IRB

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All users must have IRB approval for research projects, and must be funded via a grant for billing purposes. General information about the procedures and policies related to obtaining IRB approval for research projects conducted at Stanford University are available at the Human Subjects Research and IRB Page.

This page describes the changes you should make to an existing protocol to allow you to scan at the CNI.

Revising a protocol

This is a brief guide on how to modify an existing IRB protocol so that you can use the CNI MR scanner. For example, if you have an approved IRB protocol for scanning at Lucas, it is straightforward to revise your protocol so that you can scan at either the CNI or at Lucas.

Overview

A brief summary of what you need to do to add CNI as a scan site:

  1. Log on to the eProtocol site and begin a modification of the protocol
  2. You will be asked to summarize the changes you propose. We suggest the following language: "We propose to add the Stanford Center for Cognitive and Neurobiological Imaging (CNI) to the list of facilities at which we will be collecting data."
  3. If you are modifying a protocol that included the Lucas Center, you can get a sense for where you need to make changes as follows: Go to the Print View tab on the left. Download your protocol to your computer, open the document with Adobe Reader, and Search for all instances of the 'Lucas Center'. Wherever you find the Lucas Center you will need to add text for the CNI.
  4. Go to the Resources tab and add a mention of the CNI under c. Facilities. Sample text: "The lab utilizes the Lucas Center and the center for Cognitive and Neurobiological Imaging (CNI) for fMRI research."
  5. Go to the Protocol Information tab and change the following sections (and any other sections where your protocol mentions the Lucas Center). These are the likely places.
    • 2. Study Procedures: mention the CNI every time the Lucas Center is mentioned
    • 8h. Participant Population: In part "h. Inclusion and Exclusion Criteria, include a mention of the CNI's MR Screening form as part of the screening procedures. Download the CNI screening form.
    • 11. Privacy and Confidentiality: change a) Privacy Protections to include the possibility of interacting with volunteers in the CNI behavioral testing rooms change part b) Confidentiality Protections to list all the questions on the attached CNI MR screening form
    • 13. Consent Background: In the Consent Background table at bottom, download your consent form by clicking on it under the Title column. Go through the consent form and include the CNI wherever the Lucas Center is mentioned. Replace your consent as per the instructions on the website.
    • 16. Attachments: Attach the CNI MR Screening form under Questionnaires

Step-by-Step

  1. Login to the eProtocol site and begin a modification of your protocol.
    • Click the protocol number, and choose modification. This will open the protocol for editing and bring you to the "Modification Form".
    • The Modification Form: This form consists of a section where (among other things) you will be asked to summarize the proposed changes to the protocol. We suggest something like the following:
      "We propose to add the Stanford Center for Cognitive and Neurobiological Imaging (CNI) to the list of facilities at which we will be collecting data. Changes made to specific sections in this protocol, as well as to the consent form, are related to this purpose. We have also attached a screening form that participants will fill out prior to being scanned at the CNI."
    • There will be no change to the level of risk and no change to the Conflict of Interest Status.
  2. Add CNI training to the section on Qualified Staff
    • Click the RESOURCES tab in the sidebar. In section A. Qualified staff, add some text about the CNI safety training for your staff. We suggest something like the following:
      "Those members of the research team that will be performing scans at the Stanford Center for Cognitive and Neurobiological Imaging will complete the appropriate safety training courses required for users of the facility prior to scanning participants."
  3. Add the CNI to the list of facilities in Rescources
    • Click the RESOURCES tab in the sidebar. In section C. Facilities, add the CNI. We suggest something like the following:
      "The Stanford Center for Cognitive and Neurobiological Imaging (CNI) and the Richard M. Lucas Center for Magnetic Resonance Spectroscopy and Imaging will be the sites for all MRI data acquisition. All other aspects of the study, including data analysis, will be carried out in the Department of Psychology, Stanford University."
  4. Add the CNI scanner and related equipment to the list of IDE Exempt Devices (Commercial Devices)
    • In the GENERAL CHECKLIST, check 'yes' to "IDE Exempt Device (Commercial Device used according to label)" and 'no' to "Investigational Device / Commercial Device used off-label?"
    • Click the PROTOCOL INFORMATION tab in the sidebar. Go to section 5. Devices.
    • None of the CNI devices (scanner, coils, eye trackers) should be listed in section 5, part A (Investigational Devices and Uses).
    • In section 5b, you will list the MR scanner and any of the other CNI equipment that you plan to use (Nova coils, eye trackers).
    • Click the add button under section 5. part B. (IDE Exempt Devices (Commercial Devices)). This will open the Device Information window.
    • Device Information Window: Use the information below to fill in the fields.
      Describe the device to be used. "3.0 Tesla Magnetic Resonance Imaging device. Used to acquire functional and anatomical brain images."
      Device Name. "Sigma MR750 3T scanner"
      Manufacturer "GE Healthcare"
      IDE Exemption. Check the third radio button ("The study includes consumer preference testing, testing of...")
    • If you plan to use the Nova 32-channel coil, add:
      Describe the device to be used. "32 channel receive-only whole brain RF coil array, including preamplifiers for use on a GE 750 MRI Scanner."
      Device Name. "Nova 32 channel brain array"
      Manufacturer "Nova Medical, Inc."
      IDE Exemption. Check the first radio button ("This is a legally marketed device being used in accordance with its labeling.")
    • If you plan to use the Nova 16-channel coil, add:
      Describe the device to be used. "16 channel receive-only visual RF coil array, including preamplifiers for use on a GE 750 MRI Scanner."
      Device Name. "Nova 16 channel visual array"
      Manufacturer "Nova Medical, Inc."
      IDE Exemption. Check the first radio button ("This is a legally marketed device being used in accordance with its labeling.")
    • If you plan to use the eye tracker with the LCD display, add:
      Describe the device to be used. "Video-based eye-tracker system"
      Device Name. "EyeLink 1000"
      Manufacturer "SR Research, Ltd."
      IDE Exemption. Check the first radio button ("This is a legally marketed device being used in accordance with its labeling.")
    • If you plan to use the eye tracker with the goggle system, add:
      Describe the device to be used. "Video-based eye-tracker system"
      Device Name. "VisuaStim"
      Manufacturer "Reasonance Technology, Inc."
      IDE Exemption. Check the first radio button ("This is a legally marketed device being used in accordance with its labeling.")
  5. Add CNI screening form completion to the Inclusion and Exclusion Criteria
    • Click the PROTOCOL INFORMATION tab in the sidebar. Click the tab at top for section 8(h-m).
    • In section 8, part h) Inclusion and Exclusion Criteria, mention that subjects will be included only if they successfully complete the CNI screening form.
      We suggest the following language for Inclusion criteria: "All potential subjects will need to successfully complete the screening forms at the Stanford Center for Cognitive and Neurobiological Imaging (CNI) or the Lucas Center. Those subjects who present no contraindications to being scanned will be allowed to participate."
      The following should be included in exclusion criteria: "Volunteers will be excluded for any contraindications to MRI as identified on the CNI screening form."
  6. Add CNI screening in Subsection C. of RISKS
    • In subsection C, of section 9, within the PROTOCOL INFORMATION tab, add text stating that each subject will complete screening forms prior to being scanned in order to reduce risks for the participant.
      Add something like the following: "All subjects will complete the CNI or Lucas Center screening form prior to the scan and will not undergo the scan if there is the potential for any risk."
  7. Edit Consent Form to include the CNI
    • Click the PROTOCOL INFORMATION tab and go to tab 13 - Consent Background.
    • Click the title of your consent form to download it. Once you have downloaded it search within it to find where you have mentioned the Lucas Center. If you have instances where you have mentioned the Lucas Center be sure to include the CNI as well.
    • To attach the updated consent form, resave it and click the linked text under "Consent Type". Give the document a new version number and attach the new form.
  8. Attach the CNI Participant Screening Form to the protocol
    • Click the PROTOCOL INFORMATION tab in the sidebar. Go to section 16, Attachements.
    • Under OTHER click add. Follow the directions to attach the CNI Participant Screening Form as a questionnaire.
  9. Search protocol for instances where the Lucas Center is mentioned
    • You should review your entire protocol to make sure that you have included mention of the CNI every time that you have mentioned the Lucas Center. As this will vary by protocol you should review each of the protocols you modify, we can't give you specific sections.
    • The easiest way to do this is to search your protocol for instances of "Lucas Center" in the print view.
    • Click PRINT VIEW in the sidebar. This will generate a pdf of your protocol, which you can then use the "search" command to find instances of "Lucas Center". Once you have found them all, make sure that you have added text about the CNI at each instance.
  10. 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 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.

Creating a new protocol

To create a new IRB protocol, log into the eProtocol site and create a new IRB protocol. You can use the CNI IRB and consent form as an example. You will also need to attach the CNI Participant Screening Form to your submission.

Allowing sharing of your data

We ask that all CNI users allow sharing of their data. We hope to aggregate data (appropriately managed for HIPPA) so that users can share control groups and can provide access to colleagues who would like to collaborate on statistical or other investigations for data re-use. For example, we add the following clause to our 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.
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