Attach to Form 990 or Form 990-EZ.
Go to
www.irs.gov/Form990 for instructions and the latest information.
| (i) Name of supported organization | (ii) EIN | (iii) Type of organization (described on lines 1- 10 above (see instructions)) | (iv) Is the organization listed in your governing document? | (v) Amount of monetary support (see instructions) | (vi) Amount of other support (see instructions) | |
|---|---|---|---|---|---|---|
| Yes | No | |||||
|
Total |
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Calendar year (or fiscal year beginning in) ![]() |
(a) 2015 | (b) 2016 | (c) 2017 | (d) 2018 | (e) 2019 | (f) Total | |
|---|---|---|---|---|---|---|---|
| 1 | Gifts, grants, contributions, and membership fees received. (Do not include any "unusual grant.") .. | 34,191,654 | 33,962,482 | 35,037,897 | 35,380,575 | 37,358,195 | 175,930,803 |
| 2 | Tax revenues levied for the organization's benefit and either paid to or expended on its behalf.... | ||||||
| 3 | The value of services or facilities furnished by a governmental unit to the organization without charge.. | ||||||
| 4 | Total. Add lines 1 through 3 | 34,191,654 | 33,962,482 | 35,037,897 | 35,380,575 | 37,358,195 | 175,930,803 |
| 5 | The portion of total contributions by each person (other than a governmental unit or publicly supported organization) included on line 1 that exceeds 2% of the amount shown on line 11, column (f).. | 15,246,160 | |||||
| 6 | Public support. Subtract line 5 from line 4. | 160,684,643 | |||||
Calendar year
(or fiscal year beginning in) ![]() |
(a) 2015 | (b) 2016 | (c) 2017 | (d) 2018 | (e) 2019 | (f) Total | |
|---|---|---|---|---|---|---|---|
| 7 | Amounts from line 4.. | 34,191,654 | 33,962,482 | 35,037,897 | 35,380,575 | 37,358,195 | 175,930,803 |
| 8 | Gross income from interest, dividends, payments received on securities loans, rents, royalties and income from similar sources... | 523,425 | 620,990 | 651,730 | 748,737 | 933,257 | 3,478,139 |
| 9 | Net income from unrelated business activities, whether or not the business is regularly carried on.. | ||||||
| 10 | Other income. Do not include gain or loss from the sale of capital assets (Explain in Part VI.).. | ||||||
| 11 | Total support. Add lines 7 through 10 | 179,408,942 | |||||
Calendar year (or fiscal year beginning in) ![]() |
(a) 2015 | (b) 2016 | (c) 2017 | (d) 2018 | (e) 2019 | (f) Total | |
|---|---|---|---|---|---|---|---|
| 1 | Gifts, grants, contributions, and membership fees received. (Do not include any "unusual grants.") . | ||||||
| 2 | Gross receipts from admissions, merchandise sold or services performed, or facilities furnished in any activity that is related to the organization's tax-exempt purpose | ||||||
| 3 | Gross receipts from activities that are not an unrelated trade or business under section 513 ..... | ||||||
| 4 | Tax revenues levied for the organization's benefit and either paid to or expended on its behalf... | ||||||
| 5 | The value of services or facilities furnished by a governmental unit to the organization without charge | ||||||
| 6 | Total. Add lines 1 through 5 | ||||||
| 7a | Amounts included on lines 1, 2, and 3 received from disqualified persons | ||||||
| b | Amounts included on lines 2 and 3 received from other than disqualified persons that exceed the greater of $5,000 or 1% of the amount on line 13 for the year. | ||||||
| c | Add lines 7a and 7b.. | ||||||
| 8 | Public support. (Subtract line 7c from line 6.) | ||||||
Calendar year (or fiscal year beginning in) ![]() |
(a) 2015 | (b) 2016 | (c) 2017 | (d) 2018 | (e) 2019 | (f) Total | |
|---|---|---|---|---|---|---|---|
| 9 | Amounts from line 6... | ||||||
| 10a | Gross income from interest, dividends, payments received on securities loans, rents, royalties and income from similar sources.. | ||||||
| b | Unrelated business taxable income (less section 511 taxes) from businesses acquired after June 30, 1975. | ||||||
| c | Add lines 10a and 10b. | ||||||
| 11 | Net income from unrelated business activities not included in line 10b, whether or not the business is regularly carried on. | ||||||
| 12 | Other income. Do not include gain or loss from the sale of capital assets (Explain in Part VI.) .. | ||||||
| 13 | Total support. (Add lines 9, 10c, 11, and 12.).. | ||||||
| Section A - Adjusted Net Income | (A) Prior Year |
(B) Current Year (optional) |
||||
| 1 | Net short-term capital gain | 1 | ||||
| 2 | Recoveries of prior-year distributions | 2 | ||||
| 3 | Other gross income (see instructions) | 3 | ||||
| 4 | Add lines 1 through 3 | 4 | ||||
| 5 | Depreciation and depletion | 5 | ||||
| 6 | Portion of operating expenses paid or incurred for production or collection of gross income or for management, conservation, or maintenance of property held for production of income (see instructions) | 6 | ||||
| 7 | Other expenses (see instructions) | 7 | ||||
| 8 | Adjusted Net Income (subtract lines 5, 6 and 7 from line 4) | 8 | ||||
| Section B - Minimum Asset Amount | (A) Prior Year |
(B) Current Year (optional) |
||||
| 1 | Aggregate fair market value of all non-exempt-use assets (see instructions for short tax year or assets held for part of year): | 1 | ||||
| a | Average monthly value of securities | 1a | ||||
| b | Average monthly cash balances | 1b | ||||
| c | Fair market value of other non-exempt-use assets | 1c | ||||
| d | Total (add lines 1a, 1b, and 1c) | 1d | ||||
| e |
Discount claimed for blockage or other factors (explain in detail in Part VI): |
|||||
| 2 | Acquisition indebtedness applicable to non-exempt use assets | 2 | ||||
| 3 | Subtract line 2 from line 1d | 3 | ||||
| 4 | Cash deemed held for exempt use. Enter 1-1/2% of line 3 (for greater amount, see instructions). | 4 | ||||
| 5 | Net value of non-exempt-use assets (subtract line 4 from line 3) | 5 | ||||
| 6 | Multiply line 5 by .035 | 6 | ||||
| 7 | Recoveries of prior-year distributions | 7 | ||||
| 8 | Minimum Asset Amount (add line 7 to line 6) | 8 | ||||
| Section C - Distributable Amount | Current Year | |||||
| 1 | Adjusted net income for prior year (from Section A, line 8, Column A) | 1 | ||||
| 2 | Enter 85% of line 1 | 2 | ||||
| 3 | Minimum asset amount for prior year (from Section B, line 8, Column A) | 3 | ||||
| 4 | Enter greater of line 2 or line 3 | 4 | ||||
| 5 | Income tax imposed in prior year | 5 | ||||
| 6 | Distributable Amount. Subtract line 5 from line 4, unless subject to emergency temporary reduction (see instructions) | 6 | ||||
| Section D - Distributions | Current Year | |
|---|---|---|
| 1 Amounts paid to supported organizations to accomplish exempt purposes | ||
|
2
Amounts paid to perform activity that directly furthers exempt purposes of supported organizations, in excess of income from activity |
||
| 3 Administrative expenses paid to accomplish exempt purposes of supported organizations | ||
| 4 Amounts paid to acquire exempt-use assets | ||
| 5 Qualified set-aside amounts (prior IRS approval required) | ||
| 6 Other distributions (describe in Part VI). See instructions | ||
| 7Total annual distributions. Add lines 1 through 6. | ||
|
8
Distributions to attentive supported organizations to which the organization is responsive (provide details in Part VI). See instructions |
||
| 9 Distributable amount for 2019 from Section C, line 6 | ||
| 10 Line 8 amount divided by Line 9 amount | ||
| Section E - Distribution Allocations (see instructions) |
(i) Excess Distributions |
(ii) Underdistributions Pre-2019 |
(iii) Distributable Amount for 2019 |
|
|---|---|---|---|---|
| 1 Distributable amount for 2019 from Section C, line 6 | ||||
|
2
Underdistributions, if any, for years prior to 2019 (reasonable cause required-- explain in Part VI). See instructions. |
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| 3 Excess distributions carryover, if any, to 2019: | ||||
| a From 2014....... | ||||
| b From 2015....... | ||||
| c From 2016....... | ||||
| d From 2017....... | ||||
| e From 2018....... | ||||
| fTotal of lines 3a through e | ||||
| g Applied to underdistributions of prior years | ||||
| h Applied to 2019 distributable amount | ||||
|
i
Carryover from 2014 not applied (see instructions) |
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| j Remainder. Subtract lines 3g, 3h, and 3i from 3f. | ||||
| 4Distributions for 2019 from Section D, line 7: | ||||
| $ | ||||
| a Applied to underdistributions of prior years | ||||
| b Applied to 2019 distributable amount | ||||
| c Remainder. Subtract lines 4a and 4b from 4. | ||||
|
5
Remaining underdistributions for years prior to 2019, if any. Subtract lines 3g and 4a from line 2. If the amount is greater than zero, explain in Part VI. See instructions. |
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|
6
Remaining underdistributions for 2019. Subtract lines 3h and 4b from line 1. If the amount is greater than zero, explain in Part VI. See instructions. |
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|
7 Excess distributions carryover to 2020. Add lines 3j and 4c. |
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| 8 Breakdown of line 7: | ||||
| a Excess from 2015..... | ||||
| b Excess from 2016..... | ||||
| c Excess from 2017..... | ||||
| d Excess from 2018..... | ||||
| e Excess from 2019..... | ||||
| Facts And Circumstances Test |
|---|
| Return Reference | Explanation |
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| Software ID: | |
| Software Version: |
Attach to Form 990 or 990-EZ.
Go to www.irs.gov/Form990 for the latest information.
| Return Reference | Explanation |
|---|---|
| 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 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. HHRI is part of Hennepin Healthcare, an integrated system of care that includes Hennepin County Medical Center (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 194 investigators (MDs, MD/PhDs, PhDs, and PharmDs). In 2019, HHRI received 178 new or renewing sponsored awards for a total of $53.9 million, over 70% of which came from the federal government. Funding also came from industry partners, private foundations, 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. They conduct basic, translational, clinical, and epidemiologic research with a focus on four areas: Acute Care/Trauma, Addiction, Health Services, and Infectious Disease (HIV/AIDS). In 2019, 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 * Orthopedics and Biomechanics * Trauma and Burn * Traumatic Brain Injury ADDICTION * Addiction Medicine * Opioid Treatment Research * Tobacco Treatment Research HEALTH SERVICES * Clinical Outcomes Research * Cancer * Children's Issues * Chronic Diseases * Cognitive Issue in Aging/Geriatrics * Diabetes and Obesity * Gastrointestinal and Liver Disease * Health, Homelessness, and Criminal Justice * Heart Disease and Heart Failure * Kidney Disease * Organ Transplantation * Sleep Disorders INFECTIOUS DISEASE * HIV / AIDS * Malaria * Sexually Transmitted Infections * Tuberculosis * Viral Hepatitis 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, HHRI 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 HHRI, call 612-873-5300 or visit our website at www.hhrinstitute.org. |
| Form 990, Part VI, Section A, line 1 | The Hennepin Healthcare Research Institute (HHRI) Executive Committee of the Board is comprised of four HHRI directors: Richard King, M.D., PhD, Devdatt Kurdikar, PhD, MBA, Anne Murray, M.D., M.S., and Ajay Israni, M.D., M.S. 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) 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 2019. 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. |
| Form 990, Part VI, Section C, line 19 | The Hennepin Healthcare Research Institute (HHRI) Articles of Incorporation are available to the public through the Minnesota Secretary of State, the HHRI Bylaws are not. The HHRI Conflict of Interest policy and the HHRI Annual Report, which includes financial statements, are available on the HHRI website. |
| Form 990, Part VI, Section B, Line 12c (continued): | PURPOSE The purpose of Hennepin Healthcare Research Institute's (HHRI) Conflict of Interest (COI) policy is to enable and facilitate the research and education missions of the HHRI 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 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. - 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 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 HHRI must comply with HHRI'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 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 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 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. - t 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 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 the Grant and Contract Application for External Support. Substantial changes in a financial or business interest must be reported within 30 days of occurrence. 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, HHRI will take reasonable steps to ensure that these outside associates comply with appropriate conflict of interest reporting, disclosure review and management plan requirements. |
| Form 990, Part VI, Section B, Line 12c (continued): | Appropriate disciplinary action may be taken by the HHRI 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. 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 HHRI'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 HHRI 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 HHRI Executive Committee of the Board 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; and - to work in cooperation with campus compliance officers. This Committee shall be comprised of: the HHRI 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 HHRI. 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. |
| Form 990, Part VI, Section B, Line 12c (continued): | 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 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 HHRI. 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 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 COI. 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 HHRI 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 labor 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 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. 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 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 COI Committee plus 2 additional external non-institutional members 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 IX, line 11g | Subcontract Payments: Program service expenses 10,256,965. Management and general expenses 0. Fundraising expenses 0. Total expenses 10,256,965. Purchased Services: Program service expenses 3,257,025. Management and general expenses 79,122. Fundraising expenses 0. Total expenses 3,336,147. Consulting: Program service expenses 920. Management and general expenses 0. Fundraising expenses 0. Total expenses 920. |
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