2017-09-27T12:41:56-05:00 2016-12-31 450250958 Eide Bailly LLP 800 Nicollet Mall Ste 1300 Minneapolis MN 554027033 990 2016-01-01 411677920 Minneapolis Medical Research Foundation MINN 6128733386 701 Park Avenue Minneapolis MN 55415 Mary E Bergaas VP of Operations/COO 6128733386 2017-09-21 1 Deb Nelson CPA P01264758 6122536500 2017-09-21 199.116.173.106 2017-09-21 08:05:24 CD P 6C9B1A35775087DBDB8A6D25ECA509C7F6C27838 F6CCFCC9BA9C612BF295D4DB650AF8F15E682770 2016 2021-01-29 14:40:06Z Ajay Israni MD 701 Park Avenue Minneapolis MN 55415 57569853 0 X www.mmrf.org X 1952 MN Improve patient care and the health of our community through research and education. 15 7 250 199 0 0 34191654 33962482 59151 27462 1154075 1301465 39 0 35404919 35291409 0 0 0 0 16988881 16470115 0 0 0 18088685 18045897 35077566 34516012 327353 775397 37126698 39673361 2434364 3582320 34692334 36091041 X Improve patient care and the health of our community through research and education. 0 0 27015181 15717 Clinical Research and Educational Activities: Minneapolis Medical Research Foundation (MMRF) researchers are practicing physicians, scientists and other medical professionals using their expertise to advance medical knowledge and improve the care patients receive. MMRF's programs are diverse with a focus on four areas: Acute Care/Trauma, Addiction, Health Services and Infectious Disease (HIV/AIDS). Participants in MMRF clinical research studies (including traumatic brain injury, substance abuse, dementia, and HIV/AIDS) have access to some of the latest medical treatments available today. In addition to pursuing innovative new therapies, our investigators are training the next generation of scientists and medical professionals, - See Schedule O - General Statement 4603123 11745 Pre-Clinical and Laboratory Research:In the MMRF labs, we study the causes and treatments of disease. Our programs are diverse with a focus on four areas: Acute Care/Trauma, Addiction, Health Services and Infectious Disease (HIV/AIDS). At MMRF, we develop innovative new treatments to solve some of our community's most challenging health problems. Researchers in our labs are MDs, MD/PhDs, PhDs, PharmDs, and other medical and science professionals working to improve the care patients receive. Our investigators also publish regularly in peer-reviewed journals. See Schedule O - General Statement. 31618304 1 1 0 1 0 0 0 0 0 1 1 0 0 0 0 1 1 1 0 0 1 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 1 38 0 250 1 0 0 0 0 0 0 0 0 0 0 X 15 7 0 0 1 0 1 1 1 1 1 0 0 1 1 1 1 1 1 1 0 0 MN X X Mark Willmert 6128733386 701 Park Ave Minneapolis MN 55415 Ajay Israni MD MS Interim President/Investigator 36.70 3.30 X X 0 244353 42678 Jason Baker MD Vice President/Investigator 30.50 9.50 X X 0 212268 37314 Anne Murray MD MS Secretary/Treasurer/Investigator 30.00 10.00 X X 0 196432 35118 Richard King MD PhD Board Chair 0.30 0.00 X X 0 0 0 William Heegaard MD Director/CCO 0.50 39.50 X 0 499190 48035 Larry Kryzaniak Director/CFO 0.10 39.90 X 0 468359 43453 Janine Laird JD Director 0.30 0.00 X 0 0 0 Devdatt Kurdikar PhD MBA Director 0.10 0.00 X 0 0 0 Mark LeSage PhD Director/Investigator 40.00 0.00 X 112632 0 28694 James Miner MD Director/Physician 0.10 39.90 X 0 458963 44779 Jayant Parthasarathy PhD Director 0.10 0.00 X 0 0 0 Dean Rustad Director 0.10 0.00 X 0 0 0 Raymond Sailer Director/Finance 0.40 39.60 X 0 150036 28350 Jana Stender Director 0.10 0.00 X 0 0 0 Mary Tamborino Director 0.10 0.00 X 0 0 0 David Gilbertson Program Co-Director 40.00 0.00 X 185308 0 45118 Mary Bergaas VP of Operations & COO 40.00 0.00 X 175811 0 41967 Jon Snyder Director, Transplant Epidemiology 40.00 0.00 X 144755 0 34307 Mark Willmert Chief Financial Officer 40.00 0.00 X 143711 0 34811 Jiannong Liu Principal Biostatistician 40.00 0.00 X 138821 0 34101 Paul Pentel MD Former President/Investigator 17.80 22.20 X 0 120407 19322 901038 2350008 518047 16 1 1 0 Monash University Victoria 3800 Melbourne AS VIC 3004 Medicine, Nursing & Research Service 8009825 Hennepin Healthcare System 701 Park Avenue Minneapolis MN 55415 Physician Prof. Research Service 2529942 University of Minnesota 200 Oak Street SE Minneapolis MN 55455 Physician Prof. Research Service 799854 Mayo Clinic 200 First Street SW Rochester MN 55905 Physician Prof. Research Service 320503 HealthPartners Inst Education & Researc 8170 33rd Avenue S Minneapolis MN 55425 Physician Prof. Research Service 299395 17 2054127 22353752 9554603 33962482 Seminar & Registration Fees 541900 24040 24040 Human Studies Review 541900 3422 3422 27462 620990 620990 22958919 22278444 680475 680475 680475 35291409 27462 0 1301465 X 374618 285627 88991 12330748 10791658 1539090 916997 792838 124159 2069868 1802442 267426 777884 670302 107582 27575 7840 19735 39060 39060 1000 1000 13792591 13699551 93040 1441649 1346539 95110 68011 50 67961 1076739 861495 215244 554309 548263 6046 38853 35216 3637 1707 345 1362 515659 404572 111087 82643 82643 Subject Expenses 101072 101072 Employee Dev & Training 70962 57933 13029 Meetings and Events 67433 60776 6657 Dues and Subscriptions 55355 50303 5052 111279 100482 10797 34516012 31618304 2897708 0 3042033 4148664 1763708 699847 3544950 2478531 373208 285431 351113 365853 11764734 9849285 2026324 1915449 25122025 28860661 903337 918925 37126698 39673361 2053346 2203852 381018 1378468 2434364 3582320 X 14760121 14935559 5309579 6038290 14622634 15117192 34692334 36091041 37126698 39673361 775397 623310 0 X 0 1 X 1 1 1 X 33376495 33459772 34619393 34191654 33962482 169609796 33376495 33459772 34619393 34191654 33962482 169609796 12230311 157379485 528719 417324 535098 523425 620990 2625556 172235352 370371 0.91370 0.91360 X RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED 0 0 0 0 0 1 1000 0 0 0 1000 0 Schedule C, Part II-B,Line 1f: The Minneapolis Medical Research Foundation (MMRF) paid $2,500 in 2016 to the National Association for Biomedical Research (NABR) for membership dues. The NABR estimates 40% of the membership dues payment is attributable to nondeductible lobbying expense. The NABR is a national, non-partisan, non-profit organization dedicated solely to advocating sound public policy that recognizes the vital role of humane animal use in biomedical research, higher education and product safety testing. The NABR provides the unified voice for the scientific community on legislative and regulatory matters affecting laboratory animal research. 14622634 1118361 419587 204216 15117192 15460922 -357003 267405 213880 14622634 15472283 458504 253278 216587 15460922 13598717 2458958 384412 200980 15472283 12244704 1763974 229625 180336 13598717 1.00000 1 0 7452756 6414054 1038702 4311978 3435231 876747 1915449 X 35317286 25877 25877 35291409 0 35291409 34541889 25877 25877 34516012 0 34516012 Part V, Line 4: All Minneapolis Medical Research Foundation (MMRF) endowments are permanently restricted and are used in accordance with donor intent. Part X, Line 2: The Foundation is exempt from income taxes as a nonprofit corporation under Internal Revenue Service Code Section 501(c)(3) and is an organization that is not a private foundation under the Internal Revenue Code. The Foundation is annually required to file a Return of Organization Exempt from Income Tax (Form 990) with the IRS. In addition, the Foundation is subject to income tax on net income that is derived from business activities that are unrelated to its exempt purpose. The Foundation has determined it is not subject to unrelated business income tax and has not filed an Exempt Organization Business Income Tax Return (Form 990T) with the IRS. The Foundation believes that it has appropriate support for any tax positions taken affecting its annual filing requirements, and as such, does not have any uncertain tax positions that are material to the financial statements. The Foundation would recognize future accrued interest and penalties related to unrecognized tax benefits and liabilities in income tax expense if such interest and penalties are incurred. East Asia and the Pacific - Australia, Brunei, Burma, Cambodia, 0 0 Program services Scientific collaboration with foreign entity. 8009825 Europe (Including Iceland & Greenland) - Albania, Andorra, Austria, Belgium 0 0 Program services Scientific collaboration with foreign entity. 104610 Sub-Saharan Africa - Angola, Benin, Botswana, Burkina, Faso, 0 0 Program services Scientific collaboration with foreign entity. 131499 0 0 0 0 0 0 8245934 0 8245934 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Ajay Israni MD MS Interim President/Investigator 0 240774 0 3399 0 180 0 22328 0 20350 0 287031 0 0 Jason Baker MD Vice President/Investigator 0 209086 0 3062 0 120 0 19037 0 18277 0 249582 0 0 Anne Murray MD MS Secretary/Treasurer/Investigator 0 192714 0 2926 0 792 0 18027 0 17091 0 231550 0 0 William Heegaard MD Director/CCO 0 473140 0 25774 0 276 0 26500 0 21535 0 547225 0 0 Larry Kryzaniak Director/CFO 0 439781 0 27786 0 792 0 26500 0 16953 0 511812 0 0 James Miner MD Director/Physician 0 452479 0 6304 0 180 0 23320 0 21459 0 503742 0 0 Raymond Sailer Director/Finance 0 144893 0 5143 0 0 0 9547 0 18803 0 178386 0 0 David Gilbertson Program Co-Director 184792 0 0 0 516 0 22380 0 22738 0 230426 0 0 0 Mary Bergaas VP of Operations & COO 174287 0 0 0 1524 0 20368 0 21599 0 217778 0 0 0 Jon Snyder Director, Transplant Epidemiology 144577 0 0 0 178 0 16104 0 18203 0 179062 0 0 0 Mark Willmert Chief Financial Officer 143592 0 0 0 119 0 16068 0 18743 0 178522 0 0 0 Jiannong Liu Principal Biostatistician 138560 0 0 0 261 0 15372 0 18729 0 172922 0 0 0 Paul Pentel MD Former President/Investigator 0 116963 0 2408 0 1036 0 10595 0 8727 0 139729 0 0 Schedule J, Part I, Line 3: The Interim President was paid by a related organization, Hennepin Healthcare System (HHS). HHS is a public corporation and subsidiary of Hennepin County, Minnesota, and operates and conducts business as Hennepin County Medical Center (HCMC). HCMC has an established policy and procedure for determining compensation. Form 990, Part III, Programs 4a and 4b: At the Minneapolis Medical Research Foundation (MMRF), our investigators have been translating scientific knowledge into discoveries that make a difference since 1952. We have been actively investigating the causes of and potential treatments for diseases, guided by our mission of improving patient care and the health of our community through research and education. MMRF supports and oversees the medical research carried out at Hennepin County Medical Center (HCMC), Minnesota's premier Level 1 Adult and Pediatric Trauma Center, and an essential teaching and safety net hospital. The wide-range of medical specialites HCMC offers and a diverse patient population enable MMRF investigators to establish cross-disciplinary collaborations to explore new and innovative ways to understand and treat disease. MMRF is one of the largest nonprofit medical research organizations in Minnesota. It supports the work of 193 investigators (MDs, MD/PhDs, PhDs, and PharmDs) and in 2016 administered $34 million in research funds. Funding came from several sources, including the federal government, industry partners, private foundations, and corporate and individual donations. MMRF consistently ranks nationally in the top 10% of institutions receiving funding from the National Institutes of Health (NIH). MMRF researchers are experts in their fields. They conduct basic, translational, clinical, and epidemiologic research with a focus on four subject areas: Acute Care/Trauma, Addiction, Health Services, and Infectious Disease (HIV/AIDS). In 2016, MMRF researchers made significant contributions to the study and practice of medicine in the following specialties: ACUTE CARE/TRAUMA * Cardiac Biomarkers * Cardiopulmonary Resuscitation * Emergency Medicine * Orthopaedics and Biomechanics * Trauma and Burn * Traumatic Brain Injury ADDICTION * Addiction Medicine * Tobacco Treatment Research * Opioid Treatment Research HEALTH SERVICES * Clinical Outcomes Research * Cancer * Children's Issues * Chronic Diseases * Cognitive Issue in Aging/Geriatrics * Diabetes & Obesity * Gastrointestinal & Liver Disease * Heart Disease and Heart Failure * Kidney Disease * Organ Transplantation * Sleep Disorders INFECTIOUS DISEASE * HIV/AIDS The majority of our research projects are translational in nature. Translational research seeks to take discoveries made in a laboratory setting and translate them into therapies physicians can use in their medical practice to improve the lives of patients locally and around the globe. In an environment that emphasizes patient care, research, and teaching, MMRF is at the forefront of discovering solutions to complex medical problems. The work of our investigators is advancing medicine to ensure a healthier future for all members of our community. For more information about MMRF, call 612-873-5300 or visit our website at www.mmrf.org. Form 990, Part III, Program 4a - Continued Statement: inspiring them to carry out MMRF's mission of improving patient care and the health of our community through research and education. Our investigators also publish regularly in peer-reviewed journals. Form 990, Part VI, Section A, line 1 The Minneapolis Medical Research Foundation (MMRF) Executive Committee is comprised of four MMRF directors: Richard King, M.D., Janine Laird, M.D., Anne Murray, M.D., and Ajay Israni, M.D., M.S. The committee is designated by the MMRF directors and has the authority of the Board of Directors to manage the business of the organization in the interval between meetings of the Board of Directors. The Executive Committee is at all times subject to the control and direction of the Board of Directors. Form 990, Part VI, Section A, line 4 The bylaws were amended to change the limit on the number of directors, the nominating process, who serves as ex-officio directors, the term length of directors, who serves as officers of the board, and a change to the title and composition of the Executive Committee of the Board. Form 990, Part VI, Section A, line 6 Hennepin Healthcare System, Inc. (HHS) is the sole member of the Minneapolis Medical Research Foundation (MMRF). HHS is a public corporation and subsidiary of Hennepin County, Minnesota, and operates and conducts business as Hennepin County Medical Center (HCMC). Form 990, Part VI, Section A, line 7a The Minneapolis Medical Research Foundation (MMRF) Board of Directors includes when possible: one member of the Board of Directors of Hennepin Healthcare System, Inc. (HHS) designated by the HHS Board; two directors designated by the HHS CEO from among the executive employees of HHS; and additional directors nominated by the MMRF Board and elected by the HHS Board. Form 990, Part VI, Section A, line 7b Pursuant to Section 2.1 of the Bylaws of the Minneapolis Medical Research Foundation (MMRF), MMRF may not take any of the following actions without receiving Hennepin Healthcare System, Inc. (HHS) approval in accordance with procedures established by HHS's statutory charter and Bylaws: approval of nominees and addition of members to corporation's Board of Directors; adoption of annual or long-range financial plans; adoption of annual operating budgets; adoption of annual capital budgets; adoption or substantial modification of compensation or fringe benefit programs; incurrence of debt; mortgage or encumbrance of any asset; sale, lease, or other disposition of all or substantially all, of corporation's property and assets; amendment of corporation's Articles of Incorporation or Bylaws; and merger or consolidation with any domestic or foreign organization and voluntary dissolution of the corporation. Form 990, Part VI, Section B, line 11b The process Minneapolis Medical Research Foundation (MMRF) uses for review of the annual Form 990 before the Form is sent to the IRS includes an initial review by the Chief Financial Officer and Chief Operating Officer. The Form is then sent to our audit firm for further review and analysis. Prior to the Form 990 being sent to the IRS, the form is reviewed and approved by the Finance Committee and then sent either electronically or in paper form to our Board members and is presented to the Board at the next available meeting to discuss and approve the contents of the Form. Form 990, Part VI, Section B, line 12c See Below on Schedule O for Conflict of Interest Policy Statements Form 990, Part VI, Section B, line 15a The process for determining compensation for the Minneapolis Medical Research Foundation (MMRF) Vice-President of Operations and Chief Operating Officer, includes the Operations Committee reviewing performance and compensation information for comparable positions at similar locations including salary survey information from the University of Minnesota and Minnesota Council of Nonprofits. Minutes of the Operations Committee and subsequent budget approval by the full Board are on file. This process was last undertaken in 2016. The compensation for the MMRF President and Vice-President is paid by a related organization, Hennepin Healthcare System, Inc. (HHS), which is a public corporation and subsidiary of Hennepin County, Minnesota, and operates and conducts business as Hennepin County Medical Center (HCMC). HHS has an established policy and procedure for determining compensation. Form 990, Part VI, Section C, line 19 The Minneapolis Medical Research Foundation (MMRF) Articles of Incorporation are available to the public through the Minnesota Secretary of State, the MMRF bylaws are not. The MMRF conflict of interest policy and the MMRF annual report, which includes financial statements, are available on the MMRF website. Form 990, Part IX, line 11g Subcontract Payments: Program service expenses 12,122,013. Management and general expenses 0. Fundraising expenses 0. Total expenses 12,122,013. Purchased Services: Program service expenses 1,570,528. Management and general expenses 58,728. Fundraising expenses 0. Total expenses 1,629,256. Consulting: Program service expenses 7,010. Management and general expenses 34,312. Fundraising expenses 0. Total expenses 41,322. Form 990, Part VI, Section B, Line 12c: The purpose of Minneapolis Medical Research Foundation's (MMRF) Conflict of Interest (COI) policy is to enable and facilitate the research and education missions of the MMRF by assuming their objectivity and independence from competing financial interests. The stakeholders considered in this policy are the public, our patients and research subjects, the scientific community, the agencies who fund our activities, and our faculty, staff and trainees. An equally compelling purpose is to maintain compliance with all applicable federal and state laws and regulations related to conflicts of interests and with the policies and requirements of the regulatory agencies which oversees our activities, including but not limited to the USPHS and FDA (42CFR50 and 21CFR54.2). Conflict of interest: The specific goal of this policy is to address financial conflicts of interest. For this policy, financial conflict of interest refers to competing financial interests of incentives. Specifically, it is a situation in which a covered individual has financial incentives that may compete with his/her academic or professional interests or obligations. A conflict of interest does not imply wrong-doing or improper relationships, but does require disclosure, evaluation and sometimes mitigation. Appearance of conflict of interest: Some situations fall outside the definition of COI but may raise questions in the mind of a reasonable observer which are best addressed in order to assure that the situation has been considered. The COI committee reserves the right to include such issues of appearance in its deliberations and approaches to managing the financial relationships of investigators. POLICY This policy is applicable to: - all persons appointed, employed by or compensated by the MMRF; - all persons engaged in the conduct of research activities under the auspices of the MMRF who are in a position to influence the design, conduct or reporting of research or other scholarly activity. - all persons who have direct influence over purchasing decisions or contracts made on behalf of MMRF; - all holders of MMRF Research and Education accounts; - all members of MMRF's Board of Directors, members of MMRF's COI Committee, and members of regulatory committees including the IRB, IACUC and the IBC. - For purposes of reporting financial interests under this policy, covered individuals also include a spouse or domestic partner, dependent children and any other family member or member of a covered individual's household whom knows the covered individual knows may personally benefit from actions taken by the covered individual. Covered individuals at MMRF must comply with MMRF's Policy on COI and all applicable federal and state laws related to conflict of interest shall not engage in activities that compromise their professional judgement or compete with the fulfillment of their obligations to MMRF. Relationships constituting a potential COI must be reported to the MMRF COI Committee prior to their initiation. Changes in existing relationships must also be reported before the changes take place. The purpose of this requirement is to avoid COI when possible, or to make all parties aware of the proposed relationship and any possible mitigation requirements. Covered individuals may not participate in relationships with business entities that: - result in payments to the covered individual which are intended to influence how the covered individual conducts institutional activities; - constitute ghost writing (having one's name and institutional affiliation associated with a publication or other article where the covered individual has no substantial input into the publication or article). Authorship should be restricted to those individuals who meet the following criteria: - - made a significant contribution to the conceptualization and/or design or conduct of the project; - - participated in the analysis and interpretation of the data, or other substantial scholarly work; - - participated in drafting, reviewing and/or revising the work; and - - approved the final version of the publication. - involve the covered individual's endorsement of a product or service developed and/or sold by a particular business. This applies to both written and oral endorsements when the product or service relates to the covered individual's institution-related expertise and/or institutional activities, whether or not the individual uses his or her institutional title in making the endorsement; - involve acceptance of gifts of any amount or value from industry doing business or seeking to do business with the MMRF. Examples include but are not limited to pens, pads, other promotional items, cash, food and drink, entertainment such as tickets to events, golf and other sports outings, medical or research equipment, devices or other products or services or discounts on same, use of company vehicles or vacation facilities, hotels, transportation and other travel expenses, stocks, equity, and other such financial offerings, group gifts, textbooks, biological samples, software, computer hardware and accessories, electronic devices such as cell phones, pagers, music and video players, PDA's consulting, financial and other services and office and research supplies. - - It is recognized that there are circumstances when individuals have no control over receipt of gifts and may inadvertently violate this policy, such as attendance at Industry Sponsored professional meetings where a mandatory lunch is provided and there is no practical alternative. Covered individuals must report all external relationships annually via the Report of External Professional Activities (REPA). Annual reporting (via the REPA) is intended to be inclusive of all financial relationships and not confined to relationships relevant to specific ongoing or proposed projects. In addition, when proposing or conducting a specific research project, investigators must identify any financial interests related to that specific research project (via the Compliance Committee Standardized Reporting Form) to ensure that no arrangement has been entered into whereby the value of an ownership interest will be affected by the outcome of the reserach. This includes any financial interests in the sponsor, product or service being tested, or in any direct competitor of the sponsor, product or service being tested. This reporting will be done via the Compliance Committee Standardized Reporting Form found in application materials for the IRB, IACUC and IBC and the Grant and Contract Application for External Support. Substantial changes in a financial or business interest must be reported within 30 days of occurence. In order to make conflict information available to colleagues, collaborators, trainees and research subjects, certain information regarding the conflict situation shall be made available via a publicly accessible website or written response to any requestor within five business days of a request. This shall include, at a minimum, the following: the investigator's name; the investigator's title and role with respect to the research project; the name of the entity in which the significant financial interest is held; the nature of the significant financial interest; and the approximate dollar value of the interest, or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value. This information shall be made available prior to the expenditure of any federal funds and will be updated at least annually or within 60 days of disclosure of a newly identified financial conflict. The information will remain available for at least three years from the date that the information was most recently updated. Where a conflict of interest is identified, the covered individual may be required to follow an approved conflict mitigation plan which provides mechanisms to manage, reduce or eliminate the conflict. When covered individuals participate in sponsored research involving sub-grantees, contractors or collaborators outside the institution, MMRF will take reasonable steps to ensure that these outside associates comply with appropriate conflict of interest reporting, disclosure review and management plan requirements. Appropriate disciplinary action may be taken by the MMRF against covered individuals who violate this policy. Steps will be taken to review disclosures not made in a timely manner for financial conflicts of interest within 120 days of a determination of non-compliance, and management plans will be developed and implemented within 60 days of the retrospective review. Disciplinary actions, in addition to retraining and/or any legal penalty(ies), may include oral admonishment, written reprimand, or reassignment, demotion, suspension, or termination. Form 990, Part VI, Section B, Line 12c Continued: Investigators may also be prohibited from further grant or contract proposal submission or participation in research activities. Policy violations which involve PHS funded projects shall be reported to a reasonable grantee official and shall specify the type of administrative action taken including requesting disclosure addendums to previously published papers if necessary. Policy violations which involve other sponsored funds shall be reported to the sponsor as directed by the terms and conditions of the award. All financial conflict of interest records shall be maintained for at least three years from the date a final expenditure report is submitted for the project or from other dates as specified in the award document or contract. REPORTING AND EVALUATING A COVERED INDIVIDUAL'S RELATIONSHIPS WITH EXTERNAL ENTITIES On an annual basis, all covered individuals must complete a Report of External Professional Activities covering current relationships, those that occurred in the previous year, and those that can reasonably be expected in the next 12 months. The covered individual must report: - financial and/or business relationships and those of immediate family members which relate to or compete with the covered individuals institutional responsibilities including, but not limited to, salary or other payments for services (e.g. consulting fees or honoraria); - equity interests (e.g., stocks, whether publicly traded or not, stock options, or other ownership interests); - intellectual property rights (e.g., patents, copyrights and royalties from such rights); and - other arrangements under which financial benefits have been received (e.g., gifts, loans or services). Reporting will consist of listing the entity with which the relationship exists, or is anticipated in the next 12 months, and the dollar amount. There is no minimum dollar threshold for reporting; all covered financial relationships must be reported. The dollar amount may be reported as a range: up to $4,999; $5,000-$9,999; $10,000-$19,999; $20,000-$99,999 by increments of $20k; $100,000-$250,000 by increments of $50k; and over $250k. If needed to adequately evaluate or manage a conflict, the COI Committee may ask for more detailed information, including information going back as far as three years. Relationships that fall outside MMRF's reporting guidelines, such as those of a non-business or non-financial nature (e.g., close friend, immediate or extended family member), that may create a conflict of interest or that might influence the way a covered individual allocates institutional resources, must be reported and may require consideration by the COI Committee. The COI Committee reserves the right to make further inquiries into the nature of the covered individual's report should additional information be required. The following activities are exempt from these reporting requirements: -Salary, royalties or other remuneration from the covered individual's institution; -Income from activities sponsored by governmental agencies and entities; - Income for serving as special reviewer or on a review panel for governmental agencies or entities; - Travel expenses paid as part of a research project; - Equity interest in mutual funds, pension or other institutional funds whose investment practices are beyond the control of the individual. Covered individuals who are temporarily on a leave of absence, sabbatical or reduced appointment must also report these external relationships. The COI Committee will take into consideration the covered individual's status when reviewing reported information. THE CONFLICT OF INTEREST COMMITTEE The MMRF will maintain a COI Committee to deal with issues concerning this policy. This committee shall be chaired by the President of the Foundation, and shall have the following principle functions: - to assist in the implementation of this policy; - to answer questions concerning this policy (the identity of personnel asking questions and the specific facts of questions shall be kept private to the extent allowed by law); - to review disclosures of conflict of interest; -to develop and approve any plans to manage, reduce or eliminate conflicts; - to recommend to the MMRF Executive Committee of the Board any disciplinary action to be taken under this policy; disciplinary actions to be approved by the MMRF Board of Directors; - upon the request of affected personnel, to review a decision by an administration official that a disclosed situation constitutes an actual conflict of interest; - to periodically review this policy, including the set financial thresholds; and - to work in cooperation with campus compliance officers. This Committee shall be comprised of: the MMRF Executive Committee of the Board (composed of at least four directors including the three Officers of the Board), HCMC's Chief of Clinical Operations, the Chair of Institutional Review Board (IRB) and the Chair of the Institutional Animal Care and Use Committee (IACUC) and a community member to be appointed by the President of the MMRF. Should the Committee require additional expertise, including legal counsel, ad hoc members may be asked to participate as non-voting members. Under certain circumstances, the COI Committee may delegate the review of a conflict of interest disclosure to at least two members of the full COI Committee (the President and/or the Vice President of Operations or another member). This executive review may be used when one or more of the following criteria are met: the financial disclosure is less than $5k; the disclosure involves an anticipated conflict; the proposed project involves minimal risk to humans; the proposed project requires minimal involvement of the conflicted person; the disclosed conflict involves minimal risk to study integrity (study design, generation of data, analysis of data, or presentation of results). Details of the conflict and any necessary mitigation will be documented and a summary or the review and any actions taken will be presented as part of a consent agenda at the next meeting of the full COI Committee. DETERMINING WHETHER A CONFLICT OF INTEREST REQUIRES MANAGEMENT OR ELIMINATION The COI Committee's criteria for evaluating disclosures will include but not limited to 1) risks to research subjects; 2) risks to the scientific integrity of study design, data collection, analysis and reporting; and 3)expected benefits of activity. Whenever a covered individual's activities or relationships are under review by the COI Committee, the covered individual will have an opportunity to provide information to the committee either in person or by submission of a written statement and/or the provision of other written information. MANAGING CONFLICT OF INTEREST When the COI Committee determines that a conflict of interest exists, the committee will evaluate the conflict situation considering factors including: the nature of the activity; the nature of the financial interest; and the potential for the conflict to influence the activity in question. Where research is involved, the committee will evaluate the risk the research poses to research subjects and the degree to which the outcome of the research may be affected by any financial interest. The committee will determine whether the conflict situation 1) can be effectively managed through development and implementation of a conflict mitigation plan; 2) can be managed by changing the covered individual's terms of participation in an institutional activity; or 3) needs to be eliminated. Possible recommendations include approval of the activity as proposed if it is concluded that the potential for conflict is so remote or inconsequential that there is minimal probability for biasing the objectivity of the activity. Form 990, Part VI, Section B, Line 12c Continued: Other possible recommendations are to require periodic peer review of the activity (oversight) by individuals independent of the employee, outside monitors for the activity, divestiture of the financial or business interest, modification of the plan of work, or assignment of different employees without a financial or business interest to control the activity, or limiting the individual's role and responsibilities in the project. To the extent possible and reasonable under the circumstance, and in light of the importance of the activity, the review committees and responsible administrators will work with employees to develop means for the activity to take place while protecting the integrity and reputation of the employees and the MMRF. If the COI Committee determines that a conflict mitigation plan can effectively manage the conflict situation, the committee will work with the covered individual to develop a conflict mitigation plan that will: -describe the circumstances that give rise to the conflict of interest under the institutional policy; - set forth specific mandatory mitigation mechanisms; - set forth a plan for monitoring and follow-up; - address any disclosures required; - require a written confirmation of consent from the covered individual to all requirements of the management plan; - comply with the requirements of any applicable sponsor regulations. When personnel participate in sponsored research involving sub-grantees, contractors or collaborators outside the MMRF, reasonable steps will be taken to ensure that investigators working for these outside entities comply with appropriate conflict of interest disclosure, review, and management requirements. These steps may include requiring the investigators to comply with MMRF's policy or obtaining written assurances from the outside entity that it complies with applicable federal regulations or sponsor policies on conflict of interest. The outcome of the COI Committee deliberations and any mitigation plan(s) will be shared with the covered individual's supervisor/department head. DISCLOSURE OUTSIDE THE INSTITUTION Covered individuals must disclose their conflicts of interest when submitting research reports, reviews, opinion pieces, and letters to the editor or other types of communications for publication. Such disclosures must be made to the audience for educational presentations, and to the responsible reporter or editor for news articles, interviews or press releases. Journal articles and research reports may follow individual journal or funding agency reporting formats. INSTITUTIONAL CONFLICT OF INTEREST Institutions such as the MMRF may have financial conflicts of interest independent of those of specific individuals. Examples include gifts or royalties accruing to the institution rather than to an individual or specific lab or department, or support of institutional educational conferences. Institutional COI raises issues similar to those raised by individual COI, and should be subject to the same scrutiny, disclosure and management procedures. Educational activities - When an educational activity is conducted by MMRF as the sole organizer, these activities may not be supported by funds from vendors doing business with MMRF. When educational activities are co-sponsored by MMRF and other institutions (e.g. Hennepin Health System) which do not have a similar prohibition, the criteria of the Accreditation Council for Continuing Medical Education (ACCME)for COI in continuing medical education must be adhered to by all organizations involved. Gifts - The MMRF may not accept gifts or contributions from vendors with which it conducts business or when the donor has an interest in the research being supported, such as purchasing of common equipment, on an institutional level. This policy would not apply to vendors providing goods or services to individual faculty or staff or laboratories (in which MMRF as an institution does not influence the choice of vendor other than by guaranteeing competitive bidding when required) but would apply to vendors in the case that the MMRF makes purchasing decisions as an institution, e.g. common equipment, biohazard disposal services. An Institutional Conflict Committee consisting of the MMRF COI Committee plus 2 additional external non-institutional members will review all institutional conflicts of interest. The MMRF COO will report all institutional financial conflicts of any amount to the committee for review. Hennepin Healthcare System 701 Park Avenue Minneapolis MN 55415 421707837 Hospital MN 501(c)(3) Line 3 N/A 0 Hennepin Health Foundation 701 Park Avenue Minneapolis MN 55415 410845733 Philanthropic support MN 501(c)(3) Line 12a, I N/A 0 0 0 1 0 0 0 0 0 0 1 1 0 1 1 1 1 1 0 0