IRB Protocols
- Investigators should include in their PRISM PSFs:
Exclusion: Any material in the body that is a contraindication for MRI procedures
Method of Ascertainment: Interview*
* The MRI Unit Screener must also be completed and approved prior to scanning
Exclusion: Pregnancy of participant
Method of Ascertainment:Interview*
* Negative urine pregnancy test is also required on the day of scan for participants with childbearing potential
- Investigators should include in their CFs:
Template wording regarding risks, mitigation of risks, and safety neuroreads posted on the IRB website.
(Note that eligibility concerns such as claustrophobia are addressed in the MRI Screening Form.)
Screening for MRI contraindications
- MRI Unit Screener:
The MRI Unit Screener is a part of the eligibility criteria to proceed with an MRI scan. This document is available on REDCap and must be completed by the research team with the participant (and, if a minor, the parent or legal guardian). A ‘yes’ response to any item on the screening form may necessitate a consultation with the MRI safety team. Consultation may lead to a request for further documentation (e.g., surgeon’s documentation; type of tattoo ink).
- Timing of the screening form:
- If your IRB protocol requires inclusion/exclusion criteria to be met before consent, you must conduct the NYSPI MRI REDCap MRI Unit Screener and complete any supplementary documentation if requested by medical or operations director (e.g., surgeon’s documentation; type of tattoo ink) by the time of consent. If your protocol permits screening following consent, you may screen for metal or MRI-contraindicated materials informally at the time of initial evaluation. FOR ALL PROTOCOLS, APPROVAL OF THE REDCap MRI SCREENING FORM BY THE MRI SAFETY TEAM INCLUDING ANY REQUIRED SUPPLEMENTARY DOCUMENTATION IS REQUIRED PRIOR TO SCANNING AND WILL BE DOCUMENTED ON THE SCREENER FORM.
- You must update and reconfirm the screening form with participant (and parent or legal guardian if under 18 years of age) within 24 hours of scan for each scan in the protocol. Once confirmed, screening form should be signed by the research staff member who administers it before it is emailed to the scan tech.
- The completed REDCap MRI Screening Form and any supplemental documentation (e.g., surgeon documentation, approval emails) should be saved as a PDF and added to the participant’s research chart by the study team. In all cases, persons present during completion of the MRI screening form (in person, virtually, or by phone) will be documented.
- All consultations with a safety officer will be logged in a spreadsheet maintained by the MRI unit and all completed MRI Screening Forms will be accessible through REDCap by the MRI unit.
Special practices required for scanning of minors:
- Minors must be accompanied by an adult to the MRI unit.
- MRI Screening Forms must be completed with a parent or legal guardian physically or virtually present.
- The NYSPI MRI Director will personally approve MRI procedures for each protocol involving minors.
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