Processes for Conducting Research at Jewish Hospital & St. Mary's HealthCare (JHSMH) Facilities

All research conducted at Jewish Hospital or its affiliated institutions must receive JHSMH Institutional approval through the Center for Advanced Medicine prior to submitting to the IRB of oversight.

Instructions for Study Submissions to Western IRB (WIRB) or the UofL Human Subjects Protection Program (HSPPO)

Forms Required for New Studies:

Western IRB (WIRB)

Initial Submission:

• JHSMH/WIRB New Study Submission Checklist - (word)
• WIRB Submission Application
• MIRA (Multi Institutional Research Application)
• JHSMH Clinical Research Services Agreement - (word)
• Study Synopsis Form - (word)
• CITI and HIPAA Research Training

Subsequent Changes or additional WIRB information: http://www.wirb.com/

University of Louisville Human Subjects Protection Program (HSPPO)

Initial Submission:

• JHSMH/UofL HSPPO New Study Submission Checklist - (word)
• UofL Submission Application and Checklist
• MIRA (Multi Institutional Research Application)
• JHSMH Clinical Research Services Agreement - (word)
• Study Synopsis Form - (word)
• CITI and HIPAA Research Training

Subsequent Changes or additional UofL HSPPO information: http://research.louisville.edu/UHSC/

JHSMH Billing Compliance Requirements

JHSMH Center for Advanced Medicine (CAM) requires that the study site notify the CAM office of any subject that will be enrolled in a study who has a procedure performed within or through a JHSMH facility. Failure to comply with the research billing compliance subject notification process will result in loss of Institutional approval.

• Enrollment Notification Form - (word)
• Follow Up Notification Form - (word)
• Billing Error/Rejected Bill Notification Form - (word)

All Forms