1.
Name of the Principal Investigator: ______________________________________
2.
Protocol Number: ___________________________________________________
3.
Protocol Name: _____________________________________________________
4.
Protocol Amendments (if applicable):
Amend version # Amend version date IRB approval letter date
5.
Informed consent: Attach copy of the current informed consent form (both Arabic and English consent forms, if both languages are used)
5. a. If revision(s) in the current consent form is proposed, attach a copy of the proposed consent form (include both Arabic and English consent forms) Please highlight (or show ‘track changes”) to make proposed changes obvious.
6.
Assent Forms: If your research requires the use of assent forms, kindly attach the currently-used assent forms (English assent form in addition to Arabic assent form if the latter is used).
6. a. If revision(s) in the current assent form is proposed, attach a copy of the proposed assent form
(Arabic and English assent forms). Please highlight (or show ‘‘track changes”) to make proposed changes obvious.
7.
Have any changes been made (or are there proposed changes at this time) in the subject populations, recruitment procedures, the research design, methodologies, analysis of data, including tissues, biopsies, genetic materials? Please explain.
Proposed Modifications to the existing approved research study (which already includes any IRB approved amendments/ modifications) should be addressed thoroughly in a separate document
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attached to this Application.
8.
Current status of the study:
[ ] Ongoing (still open to additional enrollment).
[ ] Ongoing (permanently closed to additional enrollment; subjects continue to undergo research-related intervention(s)
[ ] Ongoing (permanently closed to additional enrollment; all subjects have completed protocol- related treatment(s)/intervention(s); the research remains active for long-term follow-up of subjects).
The IRB considers long-term follow-up to be limited to review of medical records (i.e. information collected for clinical purposes) and checking for survival status either through contact with the subject or by a review of the National Death Index).
[ ] Ongoing (the remaining research activities are limited to data analysis) . Continuing
Review may be expedited.
Note: Studies designated as minimal risk either through earlier expedited review process or by a full board committee may be eligible for expedited review at the time of continuing review.
Substantial modifications in protocol recruitment, design, consent process, risk/benefit ratio may require full IRB committee review.
[ ] has been terminated by PI (Date of termination: dd/mm/yyyy). PI should file Project
Closure Form https://cms.aub.edu.lb/irb/Documents/proj_b.doc
. Do not submit Continuing
Review Application to IRB if project has been terminated.
[ ] Did not commence
[ ] Canceled/Aborted: Explain the reasons
If research study has been ended, PI should submit Project Closure Form https://cms.aub.edu.lb/irb/Documents/proj_b.doc
. Do not submit Continuing Review Application.
[ ] Study, including data analysis, is completed: Date of completion: dd /mm/ yyyy
PI should complete Project Closure Form https://cms.aub.edu.lb/irb/Documents/proj_b.doc
. Do not submit Continuing Review Application if project is completed.
9.
Answer the following questions:
1) During the current IRB approval interval, how many subjects were entered into this research study at all sites under the authority of the American University of Beirut (AUB) IRB? Do not include those subjects who failed to meet the inclusion criteria during screening (if applicable).
___________
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2) Since the study began, how many subjects have been entered into this research study at all sites under the authority of the AUB IRB? Do not include those subjects who failed to meet the inclusion criteria during screening (if applicable). ___________
3) Is this a multicenter study? [ ] Yes [ ] No
If Yes, specify the number of participants for total study from all sites, if known to AUB PI:
Since Last Approval: N=_________________
Since Original Approval: N= ________________
4) Has there been any change in the original protocol enrollment targets including AUB and other authorized sites? [ ] Yes [ ] No
If Yes, explain
5) Based on the current rate of subject accrual, will the subject enrollment plan be met?
[ ] Yes [ ] No
If No , provide (1) a justification for continuing this research study and (2) address the steps that will be taken to increase subject enrollment.
6) If signed consent is required from subjects, have ALL subjects enrolled during the current
IRB approval period signed the consent form ?
[ ] Yes
[ ] No: Explain why signed/written informed consent has not been obtained.
[ ] Not applicable: The IRB previously granted a waiver of the requirement to obtain a signed, written informed consent document but all subjects provided verbal consent.
7) During the current IRB approval period, have any subjects withdrawn from the study or been withdrawn from the study by the investigator? [ ] Yes [ ] No
If Yes , provide a summary describing the numbers of withdrawals and their reasons
[ ] Not applicable: The IRB previously granted a waiver of the requirement to obtain informed consent.
8) Since the last IRB review, have there been any subject complaints that were not reported previously to the IRB? [ ] Yes [ ] No
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If Yes, attach a summary describing the number and nature of complaints and explain whether the complaint (s) has been resolved.
9) During the current IRB approval interval, have there been any unanticipated problems involving risks to subjects and others, including breach of subject confidentiality, that met the
AUB Guidance/Timeframe for Events Requiring Prompt Reporting https://cms.aub.edu.lb/irb/Documents/guidance.pdf
[ ] Yes [ ] No
If Yes , have they already been reported to IRB if they meet the AUB IRB prompt reporting timeframe? [ ] Yes [ ] No
If No , immediately submit an Unanticipated Problem Report https://cms.aub.edu.lb/irb/Documents/b_form.doc
which must be available for the IRB's consideration during review of this continuing review. [ ] Attached
10) During the current IRB approval interval, have there been any unanticipated problems, adverse events, minor deviations, etc. that were not previously reported but that are required to be reported at the time of Continuing Review?
https://cms.aub.edu.lb/irb/Documents/guidance.pdf
[ ] Yes [ ] No
11) During the current IRB approval period, has the profile of adverse events (in terms of frequency, severity, or specificity) changed from previous experience or from protocol expectations?
If Yes , attach a summary of changes
[ ] Yes [ ] No
[ ] Attached
12) Since the last IRB review, have there been any deviations from the IRB-approved research study that were not reported previously to the IRB? (i.e. minor deviations that did not require prompt reporting may be summarized at Continuing Review. Major deviations must be reported on the Unanticipated Problems Report Form.)
If Yes
[ ] Yes
, attach a summary describing minor protocol deviations
[ ] No
At sites under AUB purview:_______________
Total for all study sites (if known):___________
13) Has there been any subject death occurring since the study initiation?
[ ] Yes [ ] No
If Yes , indicate the number of subject deaths that have occurred since the study initiation
AND
Indicate the number of subject deaths at sites under AUB purview since the most recent IRB review that occurred:______
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Were any of these deaths possibly related to the study interventions?
[ ] Yes, possibly related [ ] Yes, definitely related
[ ] Unclear as to relation [ ] No relation
If Yes , describe the possible relationship for each subject death
14) Please provide a narrative summary of the study progress to date
15) Have any preliminary results of the research come available since initial IRB review or the last continuing review? [ ] Yes [ ] No
If Yes , please explain
16) Have any publications been derived from this study [ ] Yes [ ] No
17) Provide a summary of participant benefits based on knowledge gained during study to date.
Include a current risk-benefit assessment based on study results to date. If there have been significant changes in risk/benefit from the last review period, please elaborate on the changes and the significance of these changes, particularly as to how they may affect risk/benefit assessment and could affect a subject’s willingness to continue participation in the research study.
18) Since the last IRB review, has any new information emerged either from the research itself or from other sources that could alter the IRB’s previous determinations, particularly with respect to risk to subject or that may affect the willingness of current or future research subjects to
[ ] Yes [ ] No participate in this study?
If Yes , summarize the new information:
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19) Have there been any changes in the financial/ nonfinancial interests of any current or proposed additional study personnel since the most recent IRB review, that require disclosure of this interest to AUB or which may require disclosure of interest in the consent documents or prohibit them from serving as key personnel for this study based on the AUB Conflict of interest policy.
If Yes , has this been disclosed to AUB?
[ ] Yes [ ] No
[ ] Yes [ ] No
If No, justify the reason and immediately submit the form which must be available for the
IRB's consideration during the continuing review.
[ ] Attached
AND
Describe these interests and how they are being managed to mitigate risks to participants and whether the consent has to be revised to reflect this interest.
20) During your preparation of this continuing review, have you identified the need to request a modification that must be reviewed in parallel with this continuing review?
[ ] Yes [ ] No
21) Which funding is this research receiving ( you may select more than one):
[ ] AUB funding: [ ] URB [ ] Other, specify: -------------------
[ ] Lebanese National Council for Scientific Research (LNCSR)
[ ] Commercial Sponsorship Specify: -------------------
[ ] US Federal funding: [ ] NIH [ ] NSF [ ] USAID [ ] DOD
[ ] Other US funding: specify:
[ ] Non Federal US Funding: specify: -------------------
[ ] Funding from Other External Sources: specify: -------------------------
22) Check the type of Data Safety Monitoring Plan (DSMP):
[ ] The principal investigator has sole responsibility for monitoring based on an IRB approved
DSMP at original submission, or
[ ] A group of designated AUB faculty/staff has responsibility for monitoring, or
[ ] An independent individual or group of non-AUB individuals will have responsibility for monitoring (e.g. coordinating center) and oversight of problem/events for this research, or
[ ] A designated medical monitor, or group of monitors, for commercially funded or for not for profit sponsored studies has responsibility for monitoring, or
[ ] A formal Data and Safety Monitoring Board (DSMB) has responsibility for monitoring
[ ] A mixed group including AUB and nonAUB individuals has responsibility for monitoring and oversight of problems, events, data arising from this study
[ ] There is no DSMP
23) During the current approval period, have any changes been made in the data safety monitoring plan. Describe the changes, the reasons for the changes and whether the changes are likely to
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affect the assessment of risk/benefits, review of unanticipated problems, and potential for changes to the research protocol, consent forms, investigator’s brochure, recruitment, etc.
Please provide a dated current report from the monitoring entity, such as but not limited to a data safety monitoring board report.
24) Study team identification and certification:
Provide the names of personnel who have been removed from the study and their previous role in the study
Name Role in the study
Provide the names of new personnel to be added to the research team
Name Department Role in the study
I certify that the above information is correct:
Printed Name of Principal Investigator
__________________________________
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Signature
_________________
Date of CITI
Certification
Date dd/mm/yyyy
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Required Attachments (All paperwork is required from the PI regardless of the status of the protocol) :
1.
Continuing Review Form
2.
Protocol (with highlights of all modifications introduced in the protocol since the last IRB approval or amendment.
3.
Unanticipated Problem Report Form
4.
Current Consent Document(s) (with highlights of all modifications introduced in the protocol since the last IRB approval or amendment)
5.
Proposed new Consent and Assent, if applicable, documents, with all proposed modifications highlighted.
6.
If study still in active recruitment, all currently used recruitment materials, including advertisements intended to be seen or heard by potential participants
7.
Study instruments (if still in use) such as questionnaires, surveys, etc.
8.
If changes to research study (as currently approved) are being requested in conjunction with
Continuing Review, sufficient explanation and information to permit assessment that all review criteria to approve research have been addressed.
9.
Any interim findings
10.
Any other relevant information or recent literature, especially information about risks associated with this research
11.
Data and Safety Monitoring Report:
Single site: report from the local Data and Safety Monitoring Plan as described in the research protocol.
Multicenter study: report from both the local and central Data and Safety Monitoring Plan as described in the research protocol
12.
AUB COI disclosure form (when applicable, when any changes occurred in the financial/nonfinancial interests of any current or proposed additional study personnel since the most recent approved IRB review that require disclosure to AUB or may require stating this in the consent documents or may prohibit the study personnel from serving as key personnel on this study)
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References:

University of Pittsburgh: http://www.irb.pitt.edu/irbforms/

Johns Hopkins University: http://irb.jhmi.edu/Forms/index.html

University of Wisconsin Madison http://www.grad.wisc.edu/research/hrpp/hsirbs/2.submissionforms.html

Office for Human Research Protections, Department of Health and Human Services: Guidance on
Continuing Review http://www.hhs.gov/ohrp/humansubjects/guidance/contrev2002.htm

Food and Drug administration: Guidance for IRBs, Clinical Investigators, and Sponsors, IRB continuing Review after clinical investigation approval. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM197347.pdf
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