615 N. Wolfe St, Suite E1100Baltimore, MD21205
Phone: (410) 955-3193
Fax: (410) 502-0584 / IRB Use Only: IRB X  IRB FC 
JohnsHopkinsSchool of Public Health
Institutional Review Board
Final Study Report
(must be typed)
Complete this form if:
  • IRB Approval for this research study has lapsed
  • The PI wantsto close the study
  • Data analysis using identifiable information is complete, and links or codes to the identifiers are destroyed
  • 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
Analyzing de-identified data only (no HIPAA identifiers, or codes or links to identifiers). Code or link has been destroyed.
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 / Number of Children / Total
Male / Female / Male / Female
a.Since last approval
b.Since original approval
c.Total number of subjects consented and screened who are eligible for the study:
2. Consented and Enrolled
Number of Adults / Number of Children / Total
Male / Female / Male / Female
a.Since last approval / **
b.Since original approval
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 ofexisting identifiable data or biospecimensunder an IRB waiver of informed consent
Number of Adults / Number of Children / Total
Male / Female / Male / Female
a.Since last approval
b.Since original approval
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.
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 Date
(signature of co-investigator or study staff isnot acceptable)
Please submit via email to irboffice @jhsph.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

JHSPH IRB Terminating IRB Approved Research ApplicationPage 1 of 3

05May09