To ensure that the process can move along as quickly as possible, the PI should review the application in its entirety before submission to ensure that it is ready for review. Once submitted, a Research Subjects Specialist (RSS) from the IRB Office will work with the PI to address any outstanding questions before assigning it to a faculty IRB member for review. The IRB member/reviewer may also contact the PI to resolve issues. Delays in PI response during this process will result in slower processing.
Upon submission, new applications are pre-reviewed by an RSS for completeness before being put on a meeting agenda. For an application to be complete, it means that all relevant study documents are provided and major questions or concerns from the RSS or IRB member have been answered. The IRB office is committed to moving applications through the process in as efficient a manner as possible, while adhering to high standards of human subjects protection. In general, submissions that contain the information necessary for review will be put on an agenda based on the following schedule:
IRB X meetings: Thursday mornings (minimal risk study). Submission of a new application by Tuesday afternoon at 3 p.m. will generally result in review on the second Thursday after submission (e.g., 9 days later).
IRB FC meetings: Wednesday mornings (greater than minimal risk protocol review). Submission of a new application by 3 p.m. on Thursdays will generally result in review on the second Wednesday following submission (e.g. 13 days later).
The link to the Federal Wide Assurance information for the Johns Hopkins Bloomberg School of Public Health is here.