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        <ExplanationTxt>Subrecipient Monitoring Policy-medical research subawards-BRI has formal policies and procedures to assure full compliance with applicable policies and laws governing Federal Grants. The Subrecipient Monitoring Policy provides assurance that subrecipients comply with Federal Grant regulations. This policy sets the criteria to establish eligibility of subrecipients to provide annual audited financial reports and the annual OMB single audit report that identify compliance with federal laws and regulations. The reports are analyzed with emphasis on auditors assessment of subrecipient internal controls and a standardized Risk Assessment is presented to management on each subrecipient. A Management Letter is issued to each subrecipient showing any findings on their OMB single audit report, and measurements are set for increased monitoring when an elevated level of risk is established. Management has communicated with an educated administrative staff regarding implementation of this policy. The Director of Grants and Contracts is responsible for monitoring subrecipient adherence to financial regulations. The principal investigator is responsible for overseeing the satisfactory performance of the sub-award to ensure that goals are achieved. Unusual or unforeseen items will be investigated.</ExplanationTxt>
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        <ExplanationTxt>Purposes to currently refund WEDFA Series 2006C bonds issued 11/15/2006, and to fund research facility improvements.</ExplanationTxt>
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        <ExplanationTxt>Difference between Part I, column e and Part II, Line 3 is investment earnings.</ExplanationTxt>
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        <FormAndLineReferenceDesc>Form 990, Part III, Line 1</FormAndLineReferenceDesc>
        <ExplanationTxt>Benaroya Research Institute at Virginia Mason BRI is a world-renowned medical research institute whose work has resulted in major advances against autoimmune and immune-mediated diseases. BRI is affiliated with the Virginia Mason Health System, that provides governance oversight and development support by its division the Virginia Mason Foundation. In 2015, BRI researchers generated 78 scientific publications that were published in prestigious research journals and delivered 75 presentations at domestic and international research conferences. One in 20 Americans suffers from one or more autoimmune diseases, such as type 1 diabetes, multiple sclerosis, Crohns disease and rheumatoid arthritis to name a few, and more than one out of every four Americans suffer from diseases of the immune system, such as allergies and asthma. Because these diseases are connected in the way the immune system attacks the body, BRI scientists arent focused on eliminating one or two immune system diseases - they are taking on many more. As a world leader in scientific innovation, BRIs discoveries are having significant impact on people living with these diseases today - by improving the ability to predict disease risk, decreasing disease progression and making therapies safer and better.</ExplanationTxt>
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        <FormAndLineReferenceDesc>Form 990, Part III, Line 4</FormAndLineReferenceDesc>
        <ExplanationTxt>One of the unique qualities of BRI is the close integration of three types of medical research - laboratory research, translational research and clinical research - to improve peoples lives. Our scientists can address both the basic science issues and clinical applications, which is the best way to design studies with the highest potential for success. For BRI, discovery starts in the laboratory. 2015 advancements in translational research, immunology, clinical research and other areas are highlighted below.</ExplanationTxt>
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        <FormAndLineReferenceDesc>Form 990, Part III, Line 4a</FormAndLineReferenceDesc>
        <ExplanationTxt>Funding for the Immune Tolerance Network ITN was awarded to BRIs Dr. Jerry Nepom in 2014 from the National Institute of Allergy and Infectious Disease NIAID of the National Institutes of Health NIH. The 7-year award, totaling 27 million annually supports the ITN, a research consortium established in 1999 with a primary focus on the development of new tolerogenic approaches for the treatment and prevention of disease in three clinical areas asthma and allergic diseases autoimmune diseases and immune-mediated rejection of transplanted solid organs, tissues and cells. As the Prime recipient of this grant BRI is responsible for the management of the overall grant from NIAID including oversight of all aspects of the Networks infrastructure. The major activities in 2015 were diverse, but centered on preserving the ITNs cohesive project focused environment and its framework which has proven so successful in the management of a large cooperative agreement grant. Key outcomes in 2015 include the following 1 Cross Network Integration A top priority in this reporting period was to continue the successful ITN infrastructure which is spread across three main operational sites. This required careful planning and collaboration as the ITNs major centers of operations are geographically diverse, located in Seattle, San Francisco and Bethesda. Very few changes were made to the existing network integration as the current model continues to successfully support the overall ITN program. Establishing new relationships and vital connections within the research community continued to be an ITN goal. 2 Operations and Clinical Trial Support The ITN program team at BRI issued 168 subawards in 2015 in support of 24 active ITN clinical trials and numerous supporting ITN mechanistic trials. 3 Supplemental Funding / Partnerships ITN central administration continued to focus on identifying additional opportunities for supplemental funding and/or funding partnerships. a Supplemental Funding Opportunities The ITN Program Team at BRI submitted three supplemental funding requests in 2015. All three were awarded bringing in additional funding to the ITN BRI. b Partnerships The ITN continued its relationship with pharmaceutical partners for partial funding for two ITN studies with NIAID as the clinical sponsor. 4 Publication Activity In 2015, 38 ITN publications were published in prestigious research journals and were presented at domestic and international research conferences. These publications represented ITN research in all therapeutic focus areas of the ITN Type 1 Diabetes, Transplant, Autoimmune disease and Allergy and Asthma.</ExplanationTxt>
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        <ExplanationTxt>Translational research is a scientific approach that moves findings from the bench to the bedside and back in an expedient and systematic way. It translates new laboratory discoveries quickly into medical practices. Clinician findings are in turn shared with laboratory scientists to bring medical research full circle. This transfer of knowledge between laboratory scientists and physicians leads to improved patient care, health and well-being. The research emphasis of the BRI Translational Research Program is the area of immune-mediated disease. BRI scientists and collaborators work together to study blood and serum samples along with medical and demographic data collected from people with autoimmune and immune-mediated diseases. These include multiple sclerosis, type 1 diabetes, lupus, rheumatoid arthritis, inflammatory bowel disease, allergy and asthma. BRI maintains an extensive biorepository with samples dating back to 2000, including 7 disease categories and a biorepository of healthy people for comparison purposes. Advancements in 2015 include the following 1 New Biorepository Data Management system - The research technology team at BRI finalized a two-year project to make BRIs data infrastructure more modern, powerful, and flexible. The new system dramatically improves how BRI researchers find, use and analyze information. The team imported data on approximately 9,000 participants and 25,000 samples. All samples and health information used by scientists are de-identified and coded with a number. 2 Connecting Cancer to Immunotherapy Research - In addition to autoimmune disease research, BRI scientists are making advances in other diseases of the immune system. Clinical immunotherapies for cancer treatment are actively being investigated, as well as basic research focused on understanding how aspects of the immune system might be harnessed to fight cancer. In a new collaboration, BRI has partnered with Virginia Mason and Bristol Meyers Squibb in an agreement to develop a new tumor biorepository. It will include tissue, blood samples and demographic data from Virginia Mason cancer patients and will initially focus on archiving biosamples from pancreatic, colorectal, lung and breast tumors. 3 Translational Research Symposium -- the first annual Clinical and Translational Research Symposium, sponsored by the Wilske Center for Translational Research, took place at Virginia Mason Medical Center. The event connected researchers and clinicians by highlighting the range of clinical and translational research being conducted at Virginia Mason and BRI. Of the more than 100 research abstracts submitted, the Wilske committee selected the top eight abstracts for oral presentations. 4 Food Allergy Research -- Funding was received from Food Allergy Research Education FARE to identify and isolate the T cells that cause peanut allergy. The genes used by these T cells will be studied to understand why these cells are causing allergies. This information will then be used to discover how to effectively neutralize these cells and cure peanut allergy. 5 New Translational Research Scientist - Marc Gavin, PhD, joined BRIs Translational Research Program. Dr. Gavins laboratory is focused on understanding how therapeutic manipulation of the balance between regulatory and effector T cells alters immune responses in setting of pathogenic inflammation, chronic infection, and cancer. His group is also investigating how variation in the availability and usage of interleukin-2 impacts the regulatory/effector T cell balance in human autoimmune disease.</ExplanationTxt>
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        <ExplanationTxt>BRI is dedicated to seeking ways to eliminate type 1 diabetes, while at the same time looking for therapies to prevent, reverse and intervene in the disease at all stages. BRI is an international leader in type 1 diabetes research and has investigated it for more than 30 years, starting with identification of a genetic marker for the disease. Progress in 2015 includes 1 Leadership of Diabetes Network -- BRI became the leader of Type 1 Diabetes TrialNet, a National Institutes of Health-funded clinical trial network for type 1 diabetes prevention and early treatment. Carla Greenbaum, MD, director of BRIs Diabetes Research Program, was named chair of TrialNet. BRI also became the TrialNet Hub. The hub includes 21 clinical centers working in cooperation with more than 200 screening and clinical research sites through the United States and seven other countries. 2 EXTEND Study -- A new Immune Tolerance Network ITN type 1 diabetes trial was launched. The principal investigators are BRI scientists Carla Greenbaum, MD, and Jane Buckner, MD. The EXTEND trial Preserving Beta-Cell Function with Tocilizumab in New Onset Type 1 Diabetes will test whether tocilizumab ACTEMRA Genentech, an antibody that targets the interleukin-6 IL-6 receptor, can slow disease progression and help maintain natural insulin production in adults with new-onset type 1 diabetes. There are presently no treatments that can permanently halt or reverse the autoimmune-mediated destruction of insulin-producing beta cells in patients with type 1 diabetes.</ExplanationTxt>
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        <ExplanationTxt>1 Clinical Research Program Benaroya Research Institute oversees all clinical research at Virginia Mason Medical Center and BRI, ensuring consistent application of the federal regulations governing human subject research. The Clinical Research Program CRP includes the BRI Institutional Review Board IRB, which reviews and approves all investigator-initiated clinical research conducted at BRI and the Virginia Mason Medical Center VMMC. The CRP Administrative group CRPA contributes to and maintains a clinical quality assurance program designed to ensure regulatory and financial compliance to applicable regulations and internal policies. The CRPA also maintains a cadre of highly trained clinical research staff who work closely with individual investigators at VMMC. This partnership ensures a consistent and compliant approach to the implementation of clinical studies at VMMC. Active studies span a wide variety of diseases and conditions, including cardiology, neurology, anesthesiology, and cancer. In 2015, CRPA staff enrolled over 5,000 participants into 440 open studies. Approximately 170 research investigators are conducting human subject research at VMMC. The IRB was responsible for the initial or continuing review of over 500 studies. 2 Immunology Research Program a Technology Pipeline --BRI is conducting new research to discover and interrogate the rare cells that cause autoimmune diseases to improve diagnosis and therapy. The Institute is using several of its unique and pioneering technologies together to create a technology pipeline approach to find and study these rare cells. Scientists finding key molecular patterns of the cells in individuals who have immune-mediated diseases and those patterns that determine who responds to treatment. b The Kwok laboratory extended studies of allergic T lymphocytes using tetramer technologies to include description of cells associated with walnut and cat allergies. c Dr. Bettellis laboratory used a model of multiple sclerosis to change the movement of immune cells into the central nervous system, identifying keytrafficking molecules that influence disease progression. d Dr. Peter Linsley, leading BRIs systems immunology group, characterized transcriptional profiles that distinguished immune response patterns for a dozen different tumor types, identifying tumor-specific checkpoints that correlate with the patients prognosis. 3 Matrix Biology Research Program Collaborative studies between investigators in BRIs matrix biology and immunology programs used an oral inhibitor to successfully interrupt deposition of tissue matrix molecules for prevention of autoimmune diabetes in a model system.</ExplanationTxt>
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        <FormAndLineReferenceDesc>Form 990, Part VI, Section A, Line 1a</FormAndLineReferenceDesc>
        <ExplanationTxt>The governing body delegates to an Executive Committee comprised of four officers of the Board and the Chairs of each standing Board Committee, the authority of the Board of Directors in the management of the corporation as may be deemed by the Executive Committee to be appropriate, to be exercised in time periods between regularly scheduled meetings of the Board of Directors provided that the Executive Committee has the authority to act only in time sensitive or emergency situations. The Director and the Executive Director of the corporation serve as ex officio members of the Executive Committee without voting rights. The Executive Committee does not have the authority to amend, alter or repeal the bylaws elect, appoint or remove any member of such Executive Committee or any director or officer of the corporation amend the articles of incorporation adopt a plan of merger or adopt a plan of consolidation with another corporation authorize the sale, lease or exchange of all or substantially all the property and assets of the corporation not in the ordinary course of business authorize the voluntary dissolution of the corporation or revoke proceedings therefore adopt a plan for the distribution of the assets of the corporation or amend, alter or repeal any resolution of the Board which by its terms provides that it shall not be amended, altered or repealed by such Executive Committee. The Executive Committee also serves as the planning committee for the Board of Directors and oversees any compliance issues raised by the Board of Directors.</ExplanationTxt>
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        <ExplanationTxt>Virginia Mason Health System VMHS is the sole corporate member of Benaroya Research Institute at Virginia Mason BRI. VMHS as the sole voting member has the following approval rights a election or appointment of Directors and Officers of the Board of Directors b removal of Directors and Officers of the Board of Directors including any executive officer of the corporation c approval of all long-range and short-range plans proposed by the Board of Directors d approval of the annual capital and operating budgets proposed by the Board of Directors e approval of the borrowing of funds where the amount borrowed is in excess of Five Hundred Thousand Dollars 500,000 f approval of the sale, lease, exchange, mortgage, pledge or disposal of all or substantially all of the property and assets g approval of all amendments to or repeal of the Agreement Association or the Bylaws of the corporation h all other rights and powers as specified in the Washington Nonprofit Corporation Act.</ExplanationTxt>
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        <FormAndLineReferenceDesc>Form 990, Part VI, Section B, Line 11b</FormAndLineReferenceDesc>
        <ExplanationTxt>The Virginia Mason Health System Audit and Compliance Committee ACC, a committee composed of independent community members has been delegated responsibility for oversight of the annual Form 990 preparation process including a selection, engagement, and review of the performance of the independent tax preparer b review of the annual draft Form 990 tax return, and c recommendation of the final Form 990 tax return for review to the BRI Board of Directors. Annually, at the September meeting, management and the tax preparer provides the ACC with an initial draft of the Form 990 and present an overview of the Form 990 preparation process. The final draft Form 990 is reviewed and approved by the ACC in November followed by a Board review of the final Form 990 prior to filing. The final Form 990 tax return is provided to each member of the Board of Directors via electronic delivery.</ExplanationTxt>
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        <ExplanationTxt>The Virginia Mason Health System Governance Committee has been delegated accountability for oversight of the process for disclosure, evaluation and management of conflict of interest involving any member of the Benaroya Research Institute at Virginia Mason BRI Board of Directors, executive leadership or key employees Covered Person. Pursuant to the Conflict of Interest Policy, an annual conflict of interest questionnaire is distributed to all Covered Persons. In addition, a Covered Person has an on-going duty to disclose the existence of a conflict of interest at any time an actual or potential conflict arises. Each Covered Person is required upon appointment and annually thereafter to attest to a statement that affirms that such person has a received a copy of the Conflict of Interest Policy b has read and understands the Policy c has agreed to comply with the Policy and d understands that BRI is a charitable organization and that in order to maintain its federal tax exemption must engage in activities that accomplish its tax-exempt purposes. Written disclosures are reviewed by the Governance Committee to determine if an actual or potential conflict of interest exists and if so, how it should be managed. The Covered Person is informed in writing regarding the determination the Conflict of Interest Management Plan. No Covered Person with an actual or potential conflict of interest shall engage in an activity on BRIs behalf related to the disclosed actual or potential Conflict of Interest unless such activity is permitted by the Conflict of Interest Management Plan or until the Covered Person has undertaken all steps set forth in the Management Plan to manage, reduce or eliminate the conflict. All Covered Persons have a duty to disclose the existence of any actual or potential conflict of interest with respect to meeting agenda items. The Conflict of Interest Policy requires that copies of the Conflict of Interest Questionnaire be completed annually by each covered Person and any Conflict of Interest Management Plan be maintained.</ExplanationTxt>
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        <ExplanationTxt>The VMHS Compensation and Benefits Board Committee, a committee composed solely of independent directors none of whom have a conflict of interest, is accountable for setting reasonable total compensation packages for each executive, officer and key employee Executive consistent with BRIs compensation philosophy and principles. The Committee approves annual goals and performance criteria which are used in determining merit increases and variable compensation opportunities. The Committee assesses performance against these goals. The Committee selects and engages a qualified independent compensation consultant to review and analyze the total compensation and benefits packages of the Executives. The Committee as part of its analysis obtains from the compensation consultant appropriate comparability data including total compensation paid by similarly situated organizations for positions that are functionally comparable to each of the Executives. The Committee will consider the significant terms of the agreement with each Executive including the total compensation to be paid and the employees duties and responsibilities. Consistent with the compensation philosophy and principles, the Committee approves total compensation packages for each of the Executives based on information presented to the Committee, reasonableness and the best interest of BRI. The Committees decisions regarding compensation for each Executive are documented in written resolutions and minutes of the Committee. The Committee promptly reports its actions to the VMHS board which reports are reflected in the Boards minutes. The individual positions who were reviewed in 2015 were the Board Director, Carla Greenbaum, BRI Director, and Executive Director and Chief Financial Officer.</ExplanationTxt>
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        <ExplanationTxt>The organizations Articles, Bylaws, Conflict of Interest Policy and financial statements are made available upon request.</ExplanationTxt>
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