Forms and Submission Materials
The forms have been updated and allow for digital signatures. The IRB will also begin accepting applications by email. Send completed submissions to: IRB@willseye.org.
- WEH IRB Form-1: New Prospective Study Submission Form (Instructions for completing Form 1)
WEH IRB Form 1_Addendum: Co-Investigator Statement
- WEH IRB Form-1A: New Retrospective Study Submission Form Instructions for completing Form 1A)
- WEH IRB Form-1 IND: Investigational New Drug Form
- WEH IRB Form-2: Investigational and/or Non-Formulary Drug Form (Instructions for completing Form 2)
- WEH IRB Form 3A: Off-Site Serious Adverse Event Report Form
- WEH IRB Form 3B: On-Site Adverse Event Report Forms
- WEH IRB Form-4: Annual Continuing Final Review Form
- WEH IRB Form-6: Amendment to Study Form
- WEH IRB Form 6A: Change in Investigators Only Form
- WEH IRB Form 7: Conflict of Interest Declaration
- WEH IRB Form 8: Substituted Consent Form
Wills Eye IRB Policy and Procedures Manual - click here to view
New to Research at Wills?
Click here for a presentation on Working with Human Subjects in Biomedical and Behavioral Research.
Click here for helpful guidance on the approval criteria and Points to Consider while writing you protocol.
Click here for the IRB's Google calendar.
All Key Personnel are required to have Human Subjects Protection with a refresher every two years. Wills Eye Hospital employees may access the Collaborative Investigator Training Initiative program through our sister institution Thomas Jefferson University. Click here to access CITI.
If this is your first time using CITI, you must register a new username and password. Be sure to choose "Thomas Jefferson University" as your Affiliated Institution.
- Contact IRB Coordinator for step-by-step instructions (with pictures) showing how to navigate this new module.
Upon completion, print out your certificate and send a copy to the IRB Office.
Guidance From the Feds
"Do I need IRB approval?" "Is my project considered research?" Click here for a Decision Chart from the Office of Health & Human Services.
"What is an IND/IDE?" "Does this count as a device?" Click here for non-binding information sheets, FAQs, and guidance from the FDA. Includes guidance on investigator responsibilities, the use of drugs and biologics, emergency and treatment use of unapproved drugs, and FDA compliance activities.
Simplifying Informed Consent Forms
One common delay in the approval process is an overly technical Informed Consent Form.
Protocols should be written in detailed, technical language to an audience of your scholarly peers.
Informed Consent Forms should be written in simple, uncomplicated language to a lay audience of the general public.
Avoid technical/medical jargon, complex sentence structure, and dense formatting.
PRISM (Program for Readability in Science & Medicine) has a FREE resource to help you simplify your ICFs. You can find the full toolkit and training module, templates and assessment tools, or you can download the Alternative Word List for a quick reference. Find the toolkit at www.tinyurl.com/prismtoolkit, or click here for more information on all their services.
More resource links coming soon.
840 Walnut Street, Suite 1530
Philadelphia, PA 19107
Ann Larsen, CIP