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A qualitative assessment of the needs of Ukrainian refugees and local service providers from Poland, Slovakia, and Romania for implementing and scaling up psychological interventions.

Informed Consent Form for the study titled “A qualitative assessment of the needs of Ukrainian refugees and local service providers from Poland, Slovakia, and Romania for implementing and scaling up psychological interventions.”
Principal Investigator: Professor Corrado Barbui Ph.D.
Organization: World Health Organization (WHO) Collaborating Centre for Research and Training in Mental Health and Service Evaluation, Department of Neuroscience, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona, Italy.
Sponsor: EU 4 Health (European Commission).
Call: EU4H-2022-PJ-09(EU4H-PJG); Grant agreement 101101495
Name of the Project: Ukraine’s displaced people in the EU: Reach out, Implement, Scale-up and Evaluate interventions promoting mental wellbeing (U-RISE project).
Version: Version 1.0.
Date: April 2023.

Introduction

We are a research team based at the WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, Department of Neuroscience, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona. We are going to give you information about this research study and invite you to participate. You do not have to decide today whether or not you will participate in the research. Before you decide, you can talk to anyone you feel comfortable with about the research. If you have any questions, you can contact us at any time and we will be happy to answer them.

Purpose of the study

Since the Russian invasion of Ukraine, millions of Ukrainians have been forced to flee their homes, with many seeking refuge in neighbouring countries such as Poland, Romania, and Slovakia. The World Health Organisation (WHO) has informed about the potential negative impact of this crisis on mental health and wellbeing of vulnerable populations and on the strains that this humanitarian crisis puts on the healthcare systems of the host nations, which are faced with the challenge of fulfilling the psychological needs of the millions of displaced people. We want to find out about the barriers and facilitators faced by Ukrainian refugees in accessing face-to-face or digital psychological interventions. By learning about these problems and facilitators, the WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, from the Department of Neuroscience, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona, hopes to design better programs to support Ukrainian refugees.

Type of Research Intervention and Participant Selection

This research will involve your participation in one online meeting of maximum of two hours. You are invited to participate in this research as we feel that your experience can contribute to our understanding and knowledge of the problems that refugee populations and service providers are facing because of the war in Ukraine.

Voluntary Participation

Your participation in this research is entirely voluntary. It is your choice whether to participate or not and you may change your mind later and stop participating even if you agreed earlier.

Procedures

To learn about the barriers and facilitators faced by Ukrainian refugees in accessing psychological interventions, we are interviewing people with a refugee background and local service providers working with this population, who know about the situation. If you agree to be in this study, you will be interviewed by two members of our research team who will ask you some questions about the problems and facilitators affecting the access to psychological interventions of Ukrainian refugees.

During the interviews, we will record basic non-identifying information about you. No identifying information will be collected at any point during the interview to ensure that anonymity is maintained. Next, the interviewers will ask you a series of questions about the barriers and facilitators of accessing/delivering psychological interventions to Ukrainian refugees. You will be asked about the nature of the problems, possible causes, the effects on the person with the problems and others close to them, what people currently do about them, and what should be done. If you do not wish to answer any of the questions during the interview, you may say so, and the interviewers will move on to the next question.

The entire interview will be audio-recorded, but no one will be identified by name on the tape. The information recorded is confidential, and no one else except the members of the research team will have access to it. Once the interview is finished, the recordings will be transcribed and analyzed by the research team.

The research is expected to last four months, starting from the first interview.

Risks

Talking about problems that affect the refugee community can potentially lead to increased stress. However, we will ask you general questions about your community, not personal questions about yourself. You will not be asked to share any personal experiences. Furthermore, you may refuse to answer any questions, and you may stop the interviews at any time.

Benefits

This information will help the WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, Department of Neuroscience, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona, provide better programs to improve the mental health and wellbeing of Ukrainian refugees.

Compensation

Your participation in this study will not entail any additional expenditure. If you participate, you will not receive any payment.

Data Protection and Confidentiality

Procedures for the collection and storage of personal data will comply with relevant European regulations and directives, in particular with the EU regulation 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons concerning the processing of personal data and the free movement of such data, and the EU General Data Protection Regulation (GDPR), as well as the Organic Act 3/2018 of the 5th of December on personal data protection and the guarantee of digital rights in Italy.

Your data will be processed only to fulfil the purpose for which they were collected and shall be preserved as long as it is necessary following the current regulations. The University of Verona will act as the data controller.

On a general basis, personal data shall not be transferred to third parties, to the extent required by law. You have the right to withdraw your consent at any time. You may exercise the rights of Access, Rectification, Cancellation, Limitation of the treatment, Portability of the data or Opposition to the treatment before the University of Verona (Piazzale L.A. Scuro, 10, 37134 Verona VR), along with a written statement and an identification document.

To safeguard the confidentiality of the participants, data will be safely stored in a locked cupboard at the office of the principal investigator. Data will be coded and the identifying key (a list connecting names to numbers) will be saved on the computer of the research team and secured with a password only known to the principal investigators and the main researchers. Data will only be available to the members of the research group.

Data sharing

Only de-identified data will be shared with partners in the U-RISE consortium. The identity of participants in the datasets will be fully safeguarded.No attributable data will be used in publications. Data will be disseminated through submission to leading scientific journals with broad dissemination. Also, presentations at international conferences and other external events will be held.

Who to Contact

If you have any questions, you may contact any of the following: Prof. Corrado Barbui, corrado.barbui@univr.it, WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, Department of Neuroscience, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona. Ospedale Policlinico G.B. Rossi, Piazzale L.A. Scuro, 10, 37134 Verona VR, Italy.

Disclosure and expression of consent to the processing of personal data

Title of the Study: “A qualitative assessment of the needs of Ukrainian refugees and local service providers from Poland, Slovakia, and Romania for implementing and scaling up psychological interventions.”

Data controllers and the purposes of collecting personal data

In accordance with Article 13 of the Regulation (EU) 2016/679, the Data Controller is the University of Verona, located at Via dell'Artigliere n. 8, 37129, Verona (e-mail: privacy@ateneo.univr.it, PEC: ufficio.protocollo@pec.univr.it, tel. +39 045.8028777).
The present study "“ A qualitative assessment of the needs of Ukrainian refugees and local service providers from Poland, Slovakia, and Romania for implementing and scaling up psychological interventions.” is part of the larger project " Ukraine’s displaced people in the EU: Reach out, Implement, Scale-up and Evaluate interventions promoting mental wellbeing” (U-RISE) concerning the implementation of low-intensity, evidence-based psychological interventions developed by the World Health Organization to Ukrainian refugees. The objective of the current study is to conduct a qualitative assessment of the barriers and facilitators of accessing psychological intervention among the Ukrainian refugee population.

Before you make a decision about participating in the study, it is important that you understand the reason for the study and what you will be asked to do if you decide to agree to participate. The study leaders and staff are at your complete disposal for any clarification.

Nature of the data

The data controller processes personal data and data related to attitudes and psychological well-being, provided directly by the respondent. The information about you will always be treated as confidential in accordance with current regulations (Legislative Decree No. 196 of June 30, 2003, "Code for the Protection of Personal Data").

Methods of processing

The data processed for the above purposes will be communicated or will otherwise be accessible to the employees and collaborators assigned to the project or to the competent offices of the University, or to natural or legal persons who provide consultancy or service activities towards the University or the research team, for the purpose of providing the requested services. Your personal data such as your biographical information will be managed and stored exclusively for purposes related to the objectives of the study. Data management and information will be in computerized form. Should the results of this study be the subject of scientific publications, your identity will remain confidential. The University of Verona will act as the data controller. Only de-identified data will be shared with the research team. The identity of the participants will be fully safeguarded.

Data storage

Data will be encrypted, and the identification key will be stored on the research group's computer and protected by a password known only to the research manager and key research members. To safeguard the confidentiality of the participants, the data will be stored in a locked cabinet in the Department of Neuroscience, Biomedicine and Movement Sciences. Electronic documents will be stored in a password-protected database that can be accessed only by members of the research team. The data will be processed only to fulfill the purpose for which it was collected and will be kept for as long as necessary according to current regulations.

Rights of the interested party

You are guaranteed the right to obtain, in the cases provided for, access to your personal data and the rectification or deletion thereof or the restriction of the processing concerning them or to object to the processing (art. 15 et seq. of the Regulations), by specifying the appropriate request by email.

Consent to participate i n the research project and to the processing of personal data

I declare:

that i have read the information sheet concerning the study;
that the contents of the study were explained to me in clear detail;
that i had the opportunity to present my considerations and to ask for further clarifications, as well as to have time to make a spontaneous, thoughtful and unsolicited decision.

Therefore, I am aware:

of the planned activities and modalities of participation;
that participation in the research is voluntary and that I have the right to withdraw consent at any time;
that, in accordance with current regulations, the data collected will be used only for the purposes of scientific research.

By checking the box below, I consent to my participation in the study and to the processing of my personal data for research purposes within the limits and in the manner indicated in the information provided to me with this document.

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I consent to my participation in this study and to the processing of my personal data for research purposes within the limits and in the manner indicated in the information provided to me.