DATE / PAGE
06/11/2015 / 1 of 1
After initial submission and prior to IRB presentation, all principal investigators should be prepared to receive phone call or email inquiries from an IRB member/reviewer for more information or clarification before the scheduled meeting and respond in a timely manner. Typically, this will likely be for information beyond what is normally required during the pre-review process. This could prevent studies from being tabled and deferred to the next meeting. However, there is no guarantee that a study will not be tabled even if the principal investigator has answered questions prior to the convened meeting and/or presented his/her study to the convened IRB.
All principal investigators should be prepared to present his/her new study, in person, at a convened IRB meeting. Below are some examples of why a principal investigator must present their study to the board:
1)the study is an investigator initiated/ Florida Hospital Sponsored study.
2)the reviewer has questions/concerns which were not addressed or satisfied during the pre-review process and the principal investigator was not available by phone or email to answer those questions.
3)the reviewer believes that the board and/or investigator will benefit from the principal investigator’s attendance
4)the study poses significant risk to the participant population
The following is what you can expect to take place for your presentation:
1)Upon assignment of your study to an agenda, IRB staff will send a calendar reminder with the time, date, and location of the presentation to the PI and coordinator/IRB liaison.
2)PI should arrive to the designated waiting area at the assigned time and remain in the hall until called into the meeting room. (Please keep in mind that the assigned time is approximate. The IRB office staff will do its best to notify you should there be any changes or delays. Your patience is appreciated.)
3)PI should be prepared to present the study to the IRB members by giving an overview of the purpose, procedures, risks, and benefits. IRB staff will have study documents available for projection or the PI may choose to bring those documents or, if desired, a separate presentation. Separate presentations should be emailed to at least two days in advance.
4)PI should be prepared to answer any questions from the IRB members.
5) PI will only need to be present for the presentation and follow up questions from the IRB.
If a decision is made that you are NOT required to attend the convened IRB meeting, the IRB staff will contact you and your study team as soon as possible. If you agree, you could provide a phone number at which the PI will be available should questions arise during the IRB meeting. To improve the communication with the entire IRB, please provide a landline number if at all possible.
In any case, the PI should expect a decision letter within 5 business days.