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
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): ____________________________________________________________________
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.
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).
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.
4a. Have these events been reported to the IRB or other authorities?
Yes, If yes, date reported: ___________ reported to: ______________________________________
PI Signature and Position Title Date