdrw15\brdrcf1 \clbrdrl\brdrnone \clbrdrb\brdrs\brdrw15\brdrcf1 \clbrdrr\brdrs\brdrw15\brdrcf1 \cltxlrtb\clftsWidth3\clwWidth2700\clshdrawnil \cellx5400\clvmrg\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15\brdrcf1 \clbrdrb
\brdrs\brdrw15\brdrcf1 \clbrdrr\brdrs\brdrw15\brdrcf1 \cltxlrtb\clftsWidth3\clwWidth5400\clshdrawnil \cellx10800\pard \ql \li0\ri0\sl-43\slmult0\nowidctlpar\intbl\faauto\rin0\lin0 {\f1\fs16\insrsid2651942 
\par }\pard \ql \li0\ri0\nowidctlpar\intbl\faauto\rin0\lin0 {\f1\fs16\insrsid2651942 11. Phone No.}{\i\f1\fs16\insrsid2651942  (with area code)
\par }{\f1\fs16\insrsid2651942 
\par 12. Fax No. }{\i\f1\fs16\insrsid2651942 (with area code)}{\f1\fs16\insrsid2651942 
\par 
\par 13. Email:
\par }\pard \ql \li0\ri0\sa58\nowidctlpar\intbl\faauto\rin0\lin0 {\f1\fs16\insrsid2651942 \cell }\pard \ql \li0\ri0\sl-43\slmult0\nowidctlpar\intbl\faauto\rin0\lin0 {\f1\fs16\insrsid2651942 
\par }\pard \ql \li0\ri0\sa58\nowidctlpar\intbl\faauto\rin0\lin0 {\f1\fs16\insrsid2651942 \cell \cell }\pard \ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\f1\fs16\insrsid2651942 \trowd \irow1\irowband1
\ts11\trgaph43\trleft0\trkeep\trftsWidth1\trpaddl43\trpaddr43\trpaddfl3\trpaddfr3 \clvertalt\clbrdrt\brdrs\brdrw15\brdrcf1 \clbrdrl\brdrnone \clbrdrb\brdrs\brdrw15\brdrcf1 \clbrdrr\brdrnone \cltxlrtb\clftsWidth3\clwWidth2700\clshdrawnil \cellx2700
\clvertalt\clbrdrt\brdrs\brdrw15\brdrcf1 \clbrdrl\brdrnone \clbrdrb\brdrs\brdrw15\brdrcf1 \clbrdrr\brdrs\brdrw15\brdrcf1 \cltxlrtb\clftsWidth3\clwWidth2700\clshdrawnil \cellx5400\clvmrg\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15\brdrcf1 \clbrdrb
\brdrs\brdrw15\brdrcf1 \clbrdrr\brdrs\brdrw15\brdrcf1 \cltxlrtb\clftsWidth3\clwWidth5400\clshdrawnil \cellx10800\row }\trowd \irow2\irowband2\ts11\trgaph43\trleft0\trftsWidth1\trpaddl43\trpaddr43\trpaddfl3\trpaddfr3 \clvertalt\clbrdrt
\brdrs\brdrw15\brdrcf1 \clbrdrl\brdrnone \clbrdrb\brdrs\brdrw15\brdrcf1 \clbrdrr\brdrs\brdrw15\brdrcf1 \cltxlrtb\clftsWidth3\clwWidth5400\clshdrawnil \cellx5400\clvertalt\clbrdrt\brdrs\brdrw15\brdrcf1 \clbrdrl\brdrs\brdrw15\brdrcf1 \clbrdrb
\brdrs\brdrw15\brdrcf1 \clbrdrr\brdrnone \cltxlrtb\clftsWidth3\clwWidth5400\clshdrawnil \cellx10800\pard \ql \li0\ri0\sl-43\slmult0\nowidctlpar\intbl\faauto\rin0\lin0 {\f1\fs16\insrsid2651942 
\par }\pard \ql \li0\ri0\nowidctlpar\intbl\faauto\rin0\lin0 {\f1\fs16\insrsid2651942 14. Name of Official
\par 
\par }\pard \ql \li0\ri0\sa58\nowidctlpar\intbl\faauto\rin0\lin0 {\f1\fs16\insrsid2651942 \cell }\pard \ql \li0\ri0\sl-43\slmult0\nowidctlpar\intbl\faauto\rin0\lin0 {\f1\fs16\insrsid2651942 
\par }\pard \ql \li0\ri0\sa58\nowidctlpar\intbl\faauto\rin0\lin0 {\f1\fs16\insrsid2651942 15. Title\cell }\pard \ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\f1\fs16\insrsid2651942 \trowd \irow2\irowband2
\ts11\trgaph43\trleft0\trftsWidth1\trpaddl43\trpaddr43\trpaddfl3\trpaddfr3 \clvertalt\clbrdrt\brdrs\brdrw15\brdrcf1 \clbrdrl\brdrnone \clbrdrb\brdrs\brdrw15\brdrcf1 \clbrdrr\brdrs\brdrw15\brdrcf1 \cltxlrtb\clftsWidth3\clwWidth5400\clshdrawnil \cellx5400
\clvertalt\clbrdrt\brdrs\brdrw15\brdrcf1 \clbrdrl\brdrs\brdrw15\brdrcf1 \clbrdrb\brdrs\brdrw15\brdrcf1 \clbrdrr\brdrnone \cltxlrtb\clftsWidth3\clwWidth5400\clshdrawnil \cellx10800\row }\trowd \irow3\irowband3\lastrow 
\ts11\trgaph43\trleft0\trftsWidth1\trpaddl43\trpaddr43\trpaddfl3\trpaddfr3 \clvertalt\clbrdrt\brdrs\brdrw15\brdrcf1 \clbrdrl\brdrnone \clbrdrb\brdrs\brdrw15\brdrcf1 \clbrdrr\brdrs\brdrw15\brdrcf1 \cltxlrtb\clftsWidth3\clwWidth8100\clshdrawnil \cellx8100
\clvertalt\clbrdrt\brdrs\brdrw15\brdrcf1 \clbrdrl\brdrs\brdrw15\brdrcf1 \clbrdrb\brdrs\brdrw15\brdrcf1 \clbrdrr\brdrnone \cltxlrtb\clftsWidth3\clwWidth2700\clshdrawnil \cellx10800\pard \ql \li0\ri0\sl-43\slmult0\nowidctlpar\intbl\faauto\rin0\lin0 {
\f1\fs16\insrsid2651942 
\par }\pard \ql \li0\ri0\nowidctlpar\intbl\faauto\rin0\lin0 {\f1\fs16\insrsid2651942 16. Signature
\par 
\par }\pard \ql \li0\ri0\sa58\nowidctlpar\intbl\faauto\rin0\lin0 {\f1\fs16\insrsid2651942 \cell }\pard \ql \li0\ri0\sl-43\slmult0\nowidctlpar\intbl\faauto\rin0\lin0 {\f1\fs16\insrsid2651942 
\par }\pard \ql \li0\ri0\sa58\nowidctlpar\intbl\faauto\rin0\lin0 {\f1\fs16\insrsid2651942 17. Date\cell }\pard \ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\f1\fs16\insrsid2651942 \trowd \irow3\irowband3\lastrow 
\ts11\trgaph43\trleft0\trftsWidth1\trpaddl43\trpaddr43\trpaddfl3\trpaddfr3 \clvertalt\clbrdrt\brdrs\brdrw15\brdrcf1 \clbrdrl\brdrnone \clbrdrb\brdrs\brdrw15\brdrcf1 \clbrdrr\brdrs\brdrw15\brdrcf1 \cltxlrtb\clftsWidth3\clwWidth8100\clshdrawnil \cellx8100
\clvertalt\clbrdrt\brdrs\brdrw15\brdrcf1 \clbrdrl\brdrs\brdrw15\brdrcf1 \clbrdrb\brdrs\brdrw15\brdrcf1 \clbrdrr\brdrnone \cltxlrtb\clftsWidth3\clwWidth2700\clshdrawnil \cellx10800\row }\pard \ql \fi-6480\li6480\ri0\sl192\slmult1\nowidctlpar
\tx-1440\faauto\rin0\lin6480\itap0 {\f1\fs16\insrsid2651942 Authorized for local Reproduction                                          \tab \tab \tab \tab                                                         Sponsored by HHS}{\insrsid2651942 
\par }\pard \ql \li0\ri0\sl192\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 {\insrsid2651942 
\par }{\fs16\insrsid2651942 Public reporting burden for this collection of information is estimated to average less than an hour per response. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of inform
ation unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or
\par  any other aspect of this collection of information, including suggestions for reducing this burden to: OS Reports Clearance Officer, Room 503 200 Independence Avenue, SW., Washington, DC 20201.  }{\i\fs16\insrsid2651942 
Do not return the completed form to this address.}{\fs16\insrsid2651942 
\par }}