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:
- Go to www.citiprogram.org and register.
- Once there, click on "New Users Register Here".
- In the "Select your institution or organization" section, select "Saint Joseph Mercy Health System" in the "Participating Institutions" drop down box. Selecting the incorrect institution may lead to completion of different or unnecessary modules.
- Create your own username and password, and then after logging in, select your Learner group.
- After going through the registration process, you will be ready to compete the required "Clinical Researchers-Human Subject Research, Basic Course" module. After registering, you will be able to login in as a returning user.
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.
- You may use multiple logon sessions to complete the course.
- The "Basic Course for Human Subjects Research" is the only course required and the "Good Clinical Practice Course (GCP)" is optional.
- The "IRB Members-Human Research, Basic Course" is for IRB members only.
What do I submit for a new research project?
An initial application submission includes the following required items:
- A New Project Application Form
- Your department chairperson's signature is required on the Application Form as well as the Principal Investigator and co-investigator signature(s)
- A protocol, Investigational Brochure, survey or any data collection tools that will be used must be included.
- An informed consent form and HIPAA form (utilizing the SJMHS template found on the forms page) in Word.
- CITI completion reports for all study team members for the Basic Refresher Course
- CV of the Principal Investigator
- For studies that are utilizing a device submit the Significant Risk determination from the Sponsor and/or the FDA and the FDA approval letter.
- Any documents such as advertisements, recruiting information, informational brochures or anything to be seen or used by a potential research participant must be submitted.
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.
- Highlight any changes made to the protocol or informed consent form; send an electronic version of the revised consent. If the changes are not highlighted the information will be sent back to the submitter.
- Attach the tracked changed protocol, Amendments and any other changed documents that were previously reviewed and approved.
- Indicate on the form whether the change necessitates a revision to the informed consent.
- Any modification that is substantive (e.g., change in risk - benefit ratio) will need Full Board review.
- Requesting expedited review in the submitted correspondence does not guarantee this type of review.
- The IRB reserves the right to conduct full board review on any changes.
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