Ethics

In the case of measurements on human subjects, the approval of the relevant ethics committee is always required.

If the researcher submits a project on behalf of an MU department (outside the MU Faculty of Medicine), the project is assessed by the Research Ethics Committee (REC). Projects from the Faculty of Medicine are reviewed by the MU Faculty of Medicine Ethics Committee. In other cases (outside MU), then the relevant committee according to the employer of the principal investigator of the project.

Please find below recommended/sample texts for Informed Consents:

What is the procedure in case of an incidental finding? 

The examination is conducted for the purpose of scientific research. The purpose of the examination is not to provide medical services or to determine your health status. The data collected will not be evaluated by a physician, but by a researcher. Should the researcher suspect a possible medical complication, you have the right to be informed of this suspicion and to subsequently discuss the suspicion with your physician.

Storage of data 

The MAFIL measurement database with personal data and measurement codes and the original measurement data containing personal data are stored on secure data storage facilities separated from public networks (e.g. internet) and can only be accessed by authorised staff of the MR department, after 5 years they are anonymised and the MR security forms are shredded. Security MR forms are stored in secure archives at the MR site. 

What are the disadvantages/risks of participating in this research? 

• MR 

Before the MRI scan, you will be asked by the staff about the presence of metallic materials in your body and any other implants. People who have a magnetic metal object in or on their body cannot be examined. A pacemaker or other device that can be affected by a magnetic field precludes this examination. The presence of inappropriate metallic materials or electronic devices in your body could seriously damage your health. Many new implants and devices are already designed to be MR compatible, but this must be documented by the manufacturer's certification or a medical report from the treating physician. An MRI specialist will assess the feasibility of the scan and has the right to refuse the scan if they believe your health could be harmed. We also do not recommend that you take part in the study if you have extensive tattoos on your body or if you are a pregnant woman. 

The actual magnetic field in the MRI machine is harmless to your health; in some cases, you may only feel discomfort from the enclosed space and the sound associated with the machine during the examination. Rarely, you may feel a metallic sensation in your mouth or a sensation of flashing lights. Due to the limited space during an MRI scan, the scan may not be feasible if you suffer from claustrophobia. If you are aware of this, please notify the researcher or any of the MR department staff. Magnetic resonance imaging is commonly used in medical diagnostics. Siemens Magnetom Prisma is a device approved for medical use and uses a 3 T magnetic field for imaging. 

• EEG 

Electroencephalography (EEG) is a non-invasive diagnostic method used to record the electrical activity of the brain using electrodes placed on the head. During the measurement, the patient wears a cap on the head in which the sensing electrodes are placed and coated with gel. These electrodes do not damage the integrity of the skin or hair and the test has no adverse effects.  

• rTMS 

For magnetic stimulation, the recommended parameters for safe application are followed. Adverse effects include epileptic seizure induction in a few cases (in the order of per mille) worldwide. These events are almost non-existent after the implementation of the given recommendations. In 20 years of experience with rTMS for research purposes, we have not observed any adverse effects, apart from transient headache, which may occur in a fraction of cases and resolve after administration of a conventional analgesic such as Paralen. Negative effects on other functions (memory, cognitive function) have not been demonstrated, on the contrary, the results of several studies report a positive effect of stimulation.  

What is the procedure for handling and securing the data? 

Detailed information on data handling is provided in the document Annex to the CF MAFIL Operating Regulations No. 2: Data storage and security at CF MAFIL (available here - https://mafil.ceitec.cz/dokumenty-pro-vyzkumniky/)