As appropriate, the Harvard IRB may review activities taking place at another site, where that site relies on the Harvard IRB review. The review of these participating sites (pSites) and confirmation of reliance is managed in two ways:
Projects created prior to December 15 2017
Confirmation of reliance is considered as recorded as part of the review of the main study (and as part of any subsequent modifications). Information is contained in one of three spaces:
o Research Locations page of the SmartForm (including site name and location)
o Last attachment space of the Local Site Documents page of the SmartForm (including any draft or confirmed reliance documentation)
o Review activities or notes
If a substantive change is to occur on an existing site, or if a new site must be added, the study team can request a modification to “other parts of the study” to change the type of study to collaborative where Harvard will review (questions 8 and 9 on the Basic Information page of the SmartForm) to then allow for the addition of a participating site via the Manage Participating Sites activity.
Projects created after December 15 2017
Only studies indicated as Collaborative (question 8 on the Basic Information page of the SmartForm) AND where Harvard will review for at least one site (question 9 on the Basic Information page of the SmartForm) allow for the inclusion of site review.
Review of a pSite follows an alternate workflow from a study and has some special activities
Site review involves the following additional features:
Upon completion of the Add/Manage Participating Site activity on the main study workspace, the site submission is created as pending, until pre-review has been submitted on the main study. These pending sites can be removed or changed by re-completing the manage participating sites activity. Once a site is pending and pre-review of the main study is completed OR a site is added after pre-review on the main study is completed, the site is:
- Automatically assigned to the IRB coordinator assigned to the study (if one is assigned), and
- Immediately available to the IRB for review. So, completion of “Add/Manage Participating Sites” is similar to ‘submitting’ a participating site.
- Unlike review of a study, the pSite may be edited until the confirmation of site materials received. Along with other documents, if the study team requires access to the confirmation of reliance, it may be attached to the Local Site Documents page of the SmartForm prior to (or when) confirming site materials as received.
- Notifications to the PI/Proxy and Primary Contact are from this submission and will occur in addition to any study related review. Consider this when completing site review during the review of an associated study or follow-on.
- Review cannot be completed on a pSite until the main study review is completed.
- Best practice indicates that a pSite should only be added (a) during the review of an initial submission or (b) after initial approval, when accompanied with a modification submission.
- Review of the associated main study cannot be completed unless required elements of the pSite Institution are added to the Institutional Profile. Note that the system will show an error message when attempting to complete the Send Letter activity.
pSite 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:
1. Submit Invitation Decision: (required step) allows for the recording if it is acceptable to proceed with considering the request. If question 1 on this activity is marked:
o Yes: it transitions the submission to awaiting site materials. Able to be edited on all submission types where it is.
o No: it transitions the submission to inactive. The study team can complete the Record Response activity for additional consideration of Harvard Review of the site.
2. Confirm Site Materials Received: (required step) to mark that all relevant site specific materials have been received for review.
3. Correspond with Site: (optional step) without the option for clarifications requested, this is a method to request information/changes or to communicate with individuals associated with the site (including the site IRB contact), and:
o Send a notice to any person associated with the study or site, including the other IRB office contact.
o Include the text in the activity within the email sent to the recipient(s), and
o While not preferred, if a person chooses to reply to this notice: you will receive replies to this notice in your email inbox, rather than posted on the submission workspace.
4. Track Harvard Determinations: (required step) available and editable in all states.
5. 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.
6. Determination Entry Activities: Can only be completed after approval of the associated study. Attach relevant confirmation of reliance (such as an executed IAA) to the appropriate space in this activity. However, if the study team requires access to the confirmation of reliance, it may be attached to the Local Site Documents page of the SmartForm via a Site Modification, after approval.
• 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.
7. 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) will not finalize unless they are attached 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. Prepare Letter: (required step) To inform the study team about the IRB's decision for the site. 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.
4. 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. In order to issue a final determination for the site, the Review of Required Modifications activity must be completed following response from the study team.
Modifying and Closing pSites
If the site needs to be revised while the study is active, study staff may propose a modification to the site via a site modification. A site modification only affects the site from which it is proposed. Review of a modification proceeds along the above-described site review steps. Once the site modification is approved, all of the approved elements will update the main site workspace.
If the site must be closed or made inactive during the course of the larger project, the study team may provide an update about study in ESTR in one of two ways:
1. Complete the Report Continuing Review Data activity in the site workspace to provide an update and request closure in the comment activity, OR
2. Complete the Add Comment activity to communicate an update in site status with IRB staff.
Following receipt of a continuing review or update information for the site, IRB staff may take the following actions:
1. Administratively close the site via the Close Site activity. OR
2. Complete the Update Site Status activity to move the submission to the appropriate status. Note that any status except “Terminated” may be chosen when awaiting additional information and the Site may be returned to active status by re-completing this activity. Choosing the Terminated status will end review of the site and render it no longer active.