Data Management

Data Anonymization – the MR data is collected using pseudo-anonymization (The key linking the pseudo-anonymized data and the participants’ details is held by the principal investigator ). The pseudo-anonymized data is directly sent to a dedicated HIPA-protected cloud managed by the University of Haifa.  Data from the peripheral equipment will also be sent to the same cloud folder. The data are organized using the BIDS (Brain Imaging Data Structure) format and transformed into project-specific folders. Researchers will need to download the data to analyze it. The data will be archived for 25 years.  

Helsinki-Ethical approvals and insurance

In Israel, research involving scanning human participants with MRI requires ethical approval from a medical-led Helsinki committee. This is because MRI scanners are regulated by the Ministry of Health. Hence research in UH-NRU will require ethical approval from Rambam’s Helsinki committee. We would also require ethical approval from the researchers’ institution’s ethical committee.

The Ministry of Health’s regulations require that research projects involving MRI will be led by a PI with medical qualifications (i.e. an MD doctor). By default, in UH-NRU, Dr. Ayelet Eran, who is the head of the MRI unit at Rambam Medical Care Campus will be the PI for our projects. Academic and industry-based researchers are defined as research sponsors. 

We currently have an active Helsinki protocol to cover pilot studies with consenting adults (18+ years old).

An additional requirement of the MoH is that the sponsor will provide insurance coverage for the hospital in case of harm to research participants (up to $3 million). The University of Haifa bought insurance to cover its own research projects, for other academic institutes and industries please contact us.

UH-NRU has a dedicated research coordinator who will support the Helsinki application and liaise on the researchers’ behalf with the Helsinki committee.