AZIENDA OSPEDALIERO UNIVERSITARIA MEYER IRCCS
AZIENDA OSPEDALIERO UNIVERSITARIA XXXXX IRCCS
Determina del Dirigente n. 256 del 19-07-2024
Proposta n. 746 del 2024
Oggetto: STUDIO OSSERVAZIONALE NON-PROFIT DENOMINATO “JAK INHIBITORS IN UVEITIS”, CODICE PROT. DUA00000466 - APPROVAZIONE SCHEMA DI ACCORDO CON THE CHILDREN’S MERCY HOSPITAL
Dirigente: XXXXXXXX XXXXXXXXXX
Struttura Dirigente: CONVENZIONI E AFFARI GENERALI
Determina del Dirigente n. 256 firmata digitalmente il 19-07-2024
AZIENDA OSPEDALIERA UNIVERSITARIA XXXXX I.R.C.C.S.
Istituto di Ricovero e Cura a Carattere Scientifico Xxxxx Xxxxxxxxxx, 00 - 00000 XXXXXXX
C.F. P.Iva 02175680483
DISPOSIZIONE DIRIGENZIALE
Oggetto | Studio osservazionale |
Contenuto | STUDIO OSSERVAZIONALE NON-PROFIT DENOMINATO “JAK INHIBITORS IN UVEITIS”, CODICE PROT. DUA00000466 - APPROVAZIONE SCHEMA DI ACCORDO CON THE CHILDREN’S MERCY HOSPITAL |
Struttura | CONVENZIONI E AFFARI GENERALI |
Dirigente Proponente | XXXXXXXXXX XXXXXXXX |
Responsabile del procedimento | XXXXXXX XXXXXXXX |
Immediatamente Esecutiva | SI |
Conti Economici | |||
Spesa prevista | Conto Economico | Codice Conto | Anno Bilancio |
Estremi relativi ai principali documenti contenuti nel fascicolo | ||
Allegato | N° di pag. | Oggetto |
1 | 7 | Schema accordo |
“documento firmato digitalmente”
Richiamati:
IL RESPONSABILE S.O.S.D. CONVENZIONI E AFFARI GENERALI
(Dr.ssa Xxxxxxxxxx Xxxxxxxx)
- il Decreto Legislativo n. 502 del 30.12.1992 e successive modifiche ed integrazioni, recante “Riordino della disciplina in materia sanitaria, a norma dell’art.1 della legge 23 ottobre 1992, n. 421”;
- il Decreto Legge n. 75 del 22 .06.2023, così come modificato dalla Legge n. 112 del 10.08.2023, recante “Disposizioni urgenti in materia di organizzazione delle pubbliche amministrazioni, di agricoltura, di sport, di lavoro e per l’organizzazione del Giubileo della Chiesa cattolica per l’anno 2025” ed in particolare l’art. 8-bis, contenente “Disposizioni in materia di dirigenza sanitaria, amministrativa, professionale e tecnica del Servizio sanitario nazionale”;
- la Legge Regionale Toscana n. 40 del 24.02.2005 e successive modifiche ed integrazioni, di “Disciplina del Servizio Sanitario Regionale”;
- la Legge Regionale Toscana n. 12 del 16.03.2023 e successive modifiche ed integrazioni “Disposizioni in materia di istituti di ricovero e cura a carattere scientifico pubblici. Modifiche alla l.r. 40/2005” con la quale si è proceduto alla disciplina degli istituti di ricovero e cura a carattere scientifico di diritto pubblico ed in particolare l’art. 13 con il quale sono state dettate le “Disposizioni transitorie per il passaggio da Azienda Ospedaliero Universitaria Xxxxx ad Azienda Ospedaliera Universitaria Xxxxx IRCCS…”;
Dato atto che:
- con deliberazione del Direttore Generale n. 443 del 23.09.2022 l'A.O.U. Xxxxx ha disposto la presa d'atto del Decreto del Ministero della Salute del 02.08.2022, pubblicato nella Gazzetta Ufficiale n. 200 del 27.08.2022, con cui l’Azienda Ospedaliero Universitaria Xxxxx è stata riconosciuta Istituto di Ricovero e Cura a Carattere Scientifico (I.R.C.C.S.), per la disciplina di pediatria;
- con deliberazione del Direttore Generale n. 286 del 09.05.2024 è stato adottato ai sensi dell’art. 50 novies comma 3 della L.R.T. 40/2005 e s.m.i., a seguito dei pareri favorevoli della Giunta Regionale e del Ministero della Salute, il Regolamento di organizzazione e funzionamento dell’A.O.U. Xxxxx I.R.C.C.S.;
- con deliberazione del Direttore Generale n. 296 del 10.05.2024 è stato approvato il nuovo assetto organizzativo dell'A.O.U. Xxxxx I.R.C.C.S. il cui organigramma ha decorrenza dal 01.07.2024;
Richiamata la deliberazione del Direttore Generale n. 470 dell’8.11.2017, successivamente integrata con la deliberazione n. 211 del 30.04.2020, con la quale si è provveduto, a seguito delle azioni di sistematizzazione dell’organizzazione aziendale, alla declaratoria delle attività attribuite e/o delegate dal Direttore Generale ai singoli Responsabili delle Strutture Organizzative dello Staff della Direzione Generale, dello Staff della Direzione Amministrativa e dell’Area Tecnico Amministrativa, anche ai fini dell’adozione degli atti gestionali;
Dato atto che il Responsabile della S.O.S.D. Convenzioni e Affari Generali, Dr.ssa Xxxxxxxxxx Xxxxxxxx, con riferimento alla presente procedura, attesta la regolarità amministrativa e la legittimità dell’atto;
Considerata la richiesta da parte del promotore The Children’s Mercy Hospital, un ospedale pubblico con sede a Kansas City (Missouri, Stati Uniti), per la conduzione dello studio osservazionale non-profit denominato “JAK Inhibitors in Uveitis”, codice prot. DUA00000466, presso la SOSD Reumatologia sotto la responsabilità del Xxxx. Xxxxxxxx Xxxxxxxx;
Atteso che lo studio si configura come multicentrico e internazionale e che il promotore ha proposto un Accordo per la conduzione dello studio medesimo;
Preso atto che il Comitato Etico Regione Toscana - Pediatrico, nella seduta telematica del 09.07.2024, ha esaminato e approvato il protocollo relativo allo studio in oggetto;
Verificato che dal presente atto non derivano oneri economici a carico dell’AOU Xxxxx IRCCS;
Ritenuto, pertanto, di autorizzare lo studio in oggetto e di approvare lo schema di Accordo da stipulare con The Children’s Mercy Hospital per la disciplina delle condizioni normative ed operative dello studio medesimo secondo lo schema che, allegato N. 1 al presente atto, ne forma parte integrante e sostanziale;
Considerato che il Responsabile del Procedimento, individuato ai sensi della Legge n. 241/1990 nella persona del Dr. Xxxxxxx Xxxxxxxx sottoscrivendo l’atto attesta che lo stesso, a seguito dell’istruttoria effettuata, nella forma e nella sostanza è legittimo;
DISPONE
Per quanto esposto in narrativa che espressamente si richiama,
1. Di prendere atto del parere favorevole all’esecuzione dello studio in oggetto espresso dal Comitato Etico Regione Toscana - Pediatrico nella seduta 09.07.2024.
2. Di autorizzare lo svolgimento dello studio di cui al punto precedente presso la SOSD Reumatologia.
3. Di approvare lo schema di Accordo per la conduzione dello studio da stipulare con The Children’s Mercy Hospital che, allegato N. 1 al presente atto, ne forma parte integrante e sostanziale.
4. Di dare atto che il Xxxx. Xxxxxxxx Xxxxxxxx risulta essere il Responsabile dello studio di cui trattasi.
5. Di precisare che dal presente atto non derivano oneri economici a carico dell’AOU Xxxxx IRCCS.
6. Di trasmettere il presente atto al Collegio Sindacale ai sensi dell’art. 42, comma 2, della L.R.T. n. 40/2005 contemporaneamente all’inoltro all’albo di pubblicità degli atti di questa A.O.U. Xxxxx I.R.C.C.S.
IL RESPONSABILE S.O.S.D. CONVENZIONI E AFFARI GENERALI
(Dr.ssa Xxxxxxxxxx Xxxxxxxx)
ANONYMISED DATA TRANSFER AGREEMENT
by and between
The Children’s Mercy Hospital, a Missouri nonprofit corporation whose registred office is located at 0000 Xxxxxxx Xxxx, Xxxxxx Xxxx, XX 00000, XXX
(hereinafter referred to as "CMH" or “Recipient”) and
Xxxxx Children’s Hospital IRCCS, whose registred office is located at Viale Xxxxxxx Xxxxxxxxxx
24, 50139 Firenze, Italy, tax code/VAT number 02175680483, represented by its General Affairs and Development Manager, delegated to sign the present deed by Managing Director with resolution n. 470 of 8 November 2017
(hereinafter referred to as "XXX Xxxxx IRCCS" or “Provider”)
CMH and AOU Xxxxx IRCCS are hereinafter also referred to, individually, as the “Party” and, jointly, as the “Parties”.
WHEREAS
A) This is an observational study entitled “JAK Inhibitors in Uveitis” (hereinafter referred to as “Study”), an observational, prospective, multicentre study aimed at describing the collective experience of the collaborating investigators using JAK inhibitors in children with inflammatory eye disease.
B) The Study is conducted under the responsibility of Dr. Xxxxxx Xxxxxx (the “Principal Investigator”).
C) Among its objectives, the Study is designed to create a collaborative database managed through REDCap (the “Database”) for the purposes of the Study.
D) The Database is made up of a main dataset for analysis out of different datasets collected by several partners of the Study. The Database is hosted at Recipient’s facilitie , data access is only permitted through REDCap, and the Database is managed via a secure network with encrypted transfer protocols and access credentials are provided, administered, revoked, and controlled by the IT system administrators responsible for managing the REDCap platform. In its role as administrator of the Database, Recipient ensures the security, integrity, and availability of services and data, in accordance with local and national applicable law on data protection and management.
E) XXX Xxxxx IRCCS’s Reumathology Department, as a trial site (“Study Site”) within the Study, is willing to provide, through its Investigator Xxxx. Xxxxxxxx Xxxxxxxx (the “Study Site Investigator”), head of the aforementioned Department, health-related data ("Data") relevant for the above-mentioned Study objectives and in compliance with the Study protocol, subject to the terms and conditions of this Anonymised Data Transfer Agreement (the “Agreement”).
F) Data will be sent from the Study Site to Recipient as anonymised data. No patient associated ID code will be generated and kept by the Study Site for the purspose of the Study and the Database. Data will be stored on the Database in accordance with this Agreement.
Now therefore, on the basis of the foregoing, the Parties agree to the following terms and conditions:
1. Subject Matter
1.1 Data is provided to Recipient under the responsibility of the Study Site Investigator and will be inserted into the Database for the pursposes of the Study and in accordance with the Study protocol.
2. Data Processing
2.1 Data is governed by Recipient through its Principal Investigator who, together with Recipient personnel working on the Study, shall treat Data as “Confidential Information”pursuant to the Confidentiality provision below and not distribute it to third parties, provided that Recipient shall be allowed to transfer extracts of datasets to the partners of the Study and upon consent of the partner providing Data.
2.2 Each Party shall retain control of the anonymised Data in its possession in accordance with the terms and conditions of this Agreement.
2.3 Notwithstanding anything to the contrary herein, the Database and all Study documentation will be held for the greater of: three (3) years after completion of the Study, or for the time period needed to conduct and complete the Study, unless in each case, applicable law requires a longer period of retention in which case Data shall be retained in accordance with the same. .
2.4 Each Party shall, to the extent permitted by the law applicable to each Party and without waiving sovereign immunity, indemnify and defend the other against any claims, damages or expenses arising out of the indemnitor’s acts or omissions under this Agreement.
3. Obligations of the Recipient
3.1 As data processor, Recipient shall process data solely for the purpose of conducting the Study and Recipient is not allowed to transfer data to third parties without the previous written
consent from Provider. Recipient shall follow the instructions herein and abide by legislation in force on processing personal data.
3.2 Copies and duplicates of Data shall not be made without first informing Provider and obtaining its consent, except for Recipient’s automatic backup and recovery sytems. Recipient shall also guarantee compliance with the obligations of confidentiality relating to Data processed.
3.3 Recipient will cause its personnel authorised to process Data to: (i) be bound by obligations of confidentiality no less restrictive than those set forth herein; (ii) be trained with regard to data processing.
3.4 Recipient shall implement reasonable technical and organisational measures to protect and secure the Data consistent with Recipient’s data security policy applicable to like data, but in any event in compliance with data security law applicable to the Data. To this end Recipient shall:
• Ensure confidentiality, integrity, availability and resilience of processing systems and services;
• Ensure the ability to restore the availability and access to personal data in a timely manner in the event of a physical or technical incident;
• Keep a process for regularly testing, assessing and evaluating the effectiveness of technical and organisational measures for ensuring the security of the processing;
3.5 Recipient undertakes to implement the following minimum security measures:
a) Preventing persons not authorised from accessing data processing systems (physical access control);
b) Preventing unauthorised use of data processing systems (logical access control);
c) Ensuring that persons authorised to use data processing systems may only process the personal data for which they are granted access and that during processing or using and after retention Data cannot be read, copied, modified or cancelled without authorisation (data access control);
d) Guaranteeing that Data cannot be read, copied, modified or cancelled without authorisation during electronic transmission, transport or storage on specific devices and that recipients of any data tranfer through transmission systems can be identified and checked (data transfer control, including encryption);
e) Ensuring that a control procedure is in place to document whether data is entered and the persons providing data entry, modification or removal from the data processing systems;
f) Eensuring that Data is only processed according to instructions of the data controller (instruction control);
g) Guaranteeing that Data is protected against accidental destruction or loss and ensuring backup and continuity;
4. Obligations of the Provider
4.1 Data provided by Provider shall be inserted onto the Database as anonymised data and Provider shall guarantee that Data is provided in compliance with applicable local and national data protection laws.
4.2 Before collecting Data, Provider shall obtain written informed consent from patients involved in the Study, in accordance with applicable national laws and regulations regulating the use and processing of personal data in clinical studies and research.
5. Notification of Personal Data Breach
5.1 If Recipient discovers a breach of personal data involving the Database, Provider shall be informed 48 hours after the breach as duly verified.
5. Data Protection Officers contacts
The Parties have designated their respective data protection officers whose contact details are indicated below:
- for the Recipient: email: xxxxxxxxxxxxxx@xxx.xxx
- for the Provider: email: xxxxxxx.xxx@xxxxx.xx
6. Confidentiality
6.1 Documents, data, and information concerning the Study disclosed from a Party (“Disclosing Party”) to the other Party (“Recipient”) will constitute confidential information (“Confidential Information”) under this Agreement. Confidential Information is information which (a) if in writing, is marked “confidential,” “proprietary,” or other similar marking at the time of disclosure; (b) if provided orally, visually or in other non-written form, is identified as confidential at the time of disclosure and confirmed in writing to the Recipient within thirty
(30) days of such disclosure; or (c) is of such a nature that a reasonable person experienced in conducting clinical research would conclude that such information was confidential or proprietary. Confidential Information will be kept confidential for a period of three (3) years from expiration of this Agreement. Recipient shall:
(a) Not use Confidential Information except for the purposes of the Study;
(b) Hold Confidential Information in strictest confidence and will not disclose Confidential Information to others, except for its employees, contractors or agents who require Confidential Information for the purposes of the Study or by law and who are subject to binding obligations of confidentiality and restricted use at least as protective as those of this Agreement;
(c) Protect the confidentiality of Confidential Information using at least the same level of efforts and measures used to protect its own confidential information; and
(d) Notify the Disclosing Party as promptly as practicable of any unauthorized use or disclosure of Confidential Information.
6.2 The non-disclosure and non-use obligations agreed to herein shall not apply to any Confidential Information that:
(a) Recipient knew prior to learning it from Disclosing Party, as demonstrated by competent evidence that documents receiving Party’s prior knowledge;
(b) is now, or becomes in the future, publicly available information other than through an act or omission of Recipient;
(c) a third party discloses to Recipient without any breach of any obligation of confidentiality to Disclosing Party, as shown by Recipient’s written records contemporaneous with such third party disclosure; or
(d) Recipient independently develops without use of or reliance on Confidential Information, as demonstrated by Recipient’s independent written records contemporaneous with such development.
6.3 Notwithstanding other provisions of this Agreement, Recipient may disclose Confidential Information to the extent and to the persons, representatives, consultants or entities required under applicable governmental law, rule, regulation or order or provision by a court of competent jurisdiction or governmental authority, who need to know the Confidential Information to assist the Recipient or act on its behalf in relation to the purpose of the Study or to exercise its rights herein, provided that Recipient (a) gives prompt notice of such disclosure requirement to Disclosing Party so as to enable the latter to seek any limitations on or exemptions from such disclosure requirement and (b) reasonably cooperates at Disclosing Party’s request in any such efforts.
7. Intellectual Property
7.1 Parties agree that intellectual property (IP) generated in the course of the Study activities and arising from Data shall be identified and settled in specific IP agreements between the Parties and, as the case may be, other partners of the Study. This will involve, where necessary, interaction with other Study partners to ensure IP is appropriately protected and shared through specific IP agreements.
8. Publication
8.1. Recipient is encouraged to make publicly available the results of the Study. Before Recipient submits a paper or abstract for publication or otherwise intends to publicly disclose information about the results of the Study, Provider will have thirty (30) days to review proposed manuscripts and ten (10) days to review proposed abstracts to ensure that the Data is protected. Provider may request in writing that the proposed publication or other disclosure be delayed for up to thirty (30) additional days as necessary to protect proprietary information/remove confidential information.
8.2. Recipient agrees to recognize the contribution of the Provider as the source of the Data in all written or oral public disclosures concerning Recipient’s research using the Data, as appropriate in accordance with scholarly standards.
9. Duration and Termination
9.1 Parties agree that this Agreement will become valid upon the date it is signed by the last Party (“Effective Date”), and will remain in effect until the Study is closed at the Study Site.
9.2 This Agreement will automatically terminate without further notice five (5) years from the Effective Date. Should Recipient desire to use the Data for a longer period, Recipient shall notify Provider at least thirty (30) days prior to the date of automatic termination, and if the Parties agree, the term of this Agreement may be extended pursuant to a signed writing. Either Party may terminate the Agreement should the other Party fail to comply with one or more of the essential obligations set forth in this Agreement and fails to remedy within 15 (fifteen) days from receiving notification of such violation by the other Party or to provide proof of the impediment resulting from a case of “force majeure”. Notification shall be communicated by registered letter with acknowledgement of receipt or certified E-mail.
9.3 Each Party may rescind this Agreement at any time for justified reasons to be given by written notice by registered letter with acknowledgement of receipt or certified E-mail. Rescission will take place after 30 (thirty) days from formal notification. Nevertheless, the rescinding Party shall honour its commitments hereof until rescission is effective.
9.4 In the event of termination or rescission, Recipient shall not further use Data provided by Provider, being it understood that Data will be cancelled from the Database and not used any more for future activities related to the Study. Notwithstanding the foregoing, Recipient may retain such copy of the Data to the extent necessary to comply with the records retention requirements under any applicable law, and for the purposes of research integrity and verification.
9.5 Without prejudice to the foregoing, the Parties agree that the previous or the ongoing use of Data at the time of written notice for termination or rescission shall not preclude the previous or ongoing Study activities which include the use of Data referred to in the communication of termination rescission. Data already used and processed in the framework of the Study before the communication of termination or rescission cannot be the subject of disputes by the Study Site.
10. Governing Law and Dispute Resolution
10.1 Any dispute relating to, arising from or, in any event, connected to this Agreement, its construction, performance or termination shall be firstly settled amicably through negotiations; if no settlement is amicably reached, this Agreement shall be interpreted under the laws of the State of Missouri, USA exclusive of its choice of law provisions. All disputes arising under this Agreement shall be adjudicated in the state or federal courts having jurisdiction over such disputes arising in Xxxxxxx County, Kansas City, Missouri, USA.
Read, signed and approved by the Parties.
The Children’s Mercy Hospital | Xxxxx Children’s Hospital IRCCS |
Kansas City, Date: | Florence, Date: |
Xxxxxxx Xxxxxxx, MBA Sr. Director, Research & Sponsored Projects Administration | Dr Xxxxxxxxxx Xxxxxxxx Xxxxxxx Affairs and Development Department Manager |
For acceptance and acknowledgement
Study Site Investigator Xxxx. Xxxxxxxx Xxxxxxxx