Brief Responsibilities of an MR-IRB Member

Welcome to the Health Sciences Minimal Risk IRB!  Below you will find key information you will need to order to serve as an IRB member, including meeting information and attendance expectations, accessing materials for reviews, and where to go for answers to your questions.

Meetings

• Meetings are the 1st and 3rd Mondays of the month and begin at 3:15 pm. Meeting dates and times are listed on the “For IRB Members” link on the Health Sciences IRBs website.
• Regular meeting attendance is expected, as is arriving on time and remaining for the entire meeting. 
• If you cannot attend a meeting you have been scheduled for, you are expected to find an alternate within your review group to attend on your behalf and notify the IRB Office of this substitution. If no one from your review group can attend, inform the IRB Office promptly. 
• If you confirmed your meeting attendance, but cannot make it due to an unexpected conflict, you will be expected to complete your reviews in most cases. Please inform the IRB of your absence and forward your completed reviews to the staff reviewer assigned to the study with a copy to the IRB Director. If you cannot complete your reviews, contact the IRB Director as soon as possible so that she can reassign to another committee member if possible.
  

• All materials are available in the ARROW system.  ARROW is an electronic platform the Health Sciences IRB adopted for the submission, review, and tracking of protocols.
• You will need a NetID and password to login to ARROW.
• When an agenda has been finalized for a meeting, members who have been scheduled to attend that meeting will receive an email notification that the materials are ready for review.  The agenda is generally finalized by the Thursday morning prior to the meeting.  In order to access a meeting agenda and meeting materials, you can use the link sent to you in the email or can log into ARROW and then click on the "Upcoming Meetings" tab, then click on the appropriate meeting link under this tab.  This will take you to the meeting space which lists all items for review in ARROW.  Please see Meeting Workspace Navigation Guide for IRB Members for assistance navigating the IRB Meeting workspace.
• You are responsible for identifying any items for which you are assigned as a primary or secondary reviewer. The agenda reflects who has been assigned as primary and secondary reviewers, as well as the staff reviewer assigned.  
• Any item for which you have been assigned as a primary or secondary reviewer will appear in one of your Inbox tabs; either Inbox: Initials if it is a new submission or Inbox: PRS and other if it is anything else (e.g. reportable event, change of protocol, etc.).  
  

• New Applications (Initial Review):
• IRB members assigned to review new applications complete a Primary Reviewer Form. This form is uploaded in ARROW by the staff reviewer. You can insert your comments on the form electronically or by hand. This form should be brought to the meeting and can be updated as needed based on the meeting discussion. Please place the completed, signed form in the basket provided by the IRB staff at the meeting. A copy of this form and instructions regarding how to complete the form are posted on the IRB website under the “For IRB Members" (Primary Reviewer Form and Primary Reviewer Guidance for Initial Reviews ).
• If you are assigned to a protocol or issue as a primary or secondary reviewer, you are strongly encouraged to discuss any questions or concerns you have directly with the research team prior to the review of the protocol. These findings can be presented to the committee during the IRB meeting.
• The following motions can be made related to the approval of a new protocol:
• Approve
• Modifications requested
• Response can be reviewed by IRB staff as simple concurrence
• Response can be reviewed by IRB member(s) as an expedited change
• Deferred (when a protocol is incomplete or you cannot adequately evaluate whether study meets the criteria for IRB approval)
• Disapproved (this is rare and the investigator is given an opportunity to respond before this action is taken by the IRB)
• Continuing Reviews and Changes of Protocol:
• Review of these submissions involves a process called a preliminary review session (PRS). IRB members are assigned to serve as primary reviewers for changes and continuing reviews for a particular meeting. IRB members assigned to evaluate continuing reviews and changes come to the IRB Office approximately a week before the meeting and review the submission in conjunction with the entire IRB file. These sessions occur on the Monday or Tuesday before the full IRB meeting. The IRB Office sets a computer up for you to access any reviews in ARROW.  The reviews occur in the IRB Office at 800 University Bay Drive, Suite 105. You will be asked to complete an electronic form to provide your assessment of the submission.  IRB members are assigned to serve as primary reviewers for changes and continuing reviews approximately 2 times per year.  IRB staff will be available to provide instruction or answer questions regarding completing reviews in ARROW.
• If you feel additional expertise is required to review the submission, indicate this on your review and the IRB staff will arrange for such a review.
• The following motions can be made related to the approval of a continuing review or change of protocol:
• Approve
• Modifications requested
• Response can be reviewed by IRB staff as simple concurrence
• Response can be reviewed by IRB member(s) as an expedited change
• Deferred (when a protocol is incomplete or you cannot adequately evaluate whether study meets the criteria for IRB approval)
• Disapproved (this is rare and the investigator is given an opportunity to respond before this action is taken by the IRB)
• Protocol Violations and Noncompliance:
• The IRB is expected to determine whether or not protocol violations and deviations that occur constitute serious and/or continuing noncompliance with campus policy or the federal regulations governing human subjects research.
• The following motions can be made related to the review of noncompliance:
• Noncompliance is neither serious nor continuing
• Noncompliance is serious and/or continuing and requires reporting to the institutional official
• Noncompliance is serious and/or continuing and a recommendation to the institutional official to report the event(s) to OHRP, FDA, and/or VA
• The IRB may suspend or terminate a protocol if the noncompliance raises extraordinary concerns.
• Unanticipated Problems and Adverse Events:
• The IRB is expected to determine whether or not the event posed greater risks to subjects or others than previously anticipated or expected by the IRB based on the protocol, consent documents, and support documents such as an Investigator’s Drug Brochure. The IRB determines whether any changes to the study are needed or whether new information should be provided to subjects based on their review of the event(s). The IRB may suspend or terminate a protocol if the event raises concerns about subject protection. If an event is judged to be an unanticipated problem, reporting to the Institutional Official or an external agency may be required.
  

• Meeting Minutes - the IRB must ratify the minutes from prior meetings and vote upon the recommendations of two IRB members who were assigned as primary reviewers for the documents.  If you are assigned as a primary reviewer, please assess whether the minutes are accurate.  For more guidance accessing and reviewing minutes, please see Reviewing IRB Meeting Minutes in ARROW .
• The IRB staff may contact you for review of modification responses that require your expertise to resolve.
  

• If you have or feel you have a potential conflict of interest in reviewing a protocol, inform the IRB Chair or Director and recuse yourself from the vote. If you have been assigned as a primary reviewer to the protocol either at the full IRB meeting or at PRS and feel you have a potential conflict of interest, please inform the IRB Director of this as soon as possible so that a re-assignment can be made.

• ARROW Help Documents tailored for IRB members
• Reviewer forms and guidance
• IRB Member Newsletters
• IRB Member Fact Sheets that provide concise descriptions of topics of importance for IRB members
  

• IRB Meeting dates
• Contact information for the IRB office
• Campus policies related to the protection of human subjects and conduct of human subjects research
• Links to the federal regulations governing human subjects research
  

• Question or concerns about your appointment as an IRB member:
• IRB Director, irbdirector@hsirb.wisc.edu
• If you cannot attend a meeting you have been scheduled for, will need to leave early or will be late for a meeting:
• irbreview@medicine.wisc.edu
• 263-2362
• If you have concerns or special requests about your protocol assignments:
• Gretchen Anding, 263-4170, ganding@wisc.edu
• Help with navigating and using ARROW
• Contact the IRB Member Liaisons Jackie Lee at jalee6@wisc.edu or 261-1157 and Jessica Johnson, jessicascott@wisc.edu or 263-0835
• Questsion about a specific protocol
  
• Contact the assigned staff reviewer
  
• IRB Website: http://kb.wisc.edu/hsirbs