Pre-IRB

Details about the pre-IRB review and required forms

CMRR has worked with the University IRB office to streamline the process of gaining IRB approval for a project using the CMRR resources. This framework relies on two key components:

  1. The CMRR safety committee conducts a pre-approval review of the project. This step allows you to eliminate Appendix F for the CMRR MRI systems (an appendix may be required for other equipment used in a study). This approval letter must be included with the IRB submission
  2. CMRR has developed several universal forms, templates, and template language to be used in your IRB protocol and consent form

Each element is described below, including links to specific forms and to full policies which must be adhered to when using CMRR resources.

Before submitting your protocol to the IRB, it must go through a review by the CMRR; successful completion of the review will result in a letter that you must include in your IRB application. You will need to gather the following information for the pre-review:

  1. A list of the MR field strengths you plan to use; you will need an assessment for each field strengh
  2. Will you be using non-FDA approved RF coils? if so, please describe 
  3. Will any other devices be used in the scanning room, such as stimulus presentations, button boxes, physiological monitoring, power injectors, etc? If so, please describe
  4. Will you administer any drugs, including contrast agents, as part of the study? If so, please describe
  5. Will the MR system be operated in accordance with the iEC guidelines? If not, please describe specifically where you will not be following the guidelines
  6. You must use the CMRR MRI Screening form; you may also use additional screening criteria. IF you will be using additional criteria, please describe
  7. You will need to attest to adhering to CMRR Research SOPs and policies which are available at this link
  8. You will need to adhere to a standardized procedure for incidental findings and include specific approved language in the consent form; the consent form template is available at this link
  9. You will need a list of who will operate the MR system
  10. You will need to identify the Device Sponsor; typically this is the PI but see below for additional information
  11. A draft copy of your IRB application and experimental protocol

Further information about the Device Sponsor

For research falling under FDA jurisdiction: Sponsor Investigator is a PI who both initiates and actually conducts, alone or with others, an investigation, that is, under whose immediate direction the investigational device is administered, dispensed, or used. Sponsor Investigators must comply with both Sponsor and Investigator responsibilities under FDA 21CFR812. Sponsor Investigators must also comply with UMN Policy, Federal regulations requiring controlled use of experimental devices, and complete additional web-based training on the regulatory and institutional responsibilities of the sponsor-investigator role in device studies.

All studies at CMRR that scan human subjects must use the CMRR Subject Safety Screening form and template language in the consent form. There are additional standardized forms that may be required depending on the study specifics as noted below.

Rationale for having standardized forms

Safety of our human subject volunteers is a high priority. Use of a single, consistent screening form has several advantages:

  • it supports all of our researchers in conducting research safely
  • it improves the efficiency of IRB review, as they can rely on a pre-approved screening form
  • when CMRR needs to make changes to the safety form this "propagates" to all current protocols

Form requirements

Form 3T  7T 10.5T Comments
CMRR Subject Safety Screening Form required required required Required for all human subjects at CMRR
CMRR Subject Information Form optional required required Can be used by Radiology Faculty for subject payment
Exit Questionnaire optional optional required  
Template language in consent form required required required