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IRB Protocols
Include in 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* - * A negative urine pregnancy test is required on the day of scan for participants with childbearing potential.
Include in Consent Forms (CFs)
Template language regarding risks, mitigation of risks, and safety neuroreads is posted on the IRB website.
Note: Eligibility concerns such as difficulty with enclosed spaces are addressed in the MRI Screening Form.
Screening for MRI Contraindications
MRI Unit Screener
The MRI Unit Screener is part of the eligibility criteria to proceed with an MRI scan. It is available in 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 may necessitate consultation with the MRI safety team and may require further documentation (e.g., surgeon’s documentation; type of tattoo ink).
Timing & Documentation
- 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 requested supplemental documentation by the time of consent.
- If your protocol permits screening following consent, you may screen for metal or MRI-contraindicated materials informally at initial evaluation.
- For all protocols, approval of the REDCap MRI Screening Form by the MRI Safety Team— including any required supplemental documentation— is required prior to scanning and will be documented on the screener form.
- Update and reconfirm the screening form with the participant (and parent/guardian if <18) within 24 hours of each scan. Once confirmed, the form must be signed by the administering research staff member before emailing to the scan tech.
- Save the completed REDCap MRI Screening Form and any supplemental documentation as a PDF and add to the participant’s research chart. Document all persons present (in person, virtual, or phone) during screening completion.
- All safety consultations are logged by the MRI unit; completed MRI Screening Forms are accessible through REDCap by the MRI unit.
Special Practices for 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.
IRB Protocols
Include in 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* - * A negative urine pregnancy test is required on the day of scan for participants with childbearing potential.
Include in Consent Forms (CFs)
Template language regarding risks, mitigation of risks, and safety neuroreads is posted on the IRB website.
Note: Eligibility concerns such as difficulty with enclosed spaces are addressed in the MRI Screening Form.
Screening for MRI Contraindications
MRI Unit Screener
The MRI Unit Screener is part of the eligibility criteria to proceed with an MRI scan. It is available in 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 may necessitate consultation with the MRI safety team and may require further documentation (e.g., surgeon’s documentation; type of tattoo ink).
Timing & Documentation
- 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 requested supplemental documentation by the time of consent.
- If your protocol permits screening following consent, you may screen for metal or MRI-contraindicated materials informally at initial evaluation.
- For all protocols, approval of the REDCap MRI Screening Form by the MRI Safety Team— including any required supplemental documentation— is required prior to scanning and will be documented on the screener form.
- Update and reconfirm the screening form with the participant (and parent/guardian if <18) within 24 hours of each scan. Once confirmed, the form must be signed by the administering research staff member before emailing to the scan tech.
- Save the completed REDCap MRI Screening Form and any supplemental documentation as a PDF and add to the participant’s research chart. Document all persons present (in person, virtual, or phone) during screening completion.
- All safety consultations are logged by the MRI unit; completed MRI Screening Forms are accessible through REDCap by the MRI unit.
Special Practices for 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.