| Information letter and Consent form Patient considerations for participation in registries, patient-relevant information and current practices Welcome and thank you for your interest in our study. Before you can participate, we would like you to read the information below, and to fill in a few questions. Subsequently, we will contact you to arrange an interview at a convenient time. Principal Investigators: Sieta de Vries, University Medical Center Groningen Olmo van den Akker, QUEST Center for Responsible Research Berlin Corresponding investigator: Fabian Windfuhr, University Medical Center Groningen (f.a.windfuhr@umcg.nl) What is the study about? In a registry, health information is collected about a specific disease, such as multiple sclerosis. This study aims to investigate your perspectives regarding registries and the collection of information from patients for such a registry.
Before you decide whether you want to take part, it is important for you to understand why the research is being done and what taking part will involve. Please take time to read this information carefully and discuss it with others if you wish. Contact the corresponding investigator if there is anything that is not clear or if you would like more information. Who is responsible for carrying out this study? This study is being carried out by the University Medical Centre Groningen (UMCG) in the Netherlands, the Berlin Institute of Health (BIH) in Germany, the University of Lisbon (UL), and the European Multiple Sclerosis Platform (EMSP). The study is conducted in the context of the EU-funded More-EUROPA project (https://more-europa.org, grant number 101095479) and is supported by the Ethics Committee of the UMCG and Charité - Universitätsmedizin Berlin (which is integrated with the BIH). The UMCG and the BIH are responsible for conducting and processing data for this research project in accordance with ethical conduct codes and data protection laws. For questions or comments about how data is processed, please contact the BIH via the contact information at the bottom of this information letter. Who can participate in this study? You can participate in this study if you have been diagnosed with Multiple Sclerosis. You can also participate if you are a caregiver for someone with Multiple Sclerosis, or if you are a patient representative / advocate in the field of Multiple Sclerosis. In this case, you will be asked to describe patients' perspectives that you have experienced in your caregiver or representative role. What is the study's purpose? Registries can be a useful source of data for information about the effects of medicines. For instance, they can help doctors understand more about different treatments and how effective they are. Patients play an important role in registries, because they can freely decide if they want to participate. Therefore, it is important to know which aspects positively or negatively affect a patient in this decision. Participation means to allow the inclusion of their existing health data, and sometimes, agreeing to the collection of new data. In this study, we want to find out patients' perspectives on registry participation. We also aim to assess patients' perspectives on the different kinds of data that registries obtain directly from patients, and the information that the registries provide back to the patients. These perspectives will be used to evaluate and improve the current practices of registries concerning data collection and providing information to patients. Ultimately, with this research, we want to improve the experiences of patients and to represent their interests concerning patient registry participation. How can I participate? Participation in this study is entirely voluntary. The study consists of answering some demographic questions and participating in an interview, which is expected to last about 1,5 hours and will take place online. You can stop participating at any time, discontinue the ongoing interview or withdraw your consent to the recording and transcription of the interview without the need to give a reason or without any negative consequences. In case you have second thoughts and would like to revoke your participation after completing the interview, you can notify the corresponding investigator. In case your data has not been processed yet, the information you provided will not be used and will be deleted.
What are the possible benefits and disadvantages or risks of taking part? Your participation in this study can increase your knowledge of current practices regarding patient registries and help improve these practices in the future. As compensation for your participation, you will receive a gift card worth 25 euros. No adverse effects or risks are expected from participating in this study.
What will happen to the data provided in the interview? Only the researchers involved in this study will know that you participate. Beyond this, the responses and any data we will collect from you will be treated confidentially. We will record the interview with you, but the recording of the interview will only be accessible to the involved researchers in a restricted-access folder and will only be used to create a transcript. The transcript of the interview, in which you will not be identifiable, will be shared only with the researchers of this project for processing and analysis of the data for research purposes. All data sharing and storage will be in line with European regulations. The data will be archived for a period of 15 years, after which the data will be deleted. Your identity and all identifying information mentioned in the interview will remain confidential in reports, presentations, or publications resulting from this study.
Legal Basis for Data Processing, Legal Rights The legal basis for processing your data by us is your consent (Art. 6(1)(a) GDPR). You have the following rights in connection with the processing of personal data within this project: (1) You can withdraw your given consent at any time with future effect (Art. 7 GDPR). The legality of data processing until the withdrawal remains unaffected. (2) You have the right to access the data stored about you. Additionally, you have the right to rectification and deletion of your data, the right to restrict processing, and the right to data portability. Please note that from the time your contact data is deleted, it will no longer be possible to withdraw consent, access, correct, delete, or block your data, as we will no longer be able to associate the data with you personally.
Contact Information To exercise the aforementioned rights, please contact the responsible entity for processing personal data: Charité - Universitätsmedizin Berlin, Körperschaft des öffentlichen Rechts, Charitéplatz 1, 10117 Berlin. Executing entity: BIH QUEST Center for Responsible Research, Berlin Institute of Health at Charité, Anna-Louisa-Karsch-Straße 2, 10178 Berlin. Contact: Olmo van de Akker, email: olmo.van-den-akker@bih-charite.de. For questions about data processing and compliance with data protection requirements, you can also contact the Data Protection Officer of Charité: Official Data Protection Officer of Charité - Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin, email: datenschutzbeauftragte@charite.de. If you believe data processing is unlawful, you have the option to file a complaint with the supervisory authority responsible for Charité - Universitätsmedizin Berlin. The complaint can be made informally: Berlin Commissioner for Data Protection and Freedom of Information, Friedrichstraße 219, 10969 Berlin, email: mailbox@datenschutz-berlin.de, phone: +49 30 13889-0. For any other questions, concerns, or complaints you can contact Fabian Windfuhr by calling +31(0)50 3617897 or by email via f.a.windfuhr@umcg.nl.
Thank you for reading this information and for considering taking part in this study.
Sincerely, Mohsharif Nasrulloeva, Elisabeth Kasilingam, Fabian Windfuhr, Sieta de Vries, Peter Mol, Olmo van den Akker, Susanne Stark, Diogo de Almeida, Carla Torre, and Bruno Sepodes |