Important PREREQUISITES

• known diabetes mellitus type 2
• High blood pressure
• Increased blood fat values (hypercholesterolemia)
• Minimum age 18 years, good German language skills
• NO history of heart attack or stroke
• NO history of hospitalization for heart failure (acute heart failure)
• Willingness to participate in the on-site examination appointments

If you are interested, please use our checklist for possible participation or simply write to us:

belove-teilnahme@bih-charite.de

You will initially receive a patient fee of 50€ for participating in the first inclusion visit (Visit 1). If you participate in the 2-day Standard Plus Program at the main study visit (Visit 3) at the study center, you will receive 100€ per day (i.e. a total of 200€). If you decide to participate in the shorter Standard Program (1 day) at Visit 3 instead, you will receive 100 € for this effort. If you participate in the very reduced Basic examination program, you will receive a patient fee of 50€.

This "compensation" is not subject to social insurance, but must be reported to the tax office as "other income". This expense allowance also covers, among other things, the costs of travel, a parking space, etc.

If you have been registered as a study participant, the following personal master data will be transferred from the hospital information system of Charité Universitätsmedizin Berlin:  

• Surname, first name, address, date and place of birth. 
• telephone number, e-mail address
• Attending general practitioner
• case number and patient ID 

In addition, other types of medical data are collected as part of the study, which are generated on different devices during the examinations and subsequently stored centrally. In the language of the General Data Protection Regulation (GDPR), this would be the so-called "health data".  Health data is data describing physical and mental characteristics (e.g., blood pressure measurement) as well as biometric data (e.g., data from a head MRI), which in principle also enables identification.

Medical data also includes biological samples that go to the laboratory for analysis and storage. Genetic tests can also be performed on biological samples. These are referred to as "genetic data" in the GDPR (Art. 9 GDPR). 

In addition, the questionnaires that you fill out during the visits also ask questions that also fall within the scope of Article 9 DS-GVO.  

In any case, the medical data will be stored in a different location than the personal master data and using a pseudonym (encryption). Strict separation of the data groups is required from the data protection side in order to exclude unauthorized references. Only authorized study personnel are permitted to create the patient reference.

It is not intended, nor is it possible, to inform you of all research results that may arise from the use of your biomaterials and medical data. Some of these results come from purely experimental examination methods that are not established in medical care and do not provide any information about your personal condition or health. Other examination methods are also used in medical practice, but in the context of the study they are performed with different questions and sometimes different standards. Therefore, they may lead to results with unclear significance or no direct significance for your health. However, such results, which are very numerous due to the extent of the study investigations, can cause inappropriate fears and stress, which are often very difficult to dispel subsequently. Therefore, we do not communicate such research results to you. Accordingly, if we do not communicate the results of an examination, you cannot assume that there were no abnormalities in the organs examined or that diseases have been ruled out. A response can be given if the results of your examinations have consequences for treatment or if information is of considerable importance for your health from our point of view. This is the case if, for example, the outbreak of a (possibly life-threatening) disease can be avoided or a previously possibly unrecognized disease can be treated. The communication of such information may then make it necessary for you to seek medical treatment immediately or promptly for further clarification of these results; further specific examinations or assessments cannot be carried out within the framework of the study. 

However, you may then have to disclose the information or diagnoses made by other physicians in the course of further clarification to other bodies (e.g. before taking out an insurance policy).

In addition, we are obligated to inform you of the legal consequences in the event that examination results (e.g. limitations of the visual field in the neurological examination) indicate a restriction of your fitness to drive.

If there are indications of the presence of a disease that must be reported in accordance with the Infection Protection Act, we are obliged in some cases to already report a justified suspicion to the responsible public health office. The health office could then in turn order mandatory measures for you (e.g. domestic isolation).

In any case, we would inform you of some results that are directly relevant to your health, such as life-threatening acute illnesses. Your consent to the transmission of such results to you is therefore a prerequisite for participation in the study. Other health-related results will only be communicated to you if you agree to be contacted by us in this regard. If you do not wish to be contacted in this regard or to be informed of such findings by our study physicians, but would still like to learn about the results and discuss them with a physician you trust, you have the alternative option of having us send the results to your family physician. You can choose one of these two options in the consent form. If you do not wish to be informed of such results at all, you can have both the option of being contacted in this regard and the option of having the results sent to your primary care physician deleted from the consent form. We will be happy to provide you with a list of examinations and examination results that we would always disclose to you, or only with your consent, if they were present in your case, as well as examples of results that we would not disclose. In addition, we are planning to prepare a (standardized) informative report of the results.

A major goal of BeLOVE is to build up a large data collection. It should be possible to investigate questions that reach very far into the future, also through other research projects. These can either also be located at Charité Universitätsmedizin Berlin or at other hospitals, possibly also nationwide or internationally. In order to be able to deal with these data use requests, special committees are set up and persons are appointed who, with the appropriate professional expertise and experience, decide on the releases of the data or samples. The procedure for such a data use request will be briefly explained below. 

The person officially (legally) responsible for a study/research project submits a data use request to the committee to be set up specifically for this purpose (the so-called "Data Use and Access Committee", (DUAC)). This must be done in a standardized manner according to templates provided by the DUAC. The applicant will usually be a researcher of university or non-university institutions of the above mentioned categories. The DUAC is composed of high-ranking representatives of various disciplines and departments within Charité Universitätsmedizin Berlin and MDC. Within this DUAC, a number of formal and substantive requirements are now reviewed - in particular, the purpose-relatedness and the specific need for the use of your data donation. After a multi-stage review and inquiry process with a number of documents to be submitted (such as a valid vote of the responsible ethics committee), a positive notice of use will be issued if necessary. In this process, the scope of use and the return, storage and destruction/erasure/anonymization agreements are contractually defined.

Thus, when the applicant finally receives the data, he or she is bound by a narrow legal framework.