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USE OF OUTSIDE FACILITY FOR UM HUMAN SUBJECT RESEARCH
This Agreement is executed this ____ day of ______, between the University of Miami (hereinafter referred to as “University”) and ______(hereinafter referred to as “Facility”), located at ______.
WHEREAS, the University wishes to conduct certain research using patients, clients or other individuals associated with the Facility; and
WHEREAS, the Facility agrees that the University may use its facilities to conduct such research.
NOW, THEREFORE, the parties, for and in consideration of the promises and covenants contained herein, agree as follows:
1. Facility Use. Facility agrees to make available to the University its facilities and patients, clients or other individuals associated with the Facility for the period beginning ______and ending on ______.
2. Study Conditions and Standards. University shall conduct research in accordance with the protocol attached hereto as Exhibit 1, incorporated herein by reference and hereafter referred to as the “study” or the “protocol”. University and Facility agree to comply with (and to cause their agents and investigators to comply with) the terms of the protocol, the Statement of Investigator (Form 1583) and any and all federal, international, state, local and institutional laws, rules, regulations and policies that may be applicable to the conduct of this study or that may provide additional protection for human subjects participating in research conducted hereunder, including but not limited to the United States Food and Drug Administration Regulations 21 CFR Parts 50 and 56 and the United States Department of Health and Human Services Regulations 45 CFR Part 46, as well as any decisions, determinations and conditions imposed by the reviewing University Institutional Review Board (“IRB”), as may be amended from time to time. The Facility shall be responsible for complying with any locally required authorizations and institutional policies and regulations applicable to its involvement in the research.
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3. Data. Any presentation or publication of data or laboratory results, including case report forms and other relevant information generated or required to be generated as a result of this study shall belong to the University, including any publication, copyrights or patent rights associated with the data, the study or any invention created in connection therewith, the rights to and ownership of all of which shall remain with the University. All documents, protocols, data, know-how, methods, operations, formulas, confidential Information and materials of any kind provided to the Facility by University pursuant to this Agreement are and shall remain the property of University.
4. Confidential Information. During the course of the study, certain confidential information and materials may be disclosed to the Facility or its agents and employees (collectively, the “Facility”). It is agreed that such materials, information and data, except that which is or becomes public knowledge through means other than the unauthorized disclosure by the Facility, constitutes the property of the University, and that Facility will not disclose such information during or after the term of the study without the prior written consent of the University. All such materials, information, and data in Facility’s custody shall be promptly delivered to the University at its request or upon termination of the study. Facility shall ensure that all employees or agents of Facility shall be bound by the terms of this paragraph.
5. Liability and Insurance. (a) Facility agrees to indemnify, defend and hold harmless the University, its trustees, IRB members, officers, faculty, agents, employees, and students from and against any and all liabilities, claims, losses, lawsuits and judgments and/or expenses including attorney’s fees through the appellate levels, which may be incurred by or brought against the University or its trustees, IRB members, officers, faculty, agents, employees, and students (1) as a result of or in connection with any decisions, actions or omissions taken by the University IRB while acting as an IRB of record for the research conducted hereunder or (2) arising directly or indirectly from or reasonably attributable to any negligent act or omission or intentional wrongdoing of Facility, persons under its control, its agents or employees, or use of the premises or any equipment located at the Facility.
(b) In the event any such claim is made or lawsuit is initiated, Facility agrees to promptly notify the University in writing, and to cooperate fully in the defense of such lawsuit.
(c) University agrees to indemnify, defend and hold harmless the Facility, its trustees, officers, faculty, agents, employees, and students from and against any and all liabilities, claims, losses, lawsuits and judgments and/or expenses including attorney’s fees through the appellate levels, which may be incurred by or brought against the Facility, arising directly or indirectly from or reasonably attributable to any negligent act or omission or intentional wrongdoing of University, persons under its control, its agents or employees, or use of the premises or any equipment located at the Facility.
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(d) Facility and University each agree to carry and keep in force, each at its expense, general liability insurance and professional liability insurance with limits not less than $1,000,000 per occurrence, $3,000,000 aggregate to cover liability for damages on account of bodily or personal injury or death to any person, or damage to property of any person. Facility and University shall furnish evidence of such insurance to the other prior to execution of this Agreement. Such insurance shall not be cancelled for any cause without at least thirty (30) days prior written notice to the other party. Such insurance shall be primary to any insurance which the other party may have. Such insurance shall contain an endorsement naming the other as an additional insured with respect to this Agreement. Each party shall provide a certificate of insurance or a self-insurance letter (if Facility is self-insured) stating the limits of coverage. Each party shall be responsible for maintaining worker’s compensation coverage in accordance with applicable law.
(e) Independent Contractors For purposes of this Agreement, the Facility, its employees and other individuals assigned by them to perform services hereunder (“Staff Members”) shall not be deemed agents, servants, partners, joint ventures or employees of the University. Thus, they do not have the authority to take action on the University’s behalf or to bind the University without its prior written consent. The Facility and Staff Members are acting in the capacity of independent contractors of University. The University shall not be responsible for withholding, and shall not withhold, FICA or taxes of any kind from any payments it might owe to the Facility, except as otherwise required by law. The Facility is responsible to provide any and all compensation, benefits and/or insurance to Staff Members. It is also understood and expressly acknowledged that the Facility and Staff Members are not eligible to participate in, nor are they eligible for coverage under, any benefit plans, programs, employment policies, procedures or workers’ compensation insurance provided by University. University shall be released from any liability arising from University’s failure to provide such plans programs, policies, procedures and workers’ compensation insurance.
(f) The provisions of Section 5 shall survive the termination of this Agreement.
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6. Notices. Any notices required to be given pursuant to the terms and provisions of this Agreement shall be in writing and shall be sent by certified mail, return receipt requested, to:
University: Humberto Speziani
Assistant Vice President of Financial Operations
University of Miami
1320 S. Dixie Highway, Suite 1230
Coral Gables, FL 33146
John Bixby, Ph.D.
Vice Provost for Research
Office of Research
1400 NW 10th Avenue
Dominion Towers 1205J-R64
Miami Florida, 33136
University of Miami
Department of ______
______
______
______
Facility: ______
______
______
______
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Either party may, at any time, designate any other address in place of those given above by written notice to the other party.
7. IRB Review. An appropriate University IRB designated under the University’s Federal-Wide Assurance, in accordance with U.S. Department of Health and Human Services regulations and Office for Human Research Protections administrative guidance, will be the IRB of record for the study. For the avoidance of doubt, such University IRB shall not be the IRB of record for any research conducted at or by the Facility other than the study conducted pursuant to this Agreement. The Facility will abide by all determinations of such University IRB (including the use of informed consent forms reviewed and approved by and on file with the University IRB) and will accept the final authority and decisions of such University IRB, including but not limited to directives to terminate participation in designated research activities. Consider provision whereby University is compensated for sending representatives to monitor study under local conditions (OHRP requirement to monitor study).
8. Cooperation. (a) The Facility acknowledges and agrees to cooperate in the University IRB’s responsibility for initial and continuing review, record keeping, reporting, and certification for the research conducted hereunder. The Facility will provide all information requested by the University IRB of record within 15 business days of receipt of request. Facility agrees to allow the University IRB to inspect its facilities, the progress of the study and any and all documentation or material as may be deemed necessary by the University IRB. University, through its authorized representatives, has the right at all reasonable times and upon reasonable notice, to inspect or otherwise evaluate the work performed or being performed at Facility under this Agreement and the information and results derived from or relating to it. All documentation from each study (including case report forms, source documents and clinical information generated as a result of the study) will be promptly and fully disclosed, as permitted hereunder, to University by the Facility upon reasonable request and also shall be made available at the Facility’s site upon request for inspection, copying, review and audit at reasonable times by representatives of University and the United States Food and Drug Administration (“FDA”) or other regulatory agencies.
(b) The Facility agrees to notify the University of all communications to and from the FDA, United States Department of Health and Human Services Office for Human Research Protections (“OHRP”) and other applicable federal and state regulatory agencies regarding the protocol or in reference to any matter that directly impacts the University’s review of protocols for the University. The Facility will promptly notify University of any proposed regulatory inspection relating to the research conducted hereunder, permit representatives of University to be present during the inspection and promptly provide University with a copy of any report issued after the inspection. The Facility agrees to take any reasonable steps requested by the University as a result of a regulatory audit to cure any deficiencies in the case report forms or other documentation from the study. Documentation from each study, as further delineated in this Section and in the applicable
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protocol, shall be retained by the Facility, if necessary, in accordance with applicable laws and regulations relating to clinical trial records, but for a minimum period of 5 years after the University IRB approval of the final report.
(c) The Facility agrees to promptly notify the University (and provide supporting documentation and explanation, if applicable) of any of the following: instances of serious or continuing noncompliance with the federal regulations or the requirements and determinations of the University IRB and any other matter, including but not limited to site adverse events, subject complaints, unanticipated problems involving risks to subjects or deviations reported to such IRB by the investigators, that comes to the attention of such IRB that may adversely affect the University’s compliance with applicable regulations and laws governing human subjects research.
9. HIPAA. The Facility agrees to comply with all provisions of the Health Insurance Portability and Accountability Act of 1996 and regulations promulgated thereunder, as such law and regulations may be amended from time to time. The Facility agrees to not use or further disclose protected health information (“PHI”), as defined under HIPAA, other than as permitted or required by an underlying agreement or as required by law. The Facility agrees to use appropriate safeguards to prevent use or disclosure of PHI other than as provided for by this Agreement. Consider whether the Facility is providing any services or otherwise accessing PHI so that the following sentence should be included: Simultaneous with the execution of this Agreement, the Facility shall enter into a Business Associate Agreement with the University pursuant to the rules and regulations promulgated under HIPAA.
10. Use of University Name. Facility agrees that it shall not use the name of the University without the express written approval from the Vice President for Business Services at the University, nor will it state or indicate that the University endorses or approves any event(s) or products. Facility shall not issue any press release or other public statement that references the study hereunder or its results, or that uses the University’s name or trademarks, without the express written consent of the University. Furthermore, the University name shall not be used in any recruitment material related to the study without prior approval from the University IRB.
11. Termination. Notwithstanding any other provision in this Agreement, University shall have the right to terminate this Agreement at its sole discretion by giving thirty (30) calendar days prior written notice of intent to terminate to Facility. University may immediately terminate this Agreement in the event that Facility fails to comply with the terms of the study protocol or otherwise breaches any terms or provisions of the Agreement in any manner.
This Agreement may also be terminated by University on prior written notice to Facility if any of the following conditions occur:
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(a) if authorization and approval to perform the study in the United States is withdrawn by the FDA;
(b) if animal, human and/or toxicological test results, in the opinion of University, support termination of the study;
(c) if the emergence of any adverse reaction or side effect with the study drug administered in the study is of such magnitude or incidence, in the opinion of University, to support termination; or
(d) if during the course of this Agreement the University determines in its opinion that the study is not worth pursuing in view of its corporate objectives.