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HomeMy WebLinkAbout064896 - General - Contract - University of PittsburghDocusign Envelope ID: 7F2519DF-3331-4F87-9EC1-AB3DC384AD6B IRBAuthAgree-05/05/2016 3 re 0 INIVISSO: T1• IRB Authorization Agreement Name of Institution or Organization Providing IRB Review (Institution A): University of Pittsburgh — Of the Commonwealth System of Higher Education IRB Registration #: IRB 00000319 OHRP Federalwide Assurance (FWA) # 00006790 Name of Institution Relying on the Designated IRB (Institution B): The City of Fort Worth, by and through the Fort Worth Fire Department: OHRP Federalwide Assurance (FWA) #: FWA00014800 Purpose This Authorization Agreement is between The University of Pittsburgh (UPitt) located in Pittsburgh, Pennsylvania and City of Fort Worth located in Fort Worth, Texas. The Officials signing below agree that the City of Fort Worth may rely on UPitt's IRB for review and continuing oversight of its human subjects research described below: This agreement is limited to the following specific protocol: Name of Research Project: Prehospital Analgesia INtervention trial (PAIN) Name of Principal Investigator: Jason Sperry, MD This document must be kept on file at both institutions and provided to the Office for Human Research Protections (OHRP) in the United States Department of Health and Human Services upon request. Responsibilities (UPitt) Institutional Review Board (IRB) Responsibilities The UPitt IRB agrees that it will: 1) Maintain an FWA with OHRP and maintain registration with both OHRP and the FDA. (Please note that UPITT only applies the Common Rule and its subparts to federally funded research. Equal protections are provided to all non -federally funded research). 2) Maintain IRB board membership that satisfies the requirements of 45 CFR 46, 21 CRF 56 and provide special expertise as needed from IRB members or consultants to adequately assess all aspects of the Study. 3) Make available to the Relying Site upon request, the UPitt IRB Standard Operating Procedures. OFFICIAL RECORD Page 1 of 7 CITY SECRETARY FT. WORTH, TX Docusign Envelope ID: 7F2519DF-3331-4F87-9EC1-AB3DC384AD6B IRBAuthAgree-05/05/2016 4) Perform initial reviews, continuing reviews, reviews of submitted unanticipated problems that involve risks to subjects or others, amendments, reviews of DSMB reports, and reviews of any other documents submitted by the Principal Investigator of the Study. 5) Maintain and make accessible to the Relying Site upon request the UPitt IRB application, protocol reviews, letters to Principal Investigators, approvals and disapprovals, approved consents, minutes of the UPitt IRB meetings relevant to the Study and the Relying Site. 6) Provide an approved study -wide informed consent form. The form will indicate areas where the Relying Site may add language or otherwise customize the form for its own site (HIPAA, payment research related injury, local contacts). Any modifications will be subject to approval by the UPitt IRB, which will then provide a final approved consent form to the Relying Site for use. 7) UPitt IRB will perform those determinations required by the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations (collectively, "HIPAA") with respect to the mechanisms for permitting the use and disclosure of Protected Health Information ("PHI") for the research protocol in this Agreement, including authorization and waivers of authorization for use and disclosure of PHI. Relying Sites will provide their own authorization but will ensure that its form of authorization explicitly permits PHI to be used and shared by and with UPitt and all participating Study sites and their investigators as necessary for conducting, reviewing, and overseeing the Study as contemplated by the protocol and this Agreement. 8) Review Relying Site management plans related to conflicts of interest reported by Relying Site investigators and others involved in the Study, as required under Relying Site policies. Determine if the management plan(s) is acceptable to the UPitt IRB under UPitt policies and practices. IF the UPitt IRB determines the management plan is not acceptable, the UPITT IRB will promptly inform the Site Official and the Study will not be eligible for review under this Agreement. 9) Notify the Site Official promptly if there is ever a suspension or restriction of the UPitt IRB's authorization to review studies. 10) Notify the Site Official promptly of any UPitt IRB policy decisions or regulatory matters that might affect the institution's reliance on UPitt IRB reviews or performance of the Study at the Relying Site. 11) Notify the Site Official promptly in writing of injuries or unanticipated problems involving injury or risks to subjects or others in the Study discovered by the UPitt IRB. 12) Notify the Site Official promptly if the UPitt IRB determines that serious or continuing non- compliance has occurred in the Study at the Relying Site, and the steps the UPitt IRB deems necessary for the remediation of the non-compliance, including but not limited to, any suspension, disapproval or termination of the Study, or any sanctions or limitations imposed on researchers at the Relying Site. UPitt may request that the Relying Site conduct its own Page 2 of 7 Docusign Envelope ID: 7F2519DF-3331-4F87-9EC1-AB3DC384AD6B IRBAuthAgree-05/05/2016 investigation and report back to UPitt or UPitt may work cooperatively to conduct its own investigation. If the UPitt IRB determines that it must report the findings of an investigation to OHRP, the FDA and/or other oversight entities, it will notify the Relying Site in advance. The UPitt IRB will provide the involved Relying Site the opportunity to review and comment on the report before it is sent to OHRP, the FDA or others. Nothing in this Agreement shall prevent a Relying Site from making its own report to OHRP or from taking additional remediation steps at its own institution. 13) Notify the Relying Site promptly if it decides to suspend, disapprove, or terminate the Study as a consequence of receiving allegations of serious or continuing non-compliance or unanticipated events that have the potential to cause harm to research subjects. 14) Notify the Relying Site about the need for a UPitt Quality Assurance Audit at the Relying Site. UPitt may ask the Relying Site to conduct its own Quality/Assurance audit and supply results to the UPitt IRB or work cooperatively to conduct such a review. Relying Site Institutional Responsibilities: The Relying Site agrees that it will, at all times while this Agreement is in effect: 1) Maintain a Federal Wide Assurance (FWA). 2) Maintain a human subject's protection program, as required by the DHHS OHRP. 3) Designate a Site Official who is responsible for, and has Relying Site authority for, all communication regarding the Study and provide to the UPitt IRB the name and contact information for that individual. 4) Provide the Relying Site Principal Investigator and other research personnel involved in the Study a resource from the Relying Site IRB to address any questions or concerns they may have and refer them to the appropriate resource at the UPitt IRB, as necessary. 5) Ensure that the investigators and other personnel at the Relying Site who are involved in the Study are appropriately qualified and meet the Relying Site's standards for eligibility to conduct research. This includes, but is not limited to, having the required professional staff appointments, credentialing, insurance coverage, and background checks for their assigned role in the Study. 6) Educate and train its investigators to perform research in compliance with human research protection regulations. 7) Perform local analysis of any specific requirements of state or local laws, regulations, policies, standards (social or cultural) or other factors applicable to this Study, and include any relevant requirements or results of the analysis that would affect its conduct of the research as part of the information provided to UPitt for consideration. Page 3 of 7 Docusign Envelope ID: 7F2519DF-3331-4F87-9EC1-AB3DC384AD6B IRBAuthAgree-05/05/2016 8) Perform local review by other local ancillary committee reviews as applicable and required by its policies (such as nursing review, radiation safety, pharmacy and any others), and include any relevant requirements or results of the reviews that would affect its conduct of the research as part of the information provided UPitt for consideration. 9) It is the sole responsibility of the Relying Site to identify and interpret the requirements of its applicable state or local laws, regulations, policies, and ancillary review processes as are relevant to the Study and to communicate the requirements to the UPitt IRB. 10) Provide to UPitt IRB the Relying Site's authorization language for HIPAA but ensure that it includes authorization that explicitly permits PHI to be used and shared by and with UPitt and all participating Study sites and their investigators as necessary for conducting, reviewing, and overseeing the Study as contemplated by the protocol and this Agreement. Remain independently responsible for your own HIPAA compliance and obligations (for example, minimum necessary requirements, or accounting of disclosures of PHI made pursuant to a waiver of authorization) in connection with the research protocol covered under this Agreement other than the initial determinations regarding mechanisms for use and disclosure of PHI. 11) Notify the UPitt IRB within twenty-four hours of becoming aware of a suspension or restriction of Relying Site investigator or other personnel involved in the Study, or the discovery of serious or continuing non-compliance, or an unanticipated problem that involves risks to subjects within the Study. 12) Cooperate promptly and upon request with any UPitt investigation regarding serious or continuing noncompliance or an unanticipated problem related to the Study. UPitt may ask the Relying Site to conduct a full investigation and report its findings to UPitt, which the Relying Site will do promptly and in compliance will all rules, regulations, and requirements. The Relying Site will provide to UPitt updates, as reasonable and upon request and a copy of the report of its findings. If the investigative process, by UPitt or the Relying Site, results in the production of a report that will be made available externally, UPitt will afford the Relying Site an opportunity to comment on a draft of such report with appropriate consideration of any confidentiality issues. Nothing in this Agreement shall prevent the Relying Site from conducting its own investigation. However, any findings of fact made by a Relying Site will be shared promptly with UPitt to ensure the safe and appropriate performance of the Study at the Relying Site. 13) Ensure an institutional mechanism exists by which complaints about the Study can be made by local Study participants or others. Promptly report such complaints to the UPitt IRB if they meet the criteria of a potential unanticipated event that causes risk to subject or others, as defined by the UPitt IRB policies. 14) Ensure that the Relying Site maintains policies regarding the disclosure and management of conflicts of interest related to research and share those policies with the UPitt IRB as requested. Ensure that Relying Site investigators and other personnel involved in the Study disclose financial interests as required under the Relying Site policies. Ensure that conflicts of interest Page 4 of 7 Docusign Envelope ID: 7F2519DF-3331-4F87-9EC1-AB3DC384AD6B IRBAuthAgree-05/05/2016 are reviewed, and a management plan is implemented, if and as required under Relying Site policies. Provide all management plans to the UPitt IRB for its review. The UPitt IRB will determine if the management plan(s) is acceptable to the UPitt IRB under UPitt policies and practices. If the UPitt IRB determines the management plan is not acceptable, the UPitt IRB will promptly inform the Site Official and the Study will not be eligible for review under this Agreement. The Relying Site will ensure the compliance of all management plans related to the Study. The UPitt IRB will apply its standard policies regarding confidentiality of review of information and disclosures submitted to it regarding potential investigator conflicts of interest. 15) Maintain policies and procedures for dealing with injuries to human research subjects and share these policies and procedures with the UPitt IRB as requested. To the extent of its own policies, the Relying Site shall provide or arrange for treatment of injuries to human subjects, if any, that may result from Study -related procedures that occur at the Relying Site. Nothing in this Agreement shall prevent institutions collaborating on a specific Study to make other arrangements between or among them at the outset of a specific Study to allocate differently the responsibility for costs associated with injuries to human subjects that might occur in the course of the Study. 16) Cooperate with and use all reasonable efforts to ensure Relying Site investigators' cooperation with any inquiry by the UPitt Research Quality Assurance Office requests relating to a Study. Such cooperation will include, but is not limited to, providing research records and related information and meeting with institutional research representatives upon request. In addition, the UPitt may ask the Relying Site to conduct its own Quality/Assurance/ Quality Initiative which the Relying Site shall promptly conduct and will supply the Relying Site results to the UPitt IRB. 17) Ensure compliance by its investigators and research staff (including, but not limited to, physicians, research nurses, coordinators, data managers, or other members of the research team) in the conduct of the Study. 18) Require Relying Site investigators to maintain records of all Study and related activities conducted under this Agreement for at least seven years and longer if required by law, after completion of any Study. Signatures: Once IRB review for a study has been ceded to UPitt pursuant to this Agreement, the research protocol will remain under UPitt IRB authority for the life of the research protocol unless this Agreement is terminated as set forth below. This Agreement will become effective as of the date of the last signature below and will remain in effect until the conclusion of the Study, defined as the time when all human subject activities at the Relying Site conclude. The Agreement may be terminated by (i) either party without cause; such termination will be effective upon the UPitt IRB receiving notification from the Relying Site IRB that Page 5 of 7 Docusign Envelope ID: 7F2519DF-3331-4F87-9EC1-AB3DC384AD6B IRBAuthAgree-05/05/2016 the Relying Site IRB has assumed responsibility for the Study; (ii) by either party upon breach of the other parry which in the sole discretion of the non -breaching party is capable of cure, if the breach has not been cured to the satisfaction of the non -breaching party within 30 days of notification of breach; or (iii) by either party immediately upon written notice upon breach of this Agreement which in the sole discretion of the non -breaching party is not capable of cure, including but not limited to any activity or reason that may place human subjects at risk. All notices under this Agreement shall be sent to the addresses set forth above addressed to the Site Official. The officials having signed below commit their respective institutions to this IRB Authorization Agreement. Both institutions shall follow agreed upon written policies and procedures relevant to the agreement. Docusi ned by: @ 03-06-2026 4:39 PM EST Signature of Signatory Official (Institution A): // Date: Name: Bill J. Yates, PhD Title: Acting Vice Chancellor for Research Protections Institution: University of Pittsburgh Suite 401, Hieber Building 3500 Fifth Avenue Pittsburgh, PA 15213 Phone: 412- 383-0131 Fax: 412-648-4010 Email: vcor cbpitt.edu Signature of Signatory Official (Institution B): Valerie �shington (Mar 4, 2026 16:27:09 CST) Date: Name: Valerie Washington Title: Assistant City Manager Institution: City of Fort Worth Phone: 817-392-1234 Fax: Email: valerie.washington@fortworthtexas.gov Page 6 of 7 Docusign Envelope ID: 7F2519DF-3331-4F87-9EC1-AB3DC384AD6B IRBAuthAgree-05/05/2016 CITY OF FORT WORTH INTERNAL ROUTING PROCESS: Approval Recommended: By: Name: Dr. Jeffrey Jarvis Title: Chief Medical Officer, Office of Medical Director Approved as to Form and Legality: By: Name: Taylor Paris Title: Assistant City Attorney Contract Authorization: M&C: N/A Contract Compliance Manager: By signing I acknowledge that I am the person responsible for the monitoring and administration of this contract, including ensuring all performance and reporting requirements. By: Name: Dwayne Howerton Title: DD, Office of the Medical Director City Secretary: By: Name: Title: Page 7 of 7 q A.ems (1 Jannette S. Goodall City Secretary A, olo �o dvo �=d as an��°U°Eaa °5a4.o� OFFICIAL RECORD CITY SECRETARY FT. WORTH, TX Docusign Envelope ID: 7F2519DF-3331-4F87-9EC1-AB3DC384AD6B FORTWORTH. City Secretary's Office Contract Routing & Transmittal Slip Contractor's Name: University of Pittsburgh Subject of the Agreement: This Authorization Agreement is between The University of Pittsburgh (UPitt) and City of Fort Worth agreeing to rely on UPitt's IRB for review and continuing oversight of its human subjects research for the Prehospital Anagesia INtervention trial (PAIN). M&C Approved by the Council? * Yes ❑ No If so, the M&C must be attached to the contract. Is this an Amendment to an Existing contract? Yes ❑ No If so, provide the original contract number and the amendment number. Is the Contract "Permanent"? *Yes ❑ No IZI If unsure, see back page for permanent contract listing. Is this entire contract Confidential? *Yes ❑ No © If only specific information is Confidential, please list what information is Confidential and the page it is located. Effective Date: Expiration Date: 9/30/2028 If different from the approval date. If applicable. Is a 1295 Form required? * Yes ❑ No *If so, please ensure it is attached to the approving M&C or attached to the contract. Project Number: If applicable. *Did you include a Text field on the contract to add the City Secretary Contract (CSC) number? Yes © No IZI Contracts need to be routed for CSO processing in the following, order: 1. Katherine Cenicola (Approver) 2. Jannette S. Goodall (Signer) 3. Allison Tidwell (Form Filler) *Indicates the information is required and if the information is not provided, the contract will be returned to the department. 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