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  • Human Subjects Division - Documents
    Submission Guide Researcher s Guide You are here HSD Home Browse A Z Documents 853 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 Consent Assent and Waivers HIPAA and 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 853 Last Updated 10 19 2013 Version 1 20 Filesize 136 KB Audiences HSD Staff IRB Member Researcher Doc Type Form SUPPLEMENT Waiver Request HIPAA Authorization Purpose Use this form to request a waiver of the requirement for HIPAA Authorization This means that you are requesting permission to access obtain use or disclose a research subject s Protected Health Information PHI for research purposes without obtaining the subject s specific authorization for that access use or disclosure Change

    Original URL path: http://www.washington.edu/research/hsd/docs/853 (2014-06-24)
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  • Human Subjects Division - Documents
    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 Consent Assent and Waivers 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 53 Last Updated 01 31 2014 Version 1 10 Filesize 46 KB Audiences HSD Staff IRB Member Researcher Doc Type Template TEMPLATE Assent Form Purpose This document has sample language at the grade 2 reading level for children to assent to research Related Documents TEMPLATE Consent Form Standard TEMPLATE Assent Form Blood Draw TEMPLATE Consent Form HIV Antibody Test TEMPLATE Consent Form Identifiable Specimens TEMPLATE Consent Form Medical Records TEMPLATE Consent Form Non Identifiable Specimens Change Notes Related to Ver 1 10 noted 01 31 2014 09 29am Changes to who needs to be listed at

    Original URL path: http://www.washington.edu/research/hsd/docs/53 (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 Consent Assent and Waivers 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 52 Last Updated 01 31 2014 Version 1 10 Filesize 46 KB Audiences HSD Staff IRB Member Researcher Doc Type Template TEMPLATE Assent Form Blood Draw Purpose This document has sample language at the grade 2 reading level for children to assent to a blood draw Related Documents TEMPLATE Consent Form Standard TEMPLATE Assent Form TEMPLATE Consent Form HIV Antibody Test TEMPLATE Consent Form Identifiable Specimens TEMPLATE Consent Form Medical Records TEMPLATE Consent Form Non Identifiable Specimens Change Notes Related to Ver 1 10 noted 01 31 2014 09 30am Changes to who needs to be listed

    Original URL path: http://www.washington.edu/research/hsd/docs/52 (2014-06-24)
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  • Human Subjects Division - Documents
    Excellence Energy at UW eScience Guides Clinical Trials Handbook Grants gov Submission Guide Researcher s Guide You are here HSD Home Browse A Z Documents 466 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 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 466 Last Updated 10 19 2013 Version 1 20 Filesize 25 5 KB Audiences Researcher Doc Type Template TEMPLATE Assurance Sponsor Letter Purpose This is a template letter for sponsors requesting assurance that the UW IRBs operate in compliance with 21 CFR Part 50 and 56 and with the ICH guidelines adopted by the FDA on May 9 1997 Change Notes Related to Ver 1 20 noted 10 19 2013 04

    Original URL path: http://www.washington.edu/research/hsd/docs/466 (2014-06-24)
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  • Human Subjects Division - Documents
    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 393 Last Updated 01 31 2014 Version 3 00 Filesize 1 1 MB Audiences Researcher Doc Type Form TEMPLATE Confidentiality Agreement Purpose Washington State law places limits and conditions on the release and use of individually identifiable records held by the University of Washington UW The UW Institutional Review Board IRB must review and approve the research use of UW records if those records are being accessed without subjects written consent even if the research activities are reviewed by another IRB The UW also must obtain a signed and legally binding Confidentiality Agreement with the lead researcher PI and all individuals who will have access to the records or identifiable information extracted from them Those individuals may include other researchers staff statisticians consultants or others collectively referred to as the Study Team The Agreement must be reviewed approved signed on behalf of the UW and returned to the researcher before the records can be accessed Related Documents Confidentiality Agreement Guidance REPORT CHANGE Confidentiality Agreement Personnel Change Notes Related to Ver 3 00 noted 01 31 2014 09 34am Changed instructions on face page and added instructions stating that not everyone on the Confidentiality Agreement needs to be listed on the Application Please use this version going forward sherrye Related to Ver 2 40 noted 01 31 2014 09 33am Changed instructions on face page and added instructions stating that not everyone on the Confidentiality Agreement needs to be listed on the Application Please use this version going forward sherrye Related to Ver 2 30 noted 10 19

    Original URL path: http://www.washington.edu/research/hsd/docs/393 (2014-06-24)
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  • Human Subjects Division - Documents
    Medicine Compliance Research Excellence Energy at UW eScience Guides Clinical Trials Handbook Grants gov Submission Guide Researcher s Guide You are here HSD Home Browse A Z Documents 1755 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 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 1755 Last Updated 02 28 2014 Version 1 00 Filesize 54 01 KB Audiences Research Participant Researcher Doc Type Template TEMPLATE Consent Form Emergency and Compassionate Use Purpose Use this template consent form when requesting consent for treatment with an experimental item Related Documents INSTRUCTIONS and NOTIFICATION Compassionate Use Device INSTRUCTIONS and NOTIFICATION Emergency Use Device INSTRUCTIONS and NOTIFICATION Emergency Use Drug or Biologic SOP Device Compassionate

    Original URL path: http://www.washington.edu/research/hsd/docs/1755 (2014-06-24)
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  • Human Subjects Division - Documents
    Glossary Contact HSD Contact HSD Directions to HSD Documents Related Topics Consent Assent and Waivers 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 864 Last Updated 01 31 2014 Version 1 30 Filesize 122 5 KB Audiences HSD Staff IRB Member Research Participant Researcher Doc Type Template TEMPLATE Consent Form HIV Antibody Test Purpose The purpose of this template is to provide sample language for studies that require or request HIV testing of subjects in the State of Washington Related Documents TEMPLATE Consent Form Standard TEMPLATE Assent Form TEMPLATE Assent Form Blood Draw TEMPLATE Consent Form Identifiable Specimens TEMPLATE Consent Form Medical Records TEMPLATE Consent Form Non Identifiable Specimens Change Notes Related to Ver 1 30 noted 01 31 2014 09 28am Changes to who needs to be listed at top of form Please use this version going forward No need to

    Original URL path: http://www.washington.edu/research/hsd/docs/864 (2014-06-24)
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  • Human Subjects Division - Documents
    A Z Documents 54 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 Consent Assent and Waivers 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 54 Last Updated 01 31 2014 Version 1 10 Filesize 49 5 KB Audiences HSD Staff IRB Member Researcher Doc Type Template TEMPLATE Consent Form Identifiable Specimens Purpose The purpose of this template is to provide sample language for the consent form for future use of stored identifiable specimens in industry sponsored research Related Documents TEMPLATE Consent Form Standard TEMPLATE Assent Form TEMPLATE Assent Form Blood Draw TEMPLATE Consent Form HIV Antibody Test TEMPLATE Consent Form Medical Records TEMPLATE Consent Form Non Identifiable Specimens Change Notes Related to Ver 1 10 noted

    Original URL path: http://www.washington.edu/research/hsd/docs/54 (2014-06-24)
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