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  • Embryonic Stem Cell Research Oversight - Submission & Review Process
    Process Submission Review Process New Applications Amendments Renewals Annual Surveys How to Submit ESCRO Forms Committee Committee Committee Responsibilities ESCRO FAQ Announcements Optional Stem Cell Research Oversight Training Submission Review Process Search General Inquiries UW Embryonic Stem Cell Research Oversight Box 351202 Seattle WA 98195 1202 206 685 9210 fax Contact Info for Embryonic Stem Cell Research Oversight ESCRO Primary Contact Kim A Blakemore 206 685 7010 Compliance Analyst Office of Research Box 351202 Committee Chair Charles H Muller 206 543 9504 Lecturer Urology and Biological Structure Box 356510 ESCRO Forms SOP 003 Standard Teratoma Guidance New Applications Financial Supplement ESCRO FactSheet Amendments Review Process Deadlines for submitting new applications and amendment forms depend on the type of hESC research you are conducting For more information about deadlines and the review process go to New Applications New Applications For new proposals or for ESCRO approved existing proposals in which two or three core features might change a new ESCRO application is required More about new applications Note Principle Investigators PIs with existing hESC research protocols have until 3 31 2009 to submit a new ESCRO application Amendments to Existing Applications The two types of amendments to an ESCRO application significant

    Original URL path: http://www.washington.edu/research/index.php?page=escroProcess (2014-06-24)
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  • Embryonic Stem Cell Research Oversight - New Applications
    Chair and or Committee will make this determination Minimal Full In vitro hESC research utilizing hESC lines that have been pre approved for such use by the ESCRO Committee In vitro hESC research utilizing hESC derived cell lines obtained from hESC lines that have been pre approved for such use by the ESCRO Committee and Other types of hESC research that the Vice Provost for Research has made a written determination after due consideration of the likely risks and benefits of such research that such categories are appropriate for minimal review The above excerpt was taken from GIM 36 Section V D 3 hESC research in which further human consent beyond that already obtained is required Creation of a new hESC line or hESC derived cell line by any means including through use of SCNT human zygotes or a human embryo furnished by an in vitro fertilization clinic or other lawful source Introduction of hESC into a nonhuman animal Research in which personally identifiable information about the donor of hESC is readily ascertainable or may become known Mixing human totipotent stem cells and pluripotent stem cells with pre implantation human embryos In vitro culture of an intact human embryo and Breeding of an animal having hESC Minimal Review If your research proposal qualifies for minimal ESCRO review the review process will take approximately 2 weeks from the time the ESCRO office receives your application The ESCRO Compliance Analyst will contact you through email and or phone to communicate any findings that may need to be resolved within that 2 week period After the ESCRO Chair has approved the research proposal the ESCRO Compliance Analyst will email approved electronic copies of the ESCRO materials to the Principal Investigator and contact person s email addresses The ESCRO Chair may determine that some

    Original URL path: http://www.washington.edu/research/index.php?page=escroNewApplications (2014-06-24)
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  • Embryonic Stem Cell Research Oversight - Amendments
    ESCRO FAQ Announcements Optional Stem Cell Research Oversight Training Amendments Search General Inquiries UW Embryonic Stem Cell Research Oversight Box 351202 Seattle WA 98195 1202 206 685 9210 fax Contact Info for Embryonic Stem Cell Research Oversight ESCRO Primary Contact Kim A Blakemore 206 685 7010 Compliance Analyst Office of Research Box 351202 Committee Chair Charles H Muller 206 543 9504 Lecturer Urology and Biological Structure Box 356510 ESCRO Forms SOP 003 Standard Teratoma Guidance New Applications Financial Supplement ESCRO FactSheet Amendments Significant Amendments Not Significant Amendments Full vs Minimal Review Amendment Form Financial Supplement Significant amendments Significant amendments involve substantive changes For example if you are proposing changes to methodology objectives or source of cell lines these are considered substantive changes and would require a formal amendment form to be filed Amendments can be filed to an existing project independently or with renewals Not significant amendments Not significant amendments do not require a formal amendment form but do need to be reported at the time of renewal in applicable sections of the renewal Examples of these types of amendments include personnel changes facilities changes contact phone number changes Including not significant amendments in a formal amendment form will be accepted by the ESCRO office but is not required Full vs Minimal Review Depending on the nature of the proposed amendment it may receive full or minimal ESCRO review If an amendment requires full ESCRO review it will be placed on the next respective ESCRO Committee meeting agenda The ESCRO Compliance Analyst will inform you of the type of review by email Once the amendment is finally approved the approval information will be posted in the approval status section of the ESCRO website Approval documents will be sent to you through email The rule of thumb regarding whether an amendment

    Original URL path: http://www.washington.edu/research/index.php?page=escroAmendments (2014-06-24)
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  • Embryonic Stem Cell Research Oversight - Renewals & Annual Surveys
    be emailed to PIs by the ESCRO Compliance Analyst with some information already completed Renewals require ESCRO review and are requested at least every three years however annual surveys do not require ESCRO review and are requested annually The default approval period for ESCRO review is three years however if the ESCRO committee identifies further risks or other concerns the approval period may expire sooner and thus require renewal sooner Renewal Notice Minimal Review renewals Full Review renewals Annual Surveys No ESCRO approval is needed for annual surveys Renewal Notice The ESCRO Office will send a reminder email to the PI and contact person informing them when their current ESCRO record will expire This notice will be sent four 4 months prior to the expiration date of each respective ESCRO record Attached to the email will be a renewal form with a financial supplement if the ESCRO record involves federally disapproved hESC lines These forms will contain some prefilled information using current data on file with the ESCRO office Examples of prefilled information include contact information financial information if applicable and information related to hESC lines Renewal forms will not be available on the ESCRO website since these are routed by the ESCRO Compliance Analyst Minimal Review renewals If your existing research project requires minimal ESCRO review the ESCRO office requests that you submit the completed renewal form no later than 30 days prior to the expiration date After the ESCRO office receives the completed renewal the ESCRO Compliance Analyst will contact you through email and or phone to communicate any findings that may need resolution After the ESCRO Chair has approved the research project the approved electronic copies will be sent to the Principal Investigator s and contact person s email address Full Review renewals If your existing project

    Original URL path: http://www.washington.edu/research/index.php?page=escroAnnual (2014-06-24)
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  • Embryonic Stem Cell Research Oversight - How to Submit ESCRO Forms
    Research Excellence Energy at UW eScience Guides Clinical Trials Handbook Grants gov Submission Guide Researcher s Guide You are here ESCRO Home Submission Review Process How to Submit ESCRO Forms ESCRO Home Purpose Policy Guidance Prohibited Research Does my research require review Submission Review Process Submission Review Process New Applications Amendments Renewals Annual Surveys How to Submit ESCRO Forms Committee Committee Committee Responsibilities ESCRO FAQ Announcements Optional Stem Cell Research Oversight Training How to Submit ESCRO Forms Search General Inquiries UW Embryonic Stem Cell Research Oversight Box 351202 Seattle WA 98195 1202 206 685 9210 fax Contact Info for Embryonic Stem Cell Research Oversight ESCRO Primary Contact Kim A Blakemore 206 685 7010 Compliance Analyst Office of Research Box 351202 Committee Chair Charles H Muller 206 543 9504 Lecturer Urology and Biological Structure Box 356510 Please submit completed ESCRO forms electronically to escro u washington edu in either of the following formats MS Word Format If you would like the ESCRO office to make minor corrections to completed forms after consulting with you please send an MS Word version of the application along with a scanned pdf copy of the signature page Alternatively you can also submit the signature page

    Original URL path: http://www.washington.edu/research/index.php?page=escroHowTo (2014-06-24)
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  • Embryonic Stem Cell Research Oversight - Committee
    UW Medicine Compliance Research Excellence Energy at UW eScience Guides Clinical Trials Handbook Grants gov Submission Guide Researcher s Guide You are here ESCRO Home Committee ESCRO Home Purpose Policy Guidance Prohibited Research Does my research require review Submission Review Process Submission Review Process New Applications Amendments Renewals Annual Surveys How to Submit ESCRO Forms Committee Committee Committee Responsibilities ESCRO FAQ Announcements Optional Stem Cell Research Oversight Training Committee Search General Inquiries UW Embryonic Stem Cell Research Oversight Box 351202 Seattle WA 98195 1202 206 685 9210 fax Contact Info for Embryonic Stem Cell Research Oversight ESCRO Primary Contact Kim A Blakemore 206 685 7010 Compliance Analyst Office of Research Box 351202 Committee Chair Charles H Muller 206 543 9504 Lecturer Urology and Biological Structure Box 356510 ESCRO Committee Details The ESCRO committee meets on a monthly basis to review ESCRO applications Committee Membership ESCRO Committee members are appointed by and serve as advisors to the Office of the Vice Provost for Research ESCRO Committee membership reflects the scientific medical and ethical expertise necessary to review hESC research applications Committee Responsibilities ESCRO s responsibilities include providing ethical and scientific review of hESC research ensuring compliance to applicable regulations and policy

    Original URL path: http://www.washington.edu/research/index.php?page=escroCommittee (2014-06-24)
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  • Embryonic Stem Cell Research Oversight - Committee Responsibilities
    H Muller 206 543 9504 Lecturer Urology and Biological Structure Box 356510 The ESCRO Committee s review shall be specific to the scientific and ethical issues presented by proposals to use hESC in particular research projects ESCRO Committee review and approval shall be deemed to be separate from and in addition to any other reviews or approvals otherwise required at the UW for such research including but not limited to committees or administrative offices having responsibility for review and approvals of human subjects research animal research biological safety radioactive materials and environmental safety The responsibilities of the ESCRO Committee shall be to Provide in accordance with GIM 36 scientific and ethical review of proposed hESC research including compliance with applicable regulatory requirements and UW policies Review and approve or disapprove all hESC research at the UW or involving UW personnel requiring institutional review subject to any other UW approvals that may also be required Provide continuing review and approval of all hESC research requiring institutional review including review of progress adverse events and similar reports that may be submitted to the UW by investigators conducting hESC research Confirm that the provenance of hESC used in hESC research at the UW or involving UW personnel is adequately demonstrated and when appropriate confirm that there is IRB approval of the process for acquisition of hESC to verify adherence to basic ethical and legal principles of informed consent and protection of confidentiality Refer to and require review of research proposals by other oversight offices or committees as required by UW policies including but not limited to those relating to human subjects research IRB animal research biological safety and conflicts of interest Prescribe establish and maintain a registry of hESC lines maintained at the UW Prescribe establish and maintain a database of ongoing hESC

    Original URL path: http://www.washington.edu/research/index.php?page=escroResponsibility (2014-06-24)
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  • Embryonic Stem Cell Research Oversight - FAQ
    Handbook Grants gov Submission Guide Researcher s Guide You are here ESCRO Home FAQ ESCRO Home Purpose Policy Guidance Prohibited Research Does my research require review Submission Review Process Submission Review Process New Applications Amendments Renewals Annual Surveys How to Submit ESCRO Forms Committee Committee Committee Responsibilities ESCRO FAQ Announcements Optional Stem Cell Research Oversight Training ESCRO FAQ Search General Inquiries UW Embryonic Stem Cell Research Oversight Box 351202 Seattle

    Original URL path: http://www.washington.edu/research/index.php?page=escroFAQ (2014-06-24)
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