Leadership
- Director, Jefferson Office of Human Research Protection
- Director, Clinical Research Unit
- Professor, SKMC Department of Pharmacology & Experimental Therapeutics
For Research Activities
- Senior Associate Provost, Research Integrity, Conduct & Compliance
- Professor, SKMC Department of Pathology & Genomic Medicine
Getting Started with the IRB
Welcome to the Jefferson IRB! Below you find the requirements needed to begin human research at Jefferson. If you have questions, you can reach out to one of our staff members, submit a ServiceNow request, or attend JOHRP Office Hours.
Help Desk Zoom Information
You can get one-on-one assistance with your iRIS questions by joining the Zoom Help desk that occurs weekly on Fridays at 11AM. Click the link to join. No prior registration is required.
Meeting ID: 967 4245 0956
Step 1: CITI Training
Instructions for CITI Registration
Investigators and key personnel must complete the CITI training appropriate to their area of research.
What CITI Training Do I Need to Take?
Investigators and key personnel must complete the CITI training appropriate to their area of research.
- Those doing biomedical research must take the basic biomedical and GCP courses.
- Those doing sociobehavioral research must take either the basic sociobehavioral course alone, or the basic biomedical and GCP courses.
To maintain certification, refresher modules must be completed every three years from the initial certification.
Please view the instruction guides provided below:
Please be sure that the email in your CITI Account matches the email listed in your iRIS account. This will allow the training records the feed into iRIS.
Please direct all CITI Training questions to Kathleen.Avender@jefferson.edu
Step 2: iRIS Training
Employee & Volunteer Training & Access
Jefferson policy dictates that all users who will need to access and submit via iRIS must complete a short (~15 min) orientation training. Employees and volunteers are able to complete on myLearning. Following completion of training, your account will be automatically created within 24-48 hours by JCRI. See Self-Assigning iRIS Learning Module.
Student & Unaffiliated User Training & Access
If you are a student or an unaffiliated user who needs to access the iRIS system to enter study information, you must complete iRIS training outside of myLearning.
Please view the training below and fill out an Access Request form. Please email this document to Amera.Galal@jefferson.edu. Amera will create and enable your account within 24-48 hours.
Please note: Students who need to be added to an IRB study, but are not entering information directly into iRIS can be added to the personnel drop down menu via a ServiceNow request. Once added to the drop down menu, students will need to be formally added to the study via the submission of a personnel change. This can only be completed by a current member of the study. The Principal Investigator (PI) will also need to sign off.
If you have additional concerns, please submit a request through ServiceNow. A member of our staff will respond shortly.
Step 3: Create a New Submission in iRIS
Use the following links to open iRIS workflows in PDF form that will explain how to complete specific tasks within iRIS.
Submitting a New Study Application
| Submitting a New Study (PDF) | This workflow will walk a user through submitting a new study. Please note: This workflow walks through a basic chart review example, experience may vary based on decision branching logic. |
| Responding to Stipulations (PDF) | This workflow will walk a user through responding to stipulations requested by the IRB. |
| Resubmitting a Not Approved Study (PDF) | This workflow will walk a user through resubmitting a protocol that was Not Approved. |
| Routing a New Study for Signatures (PDF) | This workflow will walk a user through routing a new study application for signatures. Please note: Signatures are required from th Principal Investigator, Department Chair, and Business Administrator for all new studies. |
| Modify a Signature Request After Submission (PDF) | This workflow will walk a user through modifying signature requests to either remove and/or add signatory requests while the study is in draft. |
| Completing a Signoff Task (PDF) | This workflow will walk a user through completing a signoff task in iRIS. |
| Check the Assigned Analyst (PDF) | This workflow will walk a user through finding the analyst assigned to a transaction. The analyst is the best person to reach out to with any questions or concerns regarding a particular transaction. |
| Non-Jefferson IRB Submission Requirements (PDF) | This document details the required components for submissions to different external IRBs. |
If you have an existing study, you can view additional workflows for managing a study in our iRIS Toolbox.
Step 4: Obtain Required Signatures
| Type of Transaction | Principal Investigator | Department Chair | Business Administrator | iRIS Submitter |
| New study: | X | X | X | |
| Continuing Review: | X | |||
| Amendment: | X | |||
| Change of personnel: | X | |||
| Annual Check-in for exempt/NFCR: | X | |||
| External IRB Annual Check-in | X | |||
| Reliance follow-up: | X | |||
| Administrative acknowledgement: | X |
Requirement for PI signature for CR, Amendment, and Personnel change can be re-routed to a co-investigator or the chair when PI is unavailable in the short-term. For new study applications, application can be submitted without PI signature, but it must be obtained prior to release of IRB approval letter. This signature requirement cannot be delegated. In this case, you may use the PDF Signature Form to obtain signatures.
*Studies including Einstein personnel and/or facilities must route inital and continuing review submissions to Mary Klein for COI review. For this reason, Mary Klein should be listed as a signatory in Section 3.0 of the Master Application. Please reach out to Dr. Klein with any questions or concerns.
Frequently Asked Questions (FAQs)
Does iRIS send reminders to research staff alerting them when their Continuing Reviews are due to expire?
Reminder notifications are automatically generated in iRIS and sent to all personnel identified as study contact on study.
Do you have a suggested timeframe when Continuing Reviews should be submitted before the expiration date (ie 30 days, 60 days, etc) to avoid a lapse in approval?
We generally reccommend at least six (6) weeks before your protocol is due to expire.
When are the IRB meetings? When are the deadlines for the IRB meetings? What is reviewed at the IRB meetings (All submissions? Or just more than minimal risk?)
The IRB meets every Thursday, and there is a submission deadline every Friday. Assuming the transaction is complete and appropriate expertise is available to review, transactions submitted for a Friday deadline will go to the next meeting 9 business days hence. Full transactions are reviewed at the meeting. Expedited and exempt transactions are reviewed by subcommittee and documented in the minutes.
If the PI is also the Department Chair, does someone else have to sign off on the submission in iRIS? Who would that person be?
PIs cannot sign for themselves as this represents a conflict of interest. Someone in the next highest level of leadership would need to sign for a PI.
Do you have a list of incidents or problems that need to be reported to the IRB promptly?
(For example, in addition to UPs, we required non-compliance, audits, written reports of study monitors and breach of confidentiality to also be reported.)
In general, the eSAEy and eaZUP reporting systems accessible on our website capture reportable events. These systems populate from JeffTrial, so if a reportable event occurs on a study not in JeffTrial, a report can be emailed to our office by use the OHR-10 (SAE) or OHR-20 (UAP). These forms are available under Standard Forms on the forms page of IRB website. Other events that do not meet reporting requirements can be reported in individual or aggregate at the time of continuing review. When in doubt, researchers should contact our office.
Do you require the Informed Consent Document to be on letterhead. If so, do you have an electronic version that you can provide?
Yes, we generally require all Informed Consent documents to follow the OHR-8 template format. Please see the IRB Forms & Submission Materials page for blank templates.
I'm assuming that some information in our current consents (ie IRB contact information, Privacy contact information, Greenphire Clincard, MCARE, etc) will need to be updated to more align with Jefferson's template. Do you suggest that study teams submit these changes immediately with a modification, or is with the next Continuing Review or Modification submission sufficient?
If study is open to enrollment, then consent form should be updated asap so that it can be used for new enrollment. For studies closed to enrollment, investigator should make determination as to whether some, none, or all of currently enrolled subjects need to be informed of specific changes. There may also be alternate mechanisms for notification, such as a simple update document that could be mailed or handed to a participant. This should be submitted as an amendment.