archive-edu.com » EDU » W » WASHINGTON.EDU

Total: 911

Choose link from "Titles, links and description words view":

Or switch to "Titles and links view".
  • Office of Research Information Services - Contact
    Box 359562 Laura S Baldwin 206 543 4817 Technical Writer Box 354845 Maria C Balicka 206 685 8374 Office Assistant 3 Office of Research ORIS Box 359562 Ryan H Becker 206 221 7849 Software Engineer Office of Research Information Services ORIS Box 359562 Dusti Blood 206 865 4794 Box 359562 Greg Bueno 206 221 7072 Box 359562 Alejandro Camargo ruiz 206 221 0779 unlisted email SOFTWARE ENGINEER OFFICE OF RESEARCH Box 359562 Chris Carlson 206 221 6113 Business Analyst Office of Research Information Services Box 359562 Jimmy Carter 206 543 8286 Software Engineer ORIS Box 359562 Royce A Cassel 206 616 5231 ORIS HSD Program Lead ORIS Box 359562 Mathambo Chibambo 206 685 6095 Help Desk Specialist ORIS Box 359562 Judy Chung 206 543 0613 Business Analyst Lead ORIS Box 359562 Ben Cornell 206 685 8602 Software Engineer Office of Research Information Services ORIS Box 359562 Vaughan Douglas 206 685 8654 Systems Administrator Office of Research Information Services ORIS Box 359562 Richard Fenger 206 221 6729 Assistant Director Decision Support Services Office of Research Information Services ORIS Box 359562 Craig Friesen 206 616 6288 Software Developer in Test ORIS Box 359562 Susan Gants 206 221 6953 QA Analyst Office of Research Information Services ORIS Box 359562 Dan Geiger 206 685 6719 Q A Lead ORIS Box 359562 Theresa M Gilbert 206 221 6613 System Business Analyst ORIS Box 359562 Robin L Hendricks 206 221 4713 Administrator Office of Information Services ORIS Box 359562 Anne Ho 206 685 8598 Business Analyst ORIS Box 359562 Aron Knapp 206 221 0612 ORIS Program Lead ORIS Box 359562 Jim Kresl 206 543 9947 Assistant Vice Provost Office of Research Box 351202 Suzanne J May 206 543 1198 Business Analyst ORIS Box 359562 Shawn Medero 206 616 4805 Platform Program Lead Office of Research Information

    Original URL path: http://www.washington.edu/research/index.php?page=orisContact (2014-06-24)
    Open archived version from archive


  • SAGE: System to Administer Grants Electronically
    1 have not been connected to any other eGC1 and 2 come after any periods that are connected e g If period 2 is connected to a different eGC1 then you cannot connect periods 1 or 2 If you are submitting a new application or competing renewal be sure to include the Budget Total Column This displays the total for all periods on the eGC1 Budget page Click the Apply to eGC1 button Your budget is now connected to the eGC1 and any updates you or other users make to the budget worksheet will automatically display in your connected eGC1 Get Your Budget Approved The budget will route with the eGC1 This means that when the eGC1 is not editable because it is Routing or In OSP the budget will also not be editable Users with access to both the budget and the eGC1 can withdraw the eGC1 from routing from the History page of SAGE Budget Note If an eGC1 is marked as ready to submit and has In OSP status it cannot be withdrawn Instead contact OSP and request they return the eGC1 Once an eGC1 has been approved by OSP that budget period and eGC1 are locked together and cannot be disconnected unless returned or withdrawn Note An eGC1 can still be withdrawn from the Certify Route page Disconnect Your Budget Now that your budget is connected a Disconnect the budget link will display on the Budget page of your eGC1 When you disconnect a budget from the eGC1 the values on the eGC1 Budget page are cleared and the eGC1 Budget fields can be edited from the eGC1 A connected budget period must be disconnected from the eGC1 before it can be connected to a different eGC1 Tip All of the data from your budget worksheet

    Original URL path: http://www.washington.edu/research/sage-support/topic/sage/connecting-budget-egc1-form (2014-06-24)
    Open archived version from archive

  • Office of Research Information Services - Site Map
    GCA Institutional Animal Care and Use Committee IACUC UW Medicine Compliance Research Excellence Energy at UW eScience Guides Clinical Trials Handbook Grants gov Submission Guide Researcher s Guide You are here ORIS Home Site Map ORIS Home Vision Mission Programs Programs Help Desk and Support Learning The SAGE Suite The DORA Suite Web Information Services Hosted Services Contact ORIS ORIS Site Map Search ORIS Home Simplified Access to Research gov

    Original URL path: http://www.washington.edu/research/index.php?page=orisSitemap (2014-06-24)
    Open archived version from archive

  • Office of Sponsored Programs - Topics
    Subawards Using the eGC1 Submitting a Proposal Sponsor Specific Information Time of Award Time of Award Advance Budget Number Manage Award Manage Award Program Income Procedures Gifts vs Sponsored Projects Concurrence Letter New Budget Setup Budget Extension Research Performance Progress Report RPPR Forms Learning Learning Acronyms and Abbreviations Faculty Orientation to Research Faculty Development Series Policy Procedures Guidance Policy Procedures Guidance Export Compliance Outgoing Subcontracts Small Business Subcontracting Plan Preparation

    Original URL path: http://www.washington.edu/research/?page=ospTopics (2014-06-24)
    Open archived version from archive

  • Human Subjects Division - Contact
    General information hsdinfo uw edu Training information hsdtrain uw edu Website questions hsdweb uw edu Form problems hsdforms uw edu If your study has been assigned to an IRB please contact a member of that IRB Review Team Not sure who you need Minimal Risk Expedited and Exempt Studies If you have questions regarding a minimal risk or exempt study you can use our Minimal Risk Contact Lookup tool to find out who you should contact Find Contacts for a Minimal Risk Study is your study exempt or minimal risk Studies Requiring Full Board Committee Review If your study requires full board committee convened IRB review you can find the appropriate contact here All Other Questions Call the front desk 206 543 0098 By Teams All Employees A Z Galen K Basse 206 685 1211 Administrator Box 359470 Bailey Bell 206 221 7918 Administrator Box 359470 Laurie E Berger 206 543 3033 Compliance Administrator Box 359470 Janet Bissonette 206 685 0505 HSD OSP Office Administrator Box 359472 R Brzustowicz 206 543 4464 Administrator Box 359470 Kathy Buck 206 543 2529 Review Coordinator Box 359470 Brecken Q Cardinal 206 543 0639 Administrator Box 359470 Ariana Chantee 206 616 9690 Administrator Box 359470 Deborah A Dickstein 206 543 5971 Administrator Box 359470 Sherry Edwards 206 221 0994 Information Manager Box 359470 Elizabeth L Falsberg 206 543 0098 Ext 2921 Administrator Box 359470 Geri C Faris 206 616 2345 Administrator Box 359470 Greg Flynn 206 221 7862 Organizational Change Manager Box 359470 Emily H Guthrie 206 543 2305 Assistant Director for Operations Social Behavior Box 359470 Amanda C Guyton 206 221 4438 Box 351800 Laura A Henderson 206 897 1748 Administrator Box 359470 Barbara Hill 206 685 7034 Joint HSD OSP Office Manager Box 359472 Jean Kang 206 543 9474 Compliance Administrator Box

    Original URL path: http://www.washington.edu/research/hsd/contact (2014-06-24)
    Open archived version from archive

  • Financial Conflict of Interest Policy
    or Innovator a With regard to any Entity whose Equity securities are publicly traded a Significant Financial Interest exists if the aggregate value of one or more of the following exceeds 5 000 i any Compensation received during the twelve 12 months preceding the date of SFI Disclosure ii any Compensation reasonably anticipated to be received in the twelve 12 months following the date of SFI Disclosure iii the value of any Equity interest in the Entity as of the date of SFI Disclosure b With regard to any Entity whose Equity securities are not publicly traded a Significant Financial Interest exists if i the value of any Compensation received from the Entity in the twelve 12 months preceding the date of SFI Disclosure and or reasonably anticipated to be received in the twelve 12 months following the date of SFI Disclosure when aggregated exceeds 5 000 or ii the Investigator or Innovator holds any Equity interest e g stock stock option or other ownership interest c With regard to any Entity a Significant Financial Interest exists if the Investigator or Innovator has received income related to any Intellectual Property during the twelve 12 months preceding the date of SFI Disclosure and or reasonably anticipated to be received in the twelve 12 months following the date of SFI Disclosure which when aggregated with other Financial Interests in the Entity exceeds 5 000 or d With regard to any Entity a Significant Financial Interest exists if during the twelve 12 months preceding or following the date of SFI Disclosure the Investigator or Innovator receives or reasonably anticipates receiving one or more Gifts including but not limited to Reimbursed Travel or Sponsored Travel meeting the definition of Gift having an aggregate value of 50 or more from the Entity 27 Small Business Innovation Research Program or SBIR Program means an extramural federal program providing financial sponsorship or support for small businesses through PHS awarding components and certain other federal agencies established under Public Law 97 219 the Small Business Innovation Development Act as amended For purposes of this Policy SBIR Program also includes the Small Business Technology Transfer Program established under Public Law 102 564 28 Sponsored Travel means travel activity the Travel Expenses for which are paid directly by an Entity on behalf of an Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available to the Investigator Notwithstanding the foregoing Sponsored Travel shall not include Travel Expenses that are paid by the University a federal state or local government agency an Institution of Higher Education an academic teaching hospital a medical center or a research institute that is affiliated with an Institution of Higher Education 29 Technology Transfer Transaction means a transaction through which the University conveys or transfers or negotiates to convey or transfer a University Intellectual Property right to a third party 30 Travel Disclosure means a disclosure of Sponsored Travel or Reimbursed Travel as provided in this Policy 31 Travel Expenses means expenses incurred for the purpose of engaging in travel activity including but not limited to costs for transportation parking food drink lodging and related amenities 32 University Research Employee has the same meaning as set forth in RCW 42 52 010 23 For purpose of this Policy University Research Employee shall include a University faculty members and or employees with appointments in the professorial ranks Professor Associate Professor Assistant Professor Research Professor Research Associate Professor Research Assistant Professor and to the extent engaged in Research or Technology Transfer Transactions other University faculty librarians and academic personnel b University research scientists and other University employees including professional and classified staff who have been specifically assigned by the University to Research projects and whose work contributes to the design or conduct of Research or to the analysis or reporting of Research results and c Other University professional staff members who have been granted the right to apply for sponsored Research projects by the Provost or by their respective Schools Colleges or Campuses IV PROCEDURES A Use of Financial Interest Disclosure System Identification of Investigators Investigators and Innovators shall be personally responsible for ensuring that their SFI Disclosures and Travel Disclosures required to be disclosed under this Policy are submitted in a complete and timely manner through the Financial Interest Disclosure System and in accordance with procedures and guidelines established by the University For all Research projects the Principal Investigator shall be responsible for identifying all Senior Key Personnel who are also Investigators as they become known and reporting their identity within ten 10 days thereafter B Authority of Institutional Official The Institutional Official is authorized to administer and enforce this Policy Such authorization includes the authority to i obtain and review SFI Disclosures and Travel Disclosures under this Policy ii develop and implement Conflict Management Plans iii conduct any required late or retrospective FCOI reviews including issuance of reports of findings and conclusions and development and implementation of conflict mitigation plans iv communicate with federal and other sponsors on matters pertaining to this Policy v make recommendations to the University with respect to matters covered by this Policy vi develop and implement reasonable and appropriate summary procedures for the disposition of matters involving compliance with this Policy and vii suspend for good cause an ongoing Research project or pending Technology Transfer Transaction to prevent any probable or continued violations of this Policy C SFI Disclosures by Investigators All SFI Disclosures required to be disclosed by Investigators under this Policy shall be submitted through the Financial Interest Disclosure System in accordance with the following 1 PHS Funded Investigators are required to disclose all SFI s within thirty 30 days of acquiring the SFI but in no event later than submission of an application for PHS Funded Research 2 Non PHS Funded Investigators are required to disclose only those SFIs that are related to their Research no later than submission of an application for the related Research 3 Once a Research project has been funded Investigators shall disclose prior to participating in the project all SFI s that have arisen since the time of application and all changes to SFI s previously disclosed 4 With regard to ongoing Research projects a all Investigators shall submit SFI Disclosures within thirty 30 days of acquiring any new or increased SFI and b when a new Investigator joins an ongoing Research project the new Investigator shall submit SFI Disclosures within thirty 30 days of joining the project 5 All Investigators shall submit an updated SFI Disclosure annually D Travel Disclosures All Travel Disclosures required by this Policy shall be submitted by Investigators through the Financial Interest Disclosure System in accordance with the following 1 PHS Funded Investigators are required to disclose all Sponsored Travel and Reimbursed Travel in accordance with the following a The timing of Travel Disclosures shall be as follows i At the time of application for PHS Funded Research all Sponsored Travel and Reimbursed Travel occurring in the preceding twelve 12 months shall be disclosed ii Prior to participating in the PHS Funded Research project all Sponsored Travel and Reimbursed Travel that occurred since the time of application and iii Thereafter during the course of the Investigator s participation in PHS Funded Research a no more than thirty 30 days after the occurrence of any Sponsored Travel or Reimbursed Travel and b an updated disclosure of all Sponsored and Reimbursed Travel annually b If a PHS Investigator is able to reasonably anticipate the occurrence of Sponsored Travel or Reimbursed Travel the Investigator may elect to submit Travel Disclosures up to twelve 12 months in advance of the anticipated travel Unless an advance Travel Disclosure becomes materially inaccurate no further disclosure of such travel shall be required c All Travel Disclosures by PHS Funded Investigators shall include information regarding i the purpose ii the identity of the sponsor organizer iii the destination iv the duration v the inclusion of any Immediate Family Member and vi an estimate of the approximate value of the travel 2 Non PHS Funded Investigators shall submit Travel Disclosures in accordance with the following a Non PHS Funded Investigators shall disclose Sponsored Travel and Reimbursed Travel from an Entity if i Either solely or when aggregated relative to the same Entity with the value of Compensation Equity or Intellectual Property the total value constitutes an SFI and ii The SFI is related to their specific current or proposed Research project b All Travel Disclosures required by this Policy for Non PHS Funded Investigators must include an estimate of the approximate value of the travel E Disclosures by Innovators When an Innovator has an SFI related to a Technology Transfer Transaction the Innovator shall disclose the SFI prior to the conclusion of the Technology Transfer Transaction All SFI Disclosures related to Technology Transfer Transactions shall be submitted by Innovators through the Financial Interest Disclosure System The University s Center for Commercialization will be responsible for identifying Innovators and ensuring that Innovators who have an SFI related to the proposed Technology Transfer Transaction submit SFI Disclosures F Review of Disclosures Aggregation and Entity Rules 1 All SFI Disclosures and Travel Disclosures will be automatically forwarded through the Financial Interest Disclosure System to the Institutional Official for review 2 All Investigators and Innovators making SFI Disclosures or Travel Disclosures shall specify those Research projects and Technology Transfer Transactions that are related to the SFI Disclosures or Travel Disclosures With respect to PHS Funded Research the Institutional Official will have the responsibility and authority to determine whether a SFI Disclosure or Travel Disclosure is related to the PHS Funded Research and constitutes an FCOI 3 In general and except as otherwise provided in this Policy the determination of the existence of an SFI and the requirement to disclose Financial Interests constituting an SFI will be based on the aggregation of all Financial Interests by Entity 4 If an SFI Disclosure or Travel Disclosure is related to a Research or Technology Transfer Transaction the Institutional Official shall review the SFI Disclosure or Travel Disclosure to determine whether the Financial Interest constitutes an FCOI Reviews will generally not be conducted until after a Research proposal has been funded or until after a Technology Transfer Transaction has been agreed upon in principle Most reviews are completed within thirty 30 days following submission of all information required for the conduct of the review as determined by the Institutional Official 5 No Investigator having an FCOI may participate in Research without prior written approval from the Institutional Official All FCOI reviews including any required Conflict Management Plan must be completed before any Research activity begins or Research expenses are incurred under an award and before any Technology Transfer Transaction can be completed In the event the Institutional Official concludes that a FCOI cannot be reduced eliminated or managed the Research project or Technology Transfer Transaction will not be allowed to proceed G Management of Financial Conflict of Interests 1 If the Institutional Official determines that an SFI Disclosure or Travel Disclosure constitutes an FCOI relating to either Research or a Technology Transfer Transaction a Conflict Management Plan shall be developed and implemented by the Institutional Official The FCOI review and Conflict Management Plan shall be completed prior to a conflicted Investigator participating in the Research or prior to the completion of the Technology Transfer Transaction as the case may be As part of an FCOI review and development of a Conflict Management Plan the Institutional Official shall confirm with the Investigator or Innovator that SFI Disclosures and Travel Disclosures in the Financial Interest Disclosure System are current as of the date of the review 2 Conflict Management Plans shall consist of measures that in the reasonable judgment of the Institutional Official will reduce eliminate or manage the effects of the FCOI In developing a Conflict Management Plan the Institutional Official may conduct factual inquiries and consult with and receive recommendations from such persons as the Institutional Official deems necessary and appropriate The terms of a Conflict Management Plan shall be consistent with all legal and regulatory requirements the requirements of this Policy and may include one or more of the following a Disclosure of FCOIs including to the public human subjects researchers and other participants publishers and conference organizers b Monitoring or oversight of Research by independent co researchers reviewers disinterested individuals or committees c Maintaining copies of Research data with a neutral party d Restricting participation in activity affecting or affected by a Research project or Technology Transfer Transaction e Requiring that the SFI creating the FCOI be divested restructured or placed in a blind trust f Modification or severance of relationships that create or are likely to create FCOI s g Modifying the terms of written agreements relating to the Research or Technology Transfer Transaction h Reduction in University appointment i Requiring compliance with other relevant University policies including those referenced in Section VI below j Requiring that participation in the recruitment or consent of subjects in human subjects Research by a conflicted Investigator be prohibited or restricted k Requiring additional disclosures or actions with respect to matters before a human subjects review committee and l Requiring that the Investigator or Innovator not participate in any business transactions between the University and parties to agreements involving sponsored Research or Technology Transfer Transactions 3 Submission of an SFI Disclosure by an Investigator or Innovator shall not constitute approval for purposes of this policy nor be deemed to constitute compliance with any applicable provisions of the Ethics Act Compliance with the safe harbor provisions of the 2005 Ethics Act Amendment occurs if a the University has developed and issued a Conflict Management Plan in accordance with this policy b the Conflict Management Plan covers the SFI that is the subject of the SFI Disclosure and c the Investigator or Innovator has substantially complied with the terms of the Conflict Management Plan H Access to SFI Disclosures and Travel Disclosures 1 The following University individuals and groups shall have access to all SFI Disclosures and Travel Disclosures submitted under this Policy a The Chair of the Department or other head of the organizational unit of the Investigator or Innovator b The Dean s Office of the appropriate College or School of the disclosing Investigator or Innovator c Office of Sponsored Program staff d Office of Research staff responsible for conflict of interest management e The Vice Provost for Research and designee s f For disclosures related to human subjects Research the University s Institutional Review Board IRB staff and members and g The Institutional Official and designees 2 Public Access for PHS Funded Research a If Senior Key Personnel who are also Investigators are determined to have an FCOI related to PHS Funded Research the FCOI shall be posted on a publicly accessible University website and contain no less than the following information i The name of Senior Key Personnel Investigator s ii The title and role of the Senior Key Personnel s Investigator s in the Research project iii The name of the Entity giving rise to the SFI and FCOI iv The nature of the FCOI and v The approximate dollar value of the FCOI set forth in range amounts 0 4 999 5 000 9 999 10 000 19 999 amounts between 20 000 100 000 by increments of 20 000 amounts above 100 000 in increments of 50 000 or a statement that the interest is one whose value cannot readily be determined through reference to public prices or other reasonable measures of fair market value b The publicly accessible website will be maintained under the direction of the University s the Office of Research The information on the website shall be updated at least annually and in any event within sixty 60 days of the University s identification of a new FCOI of Senior Key Personnel c The FCOI information of each Senior Key Personnel shall remain available on the University s publically accessible website for at least three 3 years from the date the information was most recently updated I Annual Update Reporting All Investigators and Innovators who are subject to a Conflict Management Plan shall provide annual update reports using the Financial Interest Disclosure System in a form and in a manner specified by the University In general annual update reports shall require Investigators and Innovators to confirm there has been no material increase in the nature or amount of the Investigator s SFI and that the Investigator is complying with the terms of the Conflict Management Plan Investigators will be restricted from submitting funding applications expending funds and conducting Research on projects whose annual update reports are not current J Disclosure and Review of Increased SFI s and New Investigators 1 Any Investigator participating in an existing Research project who acquires a new or increased SFI that would otherwise be required to be disclosed under this Policy shall submit a new SFI Disclosure within thirty 30 days of the acquisition of the new or increased SFI through the Financial Interest Disclosure System The University shall complete its review of the new or increased SFI within sixty 60 days of the submission of the SFI Disclosure 2 Any University personnel joining an existing Research project who has an SFI that would otherwise be required to be disclosed under this Policy shall submit an SFI Disclosure prior to participating as an Investigator in the Research project and shall not participate as an Investigator in the Research project until an FCOI review has been completed K Retrospective Reviews of PHS Funded Research Mitigation Plans 1 For PHS Funded Research if an FCOI is not identified or managed in a timely manner due to noncompliance by the Investigator or the University including failure of an Investigator to submit SFI Disclosures or Travel Disclosures in a timely manner a failure by the University to review an SFI or manage an FCOI in a timely manner

    Original URL path: http://www.washington.edu/research/osp/gim/gim10.html (2014-06-24)
    Open archived version from archive

  • GIM 36 - Human Embryonic Stem Cell Research Policy and Guidelines
    of the reviews by the IRB and ESCRO Committee should not overlap The UW Office of Research will provide necessary administrative support for the ESCRO Committee Membership The ESCRO Committee shall consist of ten voting members appointed by and serving at the pleasure of the Vice Provost for Research Members shall serve for renewable terms of three years each except that the terms of the initial members shall be staggered to the extent practicable Except for the public representative all other committee members may be employees of the UW or an institution affiliated with the UW Appointments to the ESCRO Committee shall be made to persons from a variety of academic and professional fields in order to reflect the scientific medical and ethical expertise necessary to carry out the committee s responsibilities The ESCRO Committee shall consisting of the following Chairperson designated by the Vice Provost for Research for a renewable two year term Two public members not affiliated with the UW Administrator or researcher experienced in the regulation and or oversight of human subjects research Expert in medical ethics and or legal matters and Five researchers with terminal degrees and expertise in disciplines related to hESC research including but not limited to developmental biology stem cell research molecular biology comparative medicine and assisted reproduction At the discretion of the Vice Provost for Research one or more of the foregoing five researcher positions may be filled through the appointment of two persons to serve as alternate voting members designated to hold a single position Alternate voting members shall have similar expertise and share all responsibilities for the position and alternate attendance at meetings of the ESCRO Committee Alternates shall also be entitled to attend ESCRO Committee meetings in a non voting capacity but on such occasions may not participate in decisions or deliberations of the ESCRO Committee Meeting Attendees In addition to attendance by ESCRO Committee and supporting administrative staff members at ESCRO Committee meetings the Chairperson may invite persons with competence in certain aspects of hESC research or representing community perspectives to assist in the review of issues that require expertise beyond or in addition to that of ESCRO Committee members Non voting attendees may include on an ad hoc basis the UW s designated Institutional Official representatives of the Washington Attorney General s Office and representatives from other UW research oversight committees and UW administrative offices Attendance by other persons at meetings of the ESCRO Committee shall only be at the invitation of and with the permission of the Chairperson in consultation with other ESCRO Committee members Responsibilities 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 research at the UW including information regarding key personnel the type of hESC research and the hESC in use Monitor national state and local ethical regulatory and policy discussions regarding hESC research and from time to time propose modifications to UW policy as needed Adopt implement and publish rules of procedures that are consistent with GIM 36 and other UW policies governing the conduct of ESCRO Committee affairs and interactions by investigators with the ESCRO Committee including but not limited to rules covering quorum requirements conflict of interest disclosures by members meeting format schedules and length workload assignments content of minutes applications and other forms criteria for evaluating hESC research proposals and communication of decisions and Facilitate education and training of investigators in the policy ethical legal regulatory and compliance issues involved in hESC research including recommending minimum compliance training requirements as a condition for participating in hESC research Review Standards ESCRO Committee review shall be primarily directed to determining whether proposed hESC research is scientifically meritorious and ethically acceptable The ESCRO Committee shall only approve hESC research proposals whose goals are judged to be scientifically worthy and whose methods demonstrate sound research design such that it can be reasonably expected that the study is likely to answer the proposed questions and to achieve the stated goals of the research In so doing the ESCRO Committee shall take into account the inherent uncertainty of the outcome of scientific research while also assessing the overall importance or significance of the proposed research In carrying out its review the ESCRO Committee shall give substantial consideration to any ethical or social aspects of the proposed research and shall not approve any proposal that is inconsistent with the prohibitions set forth in section V C of GIM 36 or otherwise fails to meet generally accepted ethical principles for the conduct of hESC and other research In accordance with the ESCRO Committee s rules of procedure an investigator proposing to conduct hESC research will be required to provide the ESCRO Committee no less than a detailed description of the proposed research adequate documentation demonstrating the provenance of hESC and hESC lines to be used in the research and evidence of compliance with other required reviews In cases where a proposal fails to meet the requirements of GIM 36 the ESCRO Committee Chairperson may disapprove the application without review by the full ESCRO Committee In making determinations the ESCRO Committee shall have authority to grant full conditional approval subject to obtaining all other required UW approvals conditional approval such to specific conditions limitations or changes or disapprove proposed hESC research The ESCRO Committee may also establish rules and procedures by which applications may be reconsidered or resubmitted with substantial revisions Conflicts of Interest Researcher Significant Financial Interests All investigators participating in hESC research shall disclose personal financial interests in accordance with the UW s Significant Financial Interest Disclosure Policy GIM 10 The ESCRO Committee research proposal application shall include questions comparable to those on the UW s human subjects research application representing and affirming compliance with GIM 10 by investigators proposing to participate in hESC research ESCRO Committee Member Conflicts of Interest It shall be the responsibility of each ESCRO Committee member to disclose all personal financial and other competing interests that could reasonably be seen as affecting the ability of the committee member to impartially discharge the committee member s duties Potential conflicts include but are not limited to personal financial interests professional interests or personal relationships having a significant connection to a matter under consideration by the ESCRO Committee The ESCRO Committee as a whole shall determine whether and the extent to which a disclosure disqualifies the committee member from participating in the review of a particular matter under consideration Coordination with UW Institutional Review Board To ensure consistent and efficient processing of hESC research proposals requiring IRB review the UW Human Subjects Division shall designate a single IRB committee as having exclusive jurisdiction to review all hESC research proposals requiring IRB approval In carrying out their reviews the IRB and ESCRO Committee shall strive to coordinate their activities to avoid unnecessary overlap and duplication of reviews and shall cooperate in the sharing and interchange of information to the extent permitted by applicable rules and regulations Procurement and Transfer of hESC and hESC Lines Investigators shall procure hESC and hESC lines consistent with GIM 36 and UW purchasing rules and regulations Upon procurement the Principal Investigator having authority over such newly acquired hESC and or hESC lines shall promptly transmit required information to the ESCRO Committee for entry into the UW hESC registry described in section V K below hESC and hESC lines shall only be transferred to other investigators both at the UW and outside the UW and to other organizations consistent with the provisions of GIM 36 and other applicable UW rules and regulations hESC Derived Cell Lines and Derivatives Creation and Transfer of New hESC Derived Cell Lines NIH guidance states that creation of hESC derived cell lines from hESC lines that are not on the NIH hESC registry is considered ineligible hESC research and may not be supported by federal funds To ensure compliance with federal restrictions applicable to the creation and use of new hESC lines all PI s who are authorized to create new hESC derived cell lines must also i maintain adequate records in order to enable the UW and the PI to demonstrate the provenance of such cell lines ii upon creation promptly transmit required information to the ESCRO Committee for entry of the newly created hESC line into the UW hESC registry described in section V K below and iii restrict new uses or transfer of new hESC derived cell lines until obtaining any required approvals from the ESCRO Committee and other UW offices Use of New hESC Derived Cell Lines Prior to using any new hESC derived cell line irrespective of source the PI must ascertain the provenance of the hESC line including whether the hESC line originated from an approved hESC line In conducting hESC research involving a new hESC derived line the following rules must be followed hESC Derived Cell Lines Derived from NIH hESC Registry Lines hESC derived cell lines created from approved hESC lines may be used for subsequent federally funded research providing the subsequent use is consistent with the terms of the grant or other support provided to create the hESC derived cell line hESC derived cell lines that are created from approved hESC lines that are restricted by the federal government for use in non federally funded research may be allowed for such use provided the costs of the hESC derived cell line are not charged to the federal government and the federal grant does not prohibit use of the hESC derived cell line for non federally funded research If the nature of the hESC derived cell line is such that estimating their costs is not feasible the hESC derived cell line may be used where the hESC derived cell line is not needed to carry out the federally funded project the school or college in consultation with OSP approves the use of hESC derived cell line from federally funded research based after OSP has reviewed the terms of the federal grant and the federal government is not charged for any cost associated with use of the hESC derived cell line in non federal research hESC Derived Cell Lines Derived from non NIH hESC Registry Lines Costs associated with research on hESC derived cell lines created from hESC lines not listed on the NIH hESC registry including personnel and equipment may not be charged to federal sources even if such research is undertaken in whole or part to benefit a federally funded project Use of hESC Derivatives Data and Intellectual Property Except to the extent prohibited or restricted by federal law or rules or by the terms of financial support of research supporting their creation UW investigators may use hESC derivatives data and intellectual property in any hESC research providing the research is in accordance with GIM 36 and any other applicable UW policies rules and procedures Establishment of UW hESC Registry Through the establishment of a centralized registry prescribed by the ESCRO Committee the UW will maintain a record of all hESC lines including new hESC derived cell lines kept at UW facilities The UW hESC registry will be supported and maintained within the UW Office of Research and will contain information about the source and provenance of hESC lines the location of the hESC lines the name of the investigator responsible for the safekeeping of the hESC disposition of hESC lines and such other information the ESCRO Committee deems appropriate Establishment of UW hESC Research Database Through the establishment of a centralized database prescribed by the ESCRO Committee the UW will maintain a record of all hESC research both occurring in UW facilities or involving UW personnel In cooperation with OSP and the UW s System to Administer Grants Electronically SAGE the UW hESC research database will be supported and maintained within the UW Office of Research and will contain information identifying the investigators conducting hESC research including the PI the funding source of the research OSP and other relevant UW identifying numbers the period of the research a brief description of the research and such other information the Vice Provost for Research deems appropriate hESC Tissue Banks and Repositories Any tissue banks or repositories at the UW containing hESC and hESC lines including new hESC derived cell lines shall be subject to subject to the requirements of GIM 36 and shall be included within the UW hESC registry described above hESC Researcher Compliance Training As a condition of and prior to conducting hESC research investigators are required to be familiar with applicable UW and other compliance policies rules and regulations governing such activity including GIM 36 The ESCRO Committee will recommend to the Vice Provost of Research a hESC compliance training program that will be sufficient to demonstrate knowledge of these policies The content of such training shall include information on categories of hESC research requirements for ESCRO Committee reviews documentation of compliance permitted and prohibited use of federal funds human subjects research issues and such other matters the ESCRO Committee deems appropriate The training program shall provide instruction by means of a one hour seminar either delivered in person online or through written materials Intellectual Property and Technology Transfer Inventions and Discoveries Intellectual property discovered or created by UW investigators in the course of hESC research will be disclosed to UW TechTransfer in accordance with the UW Patent Invention and Copyright Policy http www washington edu faculty facsenate handbook 04 05 07 html All intellectual property arising from hESC research shall be managed in accordance with the foregoing policy and the rules and procedures of UW TechTransfer Consistent with the foregoing the UW recognizes that there may be instances in which it will be in the public interest to place intellectual property arising from hESC research in the public domain or by broad non exclusive licensing Decisions in such cases shall be made by UW TechTransfer after appropriate consultations with the hESC investigators Material Transfer Agreements Incoming and outgoing transfers of hESC hESC lines hESC derived cell lines hESC derivatives and other materials shall be documented through material transfer agreements approved by UW TechTransfer UW Institute for Stem Cell and Regenerative Medicine The UW Institute for Stem Cell and Regenerative Medicine ISCRM has been established for the purpose of facilitating and encouraging basic research on hESC in order to develop therapies and cures for human disease In making decisions about policies and procedures governing the conduct of hESC research the UW and the ESCRO Committee will provide reasonable opportunities for investigators who are part of ISCRM to express their views on such matters and take into account such views in making decisions The ESCRO Committee and ISCRM will strive to cooperate in establishing efficient mechanisms for review of hESC research proposals and the training of hESC research investigators Appendix Cost Allocation Guidelines Introduction Financial Definitions General Cost Allocation Principles Application of Federal Cost Principles to Specific Resources Further Questions and Information Introduction In order to carry out ineligible hESC research at the UW the UW is required to maintain careful records documenting that no federal funds are used either directly or indirectly to support research involving the use of hESC not listed on the NIH hESC registry The UW is providing these guidelines which are consistent with federal hESC research restrictions in order to set forth the steps that researchers and administrators can take to ensure that hESC research can proceed unimpeded at the UW These guidelines describe steps to take in managing resources used for hESC research including 1 facilities 2 equipment 3 personnel 4 materials supplies and other commodities 5 non capitalized equipment 6 purchased services 5 derivatives from hESC research and 6 data and intellectual property associated with hESC research These guidelines are intended to address only those issues presented by current federal hESC research policy They supplement but do not replace other UW financial and accounting policies rules and procedures Financial Definitions In addition to the definitions set forth in Section IV Definitions above the following definitions shall apply to these cost allocation guidelines Circular A 21 Principles for Determining Costs Applicable to Grants Contracts and Other Agreements with Educational Institutions promulgated by the federal Office of Management and Budget Circular A 110 A document promulgated by the federal Office of Management and Budget entitled Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education Hospitals and Other Non Profit

    Original URL path: http://www.washington.edu/research/osp/gim/gim36.html (2014-06-24)
    Open archived version from archive

  • Human Subjects Division - Topics
    WIRB Related Links UW Medicine Compliance Institute of Translational Health Sciences ITHS Medicine UW Center for Commercialization Materials Transfer Agreements Fred Hutchinson Cancer Research Center FHCRC FHCRC Training Requirements FHCRC Institutional Review Office IRO UW Office of Research FHCRC Protocol Office for Cancer Consortium members UW Medicine Clinical Research Budget and Billing Support Office CRBB UW Environmental Health and Safety EH S Institutional Biosafety Committee UW Medicine Clinical Research UW Office of Sponsored Programs UW Medicine Clinical Research Handbook FHCRC Cancer Consortium Western IRB Significant Financial Interest Disclosure GIM 10 Clinical Trials IRB Review Clinical trials conducted by UW researchers are usually reviewed by one of the following Institutional Review Boards IRBs Western Institutional Review Board WIRB reviews most industry sponsored and industry initiated trials conducted by UW faculty Industry initiated means that the sponsor writes and owns the protocol for the study The Cancer Consortium IRB CC IRB reviews most oncology trials conducted by UW faculty who are members of the Cancer Consortium The UW IRBs review clinical trials which are federally funded and or investigator initiated Investigator initiated includes any clinical trial whose protocol was developed or idea was initiated by a UW investigator regardless of funding Investigator

    Original URL path: http://www.washington.edu/research/hsd/topics/Clinical+Trials (2014-06-24)
    Open archived version from archive



  •