IRB Use Only:
IRB X
 IRB FC 
Johns Hopkins School of Public Health
Institutional Review Board
Final Study Report
JHSPH.irboffice@jhsph.edu
615 N. Wolfe St, Suite E1100
Baltimore, MD 21205
Phone: (410) 955-3193
Fax: (410) 502-0584
(must be typed)
Complete this form if:
 IRB Approval for this research study has lapsed
 The PI wants to close the study
 The IRB approved the research study, but it was never initiated
IRB Number:
IRB Approval Expiration Date:
Study Title:
Principal Investigator:
Name:
Address/Room#:
Phone:
E-mail:
Other Study
Contact, Updated
information:
(if applicable)
Name:
Address/Room#:
Phone/Email:
SECTION A: STUDY STATUS SINCE LAST IRB REVIEW AND APPROVAL (Check one category only)
Study’s IRB approval lapsed
PI wants to close the study
All study activities, including data analysis, are complete. Original research records are secured and will be
retained or destroyed in accordance with University policy
Study was never initiated
Other: Explain
SECTION B: FINAL STUDY INFORMATION ON SUBJECTS, RECORDS AND/OR SAMPLES STUDIED



Complete 1 if your study had a screening consent process to determine study eligibility
Complete 2 if you followed the IRB approved consent process (oral or written)
Complete 3 if the IRB waived consent for use of identifiable data or biospecimens
1. Consented and Screened
Number of Adults
Male
Female
Number of Children
Male
Female
a.
Since last approval
b.
Since original approval
c.
Total number of subjects consented and screened who are eligible for the study:
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Total
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2. Consented and Enrolled
Number of Adults
Male
Female
a.
Since last approval
b.
Since original approval
Number of Children
Male
Female
Total
**
NOTE: Explain enrollment numbers for specific study phases or study population subgroups in the Comments Section below.
c. For multi-site studies: Total number of subjects enrolled for all
sites
d.
IRB Approved version number(s) or approval dates of oral or written
consent/permission/ assent scripts or form(s) used to enroll subjects
Comments:
3.
Secondary data analysis studies of existing identifiable data or biospecimens under an IRB waiver of informed consent
Number of Adults
Male
Female
a.
Since last approval
b.
Since original approval
Number of Children
Male
Female
Total
SECTION C: REPORT OF PARTICIPANT WITHDRAWALS AND COMPLAINTS, STUDY PROBLEMS AND DEVIATIONS
1. During the period since the last IRB approval, have there been any participant withdrawals from the study or complaints
about the study? If yes, describe.
2. During the period since the last IRB approval, have there been any unanticipated problem events reported or protocol
deviations from the IRB approved research plan or other study documents? If yes, describe.
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SECTION D. SUMMARY FOR THIS APPROVAL PERIOD
This report should provide the IRB with a description of the progress of the study over the past approval period. It should
provide information on the following (using as much space as is needed ):

Progress towards achieving research objectives,
 Your analysis of the study’s adverse events and unanticipated problems and any effect on the research;
SECTION E. SUMMARY OF STUDY RESULTS
Describe briefly the principal findings of the research. Provide list of articles generated by this research.
SECTION F: SIGNATURE
________________________________________________________________
Signature of Principal Investigator
(signature of co-investigator or study staff is not acceptable)
______________
Date
Please submit via email to jhsph.irboffice@jhu.edu. We will accept receipt from the PI’s email address as equivalent to the
PI’s actual signature. If you must submit by hard copy, return original signed by PI, one copy, and all supporting
documentation to: JHSPH IRB Office, Suite E1100, 615 North Wolfe St, Baltimore, MD 21205
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FOR IRB OFFICE USE ONLY
________________________________________________________________
Signature of Research Subject Specialist
______________
Date
________________________________________________________________
Signature of Chair
______________
Date
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