The basic process for a study—or initial submission—is shown in the following diagram. The exploded view shows what occurs during the IRB review process.
The legend indicates who can take major actions during each state within the process. Keep in mind that the diagram does not show all possible paths that a submission may take. The diagram shows the most likely path through the review process with common options identified.
- Optional ancillary reviews that can be conducted concurrently with the IRB's reviews. For more ancillary review information, see Ancillary Review Overview.
- For collaborative studies where Harvard will be the IRB of record, Sites may be added via activity, with review and consideration of reliance managed on the site workspace. This can be conducted concurrently with IRB review but cannot be completed until initial approval is issued.
Before IRB review activities can begin, the submission must be assigned to an IRB coordinator, as described in Assigning Ownership of a Study.
|Tip||If the study is not assigned to the correct IRB, complete the Assign IRB activity to change IRB. After completing the Assign IRB activity, ensure that the SmartForm is revised to include a responsible department on the Basic Information page that is reviewed under the correct IRB. This will ensure the reassigned IRB remains correct through the life of the study.|
Notable information about several states is identified below.
Pre-Review and Clarification Requested: In the Pre-Review state, the IRB coordinator answers questions about oversight agencies, special populations, etc., that apply to the study. Instead of asking the study team to answer the questions, the IRB staff takes responsibility for reviewing the submission information and answering them. Answering these questions before a committee review can save the committee's time if information is found to be missing or inconsistent. The IRB coordinator can send the study back to the study team for clarification if needed, which lets the study team change the study.
The IRB coordinator can also edit the study or perform actions on behalf of the study team. This includes:
- Editing the study when it is in an otherwise editable state (such as clarifications requested); OR
- Completing activities (such as Submit, Submit Response, Add Participating Sites, or Assign PI Proxy).
Important! When determining if this type of submission assistance is appropriate, note that:
> On a modification, the assigned IRB Coordinator will not be able to update documents, when study staff can.
> When assigned as IRB Coordinator, if the submission is in an editable state (such as clarifications requested), activities ordinarily available to IRB staff (such as add private comment) will not be visible to this staff member. Visibility will return once the study returns to IRB review or a determination is made.
> In some circumstances, when assigned as IRB Coordinator on a main study, view of private comments or pre-review activities on already approved follow on submissions may be hidden..
IRB Study Review Activities: (relevant for Initial, Modification, or Continuing Review/Closure) IRB review is not a single state, but a collection of other states. In addition to requests for clarifications, IRB review includes the following required activity steps:
Submit Pre-Review: (required step) transitions the submission to the pre-review completed state. Able to be edited on all submission types where it is required. When pre-review is submitted, the system confirms that Harvard will review, and locks the External IRB question on the SmartForm.
Track Harvard Determinations: (required step) available and editable in all states.
Manage Ancillary Reviews: (optional step) available and editable through post-review, and on approved submissions.
Note: To share a public message with the assigned ancillary reviewer (if the add comment activity is not preferred), the individual assigning the review can: a) add the ancillary review type, b) from the Manage Ancillary Reviews list on the pop up, click update, and then c) partially fill in the activity by marking “no” to question 4 and adding comments/documents for the ancillary reviewer to view when they are completing their review.
Assign Designated Reviewer OR Assign to Committee Review: (required step) available after pre-review is first submitted and allows for routing to the appropriate type of review.
Determination Entry Activities:
• Submit Designated Review: (required step) transitions the submission to post review, Editable through post review and determination. If edited, this activity will update the effective date. If clarifications are requested during this type of review, the SmartForm may be edited as part of the response submitted by the study team.
• Submit Committee Review: (required step) transitions the submission to post review. Editable through post-review and determination. If edited, this activity will update the effective date. If clarifications are requested during this type of review, the SmartForm will be locked from edits. The submitted response must be within the Submit Response activity completed by the study team.
Post-Review: The Post-Review state gives the IRB staff the opportunity to complete the following activities:
1. Finalize Documents: (required step) Mark selected documents attached to a submission as approved to create final copies. Finalize all documents at initial review and finalize only updated documents on modifications. Documents can also be finalized on a Continuing Review, as needed per office-specific policy (CUHS does not finalize documents at the time of Continuing Review; LMA does finalize documents at the time of Continuing Review). Never finalize document that is not included in the approval.
Note: Non-document type attachments (such as compressed/zip, video, audio, or htm files) may cause a problem when finalizing. It is suggested practice to attached these to the SmartForm as a Supporting Document and categorized as attachment type “other”.
2. Track Harvard Determinations: (required step, if not completed earlier) Review the Track Harvard Determinations activity on the Reviews tab to make any necessary updates. Complete any needed updates.
3. Manage Ancillary Approvals: (optional step) Review the status of ancillary approvals on the Reviews tab to make any necessary updates. Complete any needed updates.
4. Prepare Letter: (required step) To inform the study team about the IRB's decision. IRB staff may refer to the local reference regarding specific edits associated with each system-generated template letter. Note: The Prepare Letter activity and the letter draft will not appear on the workspace until the send letter activity is completed. To view draft versions of a determination letter before the letter is sent, complete the Prepare Letter activity again.
5. Send Letter: (required step) Notifies the PI, PI Proxy, and Primary Contact that the determination letter is available. Sending the letter also transitions the submission to the state determined by the IRB, such as Modifications Required or Approved. If the IRB decided to require modifications to the study before a final determination is issued, the submission moves to the Modifications Required state to allow the study team to respond.
Review Required Modifications. (required step, for submissions in modifications submitted state)
The following must occur when the study team submits the requested modifications. The IRB coordinator, director, or committee chair can choose to review the modifications using the Review Required Modifications activity. The IRB coordinator and director can also assign the modifications to non-committee or committee review, as appropriate.
After checking the response from the study team, review required modifications, fill in updated dates, as applicable along with providing a summary of the review for study staff to see on the submission History.
• Marking “No” to the last question on the activity will return the submission back to the study team for further edits.
• Marking “Yes” to the last question on the activity will move the submission to post review (see steps above).
If the changes do not directly relate to the requirements or as needed, the IRB staff member can assign the submission to a designated reviewer (non-committee review) or a meeting (committee review) to complete review of the response.
Other Available Optional Activities:
Discard and Withdraw: After pre-submission, Withdraw can be completed at any time before post review, and returns a submission to the pre-submission state for edits and resubmission by the PI/PI Proxy. Discard can be completed when a submission is in an editable state (such as pre-submission or clarifications requested) and will remove the submission from further consideration. If during review, a member of the IRB staff would like to complete the Discard or Withdraw activity on behalf of the study team (in compliance with office procedure), the staff member must first be the assigned IRB Coordinator. If the activity is still not visible after assignment, the IRB staff member can contact email@example.com for assistance with completion of the activity.
Add Reviewer Comments is available during the IRB review collection of states, the activity as a space to take review notes. Completed activity notes are available to IRB staff and committee members via the History and Reviews tabs in the submission workspace. This information is available until a final determination is issued (not including disapproved, deferred, or modifications required). Once review is completed and when the determination letter with the final determination is sent, the system purges all individual reviewer comments.
Revert to Pre-2018 Requirements After initial or continuing approval, this activity is available on the main study workspace of studies where a continuing review occurred after the 2018 requirement change. The activity pop up has space for a comment, the addition of supporting documents, and the option to notify the PI/Proxy/Primary Contact (or not).
Important! This activity will trigger the request for a Continuing Review submission, to revert the study back to pre-2018 common rule requirements. A change in the regulatory authority can only occur on an initial submission or a Continuing Review.
Update Expiration Date: After initial or continuing approval, it may be identified that an end date of approval (or expiration date) is incorrect in the system. If this occurs, an IRB coordinator can execute the Update Expiration Date activity to change the value in the system. Changing a determination value may require additional steps to ensure the update is documented correctly. Specific steps for IRB staff include:
1. Review the determination letters issued within the last year to identify
a. If the expiration date has actually changed; and
b. If the most recent determination letter needs to be re-created and re-sent with the correct date.
2. If the expiration date on the main study is confirmed as incorrect and:
a. The study is in the “Approved” state: complete the Update Expiration Date activity on the main study, or
b. The study is in the “Lapsed” state:
i. Complete the Move to Approved activity on the main study. A notice will be sent to the PI, Primary Contact and PI Proxy.
ii. Complete the Update Expiration Date activity on the main study.
3. If the most recent determination letter contains an incorrect expiration date, on the workspace with the incorrect letter, execute the Prepare Letter and Send Letter activities.