2019-11-11T13:32:04-06:00 2018-12-31 350921680 CROWE LLP 401 East Las Olas Blvd Suite 1100 Fort Lauderdale FL 333014230 990 2018-01-01 592602318 Miami Children's Hospital Research Institute INC MIAM 3056666511 3100 SW 62nd Avenue Miami FL 33155 Matthew A Love President and CEO 2019-11-11 true Brittney Kocaj P01320603 9542028600 2018 2020-03-31 21:24:44Z Matthew A Love 3100 SW 62nd Avenue Miami FL 33155 5010922 false X www.nicklauschildrens.org X 1984 FL The Miami Children's Research Institute (MCRI) provides infrastructure and clinical research services to support and streamline clinical and translational research activity. 17 15 59 15 31636 0 1347824 2447141 2440367 2527002 0 97814 6136 3886005 4980279 0 0 3259874 4079970 0 0 830721 1303308 4090595 5383278 -204590 -402999 16150 1775252 8471241 11294404 -8455091 -9519152 The MCRI directly supports the NICKLAUS CHILDREN'S HOSPITAL ("NCH") mission to provide hope through advanced care for our children and families. (CONTINUED ON SCHEDULE O) false false 5383278 2495366 MCRI (currently operating as Nicklaus Children's Hospital Research Institute) is one of the largest providers of pediatric medical research in the southeastern United States. In 2018, The MCRI participated in approximately 300 research protocols many involving new medications and interventions for children with complex or chronic needs. The MCRI was the first pediatric research program in the state of Florida to receive accreditation by the Association for Accreditation of Human Research Protection Programs (AAHRPP) and was most recently reaccredited in 2016. AAHRPP accreditation affirms an organizational commitment to maintaining the most stringent standards in protecting the safety of research participants and in educating participants and their families regarding risks and potential benefits of taking part in research activities. (CONTINUED ON SCHEDULE O) 5383278 true true false false false false false false false true false false false true true false true false false false false false false false false false false false true false false false false false false false false false false false false false true false false false true 23 0 true 59 true true true false false false false false true false false false false false X 17 15 true false false false true true true true true false false true true true true true true false false false X Ramon Coto 3056666511 5301 Blue Lagoon Drive Miami FL 33126 Jaret Davis Chairman 0.1 1.3 X X 0 0 0 Narendra M Kini MD CEO/Director 0.1 40.4 X X 0 2186311 263462 Jodi Laurence Esq Vice Chairman 0.1 0.3 X X 0 0 0 Jefry Biehler MD Secretary 0.1 40.2 X X 0 326830 31123 Ravneet Chowdhury Esq Director 0.1 1.4 X 0 0 0 Maria Franco Director 0.1 0.3 X 0 0 0 Jorge Gonzalez Director 0.1 0.3 X 0 0 0 Drew Kern Director 0.1 0.4 X 0 0 0 Marcelo Laufer MD Director 0.1 0.3 X 0 0 0 Jay Massirman Director 0.1 1.3 X 0 0 0 Judge Fred Moreno Director 0.1 0.3 X 0 0 0 Mario Murgado Director 0.1 1.3 X 0 0 0 Joseph Nader Director 0.1 0.3 X 0 0 0 Phillip Newcomm Director 0.1 0.3 X 0 0 0 John L Nielsen Director 0.1 0.3 X 0 0 0 Alex Soto Director 0.1 1.4 X 0 0 0 Keith Ward Director 0.1 0.3 X 0 0 0 Timothy L Birkenstock Treasurer 0.1 40.4 X 0 979128 82617 Michael L Harrington President 0.1 40.3 X 0 491345 87200 Matthew Love SVP & CFO (Partial year) 0.1 40.4 X 0 93638 3818 Jennifer McCafferty Dir Research/Sponsored Prgms 40.0 0 X 219171 0 24315 Nicole S McCullough Mgr Research Regulatory Affair 40.0 0 X 107154 0 18901 Alexandra L Quittner Senior Research Scientist 40.0 0 X 178843 0 9944 Daria Salyakina Epidemiologist 40.0 0 X 104916 0 21866 610084 4077252 543247 4 false true false Western Institutional Review PO Box 150434 Hartford CT 611150434 consulting services 130075 1 2239929 207212 2447141 Clinical Trial Revenue 541700 2390903 2359267 31636 Grant Revenue 900099 136099 136099 0 0 0 0 2527002 36779 30643 6136 0 6136 6136 0 0 0 0 0 0 0 4980279 2495366 31636 6136 X 3231603 3231603 135467 135467 499896 499896 213004 213004 646058 646058 0 0 16950 16950 315365 315365 71538 71538 72392 72392 7012 7012 21855 21855 Dues & Subscriptions 23796 23796 Course expenses 13335 13335 Grant Expenses 109793 109793 Miscellaneous Expenses 5214 5214 0 0 0 0 5383278 5383278 0 0 1359854 0 0 6 240 3095091 2679939 16150 415152 0 0 0 0 16150 1775252 28476 270286 0 8442765 11024118 8471241 11294404 X -9340295 -9743294 885204 224142 -8455091 -9519152 16150 1775252 X -402999 -661062 X false true X true true true X RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED 3095091 2679939 415152 415152 Due to Affiliates 11024118 11024118 X Schedule D, Part X, Line 2 FIN 48 (ASC 740) footnote MIAMI CHILDREN'S HOSPITAL RESEARCH INSTITUTE'S FINANCIAL INFORMATION IS INCLUDED IN THE CONSOLIDATED AUDITED FINANCIAL STATEMENTS OF NICKLAUS CHILDREN'S HEALTH SYSTEM (NCHS), A RELATED ORGANIZATION. NCHS' FIN 48 (ASC 740) FOOTNOTE FOR THE YEAR ENDED DECEMBER 31, 2018, READS AS FOLLOWS: "THE SYSTEM AND CERTAIN OF ITS AFFILIATED ORGANIZATIONS QUALIFY AS TAX-EXEMPT, NONPROFIT ORGANIZATIONS UNDER SECTION 501(C)(3) OF THE INTERNAL REVENUE CODE (THE CODE). THE HOSPITAL, PSA, NCHF AND THE RESEARCH INSTITUTE ARE EXEMPT FROM FEDERAL INCOME TAX ON RELATED INCOME PURSUANT TO SECTION 501(A) OF THE CODE AS DESCRIBED IN SECTION 501(C)(3). THESE TAXEXEMPT ENTITIES HAD NO TAX PROVISION FOR THE YEARS ENDED DECEMBER 31, 2018 AND 2017. THE CAPTIVE INSURANCE COMPANY IS NOT SUBJECT TO INCOME TAXES, AS NO INCOME TAXES ARE LEVIED IN THE CAYMAN ISLANDS. THE SYSTEM BELIEVES THERE IS NO UNCERTAIN TAX LIABILITY WHICH SHOULD BE RECORDED AS OF DECEMBER 31, 2018 AND 2017. THE HEALTH PLAN IS A LIMITED LIABILITY COMPANY WHICH IS TAXED AS A PARTNERSHIP AND THEREFORE IS GENERALLY NOT A TAXPAYING ENTITY FOR FEDERAL OR STATE INCOME TAX PURPOSES. IN LIEU OF CORPORATE INCOME TAXES, THE MEMBERS ARE TAXED ON THE HEALTH PLAN'S TAXABLE INCOME. THEREFORE, NO PROVISION OR LIABILITY FOR INCOME TAXES HAS BEEN INCLUDED IN THESE FINANCIAL STATEMENTS." X true true false true false false false false false false false Narendra M Kini MD CEO/Director 0 2029253 0 126713 0 30345 0 236948 0 26514 0 2449774 0 0 Jefry Biehler MD Secretary 0 324564 0 968 0 1298 0 8250 0 22873 0 357953 0 0 Timothy L Birkenstock Treasurer 0 737250 0 126658 0 115220 0 62891 0 19726 0 1061745 0 76356 Michael L Harrington President 0 423810 0 38778 0 28757 0 78502 0 8699 0 578545 0 0 Jennifer McCafferty Dir Research/Sponsored Prgms 218809 0 354 0 8 0 6771 0 17544 0 243486 0 0 0 Alexandra L Quittner Senior Research Scientist 159617 0 17238 0 1988 0 2713 0 7230 0 188786 0 0 0 Schedule J, Part I, Line 3 ESTABLISH COMPENSATION The organization relied on the methods of establishing compensation for the organization's CEO employed by NICKLAUS CHILDREN'S HEALTH SYSTEM. (EIN: 45-3481327). NICKLAUS CHILDREN'S HEALTH SYSTEM uses the following methods to establish such compensation: - Compensation Committee - Independent Compensation Consultant - Compensation survey or study - Approval by the Board of Compensation Committee Schedule J, Part I, Line 1a Tax indemnification and gross-up payments ALL OF THE COMPENSATED INDIVIDUALS LISTED ON PART VII RECEIVED TAX GROSS-UP PAYMENTS DURING THE YEAR. THE GROSS-UP PAYMENT WAS TREATED AS TAXABLE COMPENSATION TO THEM. Schedule J, Part I, Line 4b Supplemental nonqualified retirement plan THE FOLLOWING CONTRIBUTIONS WERE MADE TO A SECTION 457(F) PLAN DURING THE YEAR - NARENDRA KINI- $228,698 TIMOTHY BIRKENSTOCK - $54,641 MICHAEL HARRINGTON - $70,252 THE FOLLOWING DISTRIBUTIONS WERE MADE FROM A SECTION 457(F) PLAN DURING THE YEAR - TIMOTHY BIRKENSTOCK - $76,356 Form 990, Part III, Line 4a PROGRAM SERVICE DESCRIPTION The MCRI provides research support services for all types of clinical research studies including those sponsored by industry partners, private foundations, granting agencies, and internal sources. Specific services include proposal and protocol development, contract and budgeting, regulatory affairs, education, training and outreach, and clinical coordinator support. In addition, the MCRI serves as the home to interdisciplinary research initiatives and engages the community by increasing awareness about Nicklaus Children's Health System (formerly Miami Children's Health System) research initiatives and providing training for clinical research teams. The MCRI supports research activities across the Miami Children's Health System including the neurosciences, surgery, hematology and oncology, radiology, cardiology, endocrinology, gastroenterology, genetics, nephrology, orthopedics, psychiatry, pulmonology and urology. In addition the MCRI works collaboratively with Graduate Medical Education to support the research efforts of our residents and fellows. As part of its work in hematology-oncology research, Nicklaus Children's Hospital maintains full membership in the Children's Oncology Group (COG), a federally funded consortium of pediatric hospitals and departments conducting a large array of clinical research studies offering latest advancements for the treatment of childhood cancers. Providing consistent and high quality support for the COG is a high priority for the MCRI. Research efforts in the neurosciences involve federal, academic and industry partnerships and include the use of investigational products and devices in both neurology and neurosurgical settings. In close collaboration with the Nicklaus Children's Hospital Brain Institute, the MCRI supports a growing number of clinical research studies in the neurosciences focused on various types of epilepsy, neuro-oncology and pediatric stroke. A primary focus of the cardiology research portfolio includes exploring better treatment options for patients with congenital heart defects and gaining insight into the long term or late effects that adults with congenital heart defects might experience. The cardiology and cardiac surgery teams participate in a number of industry sponsored studies with valve replacement therapies and the evaluation of new stents in the pediatric setting. Form 990, Part VI, Line 15 DETERMINING COMPENSATION THE ORGANIZATION AND COMPENSATION COMMITTEE OF NICKLAUS CHILDREN'S HEALTH SYSTEM INC.'S BOARD OF DIRECTORS CONTRACTS WITH AN EXTERNAL CONSULTANT TO OBTAIN MARKET SURVEYS FOR THE CEO AND OTHER EXECUTIVES. THE CONSULTANT ASSISTS THE ORGANIZATION AND COMPENSATION COMMITTEE IN ESTABLISHING A COMPENSATION PROGRAM FOR THE CEO AND OTHER EXECUTIVES. SURVEY RESULTS AND COMPENSATION BEST PRACTICES ARE SHARED WITH THE ORGANIZATION AND COMPENSATION COMMITTEE OF THE BOARD AND USED IN ESTABLISHING EXECUTIVE SALARY AND BENEFITS PROGRAMS. MCH RESEARCH INSTITUTE RELIED ON THE METHODS OF ESTABLISHING COMPENSATION USED BY NICKLAUS CHILDREN'S HEALTH SYSTEM, INC. NO COMPENSATION WAS PAID BY THIS ENTITY DURING THE YEAR, THEREFORE THIS QUESTION HAS BEEN ANSWERED NO IN ACCORDANCE WITH THE INSTRUCTIONS. Form 990, Part VI, Line 2 Family/business relationships amongst interested persons NARENDRA KINI, JAY MASSIRMAN, MARIO MURGADO, MATTHEW A. LOVE, AND TIMOTHY BIRKENSTOCK - Business relationship Form 990, Part VI, Line 6 Classes of members or stockholders Variety Children's Hospital d/b/a Nicklaus Children's Hospital, a Florida corporation, acting through its Board of Directors, is the sole Member of this corporation. Form 990, Part VI, Line 7a Members or stockholders electing members of governing body Whenever a vacancy exists on the Board of Directors whether by death, resignation, or otherwise, the vacancy shall be filled by Variety Children's Hospital (The Sole Member). Form 990, Part VI, Line 7b Decisions requiring approval by members or stockholders An amendment to the Articles of Incorporation may be proposed by the Board of Directors or Variety Children's Hospital (The Sole Member), but such amendment may be adopted only after receiving the approval of the Sole Member. The By-Laws of this corporation may be amended, repealed, or added to, or new By-Laws may be adopted, by the Board of Directors only with the approval by the Sole Member. Form 990, Part VI, Line 11b Review of form 990 by governing body THE FOLLOWING DESCRIBES THE PROCESS FOR PROVIDING THE BOARD OF DIRECTORS WITH A COPY OF THE FORM 990 AND REVIEWING IT: 1. THE DRAFT TAX FORM 990 WILL BE EMAILED TO THE AUDIT AND COMPLIANCE COMMITTEE CHAIR FOR REVIEW AND COMMENT. 2. THE PAID TAX PREPARER WILL PRESENT A SUMMARY OF THE INFORMATION TO THE FINANCE COMMITTEE OF THE BOARD. 3. QUESTIONS WILL BE ANSWERED AND IF NECESSARY, TAX FORMS WILL BE ADJUSTED. THE CHAIR WILL APPROVE THE FORM 990. 4. THE FINAL FORM 990 WILL BE POSTED ON THE BOARD WEB PORTAL. Form 990, Part VI, Line 12c Conflict of interest policy ALL MIAMI CHILDREN'S HOSPITAL RESEARCH INSTITUTE EMPLOYEES ARE INFORMED UPON HIRE, AND ON AN ANNUAL BASIS THEREAFTER, THAT THEY HAVE AN AFFIRMATIVE DUTY TO DISCLOSE ANY ACTUAL, POTENTIAL OR PERCEIVED CONFLICTS OF INTEREST. THEY ARE REQUIRED TO COMPLETE A CONFLICT OF INTEREST DISCLOSURE FORM UPON HIRE, ANNUALLY AND WHENEVER A CHANGE IN CIRCUMSTANCES WARRANTS. CONFLICT OF INTEREST DISCLOSURE FORMS ARE FORWARDED TO THE COMPLIANCE DEPARTMENT BY THE TALENT MANAGEMENT AND EFFECTIVENESS DEPARTMENT. THESE FORMS ARE INITIALLY REVIEWED BY COMPLIANCE DEPARTMENT STAFF. WHEN DEEMED NECESSARY, THE COMPLIANCE DEPARTMENT COLLABORATES WITH THE LEGAL DEPARTMENT. CONFLICTS OF INTEREST THAT NECESSITATE BOARD AWARENESS AND ACTION ARE PRESENTED TO THE AUDIT AND COMPLIANCE COMMITTEE OF THE BOARD FOR RESOLUTION AND IMPOSITION OF SANCTIONS, IF WARRANTED. IN ADDITION, ON AN ANNUAL BASIS, BOARD MEMBERS, PRINCIPAL OFFICERS AND BOARD-DELEGATED COMMITTEE MEMBERS SIGN A STATEMENT WHICH AFFIRMS THAT EACH INDIVIDUAL: (A) HAS RECEIVED A COPY OF THE CONFLICT OF INTEREST POLICY; (B) HAS READ AND UNDERSTANDS THE POLICY (C) HAS AGREED TO COMPLY WITH THE POLICY, AND (D) UNDERSTANDS THAT THE HOSPITAL IS A CHARITABLE ORGANIZATION AND THAT IN ORDER TO MAINTAIN ITS FEDERAL EXEMPTION IT MUST ENGAGE PRIMARILY IN ACTIVITIES WHICH ACCOMPLISH ONE OR MORE OF IT'S TAX-EXEMPT PURPOSES. A PROCESS IS IN PLACE FOR MANAGING SITUATIONS IN WHICH IT IS DISCOVERED THAT AN INDIVIDUAL WHO IS COVERED BY THE HOSPITAL'S CONFLICT OF INTEREST POLICY FAILED TO PROPERLY DISCLOSE A POTENTIAL CONFLICT OF INTEREST. Form 990, Part VI, Line 19 Required documents available to the public Financial statements, governing documents, and conflict of interest policies are not required disclosures pursuant to Internal Revenue Code (IRC) Section 6104. These documents are not available to the public at this time. Form 990, Part IX, Line 11g Other Fees Physician Fees - Total Expense: 232085, Program Service Expense: 232085, Management and General Expenses: , Fundraising Expenses: ; Consultant Fees - Total Expense: 365652, Program Service Expense: 365652, Management and General Expenses: , Fundraising Expenses: ; Laboratory Fees - Total Expense: 3041, Program Service Expense: 3041, Management and General Expenses: , Fundraising Expenses: ; Casual Labor - Total Expense: 5488, Program Service Expense: 5488, Management and General Expenses: , Fundraising Expenses: ; Overhead Allocation - Total Expense: 12000, Program Service Expense: 12000, Management and General Expenses: , Fundraising Expenses: ; PURCHASED SERVICES - Total Expense: 24987, Program Service Expense: 24987, Management and General Expenses: , Fundraising Expenses: ; STORAGE FEES - Total Expense: 2805, Program Service Expense: 2805, Management and General Expenses: , Fundraising Expenses: ; Form 990, Part XI, Line 9 Other changes in net assets or fund balances TRANSFER TO AFFILIATE - -106139; REFUND OF GRANTS - -554923; FORM 990, PART III, LINE 1 ORGANIZATION'S MISSION The MCRI mission is to: - Provide leadership, education, expertise, and guidance to clinical research professionals at Nicklaus Children's Hospital (NCH) and its affiliates - Serve as a centralized resource within NCH to support conduct of interdisciplinary and patient-oriented research focusing on clinical trials - Provide a primary point of contact for Sponsors and Investigators - Serve as an educational resource to Investigators and Research Staff - Provide an interface with the research participant community The Miami Children's Research Institute strives to promote efficiency, standardization, compliance and responsible clinical research conduct through education, quality assurance visits, positive influence and guided internal and community leadership. 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