American University of Beirut
Institutional Review Board
Application to Conduct Research on Human Subjects
(For proposals submitted for expedited or full committee review only)
In order to approve research involving human subjects, the IRB must determine that the research
design is scientifically sound, that the risks associated with the research are reasonable and are
justified by the expected benefits, that informed consent will be obtained from the subjects or their
legally authorized representatives, that the participants’ privacy is respected, that confidentiality of
the collected data is protected, that adequate monitoring will be performed to ensure the safety of
participants, that vulnerable subject populations will receive additional protection, and that the
selection and recruitment procedures are equitable and just.
Title of proposal:
A. Principal Investigator
Name
Degree
Title
Department
Faculty
Submission Date
Phone #
Pager #
E-mail
B. Study Coordinator
Name
Degree
Title
Department
Faculty
Submission Date
Phone #
Pager #
E-mail
C. Key Study Personnel – include all people responsible for the design and conduct of the
study (if collaborators at other institutions go to “D”)
Name
Dept or
Role in Study
CITI course
Affiliation
completed
Yes
No
h
Yes
No
h
Yes
No
h
Yes
No
h
Yes
No
h
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D. Collaborators and IRB involvement at other institutions
Name
Affiliation
Role in Study
IRB approved?
Yes
No
h
Yes
No
h
Yes
No
h
Yes
No
h
Yes
No
h
Provide information on how samples, information and data among the various collaborators will be
handled. Provide copies of IRB reviews, approvals and consent forms.
E. Funding
Is this research funded?
Proposed Annual Budget:
Yes
No
Specify the Source of Funding/Sponsor name:
Starting Date of Study:
Expected Date of Study Completion:
Site where the study will be conducted:
AUB
Outside AUB (specify)
F. Requested review
__ Expedited
__ Full Committee
(If requesting exemption from IRB review, do not fill this form; submit the exemption coversheet)
If you are applying for expedited review, please indicate the category of research by checking next
to it:
____ Collection of blood samples by finger stick, heel stick, ear stick or venipuncture. For adults,
normally not > 450 ml during an 8 week period, and not than twice a week. For children and those
< 50 kg, not more than 50 ml or 3 ml/kg whichever is less during an 8 week period and collection
may not occur more frequently than 2 times per week.
____ Prospective collection of biological specimens for research purposes by noninvasive means,
e.g.: non-disfiguring hair and nail clipping, excreta and external secretion, placenta at delivery,
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amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; mucosal
and skin cells collected by buccal scraping or swab, skin swab or mouth washings, etc.
____ Collection of data through noninvasive means (not involving general anesthesia or sedation)
routinely employed in clinical practice excluding x-rays and microwaves, e.g.: ECG, EEG, MRI,
ultrasound, echocardiography, electrocardiography, electroencephalography, ultrasound, Doppler
blood flow, thermography, body composition assessment, moderate exercise by healthy volunteers,
muscular strength testing, weighing testing, sensory acuity.
____ Research involving materials already collected (data documents, records and pathological or
diagnostic specimens) or will be collected solely for non-research purposes (such as medical
treatment or diagnosis).
____ Collection of data from voice, video, digital or image recordings made for research purposes.
____Research on individual or groups characteristics or behavior such as perception, cognition,
motivation, identity, language, communication, cultural beliefs or practices and social behavior,
test development where the investigator does not manipulate that subject’s behavior and no stress
to the subject may occur, or research using survey, interview, oral history, or quality assurance
methodologies. (some research in this category can be exempt)
H. Check which of the following categories applies to the study:
__Placebo controlled trial
__Randomized study
__Blinded study (Describe)
__ Investigational drug or device (non-approved for use): attach investigator’s brochure
I. Provide an abstract of the study not exceeding 500 words written in language understood
by LAY PEOPLE. This abstract which is different from that provided in the scientific
proposal should include:
1. Scientific context
2 Hypothesis/aims
3. Experimental design, subject selection/recruitment, procedures involving human subjects
4. Justify involvement of human subjects
5. Describe risks and benefits, and risk/benefit ratio
6. Discuss privacy and confidentiality issues
Do not use technical language. The abstract should be understood by people whose specialty
is non-scientific/non-medical.
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J. Informed Consent
1. Specify all languages to be used for the informed consent form:
__ Arabic
__ English
__ French
__ Other: specify _________
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2. Describe the setting in which an informed consent will be obtained
3. Provide the names of those who will obtain informed consent from the subjects
Name
Qualifications
CITI course
completed
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
h
h
h
h
h
h
4. Does the person obtaining consent have any relationship with the patient (e.g. personal
physician)?
__Yes
__No
If yes, describe the relationship and indicate ways of protecting against undue influence or
coercion.
5. Will you request a waiver of written informed consent or omission of any requirements (e.g.
non-disclosure of information to subject)? (Check criteria under “IRB Policies and Procedures”)
__Yes
__ No
If yes, justify the need for waiver or non-disclosure.
6. If oral consent is to be obtained, provide the IRB with the script that will be used and describe
means to document oral consent. (Check criteria for oral consent under “IRB Policies and
Procedures”)
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K. Subject Selection and Recruitment
1. Number of subjects to be recruited:
Whole study:
First year:
Total:_______ at AUB only: ___________
Total:_______ at AUB only: ___________
2. Identification and recruitment of subjects: describe the procedure, the location/setting and the
time frame (e.g. provide script for personal or phone contact).
3. Will you use advertisements to solicit participants?
__Yes
__No
If yes, provide a copy of the advertisement and choose the applicable category from below:
__ Letter
__ Mass E-mail
__ Newspaper
__ AUB publication
__ Telephone
__
__
__
__
__
Flyers
Internet
Posters
Departmental Bulletin Boards
AUB Publications (specify)
__ Other (Describe)
4. Describe the subject population.
5. Vulnerable groups:
i) Specify which, if any, of the following vulnerable groups will be included as research
subjects?
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__ Children/minors
__ Cognitively impaired
__ Comatose/Traumatized
__ Elderly
__ Terminally ill participants
__ Others, specify:
__ Pregnant women/fetal tissue/placenta
__ Prisoners
__ Subordinates/employees at institution
__ Students
__ Emergency unit patients
ii) Describe why it is necessary to include these groups in the study.
6. Criteria for inclusion/exclusion of potential subjects.
7. Justify the exclusion of any group based on age, sex, ethnicity, and social or economic factors.
L. Specimen Collection
i)
Blood drawing: describe amount per drawing, frequency, and total amount.
ii)
Other tissues; describe
iii)
If genetic tests to be done describe and use genetic template language in informed
consent form.
iv)
Distinguish between procedures that are part of normal clinical practice from those
being conducted specifically for research purposes.
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M. Risks
1. Risks: Describe the potential risks associated with the study. Risk includes physical,
psychological, social (potential stigmatization e.g. HIV), legal (research on illicit behavior) or
financial (cost of study).
Describe the frequency and magnitude (minimal1, severe, potentially fatal, etc…) of the risks.
2. Are there other methods to run the research that might minimize these risks? Describe and
justify not using them.
3. Will ionizing radiation be used as part of this study?
__Yes
__No
If yes, please fill the applicable forms. (Refer to X-ray form, or unsealed radioactive material form)
4. Describe how you will ensure that privacy will be respected and that confidentiality of the
information will be maintained. Describe the tools to be utilized in collection and storage of data.
Who will have access to it? Will any codes or locks be applied? When study is concluded, how
will the documents/files be disposed of?
5. Describe your plan for data safety monitoring and for reporting adverse effects to the IRB.
1
Minimal risk is defined as one where the probability and magnitude of harm or discomfort are not greater than those
ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or
tests.
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6. If this is a therapeutic trial, list the therapeutic alternatives.
7. If this involves use of placebo, the risk related to these must be mentioned in the protocol and
informed consent form. Check the applicable justification for use of placebo:
__ No alternative standard therapy
__ Alternative standard therapy exists but risks of placebo are minimal (discuss)
__ Alternative therapy exists, risks of placebo are > than minimal, but plans for intervention exist
(Describe plans for intervention should adverse effects occur)
__ If none of the above is applicable, justify the use of placebo
N. Benefits
1. Describe the anticipated benefits to the subject. If no direct benefits are expected – state so and
include in the consent form. (Monetary compensation is not considered a benefit)
2. Describe any anticipated benefits to the group or class to which the subjects belong.
3. Describe benefits to society or to science/medicine as a whole.
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O. Risk/Benefit Ratio
Assess the relative weights of the study’s risks and benefits. Where appropriate, discuss provisions
for ensuring medical or professional intervention in the event of adverse effects to the subject, (e.g.
an unblinded co-investigator in a high risk Phase I study). Discuss why the risks to subjects are
reasonable in relation to the anticipated benefits to subjects and in relation to the importance of the
knowledge that may reasonably be expected to be gained.
P. Compensation or Costs to Subjects
1. There are very limited circumstances under which study participants may be responsible (either
directly or via their insurance) for covering some study-related expenses. If the study participant or
their insurer(s) will be billed for any portion of the research study, describe this added expense
(e.g. extended hospitalization, extra laboratory tests, travel…) and provide a justification as to why
this is appropriate and acceptable.
2. Describe what compensation there is for participating in the study whether as cash or gifts, and
how it will be pro-rated. The IRB will not approve a study where there is only a lump sum
payment at the end of the study because this can be considered coercive.
3. For research with more than minimal risk, describe any medical treatment, insurance and/or
compensation available to the subject if he/she is injured as a result of participating in the study.
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Q. Personal/Financial Interest
Disclose any personal or financial interests in the research and the extent of such interest in the
sponsor of the study if applicable.
R. Bibliography and References:
List up to five relevant publications that, in your opinion, would be helpful to the IRB in reviewing
this study.
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Principal Investigator’s Assurance Statement
1. I certify that the information provided in this application is complete and accurate.
2. I understand that as principal investigator, I have ultimate responsibility for the conduct of
the study, the ethical performance of the project, the protection of the rights, safety and
welfare of the human participants, and strict adherence to the study protocol and any
conditions or modifications stipulated by the AUB Institutional Review Board.
3. I will submit modifications of the protocol and/or the informed consent form and/or any
other documents to the IRB for approval prior to applying those changes in the study.
4. I agree to abide by the policies and procedures of the AUB IRB regarding the protection of
human subjects including, but not limited to:
o Ensuring that all personnel involved in the study have completed the human subjects
training online course
o Ensuring that the study will be conducted by qualified personnel only
o Obtaining informed consent from participants or their legally appointed representatives
or guardians, using the informed consent form stamped with approval by the IRB and
providing a copy of the signed form to the subject.
o Reporting adverse events or other unexpected problems and risks involving human
subjects to the IRB promptly
o Promptly complying with IRB decision to stop or discontinue the research
o Obtaining approval for continuing with the study after the end of the approval period by
submitting a request for renewal before the study expires. I understand that if I fail to
apply for renewal, the study will automatically expire and all activity must cease until
IRB approval is granted.
o Maintain accurate and complete research records including all informed consent
documents, for at least 3 years from the date of study completion
o Fully informing the IRB of all locations in which participants will be recruited for this
study, and being responsible for obtaining and maintaining IRB approvals and letters of
cooperation from non-AUB sites.
o To fill the “Patient enrollment form” for Patient recruited in clinical trial & to
maintain a copy of this form in the corresponding medical record.
_____________________________________
Principal Investigator’s Signature
________________________
Date
_____________________________________
Department Chair’s Name and Signature
________________________
Date
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