{"id":6591,"date":"2017-02-02T09:43:46","date_gmt":"2017-02-02T17:43:46","guid":{"rendered":"https:\/\/www.washington.edu\/research\/?page_id=6591"},"modified":"2026-02-25T13:36:19","modified_gmt":"2026-02-25T21:36:19","slug":"embryonic-stem-cell-research-oversight-escro","status":"publish","type":"page","link":"https:\/\/www.washington.edu\/research\/embryonic-stem-cell-research-oversight-escro\/","title":{"rendered":"Human Embryo and Embryonic Stem Cell Research Oversight"},"content":{"rendered":"<h2><strong>Purpose<\/strong><strong>\u00a0<\/strong><\/h2>\n<p>The Human Embryo and Embryonic Stem Cell Research Oversight (ESCRO) program assures the compliant and ethical conduct of research involving human gametes, human embryos, human embryo models, and the development and study of human embryonic stem cells (hESCs) or human induced pluripotent stem cells (hiPSCs) and their pluripotent derivatives (\u201ccovered research\u201d). ESCRO addresses unique ethical issues specific to stem cell research, such as the use of human embryonic stem cell lines created from the destruction of a human embryo.<\/p>\n<h2><strong>Policies and Guidance<\/strong><\/h2>\n<p>The 乱伦社区 believes that such covered research is essential to expanding fundamental scientific knowledge of cellular and developmental human biology. The University has further concluded that such research offers significant potential to develop treatments for many serious and debilitating human diseases, disorders, and health conditions, including genetic diseases, tissue injuries, spinal cord injuries, degenerative diseases such as heart disease, and various diseases of the nervous system and other organs.<\/p>\n<p>It is the University\u2019s policy to permit and encourage qualified investigators to engage in responsible and ethical research involving covered research.<\/p>\n<p>University Policy\u00a0<a href=\"https:\/\/www.washington.edu\/research\/policies\/gim-36-human-embryonic-stem-cell-research-policy-and-guidelines\/\" target=\"_blank\" rel=\"noopener\">GIM 36<\/a>\u00a0on Human Embryo and Stem Cell (hESC) Research is the governing policy for UW hESC researchers and is based on the following guidance and policy:<\/p>\n<ul>\n<li><a href=\"https:\/\/stemcells.nih.gov\/research-policy\/guidelines-for-human-stem-cell-research\" target=\"_blank\" rel=\"noopener\">NIH Guidelines on Human Stem Cell Research<\/a><\/li>\n<li><a href=\"https:\/\/www.gpo.gov\/fdsys\/pkg\/FR-2009-03-11\/pdf\/E9-5441.pdf\" target=\"_blank\" rel=\"noopener\">Executive Order, March 9, 2009<\/a><\/li>\n<li><a href=\"https:\/\/www.nationalacademies.org\/our-work\/guidelines-for-human-embryonic-stem-cell-research\" target=\"_blank\" rel=\"noopener\">National Academies of Science (NAS) Stem Cell Information Guidelines and Amendments<\/a><\/li>\n<li><a href=\"http:\/\/www.isscr.org\/\" target=\"_blank\" rel=\"noopener\">International Society for Stem Cell Research<\/a>, known as the <a href=\"https:\/\/www.isscr.org\/guidelines\" target=\"_blank\" rel=\"noopener\">ISSCR Guidelines for Stem Cell Research and Clinical Translation<\/a><\/li>\n<\/ul>\n<h2><strong>Human Embryo and Embryonic Stem Cell Research Oversight (ESCRO) Committee <\/strong><\/h2>\n<p>The UW\u2019s Vice Provost for Research establishes the ESCRO Committee, which shall have general authority to review, conditionally approve, require modifications of, or disapprove all human embryo and human embryonic stem cell (hESC) research proposals at the UW requiring review under GIM 36. ESCRO Committee membership reflects the scientific, medical, and ethical expertise necessary to review hESC research applications and includes unaffiliated community members from the public. The ESCRO Committee may from time to time advise and make recommendations to the Vice Provost for Research with respect to legal, ethical and policy issues regarding hESC research. The UW Office of Research will provide necessary administrative support for the ESCRO Committee.<\/p>\n<p>The ESCRO Committee\u2019s review shall be specific to the scientific and ethical issues presented by proposals to use human gametes, human embryos, human embryo models, and the development and study of human embryonic stem cells (hESCs) or human induced pluripotent stem cells (hIPSCs) and their pluripotent derivatives in covered research 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. ESCRO Committee membership reflects the scientific, medical, and ethical expertise necessary to review hESC research applications and includes unaffiliated community members from the public.<\/p>\n<p>The 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 subject\u2019s research, animal research, biological safety, radioactive materials, and environmental safety.<\/p>\n<p>View our <a href=\"https:\/\/www.washington.edu\/research\/escro-committee\/\" target=\"_blank\" rel=\"noopener\">ESCRO Committee<\/a> information on the Committee\u2019s membership, responsibilities, review standards, conflicts of interest, and coordination with UW\u2019s IRB.<\/p>\n<h2><strong>UW Institute for Stem Cell and Regenerative Medicine<\/strong><\/h2>\n<p>The <a href=\"https:\/\/iscrm.uw.edu\/\" target=\"_blank\" rel=\"noopener\">UW Institute for Stem Cell and Regenerative Medicine (ISCRM)<\/a> has been established for the purpose of facilitating and encouraging basic research on hESCs 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 consider such views in making decisions. The ESCRO Committee and ISCRM will strive to cooperate in establishing efficient mechanisms for the review of hESC research proposals and the training of hESC research investigators.<\/p>\n<h2>Policy, Regulation, and Guidance<\/h2>\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">GIM-36<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<ul>\n<li><a href=\"https:\/\/www.washington.edu\/research\/policies\/gim-36-human-embryonic-stem-cell-research-policy-and-guidelines\/\" target=\"_blank\" rel=\"noopener\">GIM-36<\/a><\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">ESCRO Changes<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<h3>What is UW\u2019s Embryo and Embryonic Stem Cell Research Oversight?<\/h3>\n<h4>Why does ESCRO exist \u2013 what makes it unique?<\/h4>\n<p>ESCRO addresses unique ethical issues specific to stem cell research, such as the use of human embryonic stem cell lines created from the destruction of a human embryo.<\/p>\n<p>In late 2007, GIM 36 was born: UW\u2019s policy and guidelines on human embryonic stem cell research.<\/p>\n<p>Then-President Bush allowed very limited federal funding for research on a set of established hESC lines. UW responded by creating GIM 36 in anticipation of further regulation and protection of UW interests:<\/p>\n<ul>\n<li>Use of equipment, supplies, buildings for research involving hESCs ineligible for federal funding;<\/li>\n<li>Types of research that could occur at the UW;\n<ul>\n<li>ESCRO Committee composition and review;<\/li>\n<li>Establishment of registry of hESC lines at UW.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>President Obama allowed more federal funding for research using established hESCs and the creation of an NIH human embryonic stem cell registry still in effect today.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">ESCRO Committee<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<h3><strong>A. INTRODUCTION<\/strong><\/h3>\n<p>The ESCRO Committee\u2019s review shall be specific to the scientific and ethical issues presented by proposals of covered research. The UW\u2019s Vice Provost for Research establishes the ESCRO Committee, which shall have general authority to review, conditionally approve, require modifications of, or disapprove all human embryo and human embryonic stem cell (hESC) research proposals at the UW requiring review under GIM 36. The ESCRO Committee may from time to time advise and make recommendations to the Vice Provost for Research with respect to legal, ethical and policy issues regarding hESC research. The UW Office of Research will provide necessary administrative support for the ESCRO Committee.<\/p>\n<p>The 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 subject\u2019s research, animal research, biological safety, radioactive materials, and environmental safety.<\/p>\n<h3><strong>B. MEMBERSHIP<\/strong><\/h3>\n<p>The Committee is composed of members with scientific education, background, and experience relevant to subject matter described as covered research. Additionally, the Committee contains members from the public unaffiliated to the 乱伦社区, who provide input on public concerns relevant to the research.<\/p>\n<h3><strong>C. RESPONSIBILITIES<\/strong><\/h3>\n<p>The ESCRO Committee\u2019s review shall be specific for the scientific and ethical issues presented by proposals to use human embryo and hESC research in particular research projects. The Committee shall provide, in accordance with GIM 36, scientific and ethical review of proposed human embryo and hESC research including compliance with applicable regulatory requirements and UW policies. Committee responsibilities include:<\/p>\n<ol>\n<li>Review and approve or disapprove all human embryo and hESC at the UW or involving UW personnel requiring institutional review (subject to any other UW approvals that may also be required);<\/li>\n<li>Provide continuing review and approval of all human embryo and hESC research requiring institutional review, including review of progress and similar reports that may be submitted to the UW by investigators conducting human embryo and hESC research.<\/li>\n<li>Confirm that the provenance of relevant tissues and stem cell lines are used in 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 tissues and stem cell lines to verify adherence to basic ethical and legal principles of informed consent and protection of confidentiality;<\/li>\n<li>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;<\/li>\n<li>Prescribe, establish and maintain a registry of hESC lines maintained at the UW;<\/li>\n<li>Prescribe, establish and maintain a database of ongoing human embryo and hESC research at the UW, including information regarding key personnel, the type of human embryo and hESC research, and the tissues and cell lines in use;<\/li>\n<li>Monitor national, state and local ethical, regulatory and policy discussions regarding human embryo and hESC research and from time to time propose modifications to UW policy as needed.<\/li>\n<li>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 human embryo and hESC research proposals; and communication of decisions; and<\/li>\n<li>Facilitate education and training of investigators in the policy, ethical, legal, regulatory, and compliance issues involved in human embryo and human embryonic stem cell research, including recommending minimum compliance training requirements as a condition for participating in human embryo and hESC research.<\/li>\n<\/ol>\n<h3><strong>D. REVIEW STANDARDS<\/strong><\/h3>\n<p>The ESCRO Committee review shall be primarily directed to determining whether proposed human embryo and hESC research is scientifically meritorious and ethically acceptable. The ESCRO Committee shall only approve human embryo and 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 outlined in the Research and Review Categories table or otherwise fails to meet generally accepted ethical principles for the conduct of human embryo and hESC research and other research.<\/p>\n<p>In accordance with the ESCRO Committee\u2019s rules of procedure, an investigator proposing to conduct human embryo and 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 human embryo and hESC lines to be used in the research, and evidence of compliance with other required reviews.<\/p>\n<p>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 human embryo and hESC research. The ESCRO Committee may also establish rules and procedures by which applications may be reconsidered or resubmitted with substantial revisions.<\/p>\n<h3><strong>E. CONFLICTS OF INTEREST<\/strong><\/h3>\n<ol>\n<li><em>Researcher Significant Financial Interests. <\/em><\/li>\n<\/ol>\n<p>All investigators participating in human embryo and hESC research shall disclose personal financial interests in accordance with the UW\u2019s Significant Financial Interest Disclosure Policy, GIM 10. The ESCRO Committee research proposal application shall include questions, comparable to those on the UW\u2019s human subjects research application, representing and affirming compliance with GIM 10 by investigators proposing to participate in hESC research.<\/p>\n<ol>\n<li><em>ESCRO Committee Member Conflicts of Interest. <\/em><\/li>\n<\/ol>\n<p>It shall be the responsibility of each ESCRO Committee member to disclose all personal, financial, and other competing interests, in accordance with the UW\u2019s Significant Financial Interest Disclosure Policy, GIM 10, that could reasonably be seen as affecting the ability of the committee member to impartially discharge the committee member\u2019s 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.<\/p>\n<h3><strong>F. COORDINATION WITH UW INSTITUTIONAL REVIEW BOARD<\/strong><\/h3>\n<p>To ensure consistent and efficient processing of human embryo and hESC research proposals requiring IRB review, the UW Human Subjects Division shall designate a single IRB committee as having exclusive jurisdiction to review all human embryo and 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.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">ESCRO Intellectual Property and Technology Transfer Guidelines<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p>Inventions and Discoveries. Intellectual property and or materials of commercial value created by UW investigators in the course of hESC research will be disclosed to <a href=\"https:\/\/comotion.uw.edu\/\">UW CoMotion<\/a> in accordance with the UW Patent, Invention, and Copyright Policy. All intellectual property arising from human embryo and hESC research shall be managed in accordance with the foregoing policy and the rules and procedures of UW CoMotion 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 human embryo and hESC research in the public domain for broad no-cost dissemination . Provided it does not conflict with any other agreements including funding or internal UW agreements, and is not already under management by UW CoMotion, decisions in such cases shall be made by UW inventors, creators, and\/or authors after appropriate consultations with the principal investigator and co-creators on the research.<\/p>\n<p>Material Transfer Agreements. Incoming and outgoing transfers of human embryo and hESC, hESC lines, hESC derived cell lines, hESC derivatives, and other materials where UW wishes to control downstream usage and further distribution shall be documented through material transfer agreements approved by the <a href=\"https:\/\/comotion.uw.edu\/licensing\/material-transfer-agreements\/\">UW CoMotion MTA Group<\/a>.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Funding and Facilities Guidelines<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<div>According to current U.S. law, research that involves the fertilization of human oocytes or the destruction of human embryos for research purposes, including the derivation of human embryonic stem cell lines, may not be funded with Federal government funds, other than research using hESC lines in the NIH Human Embryonic Stem Cell Registry. At the 乱伦社区, investigators conducting this type of research may do so with non-Federal funds, in facilities and with equipment paid for with non-Federal funds and after seeking and receiving approval to proceed.\u00a0 If you are considering conducting human embryo and\/or hESC research, other than research using HESC lines in the NIH registry, please complete the ESCRO application and Financial Supplement, an attachment to this page.<\/div>\n<div><\/div>\n<div>Contact <a href=\"mailto:escro@uw.edu\">escro@uw.edu<\/a> with questions.<\/div>\n<h3>Cost-Allocation Guidelines:<\/h3>\n<ol>\n<li>Introduction<\/li>\n<li>Financial Definitions<\/li>\n<li>General Cost Allocation Principles<\/li>\n<li>Application of Federal Cost Principles to Specific Resources<\/li>\n<li>Further Questions and Information<\/li>\n<\/ol>\n<h4><strong>1. Introduction<\/strong><\/h4>\n<div>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 must take to ensure that hESC research is compliant with federal law.\u00a0 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 (7) derivatives from hESC research, and (8) data and intellectual property associated with hESC research.<\/div>\n<div><\/div>\n<div>These guidelines are intended to address only those issues presented by current federal hESC research policy.\u00a0 They supplement, but do not replace, other UW financial and accounting policies, rules and procedures.<\/div>\n<div><\/div>\n<h4><strong>2. Financial Definitions<\/strong><\/h4>\n<div>The following shall apply to these cost-allocation guidelines:<\/div>\n<div><\/div>\n<div><strong>Uniform Guidance (2 CFR 200):<\/strong> Principles for Determining Costs Applicable to Grants, Contracts and Other Agreements with Educational Institutions, promulgated by the federal Office of Management and Budget.\u00a0 A document promulgated by the Office of Management and Budget entitled \u201cOffice of Management and Budget Guidance for Grants and Agreements.\u201d<\/div>\n<div><\/div>\n<div><strong>Facilities and Administrative (F&amp;A) costs:<\/strong> Indirect costs incurred for common or joint objectives that cannot be identified readily and specifically with particular sponsored projects and instructional activity or any other institutional activity (Uniform Guidance (2 CFR 200).<\/div>\n<div><\/div>\n<div><strong>Materials, supplies, and other commodities:<\/strong> Consumable goods and reusable items, including laboratory supplies and equipment, with an acquisition cost of less than $5000 and an expected useful life of one year or less.<\/div>\n<div><\/div>\n<div><strong>Non-capitalized equipment: <\/strong>Reusable items, including laboratory supplies and equipment, with an acquisition cost of less than $5000 an expected useful life of more than one year.<\/div>\n<div><\/div>\n<div><strong>Purchased services:<\/strong> Professional contract services, such as the services of consultants, laborers, or maintenance and repair technicians.<\/div>\n<h4><strong>3. General Cost Allocation Principles<\/strong><\/h4>\n<div>The cost principles set out in Uniform Guidance (2 CFR 200) do not prohibit institutions that receive federal support from engaging in \u201cunallowable\u201d activities.\u00a0 Instead, they restrict the use of federal funds to pay for these activities.\u00a0 For example, costs of bad debts, donations and contributions, and entertainment, among others, are unallowable.\u00a0 \u00a0 Even though certain costs are unallowable, the UW and its researchers may still be reimbursed for other allowable expenses incurred in connection with federally supported projects.<\/div>\n<div><\/div>\n<div>Uniform Guidance indicates that federally-supported institutions can avoid the impermissible shifting of costs of unallowable activities to the federal government if it does not either (1) impose the direct costs of such activities on the federal government, or (2) request reimbursement from the federal government for F&amp;A costs associated with unallowable activities.\u00a0 Examples of indirect costs are building depreciation and use allowances, maintenance expenses, library expenses, and student and department administration expenses.<\/div>\n<div><\/div>\n<h5><em>a. Direct Costs<\/em><\/h5>\n<div>To determine if a particular direct cost can be charged to the federal government, the cost must be allowable, reasonable, and allocable to work conducted under federally sponsored agreements, and it must not include any unallowable costs.<\/div>\n<div><\/div>\n<div>Although the direct costs of unallowable activities may not be charged to the federal government, the government will pay its share of resources that are used for both federal and non-federal purposes.\u00a0 Uniform Guidance (2 CFR 200) states that \u201ca cost is allocable to a particular cost objective (i.e., a specific function, sponsored agreement, department, or the like) if the goods and services involved are chargeable or assignable to such cost objective in accordance with relative benefits received or other equitable relationship.\u201d\u00a0 For example, if personnel time or general-purpose laboratory materials are being used for both federally sponsored research and ineligible hESC research, the federal government will pay the cost of that proportion of the resource being used for federally sponsored research.<\/div>\n<div><\/div>\n<div>The process of determining the direct costs of resources used for\u00a0 human embryonic and hESC research does not differ in practice from the allocation process generally used to separate activities that may not be charged to the federal government because they are not associated with a federal agreement.\u00a0 To illustrate, assume that a faculty member divides time and effort as follows:\u00a0 60% to a federally sponsored grant, 15% to teaching and administrative duties, and 25% to ineligible hESC research.\u00a0 In this example, only 60% of the faculty member\u2019s time and effort could be allocated to the federal grant.\u00a0 For cost allocation purposes, it is irrelevant whether the other 40% devoted to performing unallowable\u00a0 hESC research (25%) or other activities that do not benefit the federally sponsored research (15%).\u00a0 In this illustration, none of the 40% time and effort may be charged to the federal government.<\/div>\n<div><\/div>\n<h5><em>b. Indirect Costs<\/em><\/h5>\n<div>In general, UW F&amp;A costs are calculated and allocated to the federal government by multiplying the direct costs of a federal project by the government-approved UW F&amp;A rate.\u00a0 This approach assumes that there is an established relationship between the direct costs of research projects and the F&amp;A costs as reflected in the F&amp;A rate and that it is therefore possible to identify the F&amp;A costs associated with a particular project by applying the predetermined rate to the total amount of direct costs associated with the project.\u00a0 The NIH guidance on hESC research indicates that the indirect costs of\u00a0 hESC research may be included in the regular F&amp;A cost allocation base, and associated indirect costs may be allocated pursuant to ordinary cost allocation principles.\u00a0 The NIH Frequently Asked Questions on these subject states that compliance with these methodologies \u201cwill prevent the shifting of unallowable stem cell research costs to federally sponsored programs.\u201d<\/div>\n<div><\/div>\n<h4><strong>4. Application of Federal Cost Principles to Specific Resources<\/strong><\/h4>\n<div>In addition to obtaining required approvals to conduct human embryo and hESC research, a PI\u00a0 must obtain confirmation from the PI\u2019s school or college that the proposal conforms to the guidelines set out below.\u00a0 These cost-allocation guidelines apply to facilities, equipment, personnel, materials, supplies, non-capitalized equipment, and purchased services, devoted in whole or part to\u00a0 human embryonic and hESC research, regardless of funding source.\u00a0 The schools and colleges are responsible for implementing the guidelines for these specific resources including recharge and cost centers involved in human embryo and hESC research activities.<\/div>\n<div><\/div>\n<h5><em>a. Facilities<\/em><\/h5>\n<div>UW facilities may be used to conduct human embryonic and hESC research only if they are approved for that use in advance.\u00a0 NIH guidance specifically provides that an investigator receiving NIH support may create new hESC derived cell lines and engage in other\u00a0 hESC research providing (i) all direct costs of such activities are allocated to a non-federal funding source, and (ii) the UW has in place a reasonable method of separating costs so that the appropriate F&amp;A costs allocable to the\u00a0 hESC research are allocated to non-federal accounts so as to prevent federal funds from improperly supporting\u00a0 hESC research.\u00a0 Prior to commencing hESC research, the PI must (i) have written confirmation from the school or college that the facility has been approved for use in the conduct of hESC research, and (ii) adhere to any limitations contained in the written approval regarding the usage of facilities and related recordkeeping.\u00a0 The following guidelines apply to the approval of facilities in which hESC research is conducted.<\/div>\n<ol>\n<li>Responsibility for Seeking Approval.\u00a0 The PI retains primary responsibility for seeking approval for facilities to be used in the conduct of hESC research.<\/li>\n<li>Tracking Usage of Facilities.\u00a0 UW\u2019s existing policies and procedures for tracking and confirming the usage of facilities for federally funded research, and the direct and indirect costs associated with that usage, will apply so that only allowable costs are charged to federal grants, and so that the costs of using facilities for other activities, including\u00a0 hESC research, are not supported by federal funds.<\/li>\n<li>Limitations on the Usage of Facilities.\u00a0 UW facilities may be used for\u00a0 hESC research, subject to approval on appropriate conditions.\u00a0 Such conditions may include, for example, limitation on time, allocation of space, or percentage of use and will in any event take into account other commitments for the facilities, if any, to federally sponsored projects and to other UW activities, including non-federally sponsored research.<\/li>\n<li>Use of Multiple Facilities.\u00a0 As part of the approval process, the PI must disclose all locations, both on-campus and off-campus, where any hESC research, will be conducted.<\/li>\n<li>Approval of Changes in Usage of Facilities.\u00a0 Any change in space usage where hESC research is conducted, whether addition or deletion of existing space, or changes in time or percentage of hESC research or usage, is also subject to these guidelines.\u00a0 Changes must be reviewed and approved by the school or college in accordance with usual and customary procedures.<\/li>\n<\/ol>\n<h5><em>b. Equipment<\/em><\/h5>\n<div>UW equipment may be used to conduct\u00a0 hESC research with advance approval of the school or college.\u00a0 According to current NIH guidance, the acquisition of equipment used in the conduct of\u00a0 hESC research may not be federally supported.\u00a0 Federal regulations (Uniform Guidance (2 CFR 200)) contain additional rules that restrict the use of federally-owned equipment or other equipment acquired with federal funds.\u00a0 Prior to commencing hESC research, the PI must (i) have written confirmation from the school or college that the equipment has been approved for use in the conduct of hESC research and (ii) agree to any limitations in the written approval regarding the use of equipment and related recordkeeping.\u00a0 Limitations may involve, for example, restrictions on time or percentage limits on equipment capacity.\u00a0 The following guidelines apply to the approval of equipment to be used in hESC research:<\/div>\n<ul>\n<li>Responsibility for Seeking Approval.\u00a0 The PI retains primary responsibility for seeking approval for equipment, whether existing or proposed for acquisition, to be used in the conduct of hESC research.<\/li>\n<li>Tracking Usage of Equipment.\u00a0 UW\u2019s existing policies and procedures for tracking and confirming the acquisition and usage of equipment for federally funded research, and the direct and indirect costs associated with acquiring and using equipment, will apply so that only allowable costs are charged to federal grants, and so that the costs of acquiring or using equipment for other activities, including\u00a0 hESC research, are not supported by federal funds.<\/li>\n<li>Use of Equipment.\u00a0 The school or college will issue approval as follows:\n<ul>\n<li>Equipment owned by UW. Equipment owned by UW may be used to conduct\u00a0 hESC research if the following conditions are satisfied:\n<ul>\n<li>Acquisition of the equipment was not supported by federal funds, and<\/li>\n<li>Use of the equipment is not subject to any other restrictions, including restrictions imposed by non-federal sponsors.<\/li>\n<li>Equipment owned by the Federal Government.\u00a0 Equipment owned by the federal government may be used in conducting\u00a0 hESC research only in the following circumstances:<\/li>\n<li>Use of the equipment is expressly permitted pursuant to the terms of the federal award under which the equipment was obtained, the terms of an equipment rental agreement, or the approval of the appropriate federal agency; or<\/li>\n<li>UW purchases the equipment from the federal government and has documentation of such transaction, including title transfer.<\/li>\n<\/ul>\n<\/li>\n<li>Equipment owned by UW but Purchased with Federal Support.\u00a0 Equipment owned by UW but acquired, in whole or in part, with federal funds may be used in conducting hESC research only in the following circumstances:<\/li>\n<li>All competitive segments of the federal grant or contract supporting the equipment purchase have been completed and UW retains title to the equipment without restriction, observing any preferences for federal usage; or<\/li>\n<li>Use of the equipment for\u00a0 hESC research is permitted pursuant to the terms of the federal grant or the approval of the appropriate federal agency; or<\/li>\n<li>UW purchases the equipment in full, without federal restriction, and has documentation of such a transaction.<\/li>\n<li>Approval in changes in Usage of Equipment.\u00a0 Any anticipated changes in usage of equipment are also subject to these guidelines.\u00a0 Changes must be reviewed and approved by the schools, and sponsor approval obtained, if required by the sponsor per the terms of the award.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h5><em>c. Personnel<\/em><\/h5>\n<div>All UW personnel participating in hESC research must have prior approval from the UW regardless of whether the research is eligible for federal funding and whether any of the personnel receive federal funding for any purpose.\u00a0 Prior to commencing hESC research, the PI must:<\/div>\n<ul>\n<li>ascertain that any required approvals have been obtained from the ESCRO Committee,<\/li>\n<li>have an approved\u00a0 eGC-1 on file, if funded by an external entity,<\/li>\n<li>and obtain the agreement of all UW personnel participating in the hESC research to follow all UW rules and procedures regarding hESC research, including GIM 36 and these hESC cost-allocation guidelines.\u00a0 In addition to the foregoing, the following rules apply to the approval of personnel to participate in hESC research, regardless of funding source:\n<ul>\n<li>Responsibility for Seeking Approval.\u00a0 The PI shall have primary responsibility for ensuring that approvals are sought and obtained for all personnel participating in hESC research.<\/li>\n<li>Tracking Effort.\u00a0 UW\u2019s existing policies and procedures for tracking and confirming work effort, both direct charged and cost shared, on federally funded research\u00a0 will apply so that appropriate effort is devoted to commitments under federal grants, and so that other activities including\u00a0 hESC research, are not supported by federal funds (See GIM 35 \u2013 Effort Reporting Policy for Sponsored Agreements<\/li>\n<li>Support and Cost Sharing.\u00a0 Non-federal funds may be used to support all hESC research. Efforts expended on\u00a0 hESC research cannot be used to meet cost share commitments to federal projects.<\/li>\n<li>Individuals Holding Multiple Appointments.\u00a0 Many UW personnel have appointments or relationships elsewhere, including with affiliated hospitals and other institutions.\u00a0 The process for approving UW personnel to engage in hESC research will consider in the usual and customary fashion other appointments, relationships, and commitments of such personnel.<\/li>\n<li>Work Benefiting Multiple Research Aims.\u00a0 From time to time certain research activities may require further analysis to determine whether they may be supported in whole, part, or not at all by federal funds.\u00a0 Research activities on approved hESC lines may be supported by federal funds to the extent permitted by the particular grant.\u00a0 On occasion, certain types of activities may be directed to research aims with respect to approved hESC lines and hESC lines not listed on the NIH hESC registry, for example, the development of a reagent of assay that can be used on both types of hESC lines.\u00a0 In such instances, time and effort performing such activities should be allocated in proportion to the benefit each receives.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h5><em>d. Materials, Supplies, Non-Capitalized Equipment, and Purchased Services<\/em><\/h5>\n<div>Materials, supplies, non-capitalized equipment, and purchased services owned or acquired by UW may be used in conducting\u00a0 hESC research.\u00a0 Prior to commencing hESC research, the PI must (i) determine, for cost-allocation purposes, which materials, supplies, non-capitalized equipment, and purchased services were purchase specifically to carry outhESC research, (ii) agree to recordkeeping requirements for tracking the usage of general-purpose materials, supplies, non-capitalized equipment, and purchased services, to ensure that the federal government is not charged for\u00a0 hESC research.\u00a0 \u00a0For acquired materials, supplies, non-capitalized equipment, and purchased services this should be done through\u00a0 appropriate financial accounting methods.\u00a0 The following guidelines apply to the usage of materials, supplies, and purchased services:<\/div>\n<ul>\n<li>Consumable Materials and Purchased Services.<\/li>\n<li>Specific Purchases.\u00a0 If purchased services, such as the services of consultants, laborers, or maintenance\/repair technicians, or purchase materials are used to carry out\u00a0 hESC research, neither the direct costs of those items nor the indirect costs associated with their acquisition may be charged to the federal government.<\/li>\n<li>Use of Materials from General Supply.\u00a0 Materials withdrawn from general supply should be charged at their actual costs \u201cunder any recognized method of pricing inventory withdrawals, consistently applied.\u201d (Uniform Guidance (2 CFR 200).\u00a0 Transportation charges may be included.\u00a0 The PI must track usage and apply a written plan for allocating costs among different projects.\u00a0 In such cases, the indirect cost must be transferred as well.\u00a0 For example, if the PI of a project desires to consume one-half of the cost of existing materials initially purchased with federal funds for $100, then the $50 of the Materials plus the associated indirect costs must be transferred to non-federal sources prior to using or consuming the materials.<\/li>\n<li>Non-Capitalized Equipment.\u00a0 The cost of non-capitalized equipment must be allocated among the projects for which they are used, under a reasonable allocation plan consistent with UW policies.<\/li>\n<\/ul>\n<h5><em>e. Data, Information and Intellectual Property Obtained from hESC Research<\/em><\/h5>\n<div>Researchers may use data, information and intellectual property obtained from any hESC research in subsequent hESC research, regardless of whether the subsequent projects are federally or non-federally funded.\u00a0 However, the federal government may not be charged for generating data for subsequent use in\u00a0 hESC research.\u00a0 These cost-allocation guidelines govern the determination as to whether resources engaged in the generation, analysis, or manipulation of data from hESC research may be charged to the federal government.\u00a0 Any use of data is subject to the usual consideration of third-party intellectual property rights, as well as any specific grant or contract constraints on data usage imposed by the suppliers or sponsors of the data, including other research institutions and federal funding agencies.<\/div>\n<div><\/div>\n<h5><em>5. Further Questions and Information<\/em><\/h5>\n<div>These cost-allocation guidelines are subject to revision in light of any changes in law, rules or regulations.\u00a0 Any questions about these guidelines and their application to specific research projects should be referred through the school or college.\u00a0 I In order that UW personnel do not receiving conflicting or incomplete information, formal inquiries on behalf of UW to federal agencies about the application of federal cost principles to hESC research shall be made through the Office of Sponsored Progams (OSP).<\/div>\n<\/div>\n<\/div>\n<\/div>\n<h2>Forms, Tools, and Resources<\/h2>\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">ESCRO Application Form<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p><a href=\"https:\/\/redcap.iths.org\/surveys\/?s=CPLXWL3HJ4JX797P\" target=\"_blank\" rel=\"noopener\">ESCRO Application Form (for new and amendments)<\/a><\/p>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Amendments to approved applications<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p>Amendments must be submitted by the\u00a0<strong>Principal Investigator<\/strong>. Amendments to approved ESCRO applications include the changes below:<\/p>\n<ul>\n<li>Changes in scientific experiments<\/li>\n<li>Changes to the Principal Investigator<\/li>\n<li>Addition of research ineligible for federal funding<\/li>\n<li>Addition of hESC or hESC like lines<\/li>\n<li>Changes to intended research<\/li>\n<\/ul>\n<p>Use the <a href=\"https:\/\/redcap.iths.org\/surveys\/?s=CPLXWL3HJ4JX797P\" target=\"_blank\" rel=\"noopener\">ESCRO Application Form (for new and amendments)<\/a> to report any changes meeting the above criteria.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Annual Updates &amp; Closed Studies<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p>Annual updates must be submitted by the Principal Investigators (PI) within a month of the annual anniversary of approved ESCRO applications.<\/p>\n<p>PIs that have submitted and received an approval to their ESCRO application will receive a yearly reminder with a link to submit their annual update in order to inform the ESCRO office of the types and sources of cells used in approved embryo and stem cell research.<\/p>\n<p>Closed studies are those that have concluded and where the cell lines and\/or tissue will no longer be used.<\/p>\n<p>The Principal Investigator must send an email to <a href=\"mailto:escro@uw.edu\">escro@uw.edu<\/a> to report a closure to an existing application.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Example of Research and Review Categories<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p><a href=\"https:\/\/uwnetid.sharepoint.com\/:b:\/r\/sites\/escro\/Shared%20Documents\/Forms,%20Tools,%20%26%20Resources\/Research-examples-and-Review-categories.pdf?csf=1&amp;web=1&amp;e=CrZGRF\">Research-examples-and-Review-categories<\/a><\/p>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Financial Supplement Form<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<ul>\n<li><a href=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Financial_Supplement-20July2023.docx\" target=\"_blank\" rel=\"noopener\">Financial Supplement<\/a><\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Frequently Asked Questions<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<ul>\n<li><a href=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Frequently-Asked-Questions.docx\" target=\"_blank\" rel=\"noopener\">Frequently Asked Questions<\/a><\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Terms &amp; Conditions<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<ul>\n<li><a href=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Terms-and-Definitions-page.docx\" target=\"_blank\" rel=\"noopener\">Terms and Definitions<\/a><\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Purpose\u00a0 The Human Embryo and Embryonic Stem Cell Research Oversight (ESCRO) program assures the compliant and ethical conduct of research involving human gametes, human embryos, human&#8230;<\/p>\n","protected":false},"author":34,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"templates\/template-big-hero.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-6591","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - 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