Yes, they will be able to access prior submissions. For prior submissions in HSERA, only dates and approval status are visible in eIRB, without details. For new eIRB protocols, future team members will have full access to submission history. 

Yes, there is greater flexibility around this. You will be able to identify more than three study contacts. “Study Contact” will no longer be a personnel role. It will be a permission that you set for each study personnel. It is already defaulted for the PI, research coordinator, and regulatory manager roles. You will want to assign study contact permissions to anyone that you want to receive communications about the application. Additionally, study contact is no longer tied to edit permissions. This is a separate permission in eIRB. 

The system includes a mechanism to grant IRB delegate access. However, the PI is responsible for all submissions to the IRB. It is still required that the PI review and approve the submissions. If access is delegated, it is the expectation of the IRB that the PI’s approval will be documented via some other mechanism (e.g., an uploaded email that indicates approval). 

Anyone who is given edit access at the time of adding them in eIRB may address the comments and make changes to the application. Study contact and edit access are no longer tied together in eIRB to allow more flexibility. Designating someone as a study contact will ensure they receive communications about the study. Designating someone as having edit access gives them edit access to the application. 

Yes, external investigators may be added to the research team panel. Adding them via this mechanism allows their research engagement to be covered by the Penn IRB, assuming they do not have their own IRB to rely on. This will not give them access to eIRB. If an external person needs access to edit/view eIRB, the IRB would have to manually create an eIRB  account for them. A Penn key is NO LONGER required. Please contact the IRB if you need this. 

The system will send a in-system task and send follow up emails. For non-Penn users, you can upload a training document.

Any personnel can run reports for the studies on which they are listed as personnel. 

There is no limit to the number of Study Contacts on a study.

Yes; Please ensure that you submit a full amendment to change the PI.

Yes, you will be able to view a history of all personnel updates. If a review is required, you will be notified in the system and through an email notification.

Upon Department Chair sign off, ancillary review groups will receive a task for their review in eIRB. Ancillary committees will also have access to view submissions prior to this point if you need to consult with them prior to submission. Ancillary committee reviews and approvals (including, as applicable approval letters) will be documented in eIRB. At this time, there are no plans to migrate study documents from eIRB to other application. It is recommended that you consult with these committees to determine if they will be any changes in their submission requirements. 

RIS number

RIS number is not a mandatory field. However, contracting groups will search by RIS number in eIRB to find the associated IRB protocol. They may require you to enter it for their purposes. The IRB recommends that you add it via an amendment when you have the number to facilitate communications with contracting groups.

Funding Information

If you do not have this information at the time of initial review, select “Pending Proposal” to the question “Indicate if any part of your project is funded” within the Connect Projects panel. Here you can indicate the planned sponsor if the proposal is not selectable.

After IRB approval, study team members with edit access can update this section and link a proposal without submitting an amendment and prompting review by the IRB. Given this, with eIRB launch, IRB staff will begin enforcing updating these fields. 

It is a required field. If you don’t have the UPCC number at the time of IRB submission, you can enter “Pending” in field within the HRPP panel.

Yes, eIRB will provide increased transparency around the IRB review process and in cases where the level of review changes for a protocol. Refer to the Requirements table which informs the submitter about the current status of the review. 

eIRB has integrated in-system notifications and also generates tasks. The system also sends out emails for notifications and tasks. You will have some control over what notifications and emails you can opt out of.  For example, when it is time to submit a continuing review, the system will generate a task to do so. If the task is not completed, the system will send out notification reminders via email and within the system. 

Yes. The system allows you to move between panels even if not all questions are answered. 

Yes. You can download any revision as a PDF. Additionally, it gives you the option to select which sections/panels to include in the generated PDF. Look for the cloud icon with a down arrow near the top right. 

Yes. Once the protocol has been received by the IRB and has a status of IRB Review Pending or Preapproval Requirements the Request Mid-Review Edits option will appear. This is not available if the protocol is pending PI approval.

To request that the IRB return the application, open the IRB application for your protocol. Look for the light blue box at the top right of the eIRB screen that says Request Mid-Review Edits. This will send a request to the IRB staff member assigned. The IRB will decide whether it is appropriate to return the application depending on the state of the review.

The IRB defines a student project as a study that is written, led, and conducted by a student with faculty mentor oversight. This would include, but is not limited to, a PhD dissertation, Master’s thesis, etc. This could also include clinical residency projects as well. In these situations, the question should be answered no. The faculty mentor should be listed as the PI with the student listed as the Co-PI or Sub-I. 

You will find your documents in the panel next to the field where you uploaded them. 

Yes, you’ll receive email notifications and in-app notifications.

Yes, you can do this whether the protocol is open or closed. Within the protocol you want to copy, look for the light blue box at the top of the protocol that says “Copy Protocol.” Click copy. You can copy a protocol in its entirety, or you can select which sections of the application form you would like to copy.

Yes, look for the light blue box at the top of the IRB application entitled New Amendment or Continuing Review. Click request. In the drop down, select Continuing Review with Amendment. This will open up the IRB application for editing and generate the continuing review form to be completed. You cannot submit a continuing review and amendment as separate submissions at the same time. 

No. The application will be locked when someone else is already in the application. It is important that you close the protocol application window when you are not actively working within it to allow other study team members, the IRB and others the ability to work within the protocol.

The submission number appears in the Requirements panel under “Submission History,” where it is listed as the revision number.

Yes. When you initiate an Amendment or Amendment with Continuing Review (CR), the system reopens the original application so you can update information and upload any new documents. 

Latest status gives the approval status of the most recent eIRB protocol stage. A protocol stage in eIRB is one of the following submission types: initial, continuing review, or amendment.

Protocol overall status is the approval status of the protocol as a whole. 

You will need to submit a combined CR / amendment to update the Study Monitoring and Quality Control questions in the Risks and Benefits panel to correct this. 

The safety monitoring and quality control questions only populate when required, which is generally for protocols requiring full board review.