The HSERA Help page contains answers to the most frequently asked questions related to utilizing HSERA. Please see the expanding sections below for answers.

If you are having technical difficulties with HSERA that are not resolved with the guidance below, please send a detailed inquiry (with screen shots if possible) to the HSERA Helpdesk.

Submission Routing

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

Creation of an initial submission follows this chain of approval:  Creator >> Principal Investigator (PI) {identified on the personnel page} approves the submission >> Department Chair/Approver {that corresponds with the Responsible ORG identified on the personnel page} approves the submission >> the IRB receives the submission for review.

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 at HSERA_help@lists.upenn.edu.  Please provide the confirmation 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 send an e-mail to the HS-ERA helpdesk (HSERA_help@lists.upenn.edu) stating that he/she is the new Department Chair/Approver for the corresponding Responsible ORG and that he/she will be taking on the responsibility of review and approval of research for that Responsible ORG.  Please be sure to ask him/her to include their 4-digit ORG code, the name of the department and his/her 8-digit Penn ID # in the response message as this information is needed to make the correction/change.

Once the e-mail is received, the routing path for the Responsible ORG can be corrected/changed.

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).

 

How do I approve a submission that is Pending my review? (for Principal Investigators and Department Heads)

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

All Initial submissions for new research require both PI approval and approval from the faculty member associated with the ORG chosen on the Personnel Page of the Application. These approvals must be completed before the IRB can review the submission.

Click here to download instructions for making PI or ORG level department approvals.

An IRB staff member has returned my submission. What do I do now?

Submissions that are returned to you can be found in HSERA under "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.

I forgot to include an important document with my recent submission. Can I submit it via email?

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 any IRB staff member 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.

Where can I find determination letters from the IRB in HSERA?

 All submissions that come through HS ERA and receive a determination have the IRB determination letters attached to them after 48 business hours for your future use and reference. (This is especially helpful for getting fresh copies of approved stamped consent forms if you’ve photocopied one too many times)

1.        Sign in to 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(The same letter that would have been emailed by the IRB to the coordinator/PI)

6.      If the link is not available 48 business hours after the determination is made, please bring it to the attention of ANY IRB staff member and we will correct the error ASAP and provide you with a letter.

 

I need to add a new study team member to my HSERA application, but their name is not selectable in HSERA. What do I do now?

This person 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 email the person's first and last name, Penn ID#, and their department 4-digit ORG code to hsera_help@lists.upenn.edu and request help with obtaining a research affiliation.

Please contact your associated department Business Administrator to obtain the department ORG code 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.

Please note that all persons being added as members of the study team must have current CITI training for protection of human subjects prior to participation in any IRB reviewed study.

My information is not showing correctly in my HSERA profile. How can I correct it?

Names, e-mail addresses, telephone and fax numbers listed in HSERA are pulled from PennERA profiles. To update this information please log in to PennERA  with your Pennkey and password at https://www.pennera.upenn.edu/. Click "My Profile" on the left menu. Click "Edit" to revise the incorrect information. Once edits are complete, click the "Save" button in the top right corner. This will push the revisions to your HSERA account.

Mailing addresses are pulled from the Penn Directory. To update this information, log into the directory at http://www.upenn.edu/directories

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

What do I do if I am having trouble with CITI training in HSERA?

Please note that it may take 24 hours or more for recently completed CITI training to feed into Knowledge Link and HSERA. CITI training completed at other institutions will require manual updates by way of submitting your report of completion. Please see the CITI training guidance page for complete information about CITI training requirements and troubleshooting.

2016 FORMS UPDATE OVERVIEW

The IRB has developed new forms for each type of submission. The new forms are available for download on the forms page starting March 1, 2016. Additional guidance for each type of submission will be published in the IRB “How to Submit” pages that are dedicated to each submission type. This new process will require that all studies use the new forms regardless of whether they are tracked in HSERA or have a paper file with the IRB.

For Paper studies:

These studies will continue to complete the Word.doc formatted submission forms as usual and submit paper printed copies of all documents to the IRB office. The only thing that has changed about this process is the IRB forms themselves.

For HSERA studies:

HSERA will be changing over the next several months but what the final product will look like is still in production by the Vice Provost office. In order to have a plan in place while these changes are developed and tested, the IRB is asking that study teams complete the new Word.doc forms for each submission and upload them as attachments to the corresponding HSERA submission in lieu of completing the old questions that are programmed into HSERA. For any required field in HSERA, just type "See attached form" or "NA" in order to move through the application smoothly. As long as the attached form is filled out compeltely the IRB will not raise issue with the HSERA fields being blank.

Please note that the Initial application for starting a new study will not be changing with the release of the new forms. The new process only applies to Continuing Review, Modification, Deviations, Exception Requests, & Reportable Event submissions.

Why is this happening?

The IRB has been receptive to the concerns and complaints from the research community and we want to change things!

                     But...                                                                                       

  • The development and maintenance of HSERA is not under IRB  direct control- we have to ask another team to make all our changes for us which slows everything down.
  • By standardizing the forms via an upload process instead of electronic “smart” form, changes and innovations can be developed, tested, piloted, revised, and implemented at a much faster rate than previously possible.  i.e. previously it was just not possible.
  • The limitations of HSERA are frustrating for research teams and the IRB alike
  • By using a form that exists outside the system, submission content can be developed , revised, and shared among the team prior to HSERA submission
  • Personnel waiting for their name to be added to the HSERA protocol can now contribute to the progress of the study

What’s new?

  • Formatting –We are not re-using the old forms that paper submitters have been using
  • Physical signatures are NOT required for these forms that are being submitted via HSERA
  • Introductory sections in each form which detail the requirements and expectations for submissions
  • Almost every question has been revised to provide more clarity
  • More links to guidance have been incorporated to assist submitters with common questions.
  • Since submitting a Continuing Review to request closure of a study is not an intuitive process, we have developed a specific Closure form that should be submitted via HSERA modification for electronic studies.

When Should I start using the new forms?

  • We understand that the development of a continuing review submission may begin up to 90 days prior to the expiration date. As such, the use of this new form will be required for all studies that expire after June 1, 2016. Failure to use the new form for a continuing review submission created after June 1 will result in a returned submission.
  • The other forms should be utilized for all submissions going forward. Use of an outdated form may result in a returned submission after April 1. If you currently have submissions in draft, you do not have to delete and start over, but please download these forms and have them handy for your next new submission for all the protocols you work on.