Date submitted______
Exp. Date______
FB_____ Exp. ____
BU Charles River IRB
Final Report
SECTION A: Protocol and Contact Information
Protocol Number:Protocol Title:
Principal Investigator:
Department/School:
Email:
Telephone:
Additional Contact Person:
Email:
Telephone:
SECTION B: Either Box 1 or Box 2 must apply in order of the study to be closed with the IRB
BOX 1
Current Protocol Status (All of the boxes below must be checked ‘Yes” in order for the study to be closed.)
YES / NO☐ / ☐ / The study is permanently closed to enrollment
☐ / ☐ / All subjects have completed all study procedures
☐ / ☐ / Data collection is complete
☐ / ☐ / All identifiers (including codes) have been destroyed OR analysis and/or use of identifiable data is complete
BOX 2
YES☐ YES
(REQUIRED) / The Principal Investigator is leaving BU and either the study will be transferred to another institution or the study is complete
If any of the boxes above are not checked ‘Yes’, the study must undergo Continuing IRB Review. The Continuing Review Application can be located at: http://www.bu.edu/researchsupport/compliance/human-subjects/.
*Definitions of identifiable:
Directly Identifiable: Data/samples are considered to be directly identifiable if they are labeled with unique identifiers that allow the identity of the subject to be ascertained or readily ascertained by the investigator or associated with the information
Indirectly Identifiable: Data/samples that have a link (code or key) to identifiable information about the person.
Non-identifiable: Data/samples are considered to be non-identifiable when the data/samples cannot be linked to a specific individual either because the link (code or key) was never created or the link was destroyed.
SECTION C: SUBJECT ENROLLMENT
Complete the boxes below. If the study involves more than one cohort, provide the information for each cohort (for both boxes).
Number approved by the IRB / Total Number enrolled* since Initial Approval / Number who have been enrolled since the last approval / Males / Females / Unknown*A subject is considered to be enrolled once he/she has given verbal consent/assent or has signed the research consent/assent form.
Enrollment / Since the last Approval / Since Initial ApprovalNumber of subjects who voluntarily withdrew
Number or subjects who are lost to contact
Number of subjects who were withdrawn by the PI
Provide the reasons for any subject withdrawals or subjects lost to contact
If your study is funded by the NIH, please complete the ethnic origin table below:
American Indian / Asian/Pacific Islander / Black / Caucasian / Hispanic / Unknown/OtherSECTION D: STUDY PROGRESS
Provide a summary of the study progress to date. Be sure to include any information about publications, presentations, etc. Indicate why the study is being closed.
SECTION E: OTHER STUDY INFORMATION
YES / NO☐ / ☐ / Since the last IRB review, have there been any subject complaints? If yes, attached a summary of the complaints.
☐ / ☐ / Since the last IRB review, have there been any adverse events or unanticipated problems involving risks to subjects or others? If yes, provide a brief summary of the events/problems. If these events or problems have not already been submitted to the IRB, submit an Unanticipated Report Form located at: http://www.bu.edu/researchsupport/compliance/human-subjects/.
☐ / ☐ / Since the last IRB review, has there been any new information or interim findings regarding this research, especially information about risks associated with the research? If yes, attach a summary of this information.
SECTION G: PRINCIPAL INVESTIGATOR CERTIFICATION
The signature line below must be signed by the PI of the study. If the PI is a student then THIS form must also be signed by the Faculty Advisor.
By signing below I certify that:
· The information in this Application is true, complete, and accurate
· I will maintain study documents for 7 years following the date of this report
PI Printed Name: ______
PI Signature: ______Date: ______
If PI is a student, signature of the faculty advisor is required below.
By signing, the faculty advisor is also indicating agreement with the statements above.
Faculty Advisor Printed Name: ______
Faculty Advisor Signature:______Date: ______
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Version: August, 2015
Submission
This form can be completed, signed, scanned and submitted to the IRB at or mailed to the IRB office at 25 Buick Street, Boston MA. Faxed documents and handwritten materials are not accepted. Be sure to include all relevant attachments (e.g. final study reports, publications, etc.).
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Version: August, 2015