Important! The information provided here is meant for IRB staff member reviewers only.

Note for committee members: An IRB staff member must submit the decision on behalf of the committee. If you are a reviewer of the study, record your comments and attach relevant files (such as reviewer checklists) as described in Preparing Comments for a Meeting.

After reviewing a study or other submission, you must record the decision in the system. Recording the decision completes the review and moves the study forward in the IRB process.

There are several types of review, with key procedures for are identified below:

• Ancillary review 
• Track Harvard Determinations
• Pre-Review
• Designated (Non-Committee) review
• Committee review

Notes:

• The procedures below assume that the study team has completed any requested clarifications.
• Specific steps to complete activities in other states of review (including External IRB and study closure) are noted in the IRB Staff Administration Guide.

To open the study:
1. From My Inbox, click the name of the study to open it.
2. Choose the appropriate procedure below.

To add or complete an ancillary review (IRB staff only):

1. Click the Manage Ancillary Review activity in the appropriate submission where the ancillary review must be recorded.
A pop up will appear.


2. Click “Add” at the left side of the table. Another pop up will appear. 
If updating an ancillary review status on behalf of the reviewer, click “Update” beside the review type and fill in the form.

3. On the Add pop up:
Question 1 Enter information in either Organization (aka Department) or Person. Only organizations with assigned reviewers will be available for selection. Selecting an organization may send a notice to multiple possible reviewers. Only one needs to complete the review. Any person can be selected.
Question 2 Select the review type.
Question 3 Indicate if response is required (per guidance/best practice).
Click OK, the additional pop up will close.

4. See the newly added or revised item display on the table in the pop up.

5. Click OK.

Any added review comments are shown in the study and are visible to the study team.

To record special Harvard Determinations (IRB staff only):

1. Click Track Harvard Determinations on the left.


2. Mark the relevant determinations and indicate the Data Security Level.

3. (Optional) Save, edit and attach documents related to the review, such as checklists to the non/committee review form.

4. Click OK.

As needed, return and perform Track Harvard Determinations again to update the information.

To complete a pre-review (IRB staff only):

1. Click Submit Pre-Review on the left.


2. If the PI is restricted, red indicator text will appear at the top of this activity form. To change PI status, view Updating a Person Profile in the IRB Staff Administration Guide.

3. Answer the relevant questions, paying special attention to each required question marked with a red asterisk (*).  Note:
•  Practice at this time is to never mark “Broad Consent”. 
•  It is important to indicate additional study features when applicable.  Specifically, if the SmartForm indicates that a study is multisite/collaborative, either multi-site or collaborative must be marked on this activity. Consult your IRB Definitions for information on the appropriate selection

4. (Optional) Attach documents related to the review, such as checklists.

5. If you are ready to move the study to the next stage of IRB review, answer Yes when asked if you are ready to submit this pre-review.
Otherwise, answer No, which enables you to return and perform Submit Pre-Review again to update the information.

6. Click OK.

Important! If you moved the review to the next state (pre-review complete):

• Now you must assign the study to a committee meeting or a designated reviewer. 
• If any sites were added via the Manage Participating Sites activity and are pending, associated site workspaces will now be created and the site submissions will be available for revision and review.

To complete a designated (or non-committee) review (IRB staff only):

1. Click Submit Designated Review on the left.

2. Answer the relevant questions, paying special attention to each required question marked with a red asterisk (*). Note when completing form elements:

• Determination:
  • Not Research: For review of studies not meeting the definition of research under 46.102(d), choose “Not Human Research”.  When generating the determination letter, be careful to edit the text to match the specific decision.
  • .118 Determination: For studies meeting criteria for documented review under 46.118, mark the “Not Human Research” determination.  When generating the determination letter, the appropriate templates will appear for selection.
  • Minor Modification: For review of minor modifications meeting Expedited criteria 46.110(b)(2), use the category “(mm) minor modification”.
  • .Modifications Required: When determining that Modifications are Required to Secure Approval on a Continuing Review, later in this form, indicate the anticipated approval date. To retain study approval while response is pending, visit the main study workspace AFTER sending the letter to complete the “Update Expiration Date” activity and confirm the newly updated expiration date.

Important! Use of “other” as an Exempt or Expedited category otherwise requires approval by leadership in the IRB office

• Dates:
  • Complete the approval, effective and expiration dates per IRB office practice for approval intervals and accounting for study anniversary dates, where appropriate.  If these items auto-populate, be sure to verify that they are correct.
  • For studies that do not require continuing review, such as those determined to meet the definition of Not Research, Not Human Subjects Research, or studies which meet Exemption criteria; remove the expiration date if it is pre-populated

3. (Optional) Add comments and attach documents related to the review.

4. If true, check the box to indicate that you do not have a conflicting interest. (For more details about conflicting interests, click the blue question mark icon.)

5. If you have entered all the relevant information and are ready to submit the final IRB decision, answer Yes when asked if you are ready to submit this review. Otherwise, answer No, which enables you to return and perform Submit Designated Review again to update the information.

6. Click OK.

If you submitted the final decision, the IRB can now officially communicate the decision to the study team. If needed, this activity form can be edited after it is completed. However, re-completing the form may update the noted effective date.

To complete a committee review (IRB staff only):

Important! An IRB staff member must submit the decision on behalf of the committee. If you are a reviewer of the study, record your comments and attach relevant files (such as reviewer checklists) as described in Preparing Comments for a Meeting.

1. Click Submit Committee Review on the left.

2. Answer the relevant questions, paying special attention to each required question marked with a red asterisk (*). See the section of this guide detailing non-committee (designated) review for additional notes about review elements on this activity.

3. (Optional) Add notes and attach documents related to the committee's review.

4. If you have entered all the relevant information and are ready to submit the final IRB decision, answer Yes when asked if you are ready to submit this review. Otherwise, answer No, which enables you to return and perform Submit Committee Review again to update the information.

5. Click OK.

If you submitted the final decision, the IRB can now officially communicate the decision to the study team. If needed, this activity form can be edited after it is completed. However, re-completing the form may update the noted effective date.