SJMHS Institutional Review Board Submission Requirements
All research study team members must supply a completed certificate of human subject protection training. SJMHS requires researchers to complete the "Clinical Researchers-Human Subject Research, Basic Course" provided by the CITI training program.
To access the Clinical Researchers-Human Subject Research, Basic Course module, you will need to do the following:
Upon completion of required modules for the "Clinical Research-Human Subject Research, Basic Course", save/print the certificate to your computer. You will need to submit this certificate with any New Study Application.
This training will need to be completed every four (4) years.
What do I submit for a new research project?
An initial application submission includes the following required items:
What do I do if there is a change to the approved study protocol?
Complete a Request for Revision Form found on the forms page. The use of this form is required. Summarize the changes and how this changes the risks to participants.
What do I do if I have to report an Internal Adverse Event (unexpected serious adverse effect)?
Complete an Internal Adverse Event Form found on the forms page. The use of this form is required. Supply all the information as requested on the form.
If you have questions regarding what to report to the IRB then go to the IRB Forms page and review the Adverse Event Flow diagram.
What do I do if I have to submit a Continuing Review Report?
Complete a Continuing Review Report Form found on the Forms page. The use of this form is required. Supply all the information as requested on the form. Please be sure to summarize the activities that have occurred thus far in the study. Provide all the attachments as requested on the form.
How do I submit to the IRB?
Submit ALL materials for review electronically to the e-mail below.
Hard copy material is no longer accepted.
Please note: if any portion of the required materials/forms is not complete, it will be returned to the submitter. This includes signatures on the applicable forms, as well as human subject training.
If the Principal Investigator feels the study will be considered "exempt", the SJMHS Application, Study proposal, and applicable documentation is still required to be submitted and reviewed.
Send all IRB submissions to: email@example.com