IRB staff members play a key role in preparing for reviews, moving a submission through the stages of review, and communicating the results to the study team. Here are a few keys to the process:
- Assigning each submission to an IRB coordinator is a crucial step to allowing further actions to be taken on the submission. Any IRB staff member can assign a coordinator, as described in Assigning Ownership of a Study.
- Your inbox provides a helpful list of items that need your attention. For details, see Locating Your To-Do List and Understanding My Inbox.
- One of the more complex IRB processes is running a committee meeting. For a checklist to help you through the process, see Committee Meeting Management.
During all states of review, IRB staff can post a private comment in the submission workspace.
This helps to note any issues that arise during the review which must remain on the permanent record for the submission or study. As part of posting a private comment, you will have the option to select recipients. When completing the private comment activity, note:
- Sending a notice by selecting recipients is not required to save the comment to the workspace.
- Private comments are only visible to IRB staff and committee members.
- Based on the current set up for the Harvard IRBs, if “IRB Director” is selected, all members of the IRB office will receive a notice.
- Do not use the private comment activity to add or attach items that should be reviewed as part of the submission SmartForm.
- If you are the assigned IRB Coordinator, you will not have access to the Add Private Comment activity when a submission is in editable states (such as Clarifications Requested).