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  • Human Subjects Division - Documents
    Use 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 1756 Last Updated 05 30 2014 Version 1 10 Filesize 1 87 MB Audiences 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 INSTRUCTIONS and NOTIFICATION Compassionate Use Device Purpose If this is an emergency Do not use this document Instead use the INSTRUCTIONS and NOTIFICATION Emergency Use Device This document is used by physicians to Determine and document whether the circumstances in which they hope to make clinical use of an investigational device meets the FDA requirements for compassionate use Guide them through the procedures required by the

    Original URL path: http://www.washington.edu/research/hsd/docs/1756 (2014-06-24)
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  • Human Subjects Division - Documents
    to HSD Documents Related Topics Single Patient Emergency Use 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 1757 Last Updated 05 30 2014 Version 1 10 Filesize 2 18 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 INSTRUCTIONS and NOTIFICATION Emergency Use Device Purpose This document is used by physicians to Determine and document whether the circumstances in which they hope to make emergency clinical use of an investigational device meets the FDA requirements for emergency use Guide them through the procedures required by the FDA and the UW for emergency use and

    Original URL path: http://www.washington.edu/research/hsd/docs/1757 (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 1758 Last Updated 05 30 2014 Version 1 30 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 INSTRUCTIONS and NOTIFICATION Emergency Use Drug or Biologic Purpose This document is used by physicians to Determine and document whether the circumstances in which they hope to make emergency clinical use of an investigational drug or biologic meets the FDA requirements for emergency use Guide them through the procedures required by the FDA and the UW for emergency use and Notify the IRB of the emergency use with in 5 days after the use Related

    Original URL path: http://www.washington.edu/research/hsd/docs/1758 (2014-06-24)
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  • Human Subjects Division - Documents
    Documents 1740 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 1740 Last Updated 04 08 2014 Version 1 20 Filesize 2 69 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 REPORT CHANGE Confidentiality Agreement Personnel Purpose Use this form to add or remove individuals from an existing Confidentiality Agreement that was signed by the UW Human Subjects Division HSD Related Documents TEMPLATE Confidentiality Agreement Change

    Original URL path: http://www.washington.edu/research/hsd/docs/1740 (2014-06-24)
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  • Human Subjects Division - Documents
    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

    Original URL path: http://www.washington.edu/research/hsd/docs/76 (2014-06-24)
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  • Human Subjects Division - Documents
    Report Browse A Z Forms Policies Procedures and Guidance Topics Glossary Contact HSD Contact HSD Directions to HSD Documents Related Topics Report Problems and New Information 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 1761 Last Updated 04 04 2014 Version 1 10 Filesize 1 79 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 REPORT Problems Purpose Use this form to report study related adverse events covered by the UW Human Subjects Assistance Plan breach of confidentiality and inappropriate access of personal health information PHI to the Human Subjects Division within 24 hours

    Original URL path: http://www.washington.edu/research/hsd/docs/1761 (2014-06-24)
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  • Human Subjects Division - Documents
    Forms Policies Procedures and Guidance Topics Glossary Contact HSD Contact HSD Directions to HSD Documents Related Topics Federalwide Assurance FWA 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 458 Last Updated 01 31 2014 Version 4 30 Filesize 70 5 KB Audiences Researcher Doc Type Form REQUEST AUTHORIZATION Individual Investigator Purpose This form is used to document the extension of the UW IRB s Federalwide Assurance to an individual investigator Related Documents REQUEST AUTHORIZATION IRB Change Notes Related to Ver 4 30 noted 01 31 2014 09 15am Updated Shannon Sewards title sherrye Related to Ver 4 20 noted 10 19 2013 05 10pm Updated name to new naming convention on website sherrye Related to Ver 4 20 noted 03 29 2013 08 53am Locked the form so checkboxes function Okay to use previous version sherrye Related to Ver 4 10 noted

    Original URL path: http://www.washington.edu/research/hsd/docs/458 (2014-06-24)
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  • Human Subjects Division - Documents
    Federalwide Assurance FWA 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 459 Last Updated 06 02 2014 Version 5 50 Filesize 80 KB Audiences Researcher Doc Type Form REQUEST AUTHORIZATION IRB Purpose An IRB Authorization Agreement is an agreement between two FWA holding institutions that allows one of the institutions to review approve and oversee human subjects research on behalf of the other institution Related Documents REQUEST AUTHORIZATION Individual Investigator Change Notes Related to Ver 5 50 noted 01 31 2014 09 16am Updated Shannon Sewards title sherrye Related to Ver 5 40 noted 10 19 2013 05 11pm Updated name to new naming convention on website sherrye Related to Ver 5 40 noted 03 29 2013 08 52am Locked the form so checkboxes function Okay to use previous version sherrye Related to Ver 5 30 noted 11 30 2012 08 54am

    Original URL path: http://www.washington.edu/research/hsd/docs/459 (2014-06-24)
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