SUBCONTRACT 3
INTERNATIONALSUBCONTRACT
between
The University of Miami
And
[the non-US Institution or individual]
This subcontract shall constitute an agreement if all of the following apply:
a) the [non-US institution or investigator] is engaged in UM research; and
b) the study is not supported by extramural grants or sponsors; and
c) the [non-US institution] has its own FWA on file with OHRP and has its own IRB
This Agreement executed this day of , 200, between the University of Miami (hereinafter referred to as “University”) and (hereinafter referred to as “Collaborating Institution”), located at , is for the purpose of engaging in research pursuant to the protocol as described herein. (hereinafter referred to as “Collaborating Investigator”), employed by the Collaborating Institution, will act as the responsible investigator at the Collaborating Institution.
(1). Study. Research will be conducted in accordance with the protocol attached hereto as Exhibit 1, incorporated herein by reference, and hereafter referred to as the “study” or the “protocol”.
The Principal Investigator at the University shall be . Collaborating Institution agrees that it or persons under its employ or its agents, including the Collaborating Investigator (collectively the “Collaborating Institution”) will be the only persons performing services under this Agreement.
(2). Payment. Any payment provisions shall be as set forth on Exhibit 2. [No sponsored funds may be used as payment.]
(3). Study Conditions and Standards.
(a) The parties agree to comply with (and to cause their agents and investigators to comply with) the terms of the protocol, the Statement of Investigator (Form 1573) and any and all international, United States federal or state, [insert name of foreign country], 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 (“FDA”) Regulations 21 CFR Parts 50 and 56 and the United States Department of Health and Human Services (“DHHS”) Regulations 45 CFR Part 46. The University and Collaborating Institution (including the Collaborating Investigator), as the case may be, each agree to abide by all decisions, determinations and conditions imposed by its own reviewing institutional review board (“IRB”), as may be amended from time to time, and to accept the final authority and decisions of such IRB with respect to its own conduct of research hereunder, including but not limited to directives to terminate participation in designated research activities conducted hereunder. The Collaborating Institution and the Collaborating Investigator shall be responsible for complying with any local or institutional policies, laws, and regulations applicable to their participation in the study and in accordance with the Collaborating Institution’s federal-wide assurance (if applicable).
(b) The Collaborating Institution and the Collaborating Investigator have reviewed: (1) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (see http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm) or other internationally recognized equivalent (see section B.1. of the Terms of the Federalwide Assurance (FWA) for International (Non-U.S.) Institutions on the OHRP website at http://www.hhs.gov/ohrp/humansubjects/assurance/filasurt.htm); (2) DHHS regulations for the protection of human subjects at 45 CFR 46 (see http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm) or other procedural standards designated by a non-U.S. institution under its FWA (see section B.3. of the Terms of the Federalwide Assurance (FWA) for International (Non-U.S.) Institutions on the OHRP website at http://www.hhs.gov/ohrp/humansubjects/assurance/filasurt.htm); (3) The Federal-Wide Assurance (FWA) of the University (see https://hsro.med.miami.edu/eprost/Rooms/DisplayPages/LayoutInitial?Container=com.webridge.entity.Entity%5BOID%5BD3CCE8B6FAEDB94FA19B59C42C04A85B%5D%5D); and (4) The University of Miami’s Policies and Procedures for the protection of human participants (see https://hsro.med.miami.edu/eprost/Rooms/DisplayPages/LayoutInitial?Container=com.webridge.entity.Entity%5BOID%5B332A415E0D2156419EF987EAAF32757D%5D%5D).
(c) The Collaborating Institution and the Collaborating Investigator understand and accept the responsibility to comply with the standards and requirements stipulated in the documents referenced in the preceding paragraph and to protect the rights and welfare of human subjects involved in the research conducted hereunder. The Collaborating Institution and the Collaborating Investigator acknowledge that the subjects’ rights and welfare must take precedence over the goals and requirements of the research.
(d) The Collaborating Institution and the Collaborating Investigator represent that, to the best of their knowledge, they are not now under any agreement to conduct clinical research studies or interventions or any other agreement which could conflict with their obligations hereunder, and the Collaborating Institution and the Collaborating Investigator agree not to knowingly enter into any conflicting agreements during the term of this Agreement.
(4). Term of Agreement. This Agreement will continue for a period of one year from the date of execution of this Agreement and shall be automatically renewed for one year periods unless terminated sooner pursuant to other provisions of the Agreement.
(5). Confidential Information. During the course of the study, certain confidential information and materials may be disclosed to the Collaborating Institution or Collaborating Investigator. 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 Collaborating Institution or Collaborating Investigator, constitutes the property of the University, and that neither the Collaborating Institution nor the Collaborating Investigator will 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 Collaborating Institution’s or Collaborating Investigator’s custody shall be promptly delivered to the University at its request or upon termination of the study. Collaborating Institution and Collaborating Investigator shall ensure that all employees or agents of Collaborating Institution shall be bound by the terms of this paragraph.
(6). Treatment and Records. If applicable, Collaborating Institution and Collaborating Investigator shall obtain required clinical information, obtain tissues, and complete all medical records as necessary in the usual treatment of the patient participant and as may be required by the terms of the protocol. Any deviation from the protocol must be approved by the University prior to such deviation. Collaborating Institution and Collaborating Investigator shall make available all medical records and original source documentation to University or Principal Investigator as may be requested by University or Principal Investigator.
(7). 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 Collaborating Institution or Collaborating Investigator by University pursuant to this Agreement are and shall remain the property of University.
(8). Liability and Insurance.
(a) Collaborating Institution and Collaborating Investigator agree to indemnify, defend and hold harmless the University, its trustees, IRB members, officers, directors, faculty, agents, and employees, 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, directors, faculty, agents, and employees (1) as a result of, arising out 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 Collaborating Institution, persons under its control, its agents or employees, including the Collaborating Investigator.
(b) In the event any such claim is made or lawsuit is initiated, Collaborating Institution and Collaborating Investigator agree to immediately 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 Collaborating Institution, its trustees, officers, directors, faculty, agents, and employees including the Collaborating Investigator, 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 Collaborating Institution or the Collaborating Investigator, arising directly from any negligent act or omission or intentional wrongdoing of University or its employees. .
(d) Insurance
(i) Collaborating Institution and University each agree to carry and keep in force, each at its own expense, professional liability insurance or a self insurance plan 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. Such professional liability insurance or self insurance plan shall include coverage for clinical research related services and medical services.
(ii) Collaborating Institution and University each agree to carry and keep in force, each at its expense, general liability insurance or a self insurance plan with limits not less than $1,000,000 per occurrence, $2,000,000 aggregate. Collaborating Institution’s general liability insurance shall include product liability insurance coverage. Collaborating Institution’s general liability insurance shall contain an endorsement naming the University as an additional insured with respect to this Agreement.
(iii) Collaborating Institution and University shall furnish evidence of such insurance prior to execution of this Agreement.
(iv) Such insurance shall not be cancelled for any cause without at least thirty (30) days prior written notice to the other party.
(v) The Collaborating Institution’s insurance shall be primary to any insurance or self insurance plan which the University may have.
(vi) Each party shall be responsible for maintaining worker’s compensation coverage in accordance with applicable law.
(e) Limitation of Liability. NO PARTY TO THIS AGREEMENT SHALL, IN ANY EVENT, BE LIABLE TO ANY OTHER PARTY FOR INDIRECT, SPECIAL, CONSEQUENTIAL, PUNITIVE, OR EXEMPLARY DAMAGES, COSTS, EXPENSES, CHARGES OR CLAIMS, EXCEPT TO THE EXTENT THAT INDEMNIFIABLE LOSSES RESULTING FROM A THIRD PARTY CLAIM INCLUDE INDIRECT, SPECIAL, CONSEQUENTIAL, PUNITIVE, OR EXEMPLARY DAMAGES, COSTS, EXPENSES, CHARGES OR CLAIMS OF THE THIRD PARTY AND THEN, ONLY TO THE EXTENT OF SUCH INDEMNIFIABLE LOSSES, SUBJECT HOWEVER, TO ALL OF THE LIMITATIONS SET FORTH ELSEWHERE IN THIS AGREEMENT.
(f) Taxes. Collaborating Institution shall pay all contributions, taxes, and premiums payable under federal, state and local laws measured upon the payroll of its employees including but not limited to the Collaborating Investigator, engaged in the performance of work under this Agreement, and all sales, use, excise, transportation, privilege, occupational, and other taxes applicable to materials and supplies furnished or work performed hereunder and shall hold University harmless from liability for any such contributions, premiums, and taxes.
(g) Independent Contractors For purposes of this Agreement, the Collaborating Institution, the Collaborating Investigator, their 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, the Collaborating Institution, Collaborating Investigator and the Staff Members do not have the authority to take action on the University’s behalf or to bind the University without its prior written consent. Collaborating Institution, the Collaborating Investigator 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 owes to the Collaborating Institution, except as otherwise required by law. The Collaborating Institution and/or the Collaborating Investigator are responsible to provide any and all compensation, benefits and/or insurance to Staff Members. It is also understood and expressly acknowledged that the Collaborating Institution, the Collaborating Investigator 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.
(h) The provisions of this Section 8 shall survive termination of this Agreement.
(9). Institutional Review Board and Training.
Unless the University has previously agreed to act as the sole IRB of record for the research in which the [non-UM institution] is engaged pursuant to an IRB Authorization Agreement, or unless the University has previously agreed to designate the IRB for the [non-UM institution] as the IRB of record for the research, the following conditions shall apply:
(a) Each of the parties shall be responsible for designating its own IRB under its own FWA, in accordance with the DHHS Office for Human Research Protections (“OHRP”) and FDA regulations and administrative guidance, to be the IRB of record for the study conducted at its site and shall provide oversight of the research undertaken at its site. The Collaborating Institution shall maintain a current FWA with OHRP prior to beginning the research conducted hereunder and shall provide copies of such current FWA annually to the University.
(b) For the avoidance of doubt, the University IRB shall not be the IRB of record for any research conducted at or by the Collaborating Institution or the Collaborating Investigator. Each such IRB shall be responsible for reviewing the research undertaken hereunder (including reviewing and approving the consent form, the protocol, and other aspects of the research and providing continuing oversight of the research for the duration of the study) in accordance with such regulations and guidance and other applicable federal and state laws and regulations governing IRBs and research with human beings, and abiding by the terms of its assurance and its responsibilities as set forth in 45 CFR 46. University and Collaborating Institution (including its Principal Investigator), each agree to abide by all decisions, determinations and conditions imposed by its own reviewing IRB (including assuring that such IRB approval does not lapse), as may be amended from time to time, and to accept the final authority and decisions of such IRB with respect to its own conduct of research hereunder, including but not limited to directives to terminate participation in designated research activities conducted hereunder.
(c) This agreement shall not be effective unless and until the parties’ IRBs of record approve the study to be conducted at such party’s site.