2025-09-23T15:29:27-05:00 2024-12-31 410746749 CLIFTONLARSONALLEN LLP 121 WEST BRIDGE STREET OWATONNA MN 55060 990 2024-01-01 411677920 HENNEPIN HEALTHCARE RESEARCH INSTITUTE HENN 6128733386 701 PARK AVENUE S2100 MINNEAPOLIS MN 55415 KIM MILLER COO 6128733386 2025-09-23 1 0 JUSTIN HARTERT P02236744 5074467100 2025-09-23 2024 2025-03-06 01:10:19Z KIRSTEN L JOHANSEN MD 701 PARK AVENUE S2100 MINNEAPOLIS MN 55415 54725026 0 X HTTP://WWW.HHRINSTITUTE.ORG X 1952 MN IMPROVE PATIENT CARE AND THE HEALTH OF OUR COMMUNITY THROUGH RESEARCH AND EDUCATION. 14 7 266 202 0 0 55200822 52551531 0 0 1899286 2165690 0 0 57100108 54717221 0 0 0 0 23288550 26129366 0 0 0 32122044 27375037 55410594 53504403 1689514 1212818 72662924 75518149 12527529 10600602 60135395 64917547 X IMPROVE PATIENT CARE AND THE HEALTH OF OUR COMMUNITY THROUGH RESEARCH AND EDUCATION. 0 0 44198511 0 0 CLINICAL RESEARCH AND EDUCATIONAL ACTIVITIES:HENNEPIN HEALTHCARE RESEARCH INSTITUTE (HHRI) INVESTIGATORS ARE PRACTICING PHYSICIANS, SCIENTISTS AND OTHER MEDICAL PROFESSIONALS USING THEIR EXPERTISE TO ADVANCE MEDICAL KNOWLEDGE AND IMPROVE THE CARE PATIENTS RECEIVE. HHRI'S RESEARCH SUBJECTS ARE DIVERSE WITH A FOCUS ON ACUTE CARE/TRAUMA, ADDICTION, HEALTH SERVICES, AND INFECTIOUS DISEASES. PARTICIPANTS IN HHRI CLINICAL RESEARCH STUDIES (INCLUDING TRAUMATIC BRAIN INJURY, SUBSTANCE USE DISORDERS, DEMENTIA, CHRONIC DISEASES, 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, INSPIRING THEM TO CARRY OUT HHRI'S MISSION OF IMPROVING PATIENT CARE AND THE HEALTH OF OUR COMMUNITY THROUGH RESEARCH AND EDUCATION. OUR INVESTIGATORS ALSO PUBLISH REGULARLY IN PEER-REVIEWED JOURNALSSEE SCHEDULE O - GENERAL STATEMENT. 5131984 0 0 PRE-CLINICAL AND LABORATORY RESEARCH:IN THE HHRI LABS, WE STUDY THE CAUSES AND TREATMENTS OF DISEASE. OUR RESEARCH SUBJECTS ARE DIVERSE WITH A FOCUS ON ACUTE CARE/TRAUMA, ADDICTION, HEALTH SERVICES, AND INFECTIOUS DISEASES. AT HHRI, 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 ADVANCE MEDICAL KNOWLEDGE AND IMPROVE THE CARE PATIENTS RECEIVE. OUR INVESTIGATORS ALSO PUBLISH REGULARLY IN PEER-REVIEWED JOURNALS SEE SCHEDULE O - GENERAL STATEMENT. 49330495 1 1 0 1 0 0 0 0 0 1 1 0 0 0 1 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 67 0 1 266 1 0 0 0 0 0 0 0 0 0 0 0 0 X 14 7 0 0 0 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 AVENUE S2100 MINNEAPOLIS MN 55415 ANDREW SCHMIDT MD DIRECTOR/PHYSICIAN (UNTIL 6/24) 4.90 27.10 X 0 608540 52155 MICHAEL PUSKARICH MD MS DIRECTOR/PHYSICIAN 7.10 30.90 X 0 513475 60396 MEGHAN WALSH MD MPH FACP DIRECTOR/HHS - CARO 0.20 39.80 X 0 475382 64536 KIRSTEN L JOHANSEN MD PRESIDENT/INVESTIGATOR 29.90 11.10 X X 0 479088 58740 THERESA PESCH RN HHS VP OF PHILANTHROPHY 0.10 39.90 X 0 431214 62880 ERIC LING MD MBA MA DIRECTOR/HHS - CHIEF OF MEDICAL OFFICER 0.10 39.90 X 0 316146 46350 ANNE FROSCH MD DIRECTOR/INVESTIGATOR 27.60 12.40 X 0 279337 53536 WARREN MCKINNEY PHD DIRECTOR/VP FOR EQUITY IN RESEARCH/INVESTIGATOR 40.00 0.00 X X 117100 0 24654 EDWARD P EHLINGER MD MSPH DIRECTOR 0.10 0.00 X 0 0 0 GOPAL KHANNA MBA DIRECTOR 0.10 0.00 X 0 0 0 SIMON SHANNON MBA PHD DIRECTOR 0.10 0.00 X 0 0 0 PRAT VERMA MBA MS DIRECTOR 0.10 0.00 X 0 0 0 RICHARD KING MD PHD BOARD CHAIR (UNTIL 4/24) 0.20 0.00 X X 0 0 0 CONNIE DELANEY PHD RN FAAN BOARD CHAIR 0.20 0.00 X X 0 0 0 MIAJA CASSIDY JD CHC CCEP BOARD VICE CHAIR 0.20 0.00 X X 0 0 0 SERAFIN SAMSON MBA MS SECRETARY/TREASURER 0.50 0.00 X X 0 0 0 MARK WILLMERT CPA INACTIVE HHF/HHRI - VP OF FINANCE 23.70 16.30 X 0 209584 33166 KIM MILLER VP OF OPERATIONS & COO 40.00 0.00 X 177092 0 38973 DAVID GILBERTSON PROGRAM CO-DIRECTOR 40.00 0.00 X 260228 0 54866 RACHEL NYGAARD DIRECTOR/SURGERY RESEARCH 40.00 0.00 X 231903 0 55144 JIANNOUNG LIU DIRECTOR, ANALYSIS 40.00 0.00 X 213572 0 46142 JON SNYDER DIRECTOR, TRANSPLANT EPIDEMIOLOGY 40.00 0.00 X 213084 0 44043 SHULING LI EPIDDEMIOLOGIST & BIOSTATISTICIAN 40.00 0.00 X 174782 0 37706 JASON BAKER MD FORMER VICE PRESIDENT/INVESTIGATOR 28.80 10.20 X 0 294166 56368 AJAY ISRANI MD MS FORMER PRESIDENT/INVESTIGATOR 21.20 18.80 X 0 266063 45030 ANNE MURRAY MD MS FORMER SECRETARY/TREASURER/INVESTIGATOR 32.10 5.90 X 0 218197 41525 1387761 4091192 876210 54 1 1 0 HENNEPIN HEALTHCARE SYSTEM 701 PARK AVENUE MINNEAPOLIS MN 55415 PHYSICIAN PROFESSIONAL RESEARCH 4426996 MONASH UNIVERSITY VICTORIA 3800 MELBOURNE VIC AS 3004 MEDICINE, NURSING, AND RESEARCH 3518531 UNIVERSITY OF MINNESOTA 200 OAK STREET SE MINNEAPOLIS MN 55455 PHYSICIAN PROFESSIONAL RESEARCH 3204737 HEALTHPARTNERS INSTITUTE 8170 33RD AVENUE SOUTH BLOOMINGTON MN 55425 PHYSICIAN PROFESSIONAL RESEARCH 1906070 MAYO CLINIC 200 1ST STREET SW ROCHESTER MN 55905 PHYSICIAN PROFESSIONAL RESEARCH 892601 39 3904315 32150854 16496362 52551531 2173495 2173495 7805 -7805 -7805 -7805 54717221 0 0 2165690 X 400684 261449 139235 19862905 17667077 2195828 1416022 1285362 130660 3218047 2762790 455257 1231708 1111909 119799 67935 61320 6615 55678 55678 1000 1000 21476538 21291724 184814 2730738 2404248 326490 105000 105000 1182024 1004534 177490 541443 537694 3749 61544 61297 247 493867 386006 107861 122691 122691 SUBJECT EXPENSES 216876 216051 825 DEVELOPMENT AND TRAININ 124075 118885 5190 DUES AND SUBSCRIPTIONS 90273 61406 28867 MISCELLANEOUS EXPENSE 58143 51818 6325 47212 45925 1287 53504403 49330495 4173908 0 4680554 4458736 72649 76120 14566562 11450225 407146 556434 13278532 11823222 1800036 1455310 49721299 55460656 1414678 2060668 72662924 75518149 10903428 8324491 479271 369708 1144830 1906403 12527529 10600602 X 32928106 34736810 27207289 30180737 60135395 64917547 72662924 75518149 1212818 3569334 0 X 0 1 X 1 1 1 X 37708720 45253547 54473378 55200822 52551531 245187998 37708720 45253547 54473378 55200822 52551531 245187998 3641882 241546116 952588 2183028 1332737 1700462 2173495 8342310 253530308 0.95270 0.94580 X RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED 0 0 0 0 0 1 1000 0 0 0 1000 0 PART II-B, LINE 1: THE HENNEPIN HEALTHCARE RESEARCH INSTITUTE (HHRI) PAID $2,500 IN 2024 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 TO 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. 19200509 2313891 739980 343732 20430688 17197502 2950699 725243 222449 19200509 21292807 -3322590 543342 229373 17197502 19327501 2726548 507922 253320 21292807 19489098 2476526 429686 208437 19327501 0.00000 1.00000 0.00000 1 0 7134980 6847476 287504 6143552 4975746 1167806 1455310 DUE TO RELATED ENTITIES 1333973 SUBSCRIPTION LIABILITIES 572430 1906403 X 57997108 3569334 7805 3577139 54419969 297252 297252 54717221 53512208 7805 7805 53504403 0 53504403 PART V, LINE 4: ALL HENNEPIN HEALTHCARE RESEARCH INSTITUTE (HHRI) ENDOWMENTS ARE PERMANENTLY RESTRICTED AND ARE USED IN ACCORDANCE WITH DONOR INTENT. PART X, LINE 2: HHRI IS EXEMPT FROM INCOME TAXES AS A NONPROFIT CORPORATION UNDER IRC SECTION 501(C)(3) AND IS AN ORGANIZATION THAT IS NOT A PRIVATE FOUNDATION UNDER IRC. HHRI IS ANNUALLY REQUIRED TO FILE A RETURN OF ORGANIZATION EXEMPT FROM INCOME TAX (FORM 990) WITH THE IRS. IN ADDITION, HHRI IS SUBJECT TO INCOME TAX ON NET INCOME THAT IS DERIVED FROM BUSINESS ACTIVITIES THAT ARE UNRELATED TO ITS EXEMPT PURPOSE. HHRIS HAS DETERMINED IN 2024 THAT IT IS NOT SUBJECT TO UNRELATED BUSINESS INCOME TAX. HHRI 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. HHRI 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. HHRI'S 2021-2024 TAX YEARS ARE OPEN FOR EXAMINATION BY FEDERAL AND STATE TAXING AUTHORITIES. HHRI FILES AS A TAX-EXEMPT ORGANIZATION. SHOULD THAT STATUS BE CHALLENGED IN THE FUTURE, ALL YEARS SINCE INCEPTION WOULD BE SUBJECT TO REVIEW BY THE IRS. PART XI, LINE 2D - OTHER ADJUSTMENTS: ASSET DISPOSAL 7,805. PART XI, LINE 4B - OTHER ADJUSTMENTS: EQUITY TRANSFER 297,252. PART XII, LINE 2D - OTHER ADJUSTMENTS: ASSET DISPOSAL 7,805. EAST ASIA AND THE PACIFIC 0 0 PROGRAM SERVICES SCIENTIFIC COLLABORATION WITH FOREIGN ENTITY. 3532082 EUROPE (INCLUDING ICELAND & GREENLAND) 0 0 PROGRAM SERVICES SCIENTIFIC COLLABORATION WITH FOREIGN ENTITY. 52015 NORTH AMERICA 0 0 PROGRAM SERVICES SCIENTIFIC COLLABORATION WITH FOREIGN ENTITY. 4641 SUB-SAHARAN AFRICA 0 0 PROGRAM SERVICES SCIENTIFIC COLLABORATION WITH FOREIGN ENTITY. 325231 0 0 0 0 0 0 3913969 0 3913969 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 ANDREW SCHMIDT MD DIRECTOR/PHYSICIAN (UNTIL 6/24) 0 604676 0 0 0 3864 0 30360 0 21795 0 660695 0 0 MICHAEL PUSKARICH MD MS DIRECTOR/PHYSICIAN 0 511729 0 0 0 1746 0 30360 0 30036 0 573871 0 0 MEGHAN WALSH MD MPH FACP DIRECTOR/HHS - CARO 0 474111 0 0 0 1271 0 34500 0 30036 0 539918 0 0 KIRSTEN L JOHANSEN MD PRESIDENT/INVESTIGATOR 0 475376 0 0 0 3712 0 30360 0 28380 0 537828 0 0 THERESA PESCH RN HHS VP OF PHILANTHROPHY 0 362996 0 65344 0 2874 0 34500 0 28380 0 494094 0 0 ERIC LING MD MBA MA DIRECTOR/HHS - CHIEF OF MEDICAL OFFI 0 316077 0 0 0 69 0 32923 0 13427 0 362496 0 0 JASON BAKER MD FORMER VICE PRESIDENT/INVESTIGATOR 0 293890 0 0 0 276 0 26404 0 29964 0 350534 0 0 ANNE FROSCH MD DIRECTOR/INVESTIGATOR 0 279157 0 0 0 180 0 25305 0 28231 0 332873 0 0 DAVID GILBERTSON PROGRAM CO-DIRECTOR 259436 0 0 0 792 0 30454 0 24412 0 315094 0 0 0 AJAY ISRANI MD MS FORMER PRESIDENT/INVESTIGATOR 0 264244 0 0 0 1819 0 23720 0 21310 0 311093 0 0 RACHEL NYGAARD DIRECTOR/SURGERY RESEARCH 231723 0 0 0 180 0 27679 0 27465 0 287047 0 0 0 ANNE MURRAY MD MS FORMER SECRETARY/TREASURER/INVESTIGA 0 216673 0 0 0 1524 0 20014 0 21511 0 259722 0 0 JIANNOUNG LIU DIRECTOR, ANALYSIS 212780 0 0 0 792 0 23342 0 22800 0 259714 0 0 0 JON SNYDER DIRECTOR, TRANSPLANT EPIDEMIOLOGY 212808 0 0 0 276 0 23847 0 20196 0 257127 0 0 0 MARK WILLMERT CPA INACTIVE HHF/HHRI - VP OF FINANCE 0 209308 0 0 0 276 0 21099 0 12067 0 242750 0 0 KIM MILLER VP OF OPERATIONS & COO 176576 0 0 0 516 0 18690 0 20283 0 216065 0 0 0 SHULING LI EPIDDEMIOLOGIST & BIOSTATISTICIAN 174266 0 0 0 516 0 18201 0 19505 0 212488 0 0 0 PART I, LINE 3 THE PRESIDENT WAS PAID BY A RELATED ORGANIZATION, HENNEPIN HEALTHCARE SYSTEM, INC. (HHS). HHS IS A PUBLIC CORPORATION AND SUBSIDIARY OF HENNEPIN COUNTY, MINNESOTA. HHS UTILIZES A COMPENSATION COMMITTEE, AN INDEPENDENT COMPENSATION CONSULTANT, A COMPENSATION SURVEY OR STUDY, AND APPROVAL BY THE COMPENSATION COMMITTEE TO DETERMINE SUCH COMPENSATION. FORM 990, PART III, LINES 4A AND 4B: AT THE HENNEPIN HEALTHCARE RESEARCH INSTITUTE (HHRI), OUR INVESTIGATORS HAVE BEEN TRANSLATING SCIENTIFIC KNOWLEDGE INTO DISCOVERIES THAT MAKE A DIFFERENCE SINCE 1952. WE ACTIVELY INVESTIGATE THE CAUSES OF AND POTENTIAL TREATMENTS FOR DISEASES, GUIDED BY OUR GOALS OF ADVANCING MEDICAL KNOWLEDGE AND OUR MISSION OF IMPROVING PATIENT CARE AND THE HEALTH OF OUR COMMUNITY THROUGH RESEARCH AND EDUCATION. HHRI IS PART OF HENNEPIN HEALTHCARE, AN INTEGRATED SYSTEM OF CARE THAT INCLUDES HCMC, A NATIONALLY RECOGNIZED LEVEL 1 ADULT AND PEDIATRIC TRAUMA CENTER AND AN ESSENTIAL TEACHING AND SAFETY NET HOSPITAL. HHRI SUPPORTS AND OVERSEES THE MEDICAL RESEARCH CARRIED OUT AT HCMC. THE WIDE-RANGE OF MEDICAL SPECIALTIES HCMC OFFERS AND A DIVERSE PATIENT POPULATION ENABLE HHRI INVESTIGATORS TO ESTABLISH CROSS-FUNCTIONAL COLLABORATIONS TO EXPLORE NEW AND INNOVATIVE WAYS TO UNDERSTAND AND TREAT DISEASE. HHRI IS ONE OF THE LARGEST NONPROFIT MEDICAL RESEARCH ORGANIZATIONS IN MINNESOTA. IT SUPPORTS THE WORK OF MORE THAN 200 RESEARCH STAFF AND INVESTIGATORS (MDS, MD/PHDS, PHDS AND PHARMDS). IN 2024, HHRI RECEIVED 151 NEW OR RENEWING SPONSORED AWARDS WITH OVER 75% OF FUNDING COMING FROM STATE AND FEDERAL GOVERNMENTS. FUNDING ALSO CAME FROM PRIVATE FOUNDATIONS, INDUSTRY PARTNERS, AND CORPORATE AND INDIVIDUAL DONATIONS. HHRI CONSISTENTLY RANKS NATIONALLY IN THE TOP 10% OF INSTITUTIONS RECEIVING FUNDING FROM THE NATIONAL INSTITUTES OF HEALTH (NIH). HHRI RESEARCHERS ARE EXPERTS IN THEIR FIELDS TACKLING OUR BIGGEST HEALTHCARE CHALLENGES, INCLUDING HIV/AIDS, SUBSTANCE USE DISORDERS, LIFE-THREATENING AND TIME-SENSITIVE CONDITIONS, CHRONIC DISEASES, AND ACCESS TO CARE. THEY CONDUCT BASIC, TRANSLATIONAL, CLINICAL, AND EPIDEMIOLOGIC RESEARCH WITH A FOCUS ON ACUTE CARE/TRAUMA, ADDICTION, HEALTH SERVICES, AND INFECTIOUS DISEASES. IN 2024, HHRI RESEARCHERS MADE SIGNIFICANT CONTRIBUTIONS TO THE STUDY AND PRACTICE OF MEDICINE IN THE FOLLOWING SPECIALTIES: ACUTE CARE/TRAUMA - CARDIAC BIOMARKERS - CARDIOPULMONARY RESUSCITATION - EMERGENCY MEDICINE - FROSTBITE AND BURN - INFECTIOUS DISEASES / SEPSIS - NEUROSURGERY - ORTHOPAEDICS - PULMONARY AND CRITICAL CARE MEDICINE - TRAUMA AND CRITICAL CARE - TRAUMA AND SURGICAL CRITICAL CARE - TRAUMATIC BRAIN INJURY (TBI) - TBI AND CORTICAL SPREADING DEPOLARIZATION (CSD) ADDICTION - ADDICTION MEDICINE - OPIOID TREATMENT RESEARCH - REDUCING THE IMPACT OF TOBACCO-RELATED DISEASES - TOBACCO CESSATION / BEHAVIOR HEALTH - TOBACCO TREATMENT RESEARCH HEALTH SERVICES - BRAIN HEALTH AND CEREBROVASCULAR CARE - CLINICAL OUTCOMES RESEARCH - CANCER - CHILDREN'S ISSUES - CHRONIC DISEASES - DEMENTIA AND AGING - DIABETES AND OBESITY - HEALTH, HOMELESSNESS, AND CRIMINAL JUSTICE - KIDNEY DISEASE - NEPHROLOGY, TRANSPLANTATION AND HEALTH DISPARITIES AND PHARMACOGENOMICS - NEUROLOGY, ALS, AND NEUROPALLIATIVE CARE - ORGAN TRANSPLANTATION INFECTIOUS DISEASES - COVID-19 - HIV / AIDS - HEPATITIS B AND C - IMMUNE THERAPY AND IMMUNOLOGY - MALARIA IMMUNOLOGY - SEXUALLY TRANSMITTED INFECTIONS, HIV PREVENTION 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 PRACTICES TO IMPROVE THE LIVES OF PATIENTS LOCALLY AND AROUND THE GLOBE. IN AN ENVIRONMENT THAT EMPHASIZES PATIENT CARE, RESEARCH AND TEACHING, HHRI IS AT THE FOREFRONT OF DISCOVERING SOLUTIONS TO SOME OF THE MOST COMPLEX MEDICAL PROBLEMS. THE WORK OF OUR INVESTIGATORS IS ADVANCING MEDICINE TO ENSURE A HEALTHIER TOMORROW FOR ALL MEMBERS OF OUR COMMUNITY. FOR MORE INFORMATION ABOUT HHRI VISIT OUR WEBSITE AT WWW.HHRINSTITUTE.ORG. FORM 990, PART VI, SECTION A, LINE 1A THE HENNEPIN HEALTHCARE RESEARCH INSTITUTE (HHRI) EXECUTIVE COMMITTEE OF THE BOARD IS COMPRISED OF FIVE HHRI DIRECTORS: CONNIE DELANEY, PHD, RN, FAAN, FACMI, FNAP, MIAJA CASSIDY, J.D., CHC, CCEP, SERAFIN SAMSON, MBA, M.S., KIRSTEN JOHANSEN, M.D., AND WARREN MCKINNEY, PHD. THE COMMITTEE IS DESIGNATED BY THE HHRI DIRECTORS AND SHALL HAVE THE AUTHORITY OF THE BOARD OF DIRECTORS IN THE MANAGEMENT OF THE BUSINESS OF THE ORGANIZATION IN THE INTERVAL BETWEEN MEETINGS OF THE BOARD OF DIRECTORS, AND THE EXECUTIVE COMMITTEE SHALL AT ALL TIMES BE SUBJECT TO THE CONTROL AND DIRECTION OF THE BOARD OF DIRECTORS. FORM 990, PART VI, SECTION A, LINE 6 HENNEPIN HEALTHCARE SYSTEM INC. (HHS), A RELATED ORGANIZATION, IS THE SOLE MEMBER OF THE HENNEPIN HEALTHCARE RESEARCH INSTITUTE (HHRI). 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 HENNEPIN HEALTHCARE RESEARCH INSTITUTE (HHRI) 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 HHRI BOARD AND ELECTED BY THE HHS BOARD. FORM 990, PART VI, SECTION A, LINE 7B PURSUANT TO SECTION 3.1 OF THE BYLAWS OF THE HENNEPIN HEALTHCARE RESEARCH INSTITUTE (HHRI), HHRI 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 HENNEPIN HEALTHCARE RESEARCH INSTITUTE (HHRI) 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 AND AUDIT 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 HENNEPIN HEALTHCARE RESEARCH INSTITUTE (HHRI) 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 2024. THE COMPENSATION FOR THE HHRI 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. THE PROCESS DESCRIBED HERE WAS LAST COMPLETED IN 2024. FORM 990, PART VI, SECTION C, LINE 19 GOVERNANCE DOCUMENTS ARE AVAILABLE UPON REQUEST. FORM 990, PART VI, SECTION B, LINE 12C (CONTINUED): THE PURPOSE OF THIS POLICY IS TO ENABLE AND FACILITATE THE RESEARCH AND EDUCATION MISSIONS OF THE HHRI (INSTITUTION) BY ASSURING 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 OVERSEE OUR ACTIVITIES, INCLUDING BUT NOT LIMITED TO THE UNITED STATES PUBLIC HEALTH SERVICE (USPHS) AND FEDERAL DRUG ADMINISTRATION (FDA) (42CFR50 AND 21CFR54.2). CONFLICT OF INTEREST. THE SPECIFIC GOAL OF THIS POLICY IS TO ADDRESS FINANCIAL CONFLICTS OF INTEREST (FCOI). FOR THIS POLICY, FINANCIAL CONFLICT OF INTEREST REFERS TO COMPETING FINANCIAL INTERESTS OR INCENTIVES. SPECIFICALLY, IT IS A SITUATION IN WHICH A COVERED INDIVIDUAL (SEE DEFINITIONS, PAGE 12) HAS A RELATIONSHIP WITH AN EXTERNAL ENTITY THAT MAY CREATE FINANCIAL INCENTIVES THAT MAY COMPETE WITH HIS/HER ACADEMIC OR PROFESSIONAL INTERESTS, OBLIGATIONS, OR INSTITUTIONAL RESPONSIBILITIES. A CONFLICT OF INTEREST DOES NOT IMPLY WRONG-DOING OR IMPROPER RELATIONSHIPS, BUT DOES REQUIRE DISCLOSURE, EVALUATION AND SOMETIMES MITIGATION. IN ACCORDANCE WITH APPLICABLE FEDERAL REGULATION NOTED ABOVE, THIS POLICY IS INTENDED TO PROTECT THE DESIGN, CONDUCT AND REPORTING OF RESEARCH CONDUCTED BY HHRI (INCLUDING WORK FUNDED UNDER PHS/NIH GRANTS OR COOPERATIVE AGREEMENTS) FROM BIAS RESULTING FROM FCOIS OF COVERED INDIVIDUALS. 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 (SEE APPENDIX I, HCMC CODE OF CONDUCT FOR ADDITIONAL INFORMATION). THE COI COMMITTEE RESERVES THE RIGHT TO INCLUDE SUCH ISSUES OF APPEARANCE IN ITS DELIBERATIONS AND APPROACHES TO MANAGING THE FINANCIAL RELATIONSHIPS OF INVESTIGATORS. THIS POLICY IS APPLICABLE TO: - ALL PERSONS APPOINTED, EMPLOYED BY OR COMPENSATED BY THE HHRI; - ALL PERSONS ENGAGED IN THE CONDUCT OF RESEARCH ACTIVITIES UNDER THE AUSPICES OF THE HHRI WHO ARE IN A POSITION TO INFLUENCE THE DESIGN, CONDUCT OR REPORTING OF RESEARCH OR OTHER SCHOLARLY ACTIVITY; THIS INCLUDES "INVESTIGATORS" AS DEFINED BY 42CFR50.603 WHICH MEANS THE PROJECT DIRECTOR OR PRINCIPAL INVESTIGATOR OF ANY PHS PROPOSED OR FUNDED RESEARCH AND ANY OTHER PERSON, REGARDLESS OF TITLE OR POSITION, WHO IS RESPONSIBLE FOR THE DESIGN, CONDUCT, OR REPORTING OF RESEARCH FUNDED BY THE PHS, OR PROPOSED FOR SUCH FUNDING, WHICH MAY INCLUDE, FOR EXAMPLE, COLLABORATORS OR CONSULTANTS. - ALL PERSONS WHO HAVE DIRECT INFLUENCE OVER PURCHASING DECISIONS OR CONTRACTS MADE ON BEHALF OF HHRI; - ALL HOLDERS OF HHRI RESEARCH AND EDUCATION ACCOUNTS; - ALL MEMBERS OF HHRI'S BOARD OF DIRECTORS, MEMBERS OF HHRI'S CONFLICT OF INTEREST 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, AND DEPENDENT CHILDREN. COVERED INDIVIDUALS AT HHRI MUST COMPLY WITH HHRI'S POLICY ON CONFLICT OF INTEREST AND ALL APPLICABLE FEDERAL AND STATE LAWS RELATED TO CONFLICT OF INTEREST AND SHALL NOT ENGAGE IN ACTIVITIES THAT COMPROMISE THEIR PROFESSIONAL JUDGMENT OR COMPETE WITH THE FULFILLMENT OF THEIR OBLIGATIONS TO HHRI. RELATIONSHIPS CONSTITUTING A POTENTIAL COI MUST BE REPORTED TO THE HHRI 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 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 HHRI. 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. THE DEFINITIONS OF SIGNIFICANCE PROVIDED THROUGHOUT THIS POLICY PROVIDE THE REGULATORY BASES FOR DISCLOSURE, REPORTING, AND MANAGEMENT OF FINANCIAL CONFLICTS OF INTEREST THAT HHRI MUST ADHERE TO AND ENFORCE AS A RECIPIENT OF PUBLIC HEALTH SERVICE (PHS) FUNDING. HOWEVER, THE INSTITUTION'S DISCLOSURE THRESHOLD IS MORE RESTRICTIVE SINCE IT DOESN'T HAVE MINIMUM THRESHOLDS FOR DISCLOSURE ALL EXTERNAL FINANCIAL INTERESTS MUST BE DISCLOSED. ANNUAL REPORTING 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 RESEARCH. 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 IN THE GRANT AND CONTRACT APPLICATION FOR EXTERNAL SUPPORT. NEW FINANCIAL INTERESTS AND SUBSTANTIAL CHANGES IN A FINANCIAL OR BUSINESS INTEREST (SEE DEFINITIONS, PAGE 12) MUST BE REPORTED WITHIN 30 DAYS OF ACQUISITION OR DISCOVERY. HHRI WILL TAKE ACTION TO REVIEW REPORTED INTERESTS, MAKE A DETERMINATION OF WHETHER THE INTEREST IS RELATED TO PHS/NIH-FUNDED RESEARCH (I.E., THE SFI COULD BE AFFECTED BY THE RESEARCH OR IS IN AN ENTITY WHOSE FINANCIAL INTEREST COULD BE AFFECTED BY THE RESEARCH) AND REPRESENTS AN FCOI (I.E., COULD DIRECTLY AND SIGNIFICANTLY AFFECT THE DESIGN, CONDUCT OR REPORTING OF PHS/NIH-FUNDED RESEARCH), AND REPORT FCOIS TO THE NATIONAL INSTITUTES OF HEALTH (NIH) WITHIN 60 DAYS OF DISCLOSURE IF THE INTEREST IS RELATED TO AN NIH SUPPORTED PROJECT. 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 WEB SITE 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 FORM 990, PART VI, SECTION B, LINE 12C (CONTINUED): 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 OF INTEREST. 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 THAT 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, HHRI 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 HHRI AGAINST COVERED INDIVIDUALS WHO VIOLATE THIS POLICY. WHENEVER A FINANCIAL CONFLICT OF INTEREST IS NOT IDENTIFIED OR MANAGED IN A TIMELY MANNER, INCLUDING: - FAILURE BY THE INVESTIGATOR TO DISCLOSE A SIGNIFICANT FINANCIAL INTEREST THAT IS DETERMINED BY THE INSTITUTION TO CONSTITUTE A FINANCIAL CONFLICT OF INTEREST; - FAILURE BY THE INSTITUTION TO REVIEW OR MANAGE SUCH A FINANCIAL CONFLICT OF INTEREST; OR - FAILURE BY THE INVESTIGATOR TO COMPLY WITH A FINANCIAL CONFLICT OF INTEREST MANAGEMENT PLAN; THE INSTITUTION SHALL, WITHIN 120 DAYS OF THE INSTITUTION'S DETERMINATION OF NONCOMPLIANCE, COMPLETE A "RETROSPECTIVE REVIEW" OF THE INVESTIGATOR'S ACTIVITIES AND THE NIH SUPPORTED RESEARCH PROJECT TO DETERMINE WHETHER ANY NIH SUPPORTED RESEARCH, OR PORTION THEREOF, CONDUCTED DURING THE TIME PERIOD OF THE NONCOMPLIANCE WAS BIASED IN THE DESIGN, CONDUCT, OR REPORTING OF SUCH RESEARCH. HHRI WILL DOCUMENT THE RETROSPECTIVE REVIEW WHICH WILL INCLUDE AT LEAST THE FOLLOWING KEY ELEMENTS: - SPONSOR TYPE, NAME, AND PROJECT NUMBER; - PROJECT TITLE; - PD/PI OR CONTACT PD/PI IF A MULTIPLE PD/PI MODEL IS USED; - NAME OF THE INVESTIGATOR WITH THE FCOI; - NAME OF THE ENTITY WITH WHICH THE INVESTIGATOR HAS A FINANCIAL CONFLICT OF INTEREST - REASON(S) FOR THE RETROSPECTIVE REVIEW; - DETAILED METHODOLOGY USED FOR THE RETROSPECTIVE REVIEW (E.G., METHODOLOGY OF THE REVIEW PROCESS, COMPOSITION OF THE REVIEW PANEL, DOCUMENTS REVIEWED, ETC.); - FINDINGS OF THE REVIEW; AND - CONCLUSIONS OF THE REVIEW. IF BIAS IS FOUND RELATED TO AN NIH SUPPORTED PROJECT, THE HHRI WILL NOTIFY NIH PROMPTLY AND SUBMIT A MITIGATION REPORT. IF THE FCOI WAS PREVIOUSLY REPORTED TO THE NIH, THE MITIGATION REPORT WILL BE SUBMITTED AS A "REVISED FCOI REPORT." THE MITIGATION REPORT WILL INCLUDE, AT A MINIMUM, THE KEY ELEMENTS DOCUMENTED IN THE RETROSPECTIVE REVIEW ABOVE AND A DESCRIPTION OF THE IMPACT OF THE BIAS ON THE RESEARCH PROJECT AND THE HHRI'S PLAN OF ACTION OR ACTIONS TAKEN TO ELIMINATE OR MITIGATE THE EFFECT OF THE BIAS (I.E., IMPACT ON THE RESEARCH PROJECT, EXTENT OF HARM DONE, INCLUDING ANY QUALITATIVE AND QUANTITATIVE DATA TO SUPPORT ANY ACTUAL OR FUTURE HARM; ANALYSIS OF WHETHER THE RESEARCH PROJECT IS SALVAGEABLE). THEREAFTER, HHRI WILL SUBMIT FCOI REPORTS ANNUALLY AS PRESCRIBED BY APPLICABLE REGULATION. OTHER DISCIPLINARY ACTIONS, IN ADDITION TO RETRAINING AND/OR ANY LEGAL PENALTY(IES), MAY INCLUDE ORAL ADMONISHMENT, WRITTEN REPRIMAND, OR REASSIGNMENT, DEMOTION, SUSPENSION, OR TERMINATION. INVESTIGATORS MAY ALSO BE PROHIBITED FROM FURTHER GRANT OR CONTRACT PROPOSAL SUBMISSION OR PARTICIPATION IN RESEARCH ACTIVITIES. AS OUTLINED ABOVE, POLICY VIOLATIONS THAT INVOLVE PUBIC HEALTH SERVICE (PHS) SUPPORTED PROJECTS SHALL BE REPORTED TO A RESPONSIBLE GRANTEE OFFICIAL AND SHALL SPECIFY THE TYPE OF ADMINISTRATIVE ACTION TAKEN INCLUDING REQUESTING DISCLOSURE ADDENDUMS TO PREVIOUSLY PUBLISHED PAPERS IF NECESSARY. POLICY VIOLATIONS THAT 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. THIS INCLUDES ALL RECORDS OF ALL INVESTIGATOR DISCLOSURES OF FINANCIAL INTERESTS AND THE INSTITUTION'S REVIEW OF, OR RESPONSE TO, SUCH DISCLOSURE (WHETHER OR NOT A DISCLOSURE RESULTED IN THE INSTITUTION'S DETERMINATION OF A FINANCIAL CONFLICT OF INTEREST), AND ALL ACTIONS UNDER THE INSTITUTION'S POLICY OR RETROSPECTIVE REVIEW, IF APPLICABLE, AS FOLLOWS: - RECORDS OF FINANCIAL DISCLOSURES AND ANY RESULTING ACTION WILL BE MAINTAINED BY THE INSTITUTION FOR AT LEAST THREE YEARS FROM THE DATE OF SUBMISSION OF THE FINAL EXPENDITURES REPORT OR, WHERE APPLICABLE, FROM OTHER DATES SPECIFIED IN 45 C.F.R. 75.361, AS APPLICABLE, WHICH INCLUDES THE FOLLOWING EXCEPTIONS: - IF ANY LITIGATION, CLAIM, OR AUDIT IS STARTED BEFORE THE EXPIRATION OF THE 3-YEAR PERIOD, THE RECORDS WILL BE RETAINED UNTIL ALL LITIGATION, CLAIMS, OR AUDIT FINDINGS INVOLVING THE RECORDS HAVE BEEN RESOLVED AND FINAL ACTION TAKEN. - WHEN HHRI IS NOTIFIED IN WRITING BY AN HHS AWARDING AGENCY, COGNIZANT AGENCY FOR AUDIT, OVERSIGHT AGENCY FOR AUDIT, COGNIZANT AGENCY FOR INDIRECT COSTS, OR PASS-THROUGH ENTITY TO EXTEND THE RETENTION PERIOD. - WHEN RECORDS ARE TRANSFERRED TO OR MAINTAINED BY THE HHS AWARDING AGENCY OR A PASS-THROUGH ENTITY, THE 3-YEAR RETENTION REQUIREMENT IS NOT APPLICABLE. TRAINING ALL PERSONS ENGAGED IN RESEARCH UNDER THE AUSPICES OF THE HHRI ARE REQUIRED TO COMPLETE TRAINING IN COI PRIOR TO ENGAGING IN ANY RESEARCH THAT INVOLVES HUMAN OR ANIMAL RESEARCH SUBJECTS AND AT LEAST EVERY FOUR YEARS THEREAFTER (OR IN THE CASE OF NIH SUPPORTED RESEARCH BY THE ISSUE DATE OF THE NOTICE OF AWARD OR WITHIN THIRTY DAYS OF BEING NEW TO THE INSTITUTION). IN ADDITION TO THE REQUIRED COI TRAINING NOTED ABOVE, ANY COVERED PERSON DETERMINED TO BE NON-COMPLIANT WITH THE INSTITUTIONAL COI POLICY OR DETERMINATIONS OF THE COI COMMITTEE WILL BE REQUIRED TO REPEAT COI TRAINING IMMEDIATELY (NO LATER THAN 30 DAYS FROM NOTICE OF NON-COMPLIANCE). ADDITIONAL INFORMATION ABOUT INSTITUTIONAL REQUIREMENTS AND INSTRUCTIONS FOR COMPLETING COI TRAINING CAN BE FOUND IN THE HHRI SPONSORED PROGRAMS ADMINISTRATION GUIDANCE AND PROCEDURES MANUAL AND THE HHRI'S HUMAN RESEARCH PROTECTIONS PROGRAM INVESTIGATOR 501 MANUAL. REPORTING AND EVALUATING A COVERED INDIVIDUAL'S RELATIONSHIPS WITH EXTERNAL ENTITIES ON AN ANNUAL BASIS, ALL COVERED INDIVIDUALS MUST REPORT ALL CURRENT EXTERNAL RELATIONSHIPS AND/OR INTERESTS, THOSE THAT OCCURRED IN THE PREVIOUS YEAR, AND THOSE THAT CAN REASONABLY BE EXPECTED IN THE NEXT 12 MONTHS. FOR EXAMPLE, THE COVERED INDIVIDUAL MUST REPORT: - FINANCIAL AND / OR BUSINESS RELATIONSHIPS AND INTERESTS AND THOSE OF IMMEDIATE FAMILY MEMBERS WHICH RELATE TO OR COMPETE WITH THE COVERED INDIVIDUAL'S 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). - REIMBURSED OR SPONSORED TRAVEL 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 AND/OR INTERESTS MUST BE REPORTED. THE DOLLAR AMOUNT MAY BE REPORTED AS A RANGE: $0 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 $50,000 > $250,000 IF NEEDED TO ADEQUATELY EVALUATE OR MANAGE A CONFLICT, THE CONFLICT OF INTEREST COMMITTEE MAY ASK FOR MORE DETAILED INFORMATION, INCLUDING INFORMATION GOING BACK AS FAR AS THREE YEARS. OTHER RELATIONSHIPS AND/OR INTERESTS THAT FALL OUTSIDE OF THE SPECIFIC REPORTING GUIDELINES DESCRIBED HEREIN, SUCH AS THOSE OF A NON-BUSINESS OR NON-FINANCIAL NATURE (E.G., CLOSE FRIEND, IMMEDIATE OR EXTENDED FAMILY MEMBER SEE DEFINITIONS, PAGE 12), THAT MAY APPEAR TO CREATE A CONFLICT OF INTEREST OR THAT MIGHT INFLUENCE THE WAY A COVERED INDIVIDUAL ALLOCATES INSTITUTIONAL RESOURCES, MUST ALSO 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. FORM 990, PART VI, SECTION B, LINE 12C (CONTINUED): THE FOLLOWING FINANCIAL INTERESTS ARE EXEMPT FROM THESE REPORTING REQUIREMENTS: - SALARY, ROYALTIES OR OTHER REMUNERATION FROM THE COVERED INDIVIDUAL'S INSTITUTION; - INCOME FROM ACTIVITIES SPONSORED BY U.S. GOVERNMENTAL AGENCIES OR ENTITIES; - INCOME FOR SERVING AS SPECIAL REVIEWER OR ON A REVIEW PANEL FOR U.S. GOVERNMENTAL AGENCIES OR ENTITIES, OR A UNITED STATES INSTITUTION OF HIGHER EDUCATION, A UNITED STATES ACADEMIC TEACHING HOSPITAL, A MEDICAL CENTER, OR A RESEARCH INSTITUTE THAT IS AFFILIATED WITH A UNITED STATES INSTITUTION OF HIGHER EDUCATION. - TRAVEL EXPENSES PAID BY AN ENTITY LOCATED WITHIN THE U.S. AS PART OF A RESEARCH PROJECT (I.E. IF REIMBURSEMENT IS RECEIVED FROM A FOREIGN INSTITUTION OF HIGHER EDUCATION FOR WORK ON A RESEARCH PROJECT AT THE FOREIGN INSTITUTION, THOSE PAYMENTS ARE NOT EXEMPT FROM THE HHRI'S REPORTING REQUIREMENTS); - EQUITY INTEREST IN MUTUAL FUNDS, PENSION OR OTHER INSTITUTIONAL INVESTMENT FUNDS WHOSE INVESTMENT PRACTICES ARE BEYOND THE CONTROL OF THE INDIVIDUAL. FOR THE AVOIDANCE OF DOUBT, COVERED INDIVIDUALS MUST DISCLOSE ALL FOREIGN FINANCIAL INTERESTS (WHICH INCLUDES INCOME FROM SEMINARS, LECTURES, OR TEACHING ENGAGEMENTS, INCOME FROM SERVICE ON ADVISORY COMMITTEES OR REVIEW PANELS, AND REIMBURSED OR SPONSORED TRAVEL) RECEIVED FROM ANY FOREIGN ENTITY, INCLUDING FOREIGN INSTITUTIONS OF HIGHER EDUCATION OR FOREIGN GOVERNMENTS (WHICH INCLUDES LOCAL, PROVINCIAL, OR EQUIVALENT GOVERNMENTS OF ANOTHER COUNTRY). 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 HHRI WILL MAINTAIN A CONFLICT OF INTEREST COMMITTEE TO DEAL WITH ISSUES CONCERNING THIS POLICY. THIS COMMITTEE SHALL BE CHAIRED BY THE HENNEPIN HEALTHCARE CHIEF COMPLIANCE OFFICER, AND SHALL HAVE THE FOLLOWING PRINCIPLE FUNCTIONS: - TO ASSIST IN THE IMPLEMENTATION OF THIS POLICY; - TO REVIEW DISCLOSURES OF CONFLICT OF INTEREST; - TO DEVELOP AND APPROVE ANY PLANS TO MANAGE, REDUCE OR ELIMINATE CONFLICTS; - TO RECOMMEND TO THE HHRI EXECUTIVE COMMITTEE ANY DISCIPLINARY ACTION TO BE TAKEN UNDER THIS POLICY; DISCIPLINARY ACTIONS TO BE APPROVED BY THE HHRI 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. THIS COMMITTEE SHALL BE COMPRISED OF THE FOLLOWING ORGANIZATIONAL OFFICERS: THE HHRI PRESIDENT, VICE PRESIDENT, SECRETARY/TREASURER, AND VICE PRESIDENT OF OPERATIONS/COO OF THE INSTITUTE, HENNEPIN HEALTHCARE'S CHIEF OF CLINICAL OPERATIONS, THE CHAIR (OR VICE CHAIR) OF THE INSTITUTIONAL REVIEW BOARD (IRB), THE CHAIR OF THE INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC) AND A COMMUNITY MEMBER TO BE APPOINTED BY THE PRESIDENT OF THE INSTITUTE. SHOULD THE COMMITTEE REQUIRE ADDITIONAL EXPERTISE, INCLUDING LEGAL COUNSEL, AD HOC MEMBERS MAY BE ASKED TO PARTICIPATE AS VOTING OR NON-VOTING MEMBERS. UNDER CERTAIN CIRCUMSTANCES, THE CHAIR OF THE CONFLICT OF INTEREST COMMITTEE MAY DETERMINE THAT AN EXECUTIVE-LEVEL REVIEW OF A CONFLICT OF INTEREST DISCLOSURE INVOLVING AT LEAST TWO MEMBERS OF THE FULL CONFLICT OF INTEREST COMMITTEE (I.E. THE CHAIR AND/OR THE VICE PRESIDENT OF OPERATIONS/COO OR ANOTHER MEMBER) IS APPROPRIATE. THIS EXECUTIVE REVIEW MAY BE USED WHEN ONE OR MORE OF THE FOLLOWING CRITERIA ARE MET: THE FINANCIAL DISCLOSURE IS < $5,000; 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 SUCH CONFLICTS AND ANY NECESSARY MITIGATION ADDRESSED VIA EXECUTIVE-LEVEL REVIEW WILL BE DOCUMENTED, AND A SUMMARY OF ANY ACTIONS TAKEN MADE AVAILABLE TO THE FULL CONFLICT OF INTEREST COMMITTEE. DETERMINING WHETHER A CONFLICT OF INTEREST REQUIRES MANAGEMENT OR ELIMINATION THE COI COMMITTEE'S CRITERIA FOR EVALUATING DISCLOSURES WILL INCLUDE BUT NOT BE 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. AN FCOI EXISTS WHEN THE INSTITUTION REASONABLY DETERMINES THAT A COVERED INDIVIDUAL'S SIGNIFICANT FINANCIAL INTEREST IS RELATED TO A PROJECT (I.E., THE SIGNIFICANT FINANCIAL INTEREST COULD BE AFFECTED BY THE RESEARCH OR IS THE SIGNIFICANT FINANCIAL INTEREST IN AN ENTITY WHOSE FINANCIAL INTEREST COULD BE AFFECTED BY THE RESEARCH) AND COULD DIRECTLY AND SIGNIFICANTLY AFFECT THE DESIGN, CONDUCT OR REPORTING OF THE RESEARCH. WHENEVER A COVERED INDIVIDUAL'S ACTIVITIES, RELATIONSHIPS, OR INTERESTS 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. 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 CIRCUMSTANCES, 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 THE REPUTATION OF THE EMPLOYEES AND THE HHRI. EXAMPLES OF CONDITIONS OR RESTRICTIONS THAT MIGHT BE IMPOSED TO MANAGE A COVERED INDIVIDUAL'S FINANCIAL CONFLICT OF INTEREST INCLUDE, BUT ARE NOT LIMITED TO: - PUBLIC DISCLOSURE OF FINANCIAL CONFLICTS OF INTERESTS (E.G., WHEN PRESENTING OR PUBLISHING THE RESEARCH; TO STAFF MEMBERS WORKING ON THE PROJECT; TO THE INSTITUTION'S INSTITUTIONAL REVIEW BOARD(S), INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE(S), ETC; - FOR RESEARCH PROJECTS INVOLVING HUMAN SUBJECTS RESEARCH, DISCLOSURE OF FINANCIAL CONFLICTS OF INTEREST DIRECTLY TO PARTICIPANTS; - APPOINTMENT OF AN INDEPENDENT MONITOR CAPABLE OF TAKING MEASURES TO PROTECT THE DESIGN, CONDUCT, AND REPORTING OF THE RESEARCH AGAINST BIAS RESULTING FROM THE FINANCIAL CONFLICT OF INTEREST; - MODIFICATION OF THE RESEARCH PLAN; - CHANGE OF PERSONNEL OR PERSONNEL RESPONSIBILITIES, OR DISQUALIFICATIONS OF PERSONNEL FROM PARTICIPATION IN ALL OR A PORTION OF THE RESEARCH; - REDUCTION OR ELIMINATION OF THE FINANCIAL INTEREST (E.G., SALE OF AN EQUITY INTEREST); OR - SEVERANCE OF RELATIONSHIPS THAT CREATE FINANCIAL CONFLICTS IN ANY CASE IN WHICH THERE HAS BEEN A DETERMINATION THAT A PHS-FUNDED PROJECT OF CLINICAL RESEARCH WHOSE PURPOSE IS TO EVALUATE THE SAFETY OR EFFECTIVENESS OF A DRUG, MEDICAL DEVICE, OR TREATMENT HAS BEEN DESIGNED, CONDUCTED, OR REPORTED BY AN INVESTIGATOR WITH A FINANCIAL CONFLICT OF INTEREST THAT WAS NOT MANAGED OR REPORTED BY THE INSTITUTION AS REQUIRED BY FEDERAL REGULATION, THE INSTITUTION SHALL REQUIRE THE COVERED INDIVIDUAL INVOLVED TO DISCLOSE THE FINANCIAL CONFLICT OF INTEREST IN EACH PUBLIC PRESENTATION OF THE RESULTS OF THE RESEARCH AND TO REQUEST AN ADDENDUM TO PREVIOUSLY PUBLISHED PRESENTATIONS. 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: FORM 990, PART VI, SECTION B, LINE 12C (CONTINUED): - DESCRIBE THE CIRCUMSTANCES THAT GIVE RISE TO THE CONFLICT OF INTEREST UNDER 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 HHRI, 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 HHRI'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. PUBLIC DISCLOSURE OF FCOIS 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. DISCLOSURE TO OTHER RESEARCH PERSONNEL WORKING ON A STUDY MAY ALSO BE REQUIRED BY THE COI COMMITTEE AS A PART OF ADDITIONAL PUBLIC DISCLOSURE REQUIREMENTS FOR CONFLICT MITIGATION. INSTITUTIONAL CONFLICT OF INTEREST INSTITUTIONS SUCH AS THE HHRI MAY HAVE FINANCIAL CONFLICTS OF INTEREST INDEPENDENT OF THOSE OF SPECIFIC INDIVIDUALS. EXAMPLES INCLUDE FUNDS ACCRUING TO THE INSTITUTION RATHER THAN TO AN INDIVIDUAL OR SPECIFIC LAB OR DEPARTMENT, INVESTMENTS, INTERESTS DERIVED FROM LICENSING, TECHNOLOGY TRANSFER OR PATENTS, 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 HHRI AS THE SOLE ORGANIZER, THESE ACTIVITIES MAY NOT BE SUPPORTED BY FUNDS FROM VENDORS DOING BUSINESS WITH HHRI. WHEN EDUCATIONAL ACTIVITIES ARE CO-SPONSORED BY HHRI 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 (SEE APPENDIX II). GIFTS THE HHRI 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 THE 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 HHRI 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 HHRI MAKES PURCHASING DECISIONS AS AN INSTITUTION, E.G., COMMON EQUIPMENT, BIOHAZARD DISPOSAL SERVICES. AN INSTITUTIONAL CONFLICT COMMITTEE CONSISTING OF THE HHRI CONFLICT OF INTEREST COMMITTEE PLUS A NON-HHS/HHRI EMPLOYED HHRI BOARD MEMBER WILL REVIEW ALL INSTITUTIONAL CONFLICTS OF INTEREST. THE HHRI COO WILL REPORT ALL INSTITUTIONAL FINANCIAL CONFLICTS OF ANY AMOUNT TO THE COMMITTEE FOR REVIEW. FORM 990, PART VI, SECTION B, LINE 12C (CONTINUED): THE HHRI CONFLICT OF INTEREST POLICY, EFFECTIVE MAY 1, 2024, IS DESIGNED TO UPHOLD THE INTEGRITY OF RESEARCH AND EDUCATION BY ENSURING TRANSPARENCY AND INDEPENDENCE FROM FINANCIAL INFLUENCES. IT APPLIES TO ALL INDIVIDUALS AFFILIATED WITH HHRIINCLUDING EMPLOYEES, RESEARCHERS, BOARD MEMBERS, AND THEIR IMMEDIATE FAMILIESAND MANDATES THE DISCLOSURE OF ALL EXTERNAL FINANCIAL RELATIONSHIPS, REGARDLESS OF SIZE. THESE DISCLOSURES ARE REVIEWED BY A CONFLICT OF INTEREST COMMITTEE, WHICH MAY IMPLEMENT MITIGATION PLANS TO MANAGE OR ELIMINATE POTENTIAL CONFLICTS. THE POLICY PROHIBITS ACCEPTING GIFTS FROM VENDORS, GHOSTWRITING, AND ENDORSEMENTS TIED TO INSTITUTIONAL ROLES, AND REQUIRES REGULAR TRAINING AND STRICT COMPLIANCE. VIOLATIONS CAN RESULT IN DISCIPLINARY ACTION, INCLUDING RETRAINING, SUSPENSION, OR TERMINATION, AND ARE REPORTED TO RELEVANT FEDERAL AGENCIES WHEN NECESSARY. THIS POLICY REFLECTS HHRI'S BROADER COMMITMENT TO ETHICAL CONDUCT, SCIENTIFIC INTEGRITY, AND PUBLIC TRUST. IT ENSURES THAT BOTH INDIVIDUAL AND INSTITUTIONAL INTERESTS ARE ALIGNED WITH THE MISSION TO DELIVER UNBIASED, HIGH-QUALITY RESEARCH AND CARE. FORM 990, PART IX, LINE 11G PURCHASED SERVICES: PROGRAM SERVICE EXPENSES 1,887,689. MANAGEMENT AND GENERAL EXPENSES 184,814. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 2,072,503. SUBCONTRACT PAYMENTS: PROGRAM SERVICE EXPENSES 19,404,035. MANAGEMENT AND GENERAL EXPENSES 0. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 19,404,035. HENNEPIN HEALTHCARE SYSTEM INC 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 7 HENNEPIN HEALTHCARE SYSTEM INC 0 HENNEPIN COUNTY 300 SOUTH 6TH STREET MINNEAPOLIS MN 55487 416005801 GOVERNMENTAL UNIT MN N/A 0 0 0 1 0 0 0 0 0 0 1 1 0 1 1 1 1 1 0 0