Institutional Review Board
American University of Beirut
Faculty of Medicine
Bliss Street
Beirut, Lebanon
Tel: (01) 350-000 ext. 5445
IRB REVIEWER FORM
To be used as a tool for IRB members during their review of the proposal and as a guide while presenting the
proposal during the IRB meeting.
Principal Investigator:
Date of IRB meeting:
Protocol Title:
Protocol Number:
Kindly review the proposal/protocol and evaluate the following items by checking the appropriate box:
#
IRB Protocol
I.
Description of the Proposed Research:
1.
2.
4.
Is there a clear statement of the purpose of the study?
Is the Hypothesis or specific aim well described?
Is the Background and prior pertinent experimental findings or animal data, if
any stated? This is especially important in protocols for studies of
investigational drugs or investigational devices
Are the bibliographical references to support the research design listed?
II.
Description of Subjects/Participants:
5.
6.
7.
10.
Are the type and number of experimental subjects stated?
Are the criteria for inclusion of subjects appropriate?
Are the criteria for exclusion of subjects appropriate?
Is their rational justification for the use of vulnerable subjects (such as
children, prisoners, pregnant women, fetuses, impaired subjects (if
applicable))?
Are methods of subject recruitment legal, ethical and free from coercion or
undue influences?
Were copies of recruiting materials submitted?
III.
Description of Protocol Methodology/Procedures:
11.
12.
Are the study procedures and study visits clearly outlined and described?
Are the duration of the study and the location of the study stated?
Are the procedures described clearly defined as experimental (research
related) or routine (completely as part of the subject’s clinical care)?
Is the description of experimental controls (or non-treatment group) clear?
Is the use of placebo (dose, route of administration, etc...) where an effective
treatment exists, well justified?
3.
8.
9.
13.
14.
15.
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No
N/A
Yes
No
N/A
Yes
No
N/A
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16.
17.
18.
19.
20.
21.
IV.
22.
23.
24.
25.
Is the rationale for choosing the drug or substance dose or for choosing the
device to be used well described?
Have alternative procedures that might be advantageous to the potential
research subjects been described?
Has the management of pain in children been considered?
If the research involves study of existing samples/records, were the methods
to authorize access to samples/records well described?
If the research involves IND (Investigational New Drug)/IDE (Investigational
Device Exemption), were a summary of preclinical and early human studies
included in the protocol?
Are the study tests (including but not limited to pathological and laboratory
tests, diagnostic radiology, BMD, EEG, ECG, MRI, Ultrasound, etc) done at
AUBMC? If not, indicate the reason and where they will be performed?
Data Collection and Statistical Considerations:
V.
Risk/Benefit Ratio:
34.
Are the risks clearly described?
Were precautions/safeguards to minimize risks adopted?
Have adequate measures been taken to ensure that the occurrence of illness or
injury will be detected and treated?
Does the protocol describe procedures to maintain confidentiality of research
and subject materials?
Is the description of anticipated benefits to subjects well stated?
Are the risks and benefits in the protocol consistent with risks/benefits in the
consent form?
Are risks reasonable relative to anticipated benefits?
Do the potential benefits to the subject and/or society outweigh the risks being
incurred?
Is there any statement regarding alternative procedures?
VI.
Costs and Payments:
35.
Are costs or availability of the experimental drug/device addressed?
Is there a clear description distinguishing between the costs related to research
procedures versus clinical care procedures (regardless of study participation)?
Does the compensation for subjects (bonus, free testing, and payment) seem
sufficient yet not large enough to be coercive?
In case of adverse events resulting from the study, is there a plan to manage
the patients and to cover the costs of management?
29.
30.
31.
32.
33.
36.
37.
38.
VII. Consent Procedures:
39.
40.
No
N/A
Yes
No
N/A
Yes
No
N/A
Yes
No
N/A
Is the study population appropriate for the goals of the study? (consider both
the nature and size of the sample)
Is there a statistical justification for the sample size?
Is the proposed statistical treatment of the data (including primary outcome
variables, secondary outcome variables, interim data analysis) appropriate for
the design of the study?
Were the appropriate documents for Data Collection (surveys, interview
guides, questionnaires) submitted?
26.
27.
28.
Yes
Are the procedures to obtain and record informed consent and consent
documents stated in the protocol?
Did the investigator submit the appropriate consent forms/assent forms?
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41.
42.
Was the justification for waiver of informed consent presented?
Does the study involve genetic testing? If yes. Is there a genetic informed
consent form?
VIII. Qualifications of Investigators and Research Team
43.
44.
IX.
Multicenter Studies:
46.
X.
Additional Documents:
47.
48.
No
N/A
Yes
No
N/A
Yes
No
N/A
Did the PI/research teams complete the NIH training course (web based)?
Do the principal investigator and co-PIs have the appropriate academic and
clinical credentials and experience for this study?
If the study involves international sites, has the investigator included all
applicable information?
If the study involves non-AUB sites, has local IRB approval been obtained?
45.
Yes
If the study involves radiation, did the PI submit the Radioactive material
Form?
If the study involves the use of a drug/device, did the PI provide information
about the drug/device (for example Investigator’s Brochure)?
Additional Comments of the reviewer (if any):
Reviewer’s Name and Signature
Institutional Review Board
Version # 3, November 2007
Date
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