The basic process for reportable new information (RNI) 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.
Unlike all other submission types, an RNI submission:
- Does not include ancillary review.
- Can be reviewed and acknowledged by an IRB coordinator if not deemed to be serious.
- Transitions from completion of designated review to committee review if deemed to be serious.
- Can be assigned to a responsible party for follow-up action.
- Is visible to IRB staff at all times, independent of which IRB is assigned to review.
Any person with access to ESTR can create and submit new information. However, when linking a study to the RNI, they can only associate submissions to which they have access.
|TIP||If the RNI is not assigned to the correct IRB, complete the Assign IRB activity to change IRB.|
RNI Review Workflow
The RNI workflow uses similar states to a study, but the IRB review process routes the submission differently depending on the significance of the determinations selected. This reduces the IRB's time spent handling insignificant issues. The rules are:
- When an RNI submission is not considered a serious* issue, the submission transitions directly to the Acknowledged state and sends an e-mail notification indicating that the review is complete.
- Any RNI submission that represents a serious* issue must eventually go through committee review to determine any follow-up actions. After committee review, serious* submissions go to the Post-Review state so the coordinator can prepare and send a letter.
* Serious: For an RNI submission to be considered a serious issue, the determinations selected must include an unanticipated problem involving risks, serious or continuing non-compliance, or suspension or termination of IRB approval. If none of these are selected, the workflow routing handles the RNI as less significant.
Activities to complete review occur in the following general order:
RNI Pre-Review: The review process starts with a pre-review that enables the coordinator to make the final determinations regarding any RNI submission that is not considered serious.
If the RNI submission is not considered a serious issue and is not marked as "Additional review required," the submission transitions directly to Acknowledged and a notice is sent to the PI, RNI Reporter and Primary Contact.
Otherwise, the coordinator can assign the submission to a designated reviewer or to committee review.
Important! For RNI submissions related to VA studies, a designated reviewer or committee must always review the submission. The coordinator should select the determination "Additional review required" and then assign the submission for further review.
If the related studies are added to the RNI, the forms for Submit RNI Pre-Review and Submit RNI Designated Review display text to alert the reviewer that the submission is associated with a VA study.
If further review is needed:
RNI Designated Review: The RNI designated reviewer starts from the determinations selected in pre-review and can modify them as needed.
If the RNI submission is not considered a serious issue, the submission transitions directly to Acknowledged and a notice is sent to the PI, RNI Reporter and Primary Contact. Otherwise, the submission transitions to Committee Review so it can be assigned to a meeting.
RNI Committee Review: The committee review starts from the determinations selected in the previous review and can modify them as needed.
If clarifications are requested in Committee Review, only an IRB staff member with the “IRBD” role can Submit Response back for review to proceed.
If the RNI submission is not considered a serious issue, the submission transitions directly to Acknowledged and a notice is sent to the PI, RNI Reporter and Primary Contact. Otherwise, the submission transitions to Post-Review so a letter can be prepared and sent. The committee can also require follow-up actions to resolve the issue, as described below.
When assigning an RNI to Committee Review, complete the Track Harvard Determinations activity on the workspace (even if all items are blank or N/A). This helps to generate the meeting agenda.
- RNI Designated Review: The RNI designated reviewer starts from the determinations selected in pre-review and can modify them as needed.
Prepare Letter and Send Letter: If action is required (see below) or a determination letter must be issued. When the Send Letter activity is completed, a notice is sent to the PI, RNI Reporter and Primary Contact.
Note: If the letter will not generate, complete the Track Harvard Determinations activity (no values need to be entered on the pop up) and re-try the Prepare Letter activity.
Action Required Workflow
For issues considered serious based on the selected determinations, the committee can indicate that follow-up action is required to resolve the reported issue, specify an action plan, and assign a responsible party for carrying out the plan. In Post-Review, the generated letter includes the action plan and is sent to the responsible party in addition to the other involved individuals.
If action is required, the submission transitions from Post-Review to Action Required when the letter is sent. The responsible party can respond using the Submit Action Response activity when the action has been completed. Then the completed action can be reviewed and verified in the Action Submitted state by the coordinator, director, committee administrator, or committee chair. Alternatively, the submission can be assigned to a designated reviewer or to committee review to verify the completed action.
If the assigned responsible party is unable to complete the Submit Action Response activity, IRB staff can reassign the responsible party by completing the Assign Responsible Party activity.
To assist reviewers, the Action Plan tab displays the latest action plan and all activity history that may have specified or changed the action plan, reviewed the completed actions, or changed the responsible party.
If you assign a submission to committee to review the required actions, follow these steps to capture the correct information to be shown in the meeting minutes:
a. If the action was completed correctly, leave "Is further action required" set to Yes. Don't make changes to the action plan or other action-related questions.
The Committee Review will retain the final decision, visible on the “Reviews” tab of the workspace. View activity details to see each recorded action at the meeting and after.
Related Studies and Modifications
An RNI submission can be associated with one or more studies where review was already completed, or with no study at all. For example, a research coordinator might allege that an investigator is conducting research that was never submitted to the IRB for review. It would not make sense to associate this RNI submission with a study within the system. An RNI submission cannot be associated with a study that is currently in review. Additional considerations when relating studies and modifications:
- An RNI submission can also be associated with a modification to a study, such as a modification that is created in response to the reported information. When adding a related modification, the study that is being modified must be added first.
- When creating the RNI, one of the questions enables the submitter to add related studies and modifications.
There are a few methods for associating an RNI submission with related submissions:
- When the RNI is created from a study's workspace, that study is added to the RNI's list of related submissions.
- After creation of the RNI, the Add Related Submissions activity can be used activity to add related studies and modifications. The activity is available to the submitter, coordinator, director, committee chair or administrator, responsible party, and the PI or PI proxy of any study that is already related.
- The PIs, PI proxies, primary contacts, and study team members of all related studies are given read access to the RNI submission. All of these parties except the study team members receive the same e-mail notifications as the RNI submitter throughout the workflow.
For additional tips, see the Help for the specific question or form where you are adding the related submission.