Research Submission Process
All Research Submissions will be submitted through IRB Manager https://stjoes.my.irbmanager.com
Submitting a New Study
When submitting your application in IRB Manager, you will or may need to include with your submission:
Study Documents
All documents should contain version dates.
If there are multiple pages, please add page numbers (e.g. Page 1 of 5)
- Research Protocol *Required
- Informed Consent Form including HIPAA authorization or Waiver of Informed Consent
- Data Collection Tool(s)
- Recruitment Materials (Ads, Flyers, Posters, Phone Scripts, Press Releases, etc.)
- Investigator's Brochure, if applicable
Required Investigator / Research Study Staff Documents
- CITI Certificate of Completion *ALL research study staff
- CV *ALL research study staff
Submission Process
- You need to have a user name and password for IRB Manager. If you do not have this, please email IRBResearch@stjoeshealth.org
- After receiving your user name and password, log into IRB Manager (https://stjoes.my.irbmanager.com).
- Select Start xForm under Actions on the left side of your screen.
- Select the appropriate form for your submission
- Complete the first page and select NEXT to continue on subsequent pages.
- If you wish to add a note of clarification, there is an ADD NOTE selection in most sections of the application.
- Towards the end of your application, you will be required to attach associated documents.
- At the end of the application you, as the submitter, will be required to electronically sign your submission by entering the password you have been assigned. If you are not the Principal Investigator, an e-mail will then be sent to the Principal Investigator requiring his/her signature.
- Once the Principal Investigator has signed off on the submission, an e-mail will be generated to all listed research study staff requesting their sign-off on the financial conflict of interest disclosure. The application is not fully submitted to the IRB for review until ALL individuals have signed off on the application.
- NOTE: You may start your research only AFTER you have received the approval letter from the IRB