All materials reviewed by the SBSIRB are handled on a rolling basis and consequently the SBSIRB does not post deadlines for submittal of materials. Therefore protocols should be submitted to the SBSIRB when they are ready rather than according to any particular meeting date. If a protocol can be granted exemption or approved with an expedited review it will not have to be posted to an IRB meeting for approval.
Note that input from multiple reviewers is often obtained at different points in the SBSIRB review process. The process can therefore be iterative in nature in that even when a revision addresses all requested items, the reviewers may identify additional concerns upon reviewing revised materials. This can occur because clarification in one part of the protocol can raise additional ethical concerns, or because one reviewer failed to note changes that another reviewer believes are necessary. Expedited approval or exemption will not be granted until any/all concerns of the reviewers have been adequately addressed to the satisfaction of the IRB Chair or another designated member of the board.
Protocols which require full board review are NOT placed on a meeting agenda based on the date of submittal but rather when one of the following events occurs:
The date on which a meeting agenda is set and materials are distributed to the full membership can vary and is dependent upon a number of factors including the workload of the IRB and the number and complexity of protocols already scheduled to an agenda. However, in no case will this occur less than three (3) business days prior to the meeting so that the members will have sufficient time to review materials. Typically the SBSIRB puts sets the agenda for meetings 3-5 business days before the meeting date.
The goal of the IRB is to ensure all protocols meet the guidelines for safety and efficacy as required by federal statues and the Belmont Report. Additionally, the SBSIRB is charged with ensuring that all protocols receive a substantive review and will not rush the review process because of external time constraints. The time frame required for initial review is dependant on the complexity of the study, thoroughness of the submittal in addressing human subjects protection issues, and the workload of the board at the time of submittal. The SBSIRB members and staff strive to review materials in a timely manner and typically send requests for revisions to investigators within one week of the date on which materials were sent to the reviewers. However, due to the volume of materials received by the SBSIRB at certain times of the academic year, this initial review process may take longer and it has sometimes taken up to three weeks to send the primary reviewers' comments to investigators.
It is quite difficult to accurately predict how much time the review process will take. Often, expedited reviews can be completed in a few days but occasionally a submittal requiring full board review may take a number of weeks before the review process is complete. Investigators will need to consider the possibility of delays caused by heavy IRB volume when planning time lines for their research projects. Investigators who have concerns over receiving approval within a specific time frame are encouraged to submit their completed materials to the SBSIRB as soon as they have assembled them and checked to ensure that they meet the guidelines set forth on the SBSIRB website and also respond to any requests for changes from the SBSIRB as quickly as possible.
An investigator may, at any point in the review process, request full board review at the next available convened meeting by sending an e-mail message to the SBSIRB requesting full board review. The e-mail message must include in the first sentence the statement that, “the investigator wishes full board review of protocol (include protocol number and title).” In order for this to occur or any other materials/revisions to be considered at a convened meeting the SBSIRB must receive the request/materials before the agenda has been set and materials distributed to the members. Note, however, that once a protocol is brought to the full board, the board may determine that additional substantive changes must be made and reviewed at a subsequent convened meeting, before approval will be granted.
If an investigator disagrees with a determination of the full IRB, a written/e-mail request may be submitted to the IRB for reconsideration of the decision. The request will be discussed at a subsequent full board meeting and either the previous determination will be affirmed or a further determination will be issued. At the discretion of the Chair, the investigator may be invited to attend the open portion of the IRB meeting in order to provide information in support of his/her position.
The SBSIRB suggests that materials be submitted as soon as they are ready rather than submitting materials to meet a specific deadline because materials that are not complete typically take significantly more time to revise to the satisfaction of the IRB reviewers. While the IRB has been able to review and approve expedited proposals in as little as a few days, it is suggested that investigators plan to allow at least a one month time period for the IRB review an investigator revision process.
The SBSIRB administrator or staff will notify the PI by the Monday prior to these meetings via e-mail concerning any changes in location and an approximate time that the PI’s protocol is scheduled for discussion.
| Meeting Date | Meeting Location |
| Wed. Dec. 9, 2009 | Capen 531 |
| Wed. Jan. 20, 2010 | Capen 531 |
| Wed. Feb. 10, 2010 | Capen 531 |
| Wed. Mar. 3, 2010 | Capen 531 |
| Wed. Mar. 31, 2010 | Capen 531 |
| Wed. Apr. 21, 2010 | Capen 531 |
| Wed. May. 12, 2010 | Capen 531 |
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Chris Marks IRB Administrator Contact |