exempt

							                                       MINNESOTA DEPARTMENT OF HEALTH
                                             INSTITUTIONAL REVIEW BOARD
                                                85 East Seventh Place
                                               3RD FLOOR GOLDEN RULE
                                                 ST. PAUL, MN 55101
                                           Re-Review of Exempt Research

Instructions: Use this form when submitting a request for re-review of a protocol with exemption
from 45 CFR 46. Please send the signed original to the IRB Administrative Office at the address
listed above. Complete all applicable items and sign the form or it will be returned to you.



Title of Study or Project                                                         IRB Identification Number



Project Description



Date of Initial IRB Review/Exemption                 Last Re-Review Date                 Next Scheduled IRB Review

                             Check if PI has changed


Name of Principal Investigator                       Phone Number                                Fax Number



Address (Street or P.O. Box)                         City           State & Zip          E-mail/Internet Address


List Below names of other MDH Employee Co-investigators:




1. Is the study or project still active?              Yes           No

1a. If still active: What stage is the project in?

                Finalizing design and procedures                       Data analysis
                Data collection                                        Report writing
                Other (explain): ____________________________________________________________________




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2. Have there been any changes in the study’s objectives, methods, or subjects?
       Yes, If yes, please describe below and submit 3 unbound copies of the revised protocol.
       No




3. Have there been any changes in the study’s informed consent process or forms?
       Yes, If yes, please describe below and submit 3 unbound copies of the current consent form(s).
       No


4. Have there been any adverse events or unanticipated problems involving risks to subjects or others, any withdrawal of
subjects from the research, or complaints about the research?
       Yes, If yes, please describe below.
       No




4a. Have these events been reported to the IRB or other authorities?
       Yes, If yes, date reported: ___________ reported to: ______________________________________
       No




PI Signature and Position Title                                                         Date




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