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Your safety is our top priority. Certain conditions or implants can make MRI scanning unsafe. Please review the following lists carefully before participating in an MRI study.

You CANNOT participate if you have any of the following:  

• Cardiac pacemaker or defibrillator
• Retained wires from a removed electronic implant (e.g., pacemaker wires not attached to a device)
• Metal fragments in the eye or orbit
• Ferromagnetic aneurysm clip
• (Suspicion of) pregnancy
• Stainless steel intrauterine device (IUD)

You MAY NOT be able to participate if you have or have had: 

• Artificial heart valve
• Ear or eye implant
• Brain aneurysm clip
• Implanted electronic device (e.g., drug infusion pump, electrical stimulator)
• Coil, catheter, or filter in any blood vessel
• Shrapnel, bullets, or other metal fragments
• Surgery, medical procedure, or tattoos (including permanent makeup) in the last six weeks
• Dental braces or major dental prostheses (depending on the scanned area)
• Severe claustrophobia (the scanner is a narrow tube)

Safety Review

All MRI research participants undergo thorough safety screening for implants or devices that might interact with the scanner’s magnetic field. If potential safety issues are identified, your case will be reviewed by the MRI Safety Responsible of the facility. 

A decision about your participation will be made based on this assessment. In some cases, you may be asked to provide an operative report or implant details (such as device type and surgery date) to ensure safety.

Please ensure that a description similar to the one below, but accurate to your specific study procedure, is included in the consent form: 

• Briefing - When you arrive at the MRI Facility, the researcher will clearly explain what the study involves and what will be expected of you. You’ll receive an overview of the MRI procedure to help you feel comfortable and well-informed. You will complete a detailed MRI Safety Screening Form, which will be reviewed with you by the MRI researcher to ensure your safety during the scanning session. There will be time for questions and discussion before the scan begins.

• Changing clothes – Your clothing - including underwear - must be completely free of metal parts and metal fibers (sometimes found in antimicrobial sportswear). You'll need to remove all metal items such as
  • Glasses, hearing aids, or dentures
  • Jewelry, watches, and hairpins
  • Items from pockets (e.g., coins, paperclips, keys). These objects can be pulled toward the scanner magnet and may cause injury. It is recommended to wear long sleeves and long pants since the scanner room is relatively cool, unless the researcher provides other instructions in the context of the study.  

• Scanning – (This section should reflect your specific study procedure)  
  • Example for a brain scan: The session begins with an anatomical brain scan (about 5 minutes), followed by several task-based scans, where you will respond to visual or auditory cues by pressing buttons. The total scan time is approximately 1 hour.

• Debriefing – After the scan, you'll be asked to complete a short post-MRI checklist about your experience. This helps the research team ensure participant comfort and improve future sessions. 

This MRI examination is purely for research purposes. It is not medically indicated, is not a substitute for a clinical scan a doctor would order, and therefore has limited diagnostic value.

The design of the scan protocol may influence or even obscure abnormalities that a standard clinical MRI would detect. As a result:

• There is no routine review of scans for medical abnormalities by the researcher or a dedicated radiologist.
• No formal report will be generated.

If a researcher suspects an unexpected abnormality unrelated to the research question — which could range from minor anatomical variations to conditions requiring urgent medical attention — an expert radiologist will be consulted to:

• Confirm the finding
• Assess its clinical significance
• Recommend whether disclosure and referral to a physician are necessary

Any incidental findings will be communicated by a qualified medical professional, which could include:

• The researcher or Principal Investigator (if a medical doctor)
• Your general practitioner
• A relevant medical specialist

Your privacy and personal data are protected by law under:

• GDPR (EU) 2016/679, April 27, 2016
• Belgian law of July 30, 2018 on the protection of individuals regarding personal data

The researcher guarantees that

• Your privacy will be respected at all times
• You can request to access the data collected about you
• You can request correction of any errors in your data
• You can restrict the processing of your personal data
• You can request erasure of your data in certain circumstances
• You have the right to lodge a complaint

For more information on your rights and how to exercise them, visit the UGent website (https://www.ugent.be/nl/univgent/privacy/privacyverklaring.htm).

Data processing

By participation in this study, you consent to the processing or your data for research purposes. Only authorized personnel from the research team, under the responsibility of the Principal Investigator, will process your data. This may include internal staff without healthcare roles. The processing is lawful because it is:

• Performed in public interest (GDPR, Article 6, Paragraph 1e)
• Necessary for scientific research (GDPR, Article 9, Paragraph 2j)

Anonymity and Confidentiality

• All collected data will be pseudonymized: your data can only be linked to your personal identity via a code accessible to the investigator or their appointed delegate.
• Only pseudonymized data will be used for analysis, reports, publications, or presentations.

Data Storage

Your personal and health-related data will be retained for at least 10 years after study completion, for safety and follow-up reasons.

Data Sharing

• Pseudonymized data may be shared with future researchers for similar academic studies.
• Any re-use requires new Ethics Committee approval.
• If your data is transferred outside the European Economic Area (EEA), UGent ensures adequate protection through legal safeguards.
• Your explicit consent is required for international data transfers and is requested in the consent form below.
• If you do not want your data used for future research, you may contact the Data Protection Officer (DPO).

Contact details: privacy@ugent.be

Auditing

Representatives of the study promoter, auditors, the Medical Ethics Committee, and the competent authorities - all bound by professional secrecy - may access your study records. This access is strictly regulated by law and occurs under the responsibility of the investigator (or their authorized collaborator) to review study procedures and/or data. By signing this consent form, after receiving all preliminary explanations, you agree to this regulated access.

The Belgian supervisory Data Protection Authority, responsible for enforcing data protection legislation, can be contacted using the following contact details: