The checklists below identify the major steps for preparing for, conducting, and completing a committee meeting. The checklists assume you have already created the committee and the meeting.
Steps are performed by a member of the IRB office per office standard procedures.
Preparing for Each Meeting
Well in advance of the meeting:
1. Assign studies (including Modifications, Continuing Reviews, and Reports of New Information) to the meeting (from the submission workspace).
2. Add any non-study related agenda items or documents, as needed by completing the Update Other Agenda Items or Update Documents activities in the meeting workspace. Note that items related to the review of a submission should be associated with that submission and not added via these activities. Note that while any added Other Agenda Items appear with the list of submissions, any documents added via the Update Documents activity will only appear on the Supporting Documents tab
3. Assign reviewers to the submissions assigned to the meeting. Reviewers can be changed at any time by completing this activity. However, assign from the meeting workspace all in one activity, for notifications to be sent to assigned reviewers.
4. Prepare the agenda. If there is a problem when attempting to prepare the agenda, check each submission assigned to the meeting to ensure that the Track Harvard Determinations activity was completed (even if no values were entered on the activity form). After this is completed on each submission, retry preparing the agenda.
5. Send the agenda to committee members and any additional recipients.
Note: If you change the official agenda for any reason, such as a) for internal purposes (for example, to create a notes document based on the agenda) or b) to revise items after you have sent it out: make sure you verify and upload the final version of the meeting agenda to the meeting workspace before the meeting and as needed use the Send Agenda action to inform members of the change.
Just before the meeting:
1. Edit the meeting attendance if you know who is planning to attend.
2. Remove any studies in the Clarification Requested (Committee Review) state from the agenda if the missing clarifications warrant delaying a committee decision. Reassign the submissions to a later meeting.
Studies in the Clarification Requested (Committee Review) state that remain on the agenda will transition back to the Committee Review state when the meeting is convened.
Conducting the Meeting
We recommend dedicating one person to fill out the Submit Committee Review forms and record the non-submission information such as meeting start and end times.
During the meeting, it may be helpful to display study information and committee member review comments in the course of discussion. See tips for navigating to study information below.
1. Record meeting times, attendance, and other non-submission items. Note: You may wish to record this information using the meeting minutes template. To do so, prepare the meeting minutes, save the generated document to your computer, and then use it to record the information. When you prepare the final minutes (as instructed below), copy and paste the items recorded during the meeting into the final version of the minutes.
2. If you have not already, send the agenda. With this activity, you can select recipients of the notification that the agenda and materials are ready for review prior to the meeting.
3. Convene the meeting. Note: Convene Meeting returns agenda items in the Clarification Requested (Committee Review) state to Committee Review.
4. (Optional) Under "Previous meetings with minutes for approval," click a previous meeting to go to its workspace. Then you can display its minutes, approve them, and return to the current meeting.
5. Click the Expedited Submissions Approved link to display the report. Note: To keep a permanent record of the approved expedited submissions reviewed during the meeting, export the report to Excel and save it to your computer. Later, copy and paste the information from the report into the minutes.
Tips for navigating to submission information:
From the meeting workspace:
To show more information, click the name of a submission in the agenda items list.
From the submission workspace:
- To show study details in the forms, use View Study (or View Submission/View RNI).
- To show attached documents, use the Documents tab.
- To show information recorded during pre-review and comments from individual committee members, use the Reviews tab.
Recording decisions, events, and notes:
1. From the individual reviewer checklists, reviewer comments, and committee discussion, fill out all relevant checklists to reflect the final committee opinion and reasoning. These files will be attached in the Submit Committee Review activity.
2. Perform Submit Committee Review (or Submit RNI Committee Review for an RNI) to record decisions and information for each submission reviewed. Attach the relevant checklists. Note: The IRB coordinator assigned to the study can also submit the committee review.
If there is not enough time to completely fill out the committee review form during the meeting, finish it as soon as possible after the meeting. You can complete some of the form and select "No" to the question "Are you ready to submit this review?" The system will save what you have entered so you can update and submit it later.
Important! Don't miss the Submit Committee Review or Submit RNI Committee Review step. Correspondence cannot be prepared and sent to the investigator for a study until this step has been completed.
Wrapping Up After the Meeting
1. If you haven't yet submitted the final committee review for each study, do so now to move to the next steps. Note: From the meeting workspace, look at the Record Decision column for the agenda items. The column will indicate Submit Committee Review or Submit RNI Committee Review if the action has not yet been completed.
2. Prepare the minutes. The minutes will contain the committee decisions for each study. If there is a problem when attempting to generate the minutes, check each submission assigned to the meeting to ensure that the Track Harvard Determinations activity was completed (even if no values were entered on the activity form).
3. Open and save the minutes on your computer. Add the meeting times, attendance, and any other non-submission items to the minutes. Note: If you used the minutes template to record information during the meeting, simply cut and paste the information from that document into the minutes.
4. Perform Prepare Minutes again to upload the revised minutes.
5. Follow your internal processes to obtain the appropriate approvals of the meeting minutes.
6. Inform the IRB coordinator(s) that they can send correspondence to the investigators. For each study, the assigned coordinators:
a. Review the Track Harvard Determinations activity and the status of ancillary approvals on the Reviews tab to make any necessary updates. Complete any needed updates.
b. Finalize the study's attached documents to create an approved copy, in certain cases adding a watermark.
c. Prepare a letter to inform the study's investigator about the IRB decisions.
d. Send the letter.
7. Send the minutes to the committee members.
8. Close the meeting.
After the period for receiving comments from committee members has passed, perform Approve Meeting Minutes. Until you perform this action, the minutes are listed in the next meeting's workspace with the approve activity available there as well. If Minutes require further revision after approval, complete the Prepare Minutes activity in the appropriate meeting’s workspace again to save the revision and then re-complete the Approve Minutes activity to complete the process.