Important Information Re: The Institutional Review Board
Purpose & Role:
It is the policy of Florida Atlantic University to be in compliance with the guidelines established by the National
Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and the
ethical principles applicable to such research as summarized in the Belmont Report, the Code of Federal
Regulation Title 45 Part 46, the Office of Protection from Research Risks, the laws of the State of Florida and all
FAU policies.
It is also the policy of Florida Atlantic University that all human subject research and research related activities involving human subjects conducted within or under the auspices of the University, by any
faculty, staff or students, be subject to Institutional Review Board (IRB) review and approval. This is required
before any human subject research can begin. It is the responsibility of each investigator to make sure that
his or her research meets the criteria for compliance with these guidelines.
Copies of relevant sections of guidelines as well as the policies and procedures of the IRB of Florida Atlantic
University may be obtained from Sponsored Research, Boca Raton Campus, Administration Room 246, call (561)
297-2310, or visit our website at: http://www.fau.edu/dsr/comittee.htm.
Procedures:
Review:
The investigator must complete and submit the attached application for IRB review. There are three categories of
review: A, B, & C. The investigator must carefully review the appendix to the application (Pages 3-5) and decide the
type of review and category best qualifies their research. The investigator will then request for that type of review.
It is the final decision of the IRB to decide on the type of review and category appropriate for the research study.
The IRB reserves the right to defer to Full-Board for a decision.
Category A & B research studies are reviewed upon submission. Category C research requires that the Full Board
meet, discuss and review the application. Full Board reviews are scheduled monthly and you are encouraged to call
SR at 7-2310 or access FAU’s home page to determine the meeting and deadline dates for these meetings.
The IRB specifically must assure that: A) The procedures of the study do not place the participant 'at risk'? B) The
participants are provided with sufficient detail in the consent form to assure voluntary informed consent. C) The
confidentiality and anonymity of the participant are assured.
Informed Consent process:
One of the most important aspects of Human Subject Protection is the use of an informed consent process.
In this application package is a consent form guide (pages 6&7) that explains the elements of an informed consent
document. Page 8 provides the investigator with a standard format of the consent form with standardized wording.
It is mandatory that you follow this standard in order to simplify the consent procedures.
If your study includes subjects under the age of 18, then you must provide minor assent procedures, in addition to a
parental consent document. Minor assent is informed consent simplified to address the cognition of the target
audience. Parental consent follows the standard informed consent but again targets the specific needs of a parent
consenting for their child.
INSTITUTIONAL REVIEW BOARD (I.R.B)
APPLICATION FOR THE REVIEW OF RESEARCH INVOLVING HUMAN SUBJECTS
Directions: Please complete Sections I - IV. If you have any questions, contact Elisa Gaucher at 7-2318. Return
16 Copies if filing for Category C review or 4 copies if filing for Categories A or B review (including the original)
of the completed application and attachments to Sponsored Research, 777 Glades Road, ADM-246, at least 10
working days before the next meeting date . This application and its attachments (Protocol) will be returned without
review if this form is not COMPLETE AND TYPED.
SECTION I: TYPE OF RESEARCH (Refer to Attached Appendix I)
Category A Research
Category B Research
Category C Research;None of the above A or B categories apply.
SECTION II:
1. Responsible Project Investigator (FAU Faculty)__________________________________
FAU Phone Extension _____________________________________________________
E-Mail Address ___________________________________________________________
2. Name of Investigator (if different) )____________________________________________
FAU Phone Extension _____________________________________________________
E-Mail Address ___________________________________________________________
3. College: ________________________ Department: _____________________________
4. Sponsor (if funded) _______________________________________________________
5. Site of Work (Campus) _____________________________________________________
6. Title of Project: ___________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
7. Proposed dates for data collection. Begin date: ____________ End date: ____________
8. Investigator is:
9. This application is for a:
mendment
10. Age Range of Subjects: ________________________________________
11
(describe)____________
12
-
-
-
13. Total # of subjects:_______ # of Treatment Subjects (If Applicable):________ # of control
subjects(If Applicable):________
SECTION III: Directions: Please check the appropriate response for questions 14-17 and, in a total
of no more than four pages, please answer the questions 18-23. Please be brief and concise in
your responses to each of these questions. Failure to respond to any questions will cause significant
delays.
Yes
No 14. Will subjects receive payment or extra credit point compensation for participation? If
yes, detail amount, form, and conditions of award.
Yes
No 15. Will access to subjects be gained through cooperating institution? If yes, indicate
cooperating institution and attach copy of approval letter from that institution. (e.g. Copy of
institution's IRB approval, copy of approval letter from school board, etc.)
Yes
No 16. Does this project involve investigator(s) at another institution? If yes, identify investigator(s) and
institution and attach copy of agreement to cooperate.
Yes
No 17. Will the subjects be deceived, misled, or have information about the project
withheld? If so, identify the information involved, justify the deception, and describe the debriefing
plan if there is one.
18. Describe the objectives and significance of the proposed research.
19. Describe methods for selecting subjects and assuring that their participation is voluntary. Attach
a copy of the consent form that will be used. If no consent form will be used, explain the procedures
used to ensure that participation is voluntary. (See attached: sample/standard consent form and
guide)
20. Describe the details of the procedures that relate to the subject's participation. Attach copies of
all questionnaires or test instruments. Additionally, (NOT IN LIEU OF) attach a copy of the technical
portion of the grant application if this project is part of a sponsored funding request.
21. Describe the methods that will be used to ensure the confidentiality of all subjects' identities and
the stored data. Confidentiality of data is required.
22. Describe the risks to the subjects and precautions that will be taken to minimize the risks to the
subjects. Risk goes beyond physical risk and includes risks to the subject's dignity and self-respect, as well as
psychological, emotional, employment, legal, and/or behavioral risk. (Note: There is always minimal risk (s)
associated with a project.)
23. Describe the benefits of the project to science and/or society. Also describe benefits to
the subject, if any exist. The IRB must have sufficient information to make a determination that
the benefits outweigh the risks of the project.
SECTION D - ASSURANCES
This protocol review form has been completed and typed. I am familiar with the ethical and legal
guidelines and regulations (i.e. The Belmont Report, The Code of Federal Regulations Title 45 Part
46, and FAU's Policy) and will adhere to them. Should material changes in procedure involving
human subjects become advisable, I will submit them to the IRB for review prior to initiating the
change. Furthermore, if any problems involving human subjects occur, I will immediately notify the
IRB. I understand that IRB review must be conducted annually and that continuation of the project
beyond one year requires resubmission and review.
____________________________________
Responsible Project Investigator / Date
_________________________
Department Chair / Date
SECTION E – ASSURANCE OF SCIENTIFIC AND/OR INSTRUCTIONAL MERIT
This is to certify that I have reviewed this research protocol. I agree that this protocol meets
departmental/college standards and attest that the investigator is competent to conduct this research.
_____________________________________
Supervising Authority
Date
End of Application.
Rev 7/03
APPLICATION FOR THE REVIEW OF RESEARCH INVOLVING HUMAN SUBJECTS
(APPENDIX I)
IS THIS HUMAN SUBJECTS RESEARCH?
Ascertain whether or not your project is defined as human subjects research by reviewing the definitions below and check each box
that applies to your research. If you checked both, you are involved in research with human subjects. If you checked none, or only
one, you are not. If you are unsure or need assistance please contact DSR at X7-2310.
 "Research" means a systematic investigation designed to develop or contribute to generalizable knowledge.
 "Human subject" means a living individual about whom an investigator conducting research obtains
1.) data through intervention or interaction with the individual, or
2.) identifiable private information.
Appendix I. Part (A) CATEGORIES (These categories are derived from CFR 45 Part 46 101)
Research Categories. (If your research activities involve human subjects in only the following categories, please circle the
appropriate number below and check the appropriate box on the first page of the application form in Section I.)
A(1)
Research conducted in established or commonly accepted educational settings, involving normal educational practices, such
as:
a.) research on regular and special education instructional strategies, or
b.) research on the effectiveness of, or the comparison among, instructional techniques, curricula, or classroom
management methods.
A(2)
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), if information taken from these
sources is recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to the subject.
A(3)
Research involving survey or interview procedures, except where any of the following conditions exist:
a.) responses are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked
to the subjects; and
b.) the subject's responses, if they become known outside of the research, could reasonably place the subject at risk or
criminal or civil liability, be damaging to the subject's financial standing, employability, reputation, the research deals
with sensitive aspects of the subject's own behavior, such as illegal conduct, drug abuse, sexual behavior, or use of
alcohol.
All research involving survey or interview procedure is exempt, without exception, when the respondents are elected or
appointed officials or candidates for public office. This exemption is not applicable if subjects include minors.
A(4)
Research involving the observation (including observation by participants) of public behavior, except where any of the
following conditions exist:
a.) observations are recorded in such a manner that the human subjects can be identified, directly or through identifiers
linked to the subjects,
b.) the observations recorded about the individual, if they became known outside of the research, could reasonably place
the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or employability,
c.) the research deals with sensitive aspects or the subject's own behavior such as illegal conduct, drug use, sexual behavior
or use of alcohol.
A(5)
Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic
specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that
subjects cannot be identified, directly or through identifiers linked to the subjects.
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Appendix I. Part (B) CATEGORIES
(These categories are derived from CFR 45 Part 46 101)
Research Categories (If these categories are applicable to your research, please circle the appropriate number
below and check the appropriate box on the first page of the application form in Section I.)
B (1)
Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
(a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on
marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the
product is not eligible for expedited review.)
(b) Research on medical devices for which (i) an investigational device exemption application (21 CFR part 812) is not
required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance
with its cleared/approved labeling.
B (2)
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
(a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed
550 ml in 8 week period and collection may not occur more frequently than 2 times per week; or
(b) from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount
of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not
exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per
week.
B (3)
Prospective collection of biological specimens for research purposes by noninvasive means. Examples:
(a) hair and nail clippings in a nondisfiguring manner;
(b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;
(c) permanent teeth if routine patient care indicates a need for extraction;
(d) excreta and external secretions (including sweat);
(e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a
dilute citric solution to the tongue;
(f) placenta removed at delivery;
(g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
(h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine
prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques;
(i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;
(j) sputum collected after saline mist nebulization.
B (4)
Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical
practice, excluding procedures involving x-rays and microwaves. Where medical devices are employed, they must be
cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not
generally eligible for expedited review, including studies of cleared medical devices for new indications.) Examples:
(a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant
amounts of energy into the subject or an invasion of the subject's privacy;
(b) weighing or testing sensory acuity;
(c) magnetic resonance imaging;
(d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity,
electroetinography, ultrasound. Diagnostic infrared imaging, doppler blood flow, and echocardiography;
(e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given
the age, weight, and health of the individual.
B (5)
Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for
nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from
the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not
exempt.
B (6)
Collection of data from voice, video, digital, or image recordings made for research purposes.
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B (7)
Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition,
motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey,
interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. [NOTE:
Some research in this category may be exempt from the HHS regulations for the protection of human subjects 45 CFR
46.101(b)(2) and (b)(3).] This listing refers only to research that is not exempt.
B (8)
Continuing review of research previously approved by the convened IRB as follows:
(a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all researchrelated interventions; (iii) the research remains active only for long-term follow-up of subjects; or
(b) where no subjects have been enrolled and no additional risks have been identified; or
(c) where the remaining research activities are limited to data analysis.
B (9)
Continuing review of research, not conducted under an investigational new drug application or investigational device exemption
where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that
the research involves no greater than minimal risk and no additional risks have been identified.
Rev. 10/99
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Detailed Consent Form Guide
In order to expedite the IRB review and to make consent forms more easily understood by subjects, it is suggested that consent forms for
research studies be organized into paragraphs. Therefore, the following outline is submitted as a guide to aid you in the consent form
preparation. These requirements are Federally mandated.
1) Title of Research Study: Put the title of your research study here.
2) Investigator: List all investigators.
3) Purpose: Give the purpose and justification for this research study.
4-A) Procedures: a) Describe what the participant must do, b) including the time involved, c) where it will take place, d) the duration
and number of sessions. The subject is entitled to know just what is involved with their participation, so that they can make a voluntary
decision as to whether they choose to participate. In clinical studies go to 4-B, if not a clinical study - omit 4-B.
[4-B) Alternative Procedures: [If this is not a clinical study, then do not include part 4-B in your consent form.] In clinical studies
involving treatment or therapeutic procedures, identify those details of the procedure which are new or experimental, and indicate how
they differ from other procedures which could be followed. With any medical procedure, advise participants to check with their personal
physician regarding alternative procedures and the advisability of participating in this particular study.
5) Risks: List the risks that are involved with participation in this study --there is always some risk. Risk assessment is concerned with
the probability and magnitude of any physical, psychological, legal, social, or financial risk that would occur due to one’s participation in
this research. “Minimal” risk means that the probability and magnitude of harm or discomfort anticipated in the research is not greater
than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. For
example: “The risk involved is no more than one would experience in normal daily activities.” If greater than minimal risks exist, be
sure to describe the specific risk involved with the research procedure and list the steps to be taken if harm should come to the participant,
including any availability of medical treatment or referrals if needed. Required if more that minimal risk: “Neither the State of Florida
nor Florida Atlantic University provides insurance coverage in the event of injury.”
6) Benefits: List specific benefits to each participant and the anticipated benefits to society or science. Tell subjects that they may refuse
to participate (meaning join the study) without penalty. They may also withdraw from the study at any time without penalty unless the
study has specific participation requirements. Then describe how promised rewards, grades or other compensation will be affected if the
subject does not complete the study.
7) Data Collection & Storage: a) How will the results be identified - anonymously or confidentially? If the identity of any participant
can be traced through the data by you or anyone else, participation is NOT “anonymous.” If you are merely giving assurance that
participant identification will be restricted for use only by authorized investigators, use the term, “confidential,” to describe these data
storage procedures. b) Include a statement that the results will not be released in any way that might allow the identification of the
participants without the participants agreement (unless disclosure is required by law). c) Tell who will have access to the data. d) If using
audio or video tapes, specify how long the tapes will be kept before they are destroyed.
8) Contact Information: Please use the following wording in the consent form: “For related problems or questions regarding your rights
as a subject, the Office of Sponsored Research at Florida Atlantic University can be contacted at (561) 297-2310. For other questions
about the study, you should call the principal investigators, __________________________ at (____)_________________________”
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9) Consent Statement: It is advised that this section be written in the first person since, if signed by the subject, it summarizes the
information that has been provided to the subject and indicates the subject’s willingness to participate in the study. Include each of the
following points in the consent paragraph: a) the subject agrees to participate in the research study outlined above; b) participation is
voluntary; c) the subject is 18 years of age or older. Note: If the subjects are younger than 18, parental consent must be given and “minor
assent” wording should be specified. Obtaining “minor assent” involves oral or written description of the study to the minor subjects (if
they are at an age where they can understand an oral explanation) and asking them orally and in writing if they wish to participate.
Signature of Subject: ___________________________________________ Date: ______________________
Signature of Investigator: ________________________________________ Date: ______________________
REMINDERS
1) Use simple language
2) Be concise--short and to the point
3) Identify study as research and investigation drugs or devices as experimental
4) Use pronouns consistently
5) Avoid the use of qualifiers such as “I understand,” “I have been told,” etc.
6) For the blood drawing, include standard blood withdrawal information
7) Be sure to provide the subject with a copy of the consent form
committee\applcon. Rev. 10/99
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CONSENT FORM
(Standard
Example - Please follow the format provided below, keeping the numbered sections and headings)
1) Title of Research Study: An assessment of general social studies knowledge.
2) Investigator: [Title(s) and name(s) of investigator(s)]
3) Purpose: The purpose of this research study is to assess the level of social studies knowledge of college students in South Florida.
4-A) Procedures:
Participation in this study will require three written tests which will be administered by computer in one of the FAU computer labs (on
either the Boca or Davie campus). Each of the three tests will take about 20 minutes to complete. There will be four weeks between each
of the computer testing sessions. The subjects in this study will be asked to answer a number of questions about social studies. After all
of the questions are completed, the subject will receive a score for the number of correct responses. Each of the three testing sessions will
follow the same testing procedures.
[4-B) Alternative Procedures: (There are no alternative procedures available to the participant in this study and this point is not addressed
in this particular consent form.) Omit!!]
5) Risks:
The risks involved with participation in this study are no more than one would experience in regular daily activities. (A description of any
forseeable risks to the subject must be disclosed in this section of the consent form.)
6) Benefits:
Potential benefits that subjects may attain from participation in this research study include: a greater knowledge of
social studies facts and the satisfaction of knowing that they have contributed to a better understanding of social
studies knowledge in college students in South Florida.
7) Data Collection & Storage:
All of the results will be kept confidential and secure and only the people working with the study will see your
data, unless required by law. (Note: The phrase "…unless required by law." MUST appear in this section of the
consent form.)
8) Contact Information:
*For related problems or questions regarding your rights as a subject, the Office of Sponsored Research of
Florida Atlantic University can be contacted at (561) 297-2310. For other questions about the study, you should
call the principal investigators, __________________________at_(____)____________
9) Consent Statement:
*I have read or had read to me the preceding information describing this study. All my questions have been
answered to my satisfaction. I am 18 years of age or older and freely consent to participate. I understand that I
am free to withdraw from the study at any time. I have received a copy of this consent form.
Signature of Subject:_________________________________________________ Date: _____________________
Signature of Investigator: ____________________________________________ Date: ______________________
* This wording is standardized. Please include this wording in your consent form to avoid delays in your review.
**(Try to keep consent document on one page. If more than one page is necessary, include an initials place on the first
page)
committee\applcon. Rev. 10/99
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