Full Board Meeting Information

Your submission must make it to the IRB-01 front office prior to a meeting’s deadline in order to have it prepared and reviewed at that meeting. Click here for the list of meeting dates and their deadlines. Simply getting your submission turned in by the deadline does not guarantee that your submission will be scheduled for the meeting! New study submissions, revisions, and continuing reviews received by the office will undergo an administrative pre-review. Only submissions completed accurately, withconsistent information throughout the submission and attachments, and with the correct documents provided will be scheduled for the meeting. If you are submitting a paper submission, the correct number of copies are required. If the staff member doing the pre-review identifies significant issues with your submission, they will return it to you with instructions of what you need to correct and when you need to have the corrections completed and submitted back to the office in order for your submission to remain on the agenda for the meeting. If the corrections are not completed by the designated timeframe, the submission will be assigned to the next full board meeting.

Each meeting has its own agenda. The agenda lists which projects are scheduled to be reviewed and the order in which they will be presented. Meeting agendas are available by 8:30am on the day of the meeting, in room 104 in the Shepard Broad Building.

Each agenda is divided into sections. The Board reviews the sections in the order they are listed in the agenda. Within each section the Board reviews projects according to the following prioritization:

1. Submissions which are represented by a PI or associate who is in attendance will be addressed first in their section. If more than one representative is present, submissions within that section will be presented in the order which guests signed in.
2. The remainder of the submissions in each section which are not represented will then be presented in the order they are listed in the agenda.

No. The PI or a representative is not required to attend the meeting. HOWEVER, the Board recommends that the PI or a knowledgeable representative should be available to answer any questions which the Board may have concerning the PI’s project. If you sign-in at the beginning of the meeting and leave accurate contact information (phone number, pager), we can call you shortly before we expect your project to be reviewed.

The Board uses the following procedure for reviewing projects:

1. The Board members who were assigned to review the project will briefly present the submission (3 members for a new study review and 2 members for all other reviews).
2. The Board may discuss the project further and, if necessary, discuss any questions, comments, or concerns with the project representative.
3. If present, the study representative will be asked to leave the room for final deliberations and voting. We ask that the study representative wait outside the room in the event additional questions arise during deliberations.
4. An IRB staff member will step outside to inform the representative of the Board’s action.

After reviewing your project, the Board usually takes one of the following four actions:

Approved

The Board has approved what has been submitted and reviewed. Prior to initiating any research activity you must obtain the appropriate approval paperwork from the IRB administrative office, especially if there is a newly approved Informed Consent form.

Approved pending Explicit Changes/Contingencies

The Board has reviewed your project and deemed it approvable IF specific changes are submitted. Note, your project is not approved until you submit the changes and they are reviewed and approved. The project may be approved administratively within the IRB-01 Office if you submit all of the changes exactly as they are requested by the Board. However, additional review by a Chairperson or possibly even the Full Board will be necessary if (1) you fail to make all of the requested changes or (2) additional changes are made. NOTE: the smallest deviation from the requested changes will at least require review by a Chairperson. NOTE: we recognize that PIs may want or need to make changes which differ from what the Board has requested. If the PI feels it is inappropriate to fully comply with the requested changes, please include a cover letter indicating (1) which requested changes were not made and the reason for omitting them, and/or (2) which changes are in addition to the requested changes and why these changes are included.

Tabled

The Board has requested substantive clarifications, protocol modifications, or consent document revisions which could not be easily resolved or provided during the meeting. The submission is NOT approved. You must respond to the Board’s issues, and your response will be reviewed at another Full Board meeting. The editors work diligently to get the Tabled Letter detailing the Board’s concerns to the PI no later than 5pm on Friday following the Full Board meeting. As a courtesy to our researchers, the deadline for the next meeting is extended for tabled projects – typically 9 AM on the Monday following the meeting which the project was tabled. NOTE: the extension only applies for the meeting immediately after the project is tabled. Any responses you submit after this one time extension will be processed according to the normal Full Board deadlines.

Disapproved

The submission is unapprovable as submitted. The PI may resubmit the protocol as a new study after addressing the Board’s concerns.

The Administrative Office makes every effort to produce meeting correspondence, approval paperwork, etc as quickly as possible because we realize that researchers are eager to initiate their research. Please recognize that we have a large amount of correspondence to produce and that it takes a significant amount of time to respond to all of the items reviewed at the meeting. While some letters are available as early as the day after the meeting, it is not unusual for some paperwork to be completed up to a week after the meeting. We encourage researchers to send a representative to the meeting in order to expedite the approval process. Please contact the IRB-01 Administrative Office at 352-273-9600 if you have any questions.

Additional information is available in our Policies & Procedures Manual.

Sometimes the Board is unable to review all of the projects scheduled for a meeting. If the Board recognizes an hour or so before the end of the meeting that they will be unable to review everything that is scheduled, they will give additional priority to projects which have a representative present for the review. Thus, if a representative attends the meeting we will make every effort to review your project that day.

Unfortunately, it is sometimes impossible to review everything that was submitted in time for the meeting. If the Board is unable to address your submission, it will be scheduled to be reviewed at the beginning of the next Full Board meeting. The Board does try to schedule extra meetings when warranted.