Steps for Submitting New Studies for IRB Approval

All research conducted at Jewish Hospital or its affiliated institutions must receive Jewish Hospital Institutional approval through the Center for Advanced Medicine before submitting an IRB application for review and approval.

All submissions must be made directly to Jewish Hospital. No submissions may be made directly to Western IRB (WIRB) or the University of Louisville Human Subjects Protection Program (HSPPO). The IRB will hold your study approval process until notification has been received from Jewish stating that your study has been submitted and given Jewish Institutional Approval.

Jewish Hospital’s Center for Advanced Medicine will forward the submission packet to either Western IRB (WIRB) or the University of Louisville Human Subjects Protection Program Office (HSPPO) for IRB review once Jewish Hospital Institutional approval has been obtained.

If Jewish Hospital or one of its affiliate institutions is listed as a secondary site, the MIRA application and JHSMH required documents must be submitted directly to Jewish Hospital at the same time the IRB application packet is submitted to U of L for IRB review.

Studies that will be reviewed by WIRB

• All studies (sponsored and non-sponsored) where the PI is not affiliated with UofL

Studies that will be reviewed by UofL HSPPO

• All studies (sponsored and non-sponsored) where the PI is affiliated with the University of Louisville

WIRB Process

If the study meets the above criteria to be reviewed by WIRB, the following forms must be completed and submitted to Jewish Hospital (2 copies of the complete packet):

• JHSMH/WIRB New Study Submission Checklist. This form will guide you through all the forms that must be submitted with your packet to Jewish.
• WIRB Initial Review Submission Forms (IRB Application). To complete these forms, see instructions on WIRB web site at www.wirb.com
• MIRA Application. Multi Institutional Review Application. This form is to be used for all clinical trials and any other project/study that uses the facilities of JHSMH, NHC or UofL Hospital sites or resources to conduct the research. http://research.louisville.edu/MIRA.htm
• JHSMH Clinical Research Services Agreement. Clinical Research agreement between the Investigator and JHSMN.
• Study Synopsis Form. This form gives information about the study to medical staff caring for the subject in the hospital. It will be placed in the medical record under the “Research” tab by the research coordinator upon each hospital admission
• Human Subjects Protection (CITI) and HIPAA & Research Training. Jewish Hospital requires that every researcher have CITI and HIPAA training. After training is completed certificates must be submitted to JHSMH. Training must be updated annually.

UofL Process

If the study meets the above criteria to be reviewed by the University of Louisville Human Subjects Protection Program, the following forms must be completed and submitted to Jewish Hospital (3 copies of the complete packet, 1 JHSMH, 2 UL HSPPO). The study site is responsible for submitting the required documents to UL’s Office of Industry Contracts (OIC):

• JHSMH/UL Study Submission Checklist. This is an internal JHSMH form. This checklist will guide you through all of the forms that must be submitted with your packet to Jewish.
• UofL HSPPO application and Submission checklist. http://research.louisville.edu/UHSC/forms.htm
• MIRA Application. This form is to be used for all clinical trials and any other project/study that uses the facilities of JHSMH, NHC or UofL Hospital sites or resources to conduct the research.
• JHSMH Clinical Research Services Agreement. Clinical Research agreement between the Investigator and JHSMH.
• Study Synopsis Form. This form gives information about the study to medical staff caring for the subject in the hospital. It will be placed in the medical record under the “Research” tab by the research coordinator upon each hospital admission
• Human Subjects Protection (CITI) and HIPAA & Research Training. Jewish Hospital requires that every researcher have CITI and HIPAA training. After training is completed certificates must be submitted to JHSMH. Training must be updated annually.

Completed forms & required supporting documentation must be submitted to:

(No submissions may be made directly to WIRB or UofL IRB.)

Melissa Sewell
Jewish Hospital
Center for Advanced Medicine
200 Abraham Flexner Way, 6th Floor
Louisville, KY 40202
(502) 587-4839
Fax # (502) 587-4630
Email: research.office@jhsmh.org

Related Web sites:

Jewish Hospital Center for Advanced Medicine
Western IRB (WIRB)
University of Louisville Human Subjects Protection Program
Norton Research Office
UofL Office of Industry Contracts