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Dear Principal Investigator: Thank you for your interest in submitting a study for review by the St. Joseph Mercy Oakland Institutional Review Board (IRB). Our goal is to ensure patient safety and responsible conduct of research.
Each study submitted for IRB review should have all of the required attachments and copies as outlined on the IRB Submission sheet. All of the forms that you will need for your submission are enclosed.
Should any of the required documents or copies be missing, the study will be returned to the Principal Investigator for resubmission. This delay could cause the study to be deferred to the next month's agenda. Please be sure to check the Submission Deadline sheet for each meeting. All study correspondence with the IRB should reference the study name as it appears on the original application, the name of the Principal Investigator, and the assigned IRB number.
The IRB meets on the second Monday of each month at 8:00am. You are required to attend this meeting to present a brief overview of your study and answer potential questions. If you do not come, your study will be tabled until such time when you can be present at a regularly scheduled meeting.
Please be sure to include payment of the IRB fee in the amount of $3,000 with your new application. Your study will not be approved until payment has been received. Should you have any questions, please contact the IRB Office at 248-858-6281.
Sincerely, Susan Zonia, PhD Chairperson, SJMO IRB/RC
New Protocol Forms Chart Review Department Signature New Protocol Submission Checklist Approval Request Protocol Summary Investigational Drug Data Sheet Informed Consent Guidelines Humanitarian Use Device Review Request Disclosure: FDA
Protocol Renewal Forms Chart Review: Submission Checklist Chart Review: Review Submission
Other Forms Internal Adverse Event Form Revision Form Closure of Protocol Form
IRB Fees IRB Fees
Dates to Remember View IRB Deadline Dates
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