IRB Approval and Renewal
In compliance with the University of Michigan Human Research Protection Program, it is required that all studies seeking to perform scans at our facility be granted approval by the University's Institutional Review Board (IRB). It is expected that IRB approval will be granted before subjects are scanned at our facility, in compliance with University and federal guidelines.
Information about how to apply for IRB approval is available at: http://www.hrpp.umich.edu/irbs/.
Investigators using blanket IRB approval should refer to the following documents:
Studies are expected to upload a revised IRB approval when the approval is renewed. Please visit the user form website, enter your study nickname, and edit the attached documents associated with your user form.
IRB information for Existing Studies Considering Use of New MRI Machine
Attention users who would like to transition a study from our old MRI machine (GE Signa) to the new MRI machine (GE Discovery MR750), and whose only amendments would be a revision in the FDA numbers and the BEU numbers…
Dr. Judith Birk, Director of IRB-Med, and the rest of her team, have given special permission to investigators (whose only amendments would be as referenced above) to delay updating their protocols with this information until they submit other amendments. This is in an effort to prevent a flood of IRB amendments for simply a change in BEU and FDA numbers. Questions regarding this policy should be directed to Judith Birk (firstname.lastname@example.org, 763-4768).
Advice to Users on Consent Form Language
Recently, the Medical School Institutional Review Board (IRB-Med) instituted a new informed consent language regarding medical care for injuries for subjects. Previously the consent form indicated that medical care would be provided, but not paid for, and this language has been revised to indicate that medical care would be provided AND who would pay for this care.
Recently, the Co-Directors of Functional MRI Laboratory had a detailed meeting with Lois Brako, Assistant VP for Research over Regulator Compliance and Oversight, and Samuel Silver, Assistant Dean for Research at the Medical School and who also oversees the relevant section dealing with Financial Information in the informed consent for the Medical School.
During this meeting Drs. Brako and Silver clarified that the requirement for this language can be removed for studies with essentially no risk (for example, routine or standard fMRI studies), since the chance of injury, and therefore the chance of payment for said injuries, is so small.
Non-standard studies, such as drug studies, are not considered standard fMRI studies and you may be required to indicate that medical care would be provided AND paid for. If you are uncertain as to whether your consent form would be required to include this language, please contact Dr. Samuel Silver (email@example.com, 764-2204).
When you contact him please specify:
- The IRB number (if available)
- The nature of the study
- The risks posed to the subject
- The source of funding for your project
- Whether you are a faculty member with a primary appointment at the Medical School
Device and FDA Information for IRB Applications/Renewals
The IRB requires applications/renewals list information on the device to be used, including FDA numbers and device descriptions. Below is the information users should include with their applications:
|Machine Nickname||Device Type||Device Trade Name||FDA 510(K) Number||Manufacturer / Supplier||CFR & Product Label for Device|
|Old MRI Machine||3T MRI Scanner||GE Signa 3.0T With Excite MR System||K040444||General Electric||Product Label CFR Listing|
|New MRI Machine||3T MRI Scanner||GE MR750 3.0T With Discovery MR System||K081028||General Electric||Product Label CFR Listing|