View source for IRB

All users (a) must have IRB approval for their research project, and (b) must identify a funded grant where scans can be charged. 

General information about IRB procedures and policies for research projects conducted at Stanford University are available at the [http://humansubjects.stanford.edu/ Human Subjects Research and IRB Page].

= Revising a protocol =

This "Revising a Protocol" section is a brief step-by-step guide on how to modify an existing IRB protocol so that you can use the new CNI MR scanner, the 3T Ultra-High Performance (UHP) scanner.  This scanner is not an FDA approved scanner, but still meets safety standard UL60601-1 and is in compliance with IEC 60601-2-33 (ed 3.1) according to GE internal testing and can consequently be considered a non-significant risk device. 

In the "Creating a New Protocol" section further below we have attached as a pdf file as the most recent modification of the CNI IRB which includes scanning on the new 3T UHP system, and also the ability to scan both at CNI and at the Lucas Center.  We have also attached in this section the letter from GE that describes the safety testing the UHP system has undergone, but Stanford Human Subjects suggests this does not need to be included with other IRB protocols as they've already had a chance to see it when reviewing the CNI IRB protocol modifications. 

== Step-by-Step  ==
 
A brief summary of how to modify an existing protocol that had included the CNI as a research facility to now include the 3T Ultra-High Performance (UHP) system:
<ol>
<li>Log on to the eProtocol site and begin a modification of the protocol 

<li>You will be asked to summarize the changes you propose. We suggest the following language: "We propose to modify the description of the 3T MRI scanner at the Stanford Center for Cognitive and Neurobiological Imaging (CNI) which has been upgraded from an FDA-approved 750 DVMR to an investigational device known as the 3T Ultra-High Performance (UHP) system."

<li>Under "Indicate Level of Risk", select "No Change".  This is true if the new scanner use is the only change you are making to your protocol. 

<li>Go to the ''General Checklist tab''  and mark "Yes" next to 4. Investigational Device/Commercial Device used off-label. Mark "No" next to 4. IDE Exempt Device (Commercial Device used according to label, Investigational In Vitro Device or Assay, or Consumer Preference/Modifications/Combinations of Approved Devices) if they are being studied. 

<li>Go to the ''Resources tab'' and clarify the description of the CNI under '''c. Facilities'''. Sample text: "The Cognitive and Neurobiological Imaging facility comprises an MR scanner (a 3T Ultra-High Performance scanner manufactured by GE Healthcare) and physiological monitoring equipment."

<li> Go to the ''Protocol Information tab'' and modify any sections that mention the CNI MRI 750 DVMR scanner.  These are the likely places.
* '''2. Study Procedures b):''' Describe the new MRI scanner indicating it is a non-FDA approved device but can still be considered non-significant risk.  We suggest the following language:  "The study will use the 3T UHP system at CNI.  The UHP shares a common software and hardware architecture to GE's FDA-approved Premier system but uses a higher-performance gradient coil and is not FDA approved for diagnostic use and is subject to the 21 CFR 812 investigational device(IDE) regulations as well as 21 CFR 50 and 56. The system has been tested by GE according to UL606001-1 and also for compliance with IEC 60601-2-33 (ed 3.1) -- meeting limits and guidelines for peripheral nerve stimulation, patient thermal, SAR limit, acoustic noise, flammability rating UL94-5VA for safety covers, hydrostatic pressure, electrical hazards, dielectric strength and pinch point. The MRI scans in this study will also utilize operational parameters within FDA guidelines for Nonsignificant Risk thus an Investigational Device Exemption (IDE) from FDA should not be necessary. The research conducted under this protocol is not to evaluate the safety or efficacy of this device. In support of this research study, some of the image acquisition pulse sequences and post-processing software will be developed in collaboration with GE Healthcare. Any such software will be considered investigational, will function as a non-significant risk device, and is subject to the 21 CFR 812 investigational device(IDE) regulations as well as 21 CFR 50 and 56. The investigational image acquisition software will conform to FDA guidelines for MR safety related to heating (SAR), peripheral nerve stimulation (dB/dt), and acoustic noise. "
* '''5. Devices:''' The 3T UHP needs to be listed in section 5a) under Investigational Devices.  The Device Name should be "3T UHP", indicate it is a non-significant risk device, list the PI as the sponsor of the project, and include the following under the Rationale for the device being non-significant risk: "The GE 3T Ultra High Performance (UHP) MRI scanner is an upgrade of an FDA-approved 3T MR750 scanner but is not itself FDA approved. The UHP scanner utilizes components from GE's 3T Signa Premier scanner (an FDA approved system) including gradient drivers, power supply, transmit and receive system, but uses a higher-performance gradient coil. The scanner has been tested by GE according to UL606001-1 and for compliance with IEC60601-2-33 (ed 3.1), meeting limits and guidelines for peripheral nerve stimulation, patient thermal, SAR limit, acoustic noise, flammability rating UL94-5VA for safety covers, hydrostatic pressure, electrical hazards, dielectric strength and pinch point. MRI research scans also frequently require specialized research software, but this will conform to FDA guidelines for MR safety related to heating (SAR), peripheral nerve stimulation (dB/dt), and acoustic noise. As a result, the 3T UHP system is considered a non-significant risk investigational device and is subject to 21 CFR 812 investigational device (IDE) regulations as well as 21 CFR 50 and 56. The MRI scans in this study using the UHP scanner will utilize operational parameters within FDA guidelines for Nonsignificant Risk thus an Investigational Device Exemption (IDE) from FDA should not be necessary. In addition to the GE receive coil components that are included with the UHP system, there are some non-GE coils. These devices are legally marketed components, used in accordance with their labelling, and are of non-significant risk. They include 32 channel and 16 channel receive-only brain RF coil arrays, manufactured by Nova Medical, Inc."


<li>'''13. Consent Background: '''Modify the informed consent to include a description of the CNI UHP scanner as an investigational system but with non-significant risk.  Example of appropriate text can be found in the CNI IRB consent form [[Media:CNI_Informed_Consent.2021.08.31.pdf|CNI IRB Consent]]

<li>'''Attach the CNI Participant Screening Form to the protocol'''
*Click the PROTOCOL INFORMATION tab in the sidebar. Go to section 16, Attachements.
*Under Questionnaires click add. Follow the directions to attach the CNI Participant Screening Form [[Media:CNI_Screening_form.pdf | CNI Participant Screening Form]] as a questionnaire.


<li>'''Submit your modification'''
* Now you are ready to submit. You can go back to the MODIFICATION FORM tab in the tab bar and look under section 4 to see the sections that have been modified. Be sure that you have checked the box at the bottom of the "OBLIGATIONS" page. You will also need to view the "Potential Conflicts of Interest" page (in the Protocol Information tab) and indicate any potential conflicts. 
* You can finally click the CHECK FOR COMPLETENESS tab, and if it looks good go ahead and SUBMIT via the tab in the sidebar. 
</ol>

= Creating a new protocol =
To create a new IRB protocol, log into the [https://eprotocol.stanford.edu/irb eProtocol site] and create a new IRB protocol. You can use the [[Media:CNI_Protocol.2021.08.31.pdf|CNI IRB]] and [[Media:CNI_Informed_Consent.2021.08.31.pdf|consent form]] as examples. These documents are the most recent modfications, which include scanning on the new 3T UHP system, and also the ability to scan both at CNI and at the Lucas Center. You will also need to attach the [[Media:CNI_Screening_form.pdf | CNI Participant Screening Form]] to your submission.  

For your information, the letter from GE describing the safety tests met by the UHP is here: [[Media:UHP_3T_Safety_Letter_Signed.pdf|3T UHP Safety Letter]], but should not need to be included to any IRB submission.

=Data sharing=

We ask all CNI users to share their data upon request.  To permit data sharing in the future, say to provide access to colleagues who would like to collaborate or to permit future data re-use, we ask that you add the following clause to your consent forms:

    Your research records, including neuroimaging data and the results
    of behavioral testing, may be shared with other researchers both within
    Stanford and at other institutions outside of Stanford. In this case you will be
    identified only by a unique code and no personally identifying information 
    will be shared. Information about the code will be kept in a secure location 
    and access limited to research study personnel.