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  • Human Subjects Division - Documents
    Related Topics Department of Defense DoD Research Training Requirements Department of Defense DoD Requirements Document Update Schedule HSD posts updated documents to the web site on the last Friday of each month In rare cases due to an urgent need an updated document will be posted during the month HSD and the IRB ask that researchers make every effort to use the most recent document version Questions about a specific document version Contact hsdforms uw edu Document Details Download Document 542 Last Updated 05 30 2014 Version 4 20 Filesize 2 22 MB Audiences Researcher Doc Type Form Use of HSD PDF Forms HSD Forms are compatible with Adobe Reader Version 10 and higher though we recommend use of the most recent version You may receive messages from Adobe to upgrade For Mac users be sure to open the form in Adobe Reader or Acrobat SUPPLEMENT Department of Defense DOD Involvement Purpose This form must be completed and reviewed by the IRB for all UW human subjects research involving any component of the U S Department of Defense DOD except research that qualifies for exempt status Change Notes Related to Ver 4 20 noted 05 30 2014 09 45am Added button that allows sections to be added for more than one funding source sherrye Related to Ver 4 10 noted 01 31 2014 09 19am Removed reference to Exempt Determination Form and removed training requirements section Please use this version going forward sherrye Related to Ver 4 00 noted 11 01 2013 12 11pm Updated to PDF and newer format sherrye Related to Ver 3 50 noted 10 19 2013 04 48pm Updated name to new naming convention on website sherrye Related to Ver 3 50 noted 06 28 2013 11 41am Updated some instructions to coincide with new SOPs

    Original URL path: http://www.washington.edu/research/hsd/docs/542 (2014-06-24)
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  • Human Subjects Division - Documents
    here HSD Home Browse A Z Documents 1706 HSD Home Training Training HSD Training Videos Training Options to Meet Requirements Verification Report Browse A Z Forms Policies Procedures and Guidance Topics Glossary Contact HSD Contact HSD Directions to HSD Documents Document Update Schedule HSD posts updated documents to the web site on the last Friday of each month In rare cases due to an urgent need an updated document will be posted during the month HSD and the IRB ask that researchers make every effort to use the most recent document version Questions about a specific document version Contact hsdforms uw edu Document Details Download Document 1706 Last Updated 11 01 2013 Version 1 00 Filesize 2 15 MB Audiences Researcher Doc Type Form Use of HSD PDF Forms HSD Forms are compatible with Adobe Reader Version 10 and higher though we recommend use of the most recent version You may receive messages from Adobe to upgrade For Mac users be sure to open the form in Adobe Reader or Acrobat SUPPLEMENT Department of Justice Purpose This supplement provides the information and assurance necessary to fulfill the requirements of research that involves the Department of Justice DOJ including Funding by

    Original URL path: http://www.washington.edu/research/hsd/docs/1706 (2014-06-24)
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  • Human Subjects Division - Documents
    Home Training Training HSD Training Videos Training Options to Meet Requirements Verification Report Browse A Z Forms Policies Procedures and Guidance Topics Glossary Contact HSD Contact HSD Directions to HSD Documents Related Topics Food and Drug Administration FDA Research Document Update Schedule HSD posts updated documents to the web site on the last Friday of each month In rare cases due to an urgent need an updated document will be posted during the month HSD and the IRB ask that researchers make every effort to use the most recent document version Questions about a specific document version Contact hsdforms uw edu Document Details Download Document 1714 Last Updated 04 25 2014 Version 1 10 Filesize 1 99 MB Audiences Researcher Doc Type Form Use of HSD PDF Forms HSD Forms are compatible with Adobe Reader Version 10 and higher though we recommend use of the most recent version You may receive messages from Adobe to upgrade For Mac users be sure to open the form in Adobe Reader or Acrobat SUPPLEMENT Devices Purpose This form is a supplement to IRB applications for activity involving a medical device Related Documents CHECKLIST Device Risk Determination SOP FDA Regulated Research SUPPLEMENT Drugs Biologics

    Original URL path: http://www.washington.edu/research/hsd/docs/1714 (2014-06-24)
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  • Human Subjects Division - Documents
    You are here HSD Home Browse A Z Documents 1715 HSD Home Training Training HSD Training Videos Training Options to Meet Requirements Verification Report Browse A Z Forms Policies Procedures and Guidance Topics Glossary Contact HSD Contact HSD Directions to HSD Documents Related Topics Food and Drug Administration FDA Research Document Update Schedule HSD posts updated documents to the web site on the last Friday of each month In rare cases due to an urgent need an updated document will be posted during the month HSD and the IRB ask that researchers make every effort to use the most recent document version Questions about a specific document version Contact hsdforms uw edu Document Details Download Document 1715 Last Updated 11 01 2013 Version 1 00 Filesize 2 36 MB Audiences Researcher Doc Type Form Use of HSD PDF Forms HSD Forms are compatible with Adobe Reader Version 10 and higher though we recommend use of the most recent version You may receive messages from Adobe to upgrade For Mac users be sure to open the form in Adobe Reader or Acrobat SUPPLEMENT Drugs Biologics Botanicals Purpose This form is a supplement to IRB applications for activity involving a drug biologic

    Original URL path: http://www.washington.edu/research/hsd/docs/1715 (2014-06-24)
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  • Human Subjects Division - Documents
    site on the last Friday of each month In rare cases due to an urgent need an updated document will be posted during the month HSD and the IRB ask that researchers make every effort to use the most recent document version Questions about a specific document version Contact hsdforms uw edu Document Details Download Document 1748 Last Updated 02 28 2014 Version 1 00 Filesize 2 19 MB Audiences HSD Staff IRB Member Researcher Doc Type Form Use of HSD PDF Forms HSD Forms are compatible with Adobe Reader Version 10 and higher though we recommend use of the most recent version You may receive messages from Adobe to upgrade For Mac users be sure to open the form in Adobe Reader or Acrobat SUPPLEMENT Genetic Research Purpose Use this supplement when you are submitting 1 an Initial Application for research that involves genetics or 2 a Modification Application for genetics research procedures that have not already received IRB approval This supplement is not intended for use with gene transfer or gene therapy research Genetic research is defined as research involving the analysis of any of the following DNA RNA chromosomes mitochondria any or all parts of the human

    Original URL path: http://www.washington.edu/research/hsd/docs/1748 (2014-06-24)
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  • Human Subjects Division - Documents
    posts updated documents to the web site on the last Friday of each month In rare cases due to an urgent need an updated document will be posted during the month HSD and the IRB ask that researchers make every effort to use the most recent document version Questions about a specific document version Contact hsdforms uw edu Document Details Download Document 933 Last Updated 11 07 2013 Version 3 10 Filesize 2 28 MB Audiences HSD Staff IRB Member Researcher Sponsor Student Researcher Doc Type Form Use of HSD PDF Forms HSD Forms are compatible with Adobe Reader Version 10 and higher though we recommend use of the most recent version You may receive messages from Adobe to upgrade For Mac users be sure to open the form in Adobe Reader or Acrobat SUPPLEMENT GWAS dbGaP Purpose The purpose of this form is to provide the University of Washington UW Human Subjects Division HSD with the information that is necessary to certify submission of data to the National Institutes of Health NIH Genome Wide Association Studies GWAS database of Genotypes and Phenotypes dbGaP Related Documents SOP GWAS dbGaP dbGaP Poster Presentation Change Notes Related to Ver 3 10 noted

    Original URL path: http://www.washington.edu/research/hsd/docs/933 (2014-06-24)
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  • Human Subjects Division - Documents
    and Vulnerable Populations Document Update Schedule HSD posts updated documents to the web site on the last Friday of each month In rare cases due to an urgent need an updated document will be posted during the month HSD and the IRB ask that researchers make every effort to use the most recent document version Questions about a specific document version Contact hsdforms uw edu Document Details Download Document 322 Last Updated 04 03 2014 Version 3 10 Filesize 362 KB Audiences Researcher Doc Type Form SUPPLEMENT Protected and or Vulnerable Populations Purpose This supplement to be used in conjunction with the IRB Application Standard or Modification Form asks for required regulatory information such that the IRB can ensure the research is compliant with the numerous regulations governing the participation of protected and or vulnerable populations in research Related Documents CHECKLIST Pregnant Women SOP Children and the Internet SOP Pregnant Women Change Notes Related to Ver 3 10 noted 04 03 2014 05 18pm Added clarification that COPPA refers to collecting information about children online sherrye Related to Ver 3 00 noted 11 22 2013 09 27am Added question regarding COPPA regulation sherrye Related to Ver 2 90 noted 11 01 2013 01 28pm Updated new assent questions Use this version going forward sherrye Related to Ver 2 80 noted 10 19 2013 04 49pm Updated name to new naming convention on website sherrye Related to Ver 2 80 noted 08 30 2013 09 03am Added section for researchers to request a waiver of assent for children sherrye Related to Ver 2 70 noted 05 31 2013 09 24am Corrected small error Okay to use previous version sherrye Related to Ver 2 60 noted 03 30 2012 09 16am Corrected typo Okay to use previous version sherrye Related to Ver

    Original URL path: http://www.washington.edu/research/hsd/docs/322 (2014-06-24)
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  • Human Subjects Division - Documents
    Update Schedule HSD posts updated documents to the web site on the last Friday of each month In rare cases due to an urgent need an updated document will be posted during the month HSD and the IRB ask that researchers make every effort to use the most recent document version Questions about a specific document version Contact hsdforms uw edu Document Details Download Document 862 Last Updated 02 28 2014 Version 1 70 Filesize 305 KB Audiences HSD Staff IRB Member Researcher Doc Type Form SUPPLEMENT Waiver Request Consent Requirements Purpose Use this form if you are requesting one or more of the following a a waiver of the requirement for written documentation of consent b a waiver of the requirement for consent c a partial waiver or alteration of consent d use of the short form consent process Change Notes Related to Ver 1 70 noted 02 28 2014 11 04am Added link to SOP consent sherrye Related to Ver 1 60 noted 10 19 2013 04 50pm Updated name to new naming convention on website sherrye Related to Ver 1 60 noted 09 27 2013 11 45am Removed confusing example from instructions regarding experimental procedures Okay to

    Original URL path: http://www.washington.edu/research/hsd/docs/862 (2014-06-24)
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