The purpose of this form is to provide required information to the IRB that does not qualify as a continuing review, request for closure, or proposed modification to a currently approved study.
Reportable New Information (RNI) can be created in one of two places: the study workspace or your personal workspace. Creating the RNI from a single study workspace indicates that it is primarily associated with that study. Creating the RNI from your personal workspace (your Inbox) is used with a) you would like to submit an anonymous RNI or b) you are associating multiple submissions to a single RNI.
Important! Updating the SmartForm does not send the submission for review. The person who created the RNI (the “reporter”) must click Submit (marked with a red arrow in the submission workspace) for the submission to proceed on for the next state of review.
To create and submit an RNI to the IRB:
1. Log in to irb.harvard.edu
2. Navigate to:
> An approved study workspace (see Accessing a Submission for more information) OR
> My Inbox or IRB pages linked int he top menu (only if you do not want to associate this with a study)
3. Click the “Report New Information” button.
4. On the SmartForm, fill in the necessary items for IRB review.
1. RNI short title. A way to uniquely identify this new information report in the system. This will appear as the submission ‘name’ in all workspaces.
2. Date you became aware of the information. Indicate the date in the space provided.
3. Identify the categories that represent the new information. Mark all that apply from the list provided on the form. Information that does not fit into one of the categories provided does not need to be reported to the IRB as new information.
4. Describe the new information. Include relevant information and if the event is ongoing or resolved, including the number of participants affected, details regarding any new or increased risk or safety issue to participants or others, and procedures used to investigate the event and prevent a similar event from occurring again in the future. It is additionally helpful to note details such as:
- Explanation of how the lapse occurred.
- Strong corrective action plan in place to avoid a future lapse.
- Timeline for when the lapse will be resolved, with either a CR or closure.
- Confirmation that no human subjects research activities took place while lapsed.
- Confirmation that there are no outstanding RNIs, pending issues/Mods, participant complaints/concerns, etc.
- Verification that no prior lapses for this project have occurred before; confirm Related Submission is linked accurately.
- Verification that the lapse was reported within our 5 business day reporting policy.
- Verification that notification of lapse has been communicated to sponsor, local site/IRB, DSMB, etc., if/when applicable
5. In the submitter’s opinion. Mark yes or no to the questions provided. If it is marked that the study or consent requires revision, a separate modification request must be created and submitted for review.
6. Related studies and modifications. List all studies associated with this submission. Only active studies to which you have access will display in the search results and can be selected as associated with this submission. If this question is left blank, the RNI SmartForm you will be prompted to provided additional information.
SmartForm Sub-Section: Department
1. Associated Department. Indicate the department associated with this RNI (for example the reporter’s department or the department where the even occurred).
2. Investigator. As applicable, indicate the investigator associated with this RNI.
7. Attach files containing supporting information. Attach any additional information required to complete review of this report (such as a DSMB report or report from external agency).
5. Follow the remaining steps to Edit a Submission
6. The person completing this form must click Submit (marked with a red arrow in the submission workspace) for the submission to proceed on to the IRB for review.
Responding to Action Required for Reportable New Information (RNI):
After reviewing a new information report (or adverse event), the IRB may require specific actions to be taken in response to the reported issue. If this occurs the IRB will issue an Action Plan and assign an individual responsible for completing the required actions.
The system will send a notification to the individual responsible for completing the required actions on the RNI, as well as to the PIs, PI proxies, and primary contacts of all related studies. The RNI also appears in My Inbox of the individual responsible for completing the required actions.
To view the Action Plan and respond to the IRB:
1. From My Inbox, click the name of the RNI submission to open it
2. View the details of the RNI submission and the Action Plan, as described here:
- Read the letter: Click the letter link near the top of the page on the right side. The letter typically contains the Action Plan and a summary of the IRB's decisions.
- Review the Action Plan: Click the Action Plan tab and read the action plan listed there, plus any history of the action plan that might be helpful.
- Review the RNI submission details: If you aren't already familiar with the details of the information report, read it by clicking View RNI on the left side.
3. Take action inside or outside the system to complete the action plan. If the Action Plan requires a change to a study, create a modification and submit it for review as mentioned in other sections (Creating Modifications, Continuing Reviews). Then return to the RNI and add the modification using Add Related Submission. The study being modified must be added as a related submission before the modification can be added.
|TIP||You can add related studies to the RNI submission to indicate that the information report applies to the studies. From the RNI submission, click Add Related Submission on the left.|
4. Click Submit Action Response to indicate that the action plan is complete. The Submit Action Response form gives you space to type notes and attach a file. Summarize the actions taken to resolve the reported issue and complete the action plan.
Only the person named as the “Responsible Party” by the IRB can see and complete the Submit Action Response activity. If the response is prepared but the activity is not visible and cannot be completed, contact the assigned IRB contact to request assistance.
5. Click OK. The RNI submission is returned to the IRB to verify completion of the Action Plan.