Materials-Memo-to-IRB-Members by xiangpeng

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									                                 IRB Member Review Instructions

You are scheduled to attend the meeting on the date indicated on the enclosed agenda. The type of
meeting, its location and time are also on the agenda.

In this packet, you will find:
     The agenda for the meeting.
     Application and associated materials for all protocols to be reviewed at this meeting. Primary
         reviewers will have additional materials for the protocols they are reviewing.

Information for ALL members:

      Check the agenda to determine if you are assigned as a primary reviewer for any protocols
       on this agenda (you may be assigned to more than one). There is additional information
       below if you are a primary reviewer.

      Review the materials for all protocols in advance of this meeting. You are required to review
       all materials for each protocol in sufficient depth to discuss the information at the convened
       meeting.

      If you think you are missing any items in your packet, please call us as soon as possible at
       335-6564.

      The complete files for projects started in HawkIRB are available on HawkIRB. The back side
       of this page provides some helpful user tips for HawkIRB. If you need additional assistance,
       please give us a call.

      The complete files for Legacy projects (projects started in the paper system) will be available
       at the meeting and the HSO office prior to the meeting. After the legacy project is approved,
       the complete files for future reviews will be available on HawkIRB.

Information for PRIMARY REVIEWERS:
     Primary reviewer assignments are indicated on the agenda enclosed in this packet of
       materials. Please check the agenda and identify the studies you have been assigned to
       review and present at this meeting.

      Use the primary reviewer checklists attached to these materials to conduct your review of the
       assigned protocols. Fill out the checklists and be prepared to turn them in to the chair at the
       end of the meeting. Primary reviewer checklists can also be found on the HSO website
       (http://research.uiowa.edu/hso/index.php?get=forms01).

      You are encouraged to contact the PI in advance of the meeting if you have any questions
       concerning the study. Also, if you feel you need additional expertise in reviewing an assigned
       protocol, contact the chair of this meeting immediately to discuss an appropriate consultant.

      Continuing Review meetings: The first 15 minutes or so of the meeting is reserved so that
       you may review the entire study file prior to the discussions. This review of the past files will
       provide information on number of subjects approved by the IRB and number of subjects
       enrolled since the last continuing review for legacy projects. If you feel this is not sufficient
       time to review your assigned studies, you are welcome (as always) to come to the HSO
       offices at any time prior to the meeting for additional review.


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HawkIRB Basic User Guide for IRB Members

To log on to HawkIRB
Go to the Human Subjects Office web site at www.research.uiowa.edu/hso and click on the
“HawkIRB” icon in the upper left-hand corner of the screen. Log on with your hawkID and password.

To view a HawkIRB application
Type the IRB ID# of the study in the small textbox in the upper right-hand corner of the screen, and
then click “Go.” This takes you to the Project Summary screen for the study. You can return to this
screen anytime while viewing the project by clicking “Go.”

At the bottom of the screen under “History” you will see all of the applications that have been
submitted for the project, in reverse chronological order.

   New Project applications
    Click “New” under “History.” The next screen shows the Form Review. Click each Roman
    numeral to go through the application section by section (if you “hover” the pointer of your mouse
    over the Roman numeral, the section title will pop up). To view the Consent Document and all
    other attachments, click the “Form Attachments” tab at the top of the screen, and then click on
    the name of each attachment.

   Modification applications
    Click “Mod” under “History” (the “Mod” closest to the top of the list if there is more than one).
    Then click “Form Modifications” to view the changes being submitted and to see a side-by-side
    comparison of the old and new value. Attachments are listed at the bottom under “Attachments.”
    If attachments have been changed, or new ones are being submitted, they will be listed on the
    right side of the screen with an asterisk (*). Click on the name of the attachment to view it.
    Changes will be tracked in a different font color.

   Continuing Review applications
    Click “CR” under “History” (the “CR” closest to the top of the list if there is more than one). Click
    each Roman numeral (CRI, CRII, and CRIII) to go through the application section by section (if
    you “hover” the pointer of your mouse over the Roman numeral, the section title will pop up). To
    view the Consent Document and other attachments, go to the Project Summary screen (click
    “Go” in the upper right-hand corner), click the “Attachments” tab at the top of the screen, and
    then click on the name of each attachment.

Continuing Review/Modification applications
Click “Mod/CR” under “History” (the “Mod/CR” closest to the top if there is more than one). Click
each Roman numeral to go through the application section by section (if you “hover” the pointer of
your mouse over the Roman numeral, the section title will pop up). Click “Form Modifications” to
view the changes being submitted and to see a side-by-side comparison of the old and new value.
Attachments are listed at the bottom under “Attachments.” If attachments have been changed, or
new ones are being submitted, they will be listed on the right side of the screen with an asterisk (*).
Click on the name of the attachment to view it. Changes will be tracked in a different font color.

								
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