HSERA FAQs

Yes and no. The system will prevent a modification from being submitted while another modification is under review. This is a hard stop. Likewise, more than one continuing review submission will be blocked by the system.

The system will allow reportable event, exception requests, and deviations to be submitted while a continuing review or modification submission is pending review by the IRB.

The system will also allow a modification to be submitted concurrently while a continuing review is pending (or vice versa). A soft stop and a warning will appear, but you may proceed. However, the IRB recommends that study teams do not submit concurrent modification / continuing review submissions, unless absolutely necessary, due to complications that can occur, as detailed below. However, if you are waiting on a modification approval and your continuing review is expiring, DO NOT WAIT to submit your continuing review submission.

If you must submit concurrent modification / continuing review submissions, please note the following:

1. You must reach out to the IRB staff to facilitate the processing of these submissions and ensure that the correct documents are approved in the continuing review submission. For greater than minimal risk studies requiring convened board review, please email BOTH the coordinator and administrator for the study’s assigned board. For minimal risk research, please email the IRB PO Box.
2. It is the recommendation of the IRB that you create and submit the modification first before creating the Continuing Review (CR) application. This is to make sure that changes made within the HSERA modification submission are carried over into the continuing review application. If you do not do this, you may lose changes you made in HSERA if the create the CR first. It is preferred that the continuing review application be created after the approval letter for the modification has been uploaded for this reason.

No. The IRB does not have edit access to IRB applications. Likewise, study personnel management within HSERA is the responsibility of the study team, not the IRB. Anyone listed as a PI, Co-Investigator, or Study Contact can add new personnel to the submission in HSERA. The IRB strongly recommends having multiple study contacts listed in order to avoid situations where staff leave Penn and no one has access.

The IRB can re-route the PI approval to another co-investigator on the study who has access to HSERA. Email the HSERA help desk at and identify the individual who will approve the submission.

All submissions created in HSERA require PI approval prior to the IRB receiving the submission.

All Initial submissions for new research require both PI approval and approval from the designated Department Chair. This is a faculty member associated with the ORG code chosen on the Personnel Page of the HSERA Application. These approvals must be completed before the IRB can review the submission. Click below to download instructions for making PI or ORG level department approvals.

Submission routing is an important process but often is not really considered until something goes wrong. The Responsible ORG entered into your submission on the Personnel Page of the HSERA Application will determine how the submission routes through the system.

After an Initial Submission is received by the IRB, departmental approval of future submissions is not required. Responses to Initial Review, Modifications, Continuing Reviews (CRs) etc. will route to the IRB upon approval by the Principal Investigator (PI).

If the wrong Responsible ORG is chosen, your submission will be routed incorrectly and may not get approved. If this should happen, please e-mail the HS-ERA helpdesk. Please provide the confirmation code number for the submission and the correct name of the Department Chair/Approver so the submission can be manually re-routed.

IRB submitters are encouraged to consult with their Business Administrator to ensure the correct Responsible ORG number is chosen upon creation to avoid these issues.

In order to make a permanent routing change to the electronic routing path for a Responsible ORG, the person that is designated as the new Department Chair/Approver must complete the Qualtrics Form linked below and confirm that he/she will be taking on the responsibility of review and approval of research for that Responsible ORG. Once the form submission is received, the routing path for the Responsible ORG can be corrected/changed.

Submissions that are returned to you can be found in HSERA under My Submissions > “Items to be Resubmitted”. You may edit all sections of the submission that were originally available to you when you created the submission. Once the required edits have been completed, you should re-submit to the IRB. Re-submission will result in the creation of a new confirmation code that will be associated with the submission going forward. Do not attempt to create a new submission in response to an item that has been returned to you unless you have been instructed to do so by the IRB staff.

All application content and associated documents must be generated and added by members of the study team that are listed as either PI, CO-PI or Study Contact in the HSERA application.

The IRB staff does not have editing capabilities in HSERA. The functions accessible to the IRB staff are limited to read-only review, internal comment, returning and making determinations (Approval, Withheld Approval, etc…). If there is missing documentation that needs to be included with a submission you should email IRB PO BOX to request that the item be returned to you for revision prior to final review.

If the submission is currently under review at the time and cannot be returned, some documents may be accepted via email to assist in completion of the review in a timely manner. Documents provided via email are not able to be added to the electronic regulatory file by IRB staff. For auditing purposes, it is the responsibility of the study team to ensure that all relevant documents have been officially submitted as attachments to ensure the electronic regulatory file is complete.

All submissions have a determination letter attached to them within 48 business hours upon receiving a determination.

1. Sign into HS ERA
2. Go into your “submission history” on the blue left side menu,
3. Specify your filter for the study you are looking for (if you have the specific confirmation code it is MUCH faster than searching by protocol #)
4. Once you’ve identified the submission you are looking for, click on the Eyeglasses on the right side of the screen,
5. Scroll down to “IRB Correspondence”- there should be a clickable file name there that has been placed by the IRB. Clicking it will bring up a PDF of the approval letter for that submission.
6. If the letter is not available within 48 business hours of the determination being made (e.g., convened board meeting date), please email the IRB PO Box.

The Penn personnel is in need of an ERA account. In order to set them up with an ERA account, they will need a research affiliation added to their profile. The HSERA support team can assist you with this process. Please complete the Qualtrics Form linked below. Please contact your associated department Business Administrator to obtain the department ORG code and confirm the individual’s employee status before contacting the IRB for assistance.

If the person you are trying to add is not affiliated with Penn (doesn’t have a Penn ID#) please see the guidance page on Individual Investigator Agreements to determine whether one is required. If the individual needs a Penn Key, please reach out to your ISC provider with questions about this. The IRB cannot help you with obtaining a Penn Key. See: https://pennkeysupport.upenn.edu/sponsor-guests for more information. Please consider establishing a Penn Key for outside individuals carefully.

Please note that all persons being added as members of the study team must have current CITI Human Subjects Research training prior to participation in any IRB reviewed study.

Names, e-mail addresses, telephone and fax numbers listed in HSERA are pulled from PennERA profiles. To update this information:

1. Log in to PennERA (linked below).
2. Click “My Profile” on the left menu.
3. Click “Edit” to revise your email address.
4. Once edits are complete, click the “Save” button in the top right corner.

This will push the revisions to your HSERA account. If you have issues or questions about updating PennERA, please contact the HSERA Helpdesk.

Mailing addresses are pulled from the Penn Directory. To update this information, log into the Penn directory (linked below).

Department/school/division information cannot be updated by users. To request updates to department information listed in HSERA, please email the HSERA help desk.

Submissions can be deleted under the My Submissions menu.

For new items in draft form: Click Manage Drafts. Then click the trash can icon to the right of the submission you want to delete. If necessary, filter by confirmation code.

For items that have been returned: HSERA automatically creates a draft response under Items to be Resubmitted. If you intend to respond to the IRB, do not delete the response submission, as this will prevent you from responding and you will have to start your submission all over. If you will not be continuing with the project, click Items to be Resubmitted, find the draft response and click the trash can icon on the right-hand side to delete.

You will not be able to delete previously submitted applications.

You will have to create a new submission with the requested revisions completed and contact the IRB staff member you were working with so the new submission can be appropriately routed.

The IRB developed paper forms for each type of submission in 2016. These forms are required to be used for both HSERA and Paper studies. The electronic forms in HSERA for these submission types are outdated and do not contain all the required questions that are needed to assess submissions. The Word forms were initiated because the development and maintenance of HSERA is not under IRB direct control and requires complex coding by ISC. Within any required field for these submission types, you may type “See attached form” or “NA” in order to move through the application smoothly. As long as the attached form is filled out completely the IRB will not raise issue with the HSERA fields being blank. These forms do not require signatures when submitted in HSERA.

The PI, Co-Investigator, and all three study contacts have edit access to application drafts. Individuals listed as Key Personnel on the Personnel page do not have edit access. Two individuals cannot edit the application at the same time. If one research team member is editing the application, they will have to save their edits and close out of the submission before another team member may edit the application.

You can list one PI, up to three Study Contacts, one Other Investigator, and an unlimited number of Key Personnel. All research team members should be listed under the “Personnel” tab of the HS-ERA application.