You can access the agenda from the link in the email notifying you that the agenda is available. You can also access the agenda by:
- logging into ARROW
- selecting your IRB member role
- clicking on the meetings tab, and
- clicking the hyperlink for the upcoming meeting.
To view the printer friendly version of the agenda, click on “Print Closed Agenda” in the upper left. Of note, the printer friendly version of the agenda reminds IRB members of the meeting time, location, and conflict of interest policy.
If you are assigned to be a primary reviewer for an initial review, please come to the meeting prepared to:
- Summarize the study, including overall goals, subject population, and study procedures
- Provide an analysis as to whether the study meets each of the criteria for IRB approval
- Outline your primary concerns or questions
- Make a motion
In order to do this, primary reviewers should thoroughly review the following items associated with the submission:
Please see the Primary Reviewer Guidance for Initial Reviews
for additional information on how to complete your review.
Submitting Your Reviews
Primary reviewers must submit the completed Primary Reviewer Form
at the IRB meeting or shortly after the meeting (i.e., before the next business day). There are two ways in which reviewers can submit their checklists:
- Print the form, write your responses, sign, and place the completed form in one of the baskets at the meeting.
- Save a copy of the form on your computer and complete it electronically. Of note, an electronic signature is not required. You can type your name and date and then email the checklist to firstname.lastname@example.org.
In addition to initial reviews, you may be assigned to be a primary reviewer for:
- Deferral responses: Submissions that were previously reviewed by the IRB and determined that they could not yet be approved. The deferral response is the study team’s response to the IRB’s concerns.
- Modifications responses: Submissions that were previously reviewed and approved by the IRB pending modifications. The modifications response is the study team’s response to the IRB’s modifications.
- Changes of protocol: Request to alter study.
- Continuing reviews: Request to renew study.
- Reportable events: Noncompliance, unanticipated problems and new information are the three reportable event types.
If you are assigned to review a deferral response or modifications response, please be prepared to summarize it at the meeting and conduct an in-depth review, as described above. If the deferral response or modifications response is for an initial review, please complete the Primary Reviewer Form
and submit to the IRB as described in the Submitting Your Reviews section above.
Changes of Protocol and Continuing Reviews
In general, all changes of protocol and continuing reviews will be reviewed approximately one week prior to the meeting during the preliminary review session (PRS)
. Each IRB handles the discussion of the submissions reviewed during PRS differently. For the Minimal Risk (MR) IRB, please be prepared to summarize all changes of protocol and continuing reviews listed on the agenda. For the HS IRB, please be prepared to summarize all changes of protocol designated as a **Full Discussion Item**. There is no paperwork that needs to be completed at the meeting for changes of protocol and continuing reviews by the primary reviewers.
If you are assigned to review a reportable event, please review the reportable event submission form in ARROW along with the staff reviewer’s checklist and any other relevant materials to assess the event (e.g., the protocol). Please come to the meeting prepared to summarize the reportable event and make a motion
. Like changes of protocol and continuing reviews, there is no paperwork that needs to be completed by the primary reviewers for reportable events.
Even if you are not assigned to be a primary reviewer at the meeting, you are still expected to prepare in sufficient depth to participate in the discussion and final vote on each item on the agenda. Therefore, please read the staff reviewer’s checklist at a minimum for each item on the agenda that did not go through the PRS.