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  • Office of Research - Open Access to Research Results
    make the world a better place by seeking and discovering timely solutions to the world s most complex problems while recognizing and meeting its special obligations as a public university to improve the lives of Washingtonians through knowledge and discovery One of the primary ways in which the University fulfills its mission is by disseminating research results to specialist audiences and to the public customarily through scholarly journals as well as other channels Access for its researchers to a wide range of scholarly and research literature is fundamental to the success of the research enterprise at the University as is the ability to share research findings widely with all who could use and benefit from it including other scholars worldwide who would use them to speed the process of discovery Such access is increasingly at risk because of the market power of a few large commercial publishers and their journal pricing policies and the resulting financial pressure also has led libraries to divert funds from the purchase of the scholarly monographs that are fundamental to scholarly exchange in many disciplines Within the last couple of years a movement toward open access to research results and other scholarly materials has emerged that shows great promise for helping to foster communication within the research community and disseminate research results to the public as well as to help control the negative impact of market forces In general this movement is consistent with the mission and goals of the University and should be supported However it is essential that rigorous peer review remain a critical element of open access policies Those who conduct research and other scholarly work and seek publication of the results as well as the end users of such information e g other researchers policy makers and the public have an

    Original URL path: http://www.washington.edu/research/main.php?page=openAccess (2014-06-24)
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  • Office of Research - Principles for Community-Based Research
    institutional role in society depends on our ability to defend it against charges of research bias This means we must always bear in mind the distinction between our voices as researchers and our voices as social activists or speakers on behalf of a particular conception of social justice Particular care must be taken when money changes hands It is quite acceptable for community assets to be enhanced through research activities for example but it is violation of state law to use funds targeted to research for any activity that is not part of the research plan itself In cases where there are cultural differences or a history of tension there is no substitute for researchers and community members working through the contract with the Office of Sponsored Programs OSP personnel face to face Discussions with OSP early in the contracting process can also be help avoid problems when subcontracting with smaller community agencies For example they frequently do not have the financial reserves to carry employees who have been hired to work on a project while waiting for the typical UW payment cycle The Principles of Community based Research as originally stated probably do not provide adequate guidance regarding distinctions in roles and responsibilities The research act as we all know is a complex one involving diverse skills and decisions Community members are more appropriately part of some aspects of research than others For instance although it is both appropriate and valuable to consult with community members on the design of a survey instrument they will probably not have a role to play in the statistical interpretation of its structure Clear boundaries should be stated at the outset Community members are much more likely to let us do our job if we make it clear that we are going to

    Original URL path: http://www.washington.edu/research/main.php?page=communityPrinciples (2014-06-24)
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  • Office of Research - State Ethics Act of 2005 - Impact on UW Policy
    for the economic benefit of the State of Washington the Washington Legislature amended the Washington State Ethics in Public Service Act Ethics Act in 2005 to allow the UW to develop adopt and implement administrative processes that apply in place of the obligations imposed on universities and University Research Employees under specified sections of the Ethics Act Revisions to certain University policies have been adopted by the UW and approved by the Governor in 2007 in accordance with the provisions of the new law Changes to UW Policy University Research Employee defined The new law defines University Research Employee as a state officer or state employee employed by a university but only to the extent the state officer or state employee is engaged in research technology transfer or other approved activities related to research and technology transfer At the UW this includes all faculty in the professorial ranks and other UW employees engaged in research and tech transfer For purposes of the revised UW policies the definition of University Research Employee also includes the following professional and classified staff Research scientists and other UW employees including professional and classified staff who have been specifically assigned to sponsored research projects and whose work contributes to the design or conduct of research or to the analysis or reporting of results and Other 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 De minimis use of UW resources for consulting by University Research Employees is now allowed University Research Employees as defined above who have received required approvals for outside work activities relating to research and or tech transfer may use their assigned UW office telephone computer and email and may use all UW library facilities on a de minimis basis for this approved activity providing that no consumable UW resources are used no other UW employees are involved except those also approved for the same activity the employee is not using these UW resources to run a private business other than a consulting business pertinent to her his research or tech transfer endeavors the effort does not interfere with the normal duties of the UW employee Impact on UW Researchers Engaged in Approved Outside Work Essentially certain activities involving the use of University resources and facilities that were previously prohibited are now allowed Examples include Making a local or toll free call on a personally assigned UW telephone to discuss an approved outside work matter Using a personally assigned UW computer and email account to correspond about an approved outside work matter Meeting in a personally assigned UW office with an outside work client to discuss an approved outside work matter Drafting a report or preparing a speech or presentation on a personally assigned UW computer to be submitted as part of an approved outside work activity Using an optical microscope personally assigned to and located in a faculty member s office to view a

    Original URL path: http://www.washington.edu/research/main.php?page=stateEthicsAct (2014-06-24)
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  • Human Subjects Division - Policies, Procedures and Guidance
    Research Team Problems Noncompliance New Information REPORT Problems Closure APPLICATION Continuing Review Status Report Renew or Close SOP Status Report Reminders Pre review SOP Initial Intake SOP Signatures on IRB Forms Full Board Distribution SOP Over enrollment Review Process SOP Exempt Determination SOP IRB Review SOP IRB Member Conflict of Interest SOP IRB Consultants SOP Materials for Review SOP IRB Meeting Preparation SOP IRB Meeting Conduct SOP Expedited Review SOP IRB Actions CHECKLIST Approval WORKSHEET Options for IRB Actions SOP Modifications SOP Continuing Review SOP Management of Research Related Problems SOP Closure SOP Appeal of IRB Determination Specific Review Issues SOP Financial Conflict of Interest SOP Funding Review Risks of Harm from Standard Care SOP Subject Numbers Communication of Review Outcome Materials Consent and Recruitment Stamped with IRB Approval Procedure SOP Researcher Non Response RESPONSE Cover Sheet Conditional Approval RESPONSE Cover Sheet General back to top 5 Types of Research and Activities Industry Trials SOP WIRB Review Researcher Procedures REQUEST AUTHORIZATION UW WIRB UW WIRB Initial Submission High Level Process Diagram UW WIRB Initial Submission Detail Level Process Diagram UW WIRB FAQs and Frequent Errors TEMPLATE Consent Form UW WIRB SOP WIRB Review HSD Procedures WIRB Fee Schedule 2014 WIRB Clinical Pharmacology Unit Services Brochure WIRB Clinical Pharmacology Unit Fee Schedule TEMPLATE Consent Form UW WIRB Clinical Pharmacology Unit CPU Cancer Consortium REQUEST AUTHORIZATION UW CC IRB REQUEST TRANSFER UW CC IRB FDA Drugs Devices Biologics SOP FDA Regulated Research WORKSHEET FDA Devices and the IDE Requirement WORKSHEET FDA Drugs and the IDE Requirement SUPPLEMENT Devices SUPPLEMENT Drugs Biologics Botanicals CHECKLIST Determination Device Risk SOP Humanitarian Use Device SOP Expanded Access SOP Single Patient Emergency Use SOP Device Compassionate use INSTRUCTIONS and NOTIFICATION Compassionate Use Device INSTRUCTIONS and NOTIFICATION Emergency Use Device INSTRUCTIONS and NOTIFICATION Emergency Use Drug or Biologic TEMPLATE Consent Form Emergency and Compassionate Use Emergency Medicine SOP Emergency Medicine Consent Exception Genetics Research SUPPLEMENT Genetic Research SOP GWAS dbGaP SUPPLEMENT GWAS dbGaP Case Reports WORKSHEET Case Reports DIAGRAM Case Report IRB and HIPAA Requirements back to top 6 Additional Regulatory Requirements Specific Federal Agencies and Their Requirements See FDA Regulated Research in 5 Types of Research and Activities SOP Department of Defense CHECKLIST Department of Defense DOD SUPPLEMENT Department of Defense Involvement SOP Department of Energy Research CHECKLIST Department of Energy SOP Environmental Protection Agency Research CHECKLIST Environmental Protection Agency SOP Department of Justice Research CHECKLIST Department of Justice SUPPLEMENT Department of Justice HIPAA HIPAA and Research HIPAA Responsibilities of the IRB and HSD TEMPLATE HIPAA Authorization SUPPLEMENT Waiver Request HIPAA Authorization Clinical Trials Registration ClinicalTrials gov Instructions for Responsible Party and Releasing a Study Record ClinicalTrials gov Instructions for Registering Your Trials ClinicalTrials gov Instructions for Updating a Study Record Every 6 Months ClinicalTrials gov Results Registration ClinicalTrials gov Q A for Registering Studies ClinicalTrials gov Transferring a Study Record from NIH to the UW Investigator GWAS data and NIH dbGaP Database SOP GWAS dbGaP SUPPLEMENT GWAS dbGaP Other Regulations Federal and State See Federal Training

    Original URL path: http://www.washington.edu/research/hsd/policy (2014-06-24)
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  • GIM 17 - Administrative Review of Cooperative Agreements
    sequence has been followed These typically involve collaboration between employees of the University and the cooperating agency without specific assignment of facilities to the cooperative effort Still other agreements involve more substantial levels of cooperation including provision within University facilities of office and laboratory space as well as certain services to employees of the cooperators A number of significant fiscal and academic considerations are involved Judgments as to whether and under what conditions the University will enter into such agreements must be made on the soundest basis possible These agreements formal in nature and if not for a specified period of time terminable by either party upon written advance notice to the other generally have their origin in informal discussions on the departmental level between professional colleagues at the University and the institutions involved While each agreement may differ in detail depending upon the stated purpose and particular circumstances each must comply with the laws of the State of Washington and University policies A set of guidelines posed as a series of questions has been developed by the Office of Sponsored Programs to assist in the preparation and review of cooperative agreements A copy is attached and is referred to in the succeeding paragraphs In order to clarify the procedure as to how these agreements are to be handled administratively within the University the following guidelines are presented Faculty members who anticipate preparation of a cooperative agreement or an affiliation agreement are encouraged to consult the Office of Sponsored Programs for assistance in drafting the agreement and for advice as to the most desirable sequence of actions This consultation and advice will be based on the University s Guidelines for Review of Proposed Cooperative Agreements Guidelines Upon completion of the agreement four copies are to be signed on behalf of

    Original URL path: http://www.washington.edu/research/osp/gim/gim17.html (2014-06-24)
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  • GIM 14: Delegation of PI Signature Authority for Financial Transactions on Sponsored Projects
    acquire goods and or services for use on a sponsored project Effective budgeting appropriate expenditure procedures and oversight should minimize the need to transfer expenditures However if expenditures do require transfer the PIs may delegate the approval for the transfer of expenditures see GIM 15 Transfer of Expenditure Between Budgets Individual PIs or their units may at their discretion implement more stringent controls such as authorization limits See Attachment A The following minimum criteria are essential when delegating this authority The individual and or position to which the signature authority is delegated should have direct knowledge of the needs of the project i e how a specific purchase benefits or is needed by the project or written instructions from someone who does have such knowledge Documentation of Delegation The delegation of signature authority must be made in writing or email prior to any individual or position other than the PI initiating approving acquisition of goods and services The written document or a copy of the email must be maintained at the appropriate organizational level i e college department division etc where administrative budget records are maintained for the budget number assigned to the sponsored project One authorizing memo or email should be used for each budget number unless the same delegation criteria and individual are used among more than one budget number For example if a lab is supported by 5 sponsored projects with essentially the same personnel working on all 5 projects and the PI wishes to delegate signature authority to the same individual s and or positions for each project then one written delegation document or one email is sufficient The delegation document must be revised and updated as individuals and budget numbers change Limits of Delegation Faculty may not delegate signature certification authority for approval of their Faculty Effort Certification FEC Reports Principal Investigators may not delegate signature authority for Grant and Contract Certification Reports GCCR The FEC and GCCR forms represent the University s method for complying with the federal requirements for certifying that payroll distributions represent a reasonable reflection of actual effort directed towards individual sponsored projects FEC It is appropriate that only the faculty identified on the FEC report document and certify his her effort distribution reported on the FEC form The Dean Director or Chairperson having suitable means of verification that the work was performed first hand knowledge memo or email from the faculty may certify in the absence of the faculty GCCR It is the responsibility of the PI to certify the GCCR In rare instances when the PI is not available to certify in a timely manner the Dean Director or Chairperson having suitable means of verification that the work was performed first hand knowledge memo or email from the PI may certify in the absence of the PI Cost shared effort for non faculty Cost shared non faculty salaries effort is subject to the same certification standards as non faculty salaries charged directly to sponsored awards For this reason any

    Original URL path: http://www.washington.edu/research/osp/gim/gim14.html (2014-06-24)
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  • GIM 35 - Effort Reporting Policy for Sponsored Agreements
    grant effort both paid and committed as a percentage of total University effort Faculty generally have responsibilities for such activities as non sponsored research instruction administration service or clinical activity that would preclude their devoting 100 effort to sponsored activities Proposal preparation for new and competing renewals would also preclude faculty from devoting 100 time to research Accordingly faculty department administrators and department chairs should assure each reporting period including summer for those on a quarterly reporting period that there are no other activities required of the faculty member that would reduce the effort available for sponsored activities during that period Salary support for teaching administration service clinical activity institutional governance and proposal preparation effort must come from non sponsored funds see note below except for normal scholarly activity during summer time outside of the main nine month Academic year and sponsored projects specifically awarded for those purposes Although all university activities must be included in a faculty member s effort for reporting purposes not all of a faculty member s professional activities must necessarily be considered university activities For example outside professional work and volunteer community or public service are types of activity that would normally be deemed non university activities Interdepartmental consulting for which supplemental compensation is paid and service on review panels or other advisory activities for federal sponsors that include an honorarium and or travel reimbursement are also considered outside of total effort Activities other than research instruction administration service clinical activity and proposal writing that in the reasonable judgment of the faculty member in consultation with the chair or designee in accordance with 24 57 c of the University Handbook are over and above and separate from his or her assigned university responsibilities may also be excluded from effort for reporting and salary allocation purposes Note The policies stated above are based on the usual and customary circumstances Unusual circumstances may arise in which special treatment of a particular activity may be warranted but such special treatment should be approved in writing in advance by the Provost or designee Faculty partially without salary WOS From time to time a faculty member may become partially or fully without salary WOS due for example to loss of sponsor funding If a loss of sponsor funding occurs the faculty member will need to determine how to approach his her total UW effort In some instances although receiving less than his her base salary a faculty member may elect to continue working at the same total level of effort as s he was working prior to the WOS status distributing the time to other remaining funded activities In other instances the faculty member may elect to reduce his her effort to a level commensurate with the reduced salary It is critical that faculty work with their department administrative staff to understand in advance the impacts on effort and salary distributions resulting from the option chosen Whatever option is selected faculty paid from or having committed effort on sponsored projects

    Original URL path: http://www.washington.edu/research/osp/gim/gim35.html (2014-06-24)
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  • GIM 2 - Fiscal Responsibilities on Grant and Contract Accounts
    are as follows Principal Investigator Develops an over all plan for the commitment of grant and contract funds working with the authorized person s in the department or college and consulting other University officers as appropriate Initiates expenditures to be charged against the grant or contract account Supervises expenditure of grant or contract funds to assure That funds are used only for purposes directly related to the activity supported That expenditures are consistent with all special terms conditions or limitations that apply to expenditures under the particular grant or contract That expenditures do not exceed the total funds authorized for a given period under the grant or contract In many cases the grant or contract may also specify expenditure limits by budget category or line item Assumes accountability for deficits or disallowances that occur under a grant or contract account Chairman Director or Dean Establish systematic procedures in the college for supervision of grant and contract accounts Provide reasonable coordinated administrative support for the management of grant or contract accounts Consult with principal investigator concerning the resolution of a deficits or disallowances incurred on a grant or contract account and fix responsibility for settling the problem quickly Grant and Contract Accounting Office Provides principal investigator with detailed monthly report of grant or contract expenditures and encumbrances Provides principal investigator with information about any special terms conditions or limitations that apply to each grant or contract account Consults on specific questions about the propriety of a given expenditure on budget monitoring techniques and on other such matters Monitors certain types of grant related transactions on a sampling basis to assure consistency with sponsor and University policies Provides required fiscal report to sponsoring agencies If a deficit or disallowance occurs under a grant or contract account the principal investigator in consultation with

    Original URL path: http://www.washington.edu/research/osp/gim/gim2.html (2014-06-24)
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