Dear interested individuals or study participants,
You have expressed interest in our scientific study at the University of Tübingen. Before deciding to participate in this study, we would like to inform you comprehensively about the investigation and explicitly emphasize that your participation in the study is voluntary. You can withdraw your consent and stop at any time without any consequences.
The following outlines the procedure and expected benefits of the experiment. Please take enough time to familiarize yourself with the information. If you have any questions, feel free to contact us directly – we are happy to answer them. Only after understanding the goals and planned procedure of the study should you decide whether you want to give your consent to participate.
Have you ever made a decision that you could not understand later? Or have you changed your mind without knowing why? Humans are expected to act rationally and make decisions based on their beliefs and preferences. However, this assumption is not always accurate. People are known to act inconsistently and make different decisions when faced with the same choices.
The reasons for this inconsistent behavior are largely unknown. It is crucial, however, to understand the internal processes of decision inconsistencies, especially to help individuals for whom these inconsistencies are a symptom of a psychiatric disorder. Particularly, individuals suffering from impulsive psychiatric disorders often exhibit pronounced decision inconsistencies.
One possibility is that regular fluctuations in our brain function and overall endogenous processes may cause these inconsistencies. In this context, this research project uses fMRI to investigate non-invasively whether decision-making and learning are influenced by changes in brain activity.
No blood will be drawn, and you will not receive injections or medication in this study. The study takes approximately 3 hours on 2 different days and aims to include a total of 50 participants. To determine which parts of your brain are active and interacting, we will measure the activity of your brain using functional magnetic resonance imaging (fMRI).
In the different parts of the experiment, you will be asked to look at different visual stimuli on a screen and to answer questions and solve tasks by pressing buttons, moving your eyes or making simple verbal utterances. To measure the eye movements, we use an eye tracker that works with invisible infrared light. In addition to the fMRI measurement of brain activity, we will administer various questionnaires that record individual differences between the study participants. All medical devices used in the study are CE-certified, will be used according to their intended purpose and will only be operated, used and maintained by persons who have the necessary training or knowledge and experience.
Before the examination, we will provide you with comprehensive information about the content and purpose of the study in a personal conversation. In this discussion, we will also explain and verify all conditions under which you may not participate in the study (see Section 7 below). We are happy to address any uncertainties and answer your questions. In addition, you will receive training before the measurements with the behavioral task, during which you can practice the tasks and the corresponding feedback at your leisure.
The questionnaires will be accessible to you on a tablet on-site and will take a maximum of 60 minutes. They include questions about personality, everyday situations, general mood, and your demographic background. Please answer the questions truthfully but spontaneously and promptly.
In contrast to X-ray examinations (conventional X-ray, computer tomography), the MRI procedure does not work with ionizing radiation, but with magnetic fields (3 Tesla field strength). The MRI measurement takes about 2.5 hours in total.
The MRI examination takes place in a special room. You will be wheeled into a short tube on a movable couch. The tube is open at the front and back. During the examination, you will hear loud knocking noises, which are completely normal and harmless and are caused by electromagnetic circuits (gradient fields). To avoid excessive noise pollution, you will wear hearing protection (headphones and/or earplugs). You will also be given a rubber ball with which you can trigger a signal in the monitoring room at any time. In addition, there is ongoing voice contact via a built-in microphone. It is important that you remain completely still and breathe evenly during the examination, as any movement, no matter how slight, causes interference that reduces the quality of the images.
Before the examination, care must be taken to ensure that no metal objects enter the MRI room, as these can cause injuries and image interference. Therefore, all metallic, magnetic and electronic objects must be removed before entering the examination room (watches, glasses, jewelry, piercings, wallets, metal parts of clothing, pens, keys, pocket knives, removable dentures, braces, hearing aids, etc.). As some eye shadows and make-up may contain metallic components, you should not wear make-up in the MRI scanner.
Unexpected morphological findings of the head or brain can be detected in the MRI scan. Such unexpected findings will be presented to a radiologist at the University Hospital of Tübingen for assessment. You will be informed of the findings if they require further diagnostics or surgery.
Due to the experimental protocol, your head will need to remain stationary for the majority of the experiment's duration. This may cause a minor degree of discomfort.
For the aforementioned questionnaire collection, no known risks are associated. However, it is possible that filling out the questionnaires may, in rare cases, induce psychological stress, especially if there is a predisposition to mental health problems. If you need help regarding mental health issues, please feel free to contact the study's lead professor (via email at Tobias.Hauser@uni-tuebingen.de). We are happy to assist you and provide information on other contact points, such as the Psychotherapeutic University Outpatient Clinic (information and registration at Tel: 07071/29-78357) or the psychiatric emergency care of the Psychiatric University Outpatient Clinic (Tel: 07071/29-82311).
Today, magnetic resonance imaging is generally regarded as a low-risk and safe examination method integral to routine medical diagnostics. The examination is painless. Adverse effects on the human body are not known at the magnetic field strengths used and are not to be expected according to the current state of science. However, complications are possible in rare individual cases, which may require further treatment: mild to moderate headaches may occur, but these usually subside on their own. Noises in the ears subside generally after the examination but may persist. There may be slight circulatory problems, dizziness, nausea (similar to motion sickness), the occurrence of flashes of light or changes in taste sensation (e.g. metallic taste of the tongue). Such symptoms mainly occur when subjects move within the magnetic field, i.e. when positioning themselves within the magnet or at the end of the measurement and disappear when they leave the area of the magnet. These symptoms do not occur during the examination as long as the subject is lying as relaxed and still as possible. The irradiated waves lead to a warming of the tissue, which is sometimes noticeable and can lead to sweating and skin irritation caused by make-up and tattoos containing metal. Injuries to the patient's skin, soft tissue and nerves caused by metal objects accidentally placed in the magnetic field have been described. You should, therefore, not wear make-up during MRI examinations and remove all metal objects such as keys, coins, belt buckles, watches, small electrical devices, cheque cards or clothing with large metal applications (e.g. bra).
You cannot participate in the study if any of the following conditions apply to you:
The experimenters will reconfirm these criteria with you to ensure that only individuals meeting the eligibility criteria participate. If any of the above exclusion criteria apply to you, or if you cannot definitively rule out any of the points, it is advisable not to participate in the study. If you have concerns about the described possible risks and side effects, the examination will also not be conducted.
For your participation in our study, you will receive a compensation of €10 per hour. Additionally, you have the opportunity to earn a bonus of up to €5 if you perform well in the decision-making task during the experiment. The compensation will be paid to you either in cash or, in the case of online studies, in the form of vouchers from local providers. If you receive compensation, you must sign a receipt with your name.
We want to emphasize that your participation in the study is voluntary. You can withdraw your consent to participate in the study at any time without stating reasons and without any consequences.
In the event of accidents caused negligently, you are covered by the liability insurance of the clinic. There is no accident insurance for commuting, meaning accidents during travel to and from the study are not covered.
The documentation of your data and its archiving will be pseudonymized in a secure electronic database, accessible only to authorized personnel, including doctoral candidates bound by professional and data secrecy. All involved staff members are bound by confidentiality.
The pseudonymized data collected during the study may be used and further processed for future research projects. The processing and use of pseudonymized data typically occur for a minimum of 10 years, unless the purpose of the study, such as inclusion in a database or long-term studies, requires a longer storage period.
The information obtained during this study may be shared with collaborators within the scope of the European General Data Protection Regulation and with collaborators outside the European Economic Area, including countries with lower data protection standards (including the USA). If your data is transmitted to countries with lower data protection standards, the responsible party will take all necessary measures to ensure data protection. If this is not possible, your data will only be transmitted in completely anonymized form.
Research data and results from the study will be published in anonymized form in scientific journals or databases. Your identity will not be disclosed during the publication of research results. However, local investigators can trace back the data to your person with the help of a patient list if there are inquiries.
You can request information about your stored data at any time and demand the provision of a free copy. You have the right to correct incorrect data. You can also request the deletion or anonymization of your data so that it can no longer be associated with you. These rights arise from Articles 12ff of the European General Data Protection Regulation (EU-GDPR). These rights are limited to the extent that they are likely to make the achievement of the respective research purposes impossible or seriously impair them, and the restriction is necessary for the fulfillment of the respective research purposes. The right to information does not exist if the data is necessary for the purposes of scientific research, and providing information would require a disproportionate effort.
Prof. Dr. Tobias Hauser, the study leader, is responsible for data processing and compliance with legal data protection regulations.
For complaints, you can contact the data protection officer of the University Hospital Tübingen or the state data protection officer of the state of Baden-Württemberg.
For the collection, storage, use, and disclosure of your data, your explicit consent is required by signing the data protection consent form. The legal basis for processing your data is Article 6, 7, 9, 89 of the General Data Protection Regulation in conjunction with §§ 4, 5, 6, 8, 9, 12, 13 of the State Data Protection Act of Baden-Württemberg in the version valid from May 25, 2018.
For further questions, we are at your disposal!
Data Protection Officer of the University Hospital Tübingen
Calwerstraße 7/4, 72076 Tübingen,
Tel. 07071 29-87667, Email: dsb@med.uni-tuebingen.de
State Commissioner for Data Protection and Freedom of Information in Baden-Württemberg
Postal address: Postfach 10 29 32, 70025 Stuttgart
Tel.: 0711/615541-0, FAX: 0711/615541-15, Email: poststelle@lfdi.bwl.de
I have been informed about the objectives, duration, procedure, benefits, as well as risks and side effects of participating in the study. I have had sufficient time to decide on participating in this investigation and am aware that participation is voluntary. I confirm that none of the conditions listed in the participation information, under which I cannot participate in the study, apply to me. I have been informed that there is no separate insurance for study participants in this investigation.
I declare that I consent to the collection and processing of data within the scope of the study and its pseudonymized disclosure. I am aware that the results of this study will be published in medical journals, but in anonymized form, so that a direct reference to my person cannot be established.
I have been informed that I can request information about my stored data at any time and demand the correction of inaccurate data. I am aware that I can request the deletion or immediate anonymization of my data collected up to that point, for example, upon withdrawal from study participation. I declare that I have been adequately informed about the collection and processing of my data in this study and my rights.
I agree to the use of the data collected within the framework of this study in the form described above (see Section 10. Information on Data Protection). I hereby declare my voluntary participation in the study.