University of Tampa Exempt Research Form
►Research Title
►Principal Investigator
►Co-Investigator
►Co-Investigator
►Overseeing Faculty
Member (if investigators
are students)
►Project Dates
Name:
Department:
e-mail:
Role at UT:
Name:
Department:
e-mail:
Role at UT:
Name:
Department:
e-mail:
Role at UT:
Name:
Department:
e-mail:
Role at UT:
Anticipated start date:
Anticipated end date:
All investigators above must successfully complete the CITI researcher training Yes
program (see www.ut.edu/irb for more information). Check “Yes” if they have.
No
Screening questions: If you check Yes to any of the questions below, your research does not qualify for the
exempt category. You will need to submit an expedited or a full committee review application instead. If you
check No to all of the questions below, your research may be exempt from IRB continuing review. Please
continue with the exempt application.
1. Will prisoners, fetuses, pregnant women, the seriously ill, or mentally or cognitively
compromised adults be used as subjects?
Yes
No
2. Does the research involve the collection of behavior which, if known outside the
research, could reasonably place the subjects at risk of criminal or civil liability or be
damaging to the individual’s financial standing, employability or reputation?
Yes
No
3. Will you be collecting information regarding sensitive topics or personal aspects of Yes
the subject’s behavior (e.g., drug or alcohol use, illegal conduct, sexual behavior)
No
4. Does the research involve subjects under the age of 18?
Yes
No
5. Does any part of the research require that participants be deceived?
Yes
No
6. Will your research require a waiver from informed consent procedures? (See p. 4 Yes
which details the usual procedure).
No
7. Will the research expose human participants to discomfort or stress beyond the Yes
levels encountered in daily life?
No
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Jan. 2016
The Federal Code [45 CFR 46 (46.101)] permits research activities in the following categories to be exempted
from continuing review by the IRB. Please check the exemption category for which you are applying.
Categories of Research Activities Exempt from Continuing Review
1. Educational research in an educational setting using normal educational practices (e.g.,
research on regular and special education instructional strategies, research on instructional
techniques, curricula or classroom management methods)
2. Research using survey procedures, interview procedures, observing public behavior or
using educational tests where the information is recorded anonymously (i.e. so that the
subject cannot be identified directly or indirectly through identifiers linked to the subject.)
All survey/interview/observational research in which elected or appointed public officials
or candidates for public office serve as subjects is exempt, whether or not data collection
is anonymous.
3. Research involving collection or study of existing data, documents, records or
diagnostic specimens. These sources must be publicly available or the information must
recorded by the investigator anonymously (in such a manner that the participants cannot
be identified, directly or through identifiers linked to the participant
4. Research (and demonstration projects) conducted by or subject to the approval of
department or agency heads and designed to study evaluate or otherwise examine a)
public benefit or service programs, b) procedures for obtaining benefits or services under
those programs, c) possible changes in or alternatives to those programs or procedures, or
d) possible changes in methods or levels of services under those programs.
5. Research involving taste and food quality evaluations or consumer acceptance studies,
if wholesome foods without additives are consumed or foods which contains additives at
or below that level and for a use found to be safe by the FDA, or approved by the EPA or
the food safety and inspection service of the U.S. Department of Agriculture.
If all items were checked “No” at the bottom of the first page and at least one item is checked above, then proceed
to fill out the rest of this Exempt Research Form.
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Research Protocol
1. Please describe below your study clearly and completely, using a style of language that can be easily
understood by someone who is not familiar with your research. Include the purpose for conducting the
study (including hypotheses).
2. Research Participants: (Describe the participants you plan to recruit and the criteria used in the
selection process. Indicate whether the participants are 18 years of age or older. Indicate the
approximate number of research participants to be recruited. Indicate if there are any special inclusion or
exclusion criteria.)
3. Method of Data Collection: (Describe the means you will use to obtain the data. Describe all
procedures in which participants will participate. Include surveys and interview questions to be
administered to the participants. These may be attached in a separate document. If data collection
instruments will be used, indicate the time necessary to complete them, the frequency of administration,
and the setting in which they will be administered.)
4. Risk Level: (Describe how the proposed study presents no more than minimal risk to the participants.
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research
are not greater than those ordinarily encountered in daily life or during the performance of routine
physical or psychological examinations.)
5. Confidentiality: (Describe the measures you will take to protect the confidentiality of the information
obtained.)
6. Benefits: (Describe any benefits to the research participants directly or benefits to society).
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Informed Consent and Debriefing
Investigators are required to obtain agreement from research participants before collecting data.
Participants must be told:
1.
2.
3.
4.
5.
6.
7.
They are participating in a research study.
The purpose of the research.
What they will be asked to do if they agree to participate.
How long it will take.
How the confidentiality of the information they provide will be protected.
Their participation is voluntary.
They can refuse to answer questions that they do not wish to answer, and they can refuse to
participate or withdraw at any time without penalty or repercussion.
8. How they can contact the principal investigator and the co-investigator(s) should they have questions
or concerns about the research.
9. Your affiliation with the University of Tampa
Studies may use a written consent (see example below), or may use an oral or implied consent if deemed
appropriate by the IRB.
After the study the experimenter debriefs the participant either orally or in writing. The debriefing
contains:
1. A statement thanking the subject for participating.
2. A statement of the purpose of the study – the hypothesis/research questions being investigated and
results expected.
3. Information about when and where results will be available.
4. Information about whom to contact should there be further questions or should the person experience
undesirable consequences from participating. This should include the principal investigator and the
IRB chair and may include hotlines, counseling centers and other support contacts.
Once completed, submit this form to irb@ut.edu. Be as precise and as detailed as you can be in
addressing the above items.
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INFORMED CONSENT
THE UNIVERSITY OF TAMPA
Project Title:
Principal Investigator:
Purpose of Project:
Procedures:
Risks/Benefits:
Confidentiality:
CONDITIONS OF PARTICIPATION
Participating in this project is voluntary, and refusal to participate or withdrawing from participation at any time
during the project will involve no penalty or loss of benefits to which the subject is otherwise entitled. The
principal investigator may terminate participation of a subject or the project entirely without regard to the
subject’s consent. In the event of questions or difficulties of any kind during or following participation, the
subject may contact the Principal Investigator as indicated above.
CONSENT
I have read the above information and my questions and concerns, if any, have been responded to satisfactorily by
project staff. I believe I understand the purpose, benefits, and risks, if any, of the study, and give my informed
and free consent to be a participant.
_____________________________________
SIGNATURE
________________________
DATE
THIS RESEARCH PROJECT HAS BEEN APPROVED BY THE INSTITUTIONAL REVIEW BOARD FOR THE PROTECTION OF
HUMAN SUBJECTS OF THE UNIVERSITY OF TAMPA (Phone: 813-253-3333)
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