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: JHSPH IRB Terminating IRB Approved Research Application V5, 18Sept2014 Total Page 1 of 4 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. JHSPH IRB Terminating IRB Approved Research Application V5, 18Sept2014 Page 2 of 4 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 JHSPH IRB Terminating IRB Approved Research Application V5, 18Sept2014 Page 3 of 4 FOR IRB OFFICE USE ONLY ________________________________________________________________ Signature of Research Subject Specialist ______________ Date ________________________________________________________________ Signature of Chair ______________ Date JHSPH IRB Terminating IRB Approved Research Application V5, 18Sept2014 Page 4 of 4