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Conducting MRI Research
Laboratories interested in conducting research at the ENU must first register in the ENU system and create an ENU account (one account per laboratory). Any researcher (faculty or student) who wants to run experiments at the ENU must be certified as an “operator”.
All operators are required to follow:
- The ENU working guidelines and safety policy (available in Hebrew and English),
- The latest Helsinki regulations and updates,
- And must complete an online course on good clinical practices (GCP).
For detailed instructions on how to become an operator, see below.
Each laboratory must also designate a “Lab Coordinator.” This can be the principal investigator (PI) or anyone the PI chooses. The Lab Coordinator is responsible for submitting any Helsinki-related requests (e.g., protocol amendments, operator additions) and must be familiar with:
Procedure to become an ENU user
If the lab has a physician (MD) as its PI with an existing Helsinki approval and HUJI IRB approval, send both documents to the ENU Helsinki Coordinator and proceed to Stage 2.
Labs without their own Helsinki approvals must work with the ENU to apply for one. According to Israeli law, only physicians (MDs) can conduct human clinical research. Therefore, the ENU works with Prof. Moshe Gomori (Hadassah Hospital) to provide physician oversight for laboratories without an MD-PI. For such laboratories, the ENU provides important Helsinki services, including submission of new protocols, amendment of existing protocols, and changing informed consent forms.
Steps to obtain Helsinki approval:
- The Lab Coordinator (or PI) completes the “ENU protocol request summary” and “ENU protocol format” forms and submits them to the ENU Helsinki Coordinator via email.
- These forms will then be considered for approval by the ENU committee.
- After approval, the “Lab Coordinator” schedules a meeting with the ENU Helsinki Coordinator to finalize the protocol and informed consent forms.
In addition, an IRB (Institutional Review Board) is required for all researchers. This is solely the researcher’s responsibility. Instructions can be found here. We recommend beginning and gaining both approvals at the same time.
After obtaining Helsinki and IRB approvals, the Lab Coordinator must contact the ENU Helsinki Coordinator and complete these steps:
- Open an account in the ENU reservation system. The lab will receive a username and a temporary password. This username should be used by any lab member who wishes to log in to the ENU system.
- Deposit USD funds for estimated MRI usage (on a quarterly basis).
- Meet with the ENU operating staff (and sometimes the ENU’s MRI physicist) to build and approve scanning sequences.
- Verify that all operators are listed in the approved Helsinki (i.e., that the names of the lab members running the experiment are Helsinki-approved).
- Make sure the operators complete the ENU safety training course, the online GCP training, and read the ENU working guidelines and safety policy (available in Hebrew and English).
- Register all operators for ENU updates (e.g., scanning slot cancellations).
Only after completing all these steps will researchers be certified as ENU “operators” and allowed to use the MRI scanner.
Adding a new Helsinki research protocol to an existing laboratory’s account
Labs operate multiple research protocols, each potentially requiring different scanning sequences, equipment, or participation groups. In some cases, a separate research protocol must be created and approved by the Helsinki committee.
- If your new protocol is already approved by a Helsinki committee and IRB, follow Stage 2 steps 3-6.
- If you need to create a new research protocol, begin with Stage 1, then follow Stage 2 steps 3-6.
Modifying an approved Helsinki protocol
To amend an existing protocol or informed consent form, the Lab Coordinator must schedule a meeting with the ENU Helsinki Coordinator to submit changes. The ENU Helsinki Coordinator will secure the required signatures and submit the updated documents to the Hadassah Helsinki Committee.
Becoming an ENU operator
- A researcher who wishes to become an ENU operator must first earn the GCP certificate before being added to the Helsinki form. To earn the certificate, go to the CITI Program site. Once inside, click on “Register”, choose “Participating Institutions” and select or enter “Hebrew University”. Once you have created your account, you will be eligible to take the GCP course free of charge.
- The researcher should read the ENU working guidelines and safety policy (available in Hebrew and English), as well as the Helsinki regulations and updates.
- The researcher must register for and attend the ENU safety course and pass the safety exam (the ENU safety training is scheduled every four months).
- The lab coordinator must schedule a meeting with the ENU Helsinki Coordinator to make the requested changes.
- Once approved by the Helsinki Committee and after passing the safety exam, the researcher will be added to the ENU system as an operator and may begin scanning.
Adding an operator to an existing protocol
An operator listed under one Helsinki protocol may not run scans for another protocol (even within the same lab) unless also listed on that second protocol. To add an operator to a protocol, the Lab Coordinator must follow steps 4-5 in “Becoming an ENU operator”, above.
All requests and inquiries should be submitted through the ENU Helsinki Coordinator, Lee Ashkenazi (lee.ash@mail.huji.ac.il).