Social and Behavioral Sciences Institutional Review Board

Upcoming SBSIRB Meeting Dates

Rolling Initial Review for all Protocols.

The use of a submittal via e-mail process has allowed the SBSIRB staff to eliminate the need for a physical distribution of hard copies to the board members before a convened meeting. Therefore the designation of a deadline date for adding materials to a meeting agenda is no longer necessary and the scheduling of a protocol for review at a convened meeting will no longer be dependant upon initial receipt of materials by the SBSIRB staff by a specified date. A protocol can now be added to a meeting agenda at any point. However, addition of a protocol to a meeting agenda occurs only when there is a sufficient amount of time before the meeting for the full board to evaluate the materials that have been revised by the investigator in response to the primary reviewers' comments (see the review process summary below). The time frame for review by the full board after the initial reviewers' comments have been satisfactorily addressed will vary depending on the complexity of the protocol and number of protocols already on the meeting agenda.

Summary of the Review Process.

For full board review of protocols over the past year, the SBSIRB has used a primary reviewer system whereby one or more initial reviewers provide feedback to investigators through the SBSIRB administrator regarding human subjects issues involved with their protocol. The investigator has then been required to address these issues by changing the protocol or providing a justification for the current procedures. A protocol was then placed on the meeting agenda only after the changes or justifications were reviewed by the board chair or designated reviewers by a specified date. This procedure parallels the expedited review process where, upon receipt of revisions that address the comments to the satisfaction of the primary reviewers and/or SBSIRB chair, a protocol will be approved accordingly. In the event the primary reviewers and/or the Chair request a full board review, the submitted protocol will be added to a meeting agenda and the Principle Investigator will be notified via email. The SBSIRB will continue to use this procedure for reviewing all submittals with the exception that there are no longer set dates for adding a submittal to a meeting agenda. As a result no set deadlines exist for submittal of materials to the SBSIRB and a rolling review process will be used for review of all protocol submittals to the SBSIRB regardless of the level of review requested by the investigator.

External Time Constraints.

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. There is no way 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.

Appeals Process.

Whether the review level is exempt, expedited, or full board, the PI has the right to appeal any decision by the primary reviewers or administrator to a vote of the full board. If a PI wishes to appeal he/she must notify the IRB Administrator by e-mail. Included in the request for appeal, the PI needs to provide electronic versions of all study related materials and the justification for the request. Upon receipt of this notice, the administrator will place the protocol on the agenda for a convened meeting. Addition of an appeal to a meeting agenda occurs when there is a sufficient amount of time for the full board to evaluate the materials before the meeting. This time frame will vary depending on the complexity of the protocol and number of protocols already on the meeting agenda.

Guidance on Timing of Submittals Requiring Full Board Review

1. If complete materials are received electronically at least three weeks prior to a meeting date and revisions meeting the reviewers requests or providing a justification for not doing so are submitted to the SBSIRB electronically at least one week prior to a meeting, the SBSIRB administrator will ensure that a protocol is placed on that meeting’s agenda for review by the full board. The final decision for approval of the protocol still rests with the full board and the board also has the option of deferring judgment of a protocol to a later convened meeting because substantive issues need to be resolved before approval is granted.
2. If complete materials are received electronically at least two weeks prior to a meeting date, it is likely but not guaranteed that there will be enough time to complete the primary review and obtain revisions from the investigator by noon on the Thursday prior to the meeting so that they can be posted to the meeting agenda. The final decision for approval of the protocol still rests with the full board and the board also has the option of deferring judgment of a protocol to a later convened meeting because substantive issues need to be resolved before approval is granted.
3. In order to allow a reasonable time frame for our faculty reviewers to complete the primary review, if complete materials are not received electronically at least two weeks prior to a convened meeting date or revisions addressing the primary reviewers' concerns are not received by noon on the Thursday prior to the meeting, it is unlikely that a protocol will be able to be reviewed in time to be placed on the meeting agenda.
   

Dates and Locations of Upcoming Convened Meetings of the SBSIRB.

The SBSIRB administrator or staff will notify you by the Monday prior to these meetings via e-mail concerning any changes in location and an approximate time that your protocol is scheduled for discussion.