Brief Responsibilities of an MR-IRB Member
Brief Points About Your Role and Other Logistics
Version Date: 9/17/2015
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.
Accessing Materials for IRB Meetings
- 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.).
Reviewing a Protocol Scheduled for Full IRB Review
- 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.
Other Reviews
- 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.
Conflict of Interest
- 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.
Additional Resources
The IRB website, especially the For IRB Members link, will be a helpful source for you and includes:
- 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
Other information available on or through the IRB Website:
- 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
Who to Contact
- Question or concerns about your appointment as an IRB member:
- If you cannot attend a meeting you have been scheduled for, will need to leave early or will be late for a meeting:
- If you have concerns or special requests about your protocol assignments:
- Help with navigating and using ARROW
- Questsion about a specific protocol
- IRB Website: http://kb.wisc.edu/hsirbs