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General IRB Questions
- What is the University's policy
for the use of human subjects in research?
- What is the Institutional Review
Board (IRB)?
- What are the responsibilites of
the IRB?
- How does the IRB function?
- What is the distinction between
the Human Subjects Office (HSO) and the Institutional Review Board
(IRB)?
- Does my project involve human subjects?
- What is research?
- What are some examples of research
with human subjects conducted at the UGA?
- What is the difference betwen practice
and research?
- What is the difference between
anonymous and confidential?
- Can the Board stop me from conducting
my experiment?
- Does the IRB serve as a scientific
review panel?
- My research with human subjects
is not funded. Do I still have to submit an application to the
Human Subjects Office?
- I believe that my study is eligible
for exempt status. Do I still need to complete the entire application?
- Do student research projects have
to be submitted to the IRB?
- Is IRB approval required for graduate
level research involving human subjects?
- Is anyone availabe to speak to
classes and/or groups about the IRB process?
- Who is responsible for reporting
any problems that may occur during the conduct of approved Human
Subjects Activities?
- What should I do if I know of
research that has violated ethics?
- What is considered minimal risk?
- How can a researcher obtain further
information or advice regarding the use of human subjects?
Submittal and Review Procedures
- What materials should I submit
to the Human Subjects Office?
- Where can I get an application?
- May I submit my HSO/IRB application
before I have obtained my letters of authorization from participating
institutions?
- Can applications be sent through
e-mail?
- Are handwritten applications acceptable?
- How long does the approval process
take?
- May I call about my study?
- Will the Human Subjects Office
personnel help researchers complete the applications?
- What about meeting the Chairperson
of the IRB?
- Does the project require full
IRB Review?
- What kinds of activities are considered
"normal educational practice"?
- Do projects involving students
in the Department of Psychology require any additional information
in the consent forms?
- May deception or misrepresentation
be used in studies with human subjects?
- May I begin my human subject activity
(HAS) before I receive IRB approval?
- If I do begin my HAS before I
receive IRB approval, what action may be taken against me?
- Do I need IRB approval if my Human
Subjects Activities will be conducted someplace other than the
University campus? Do I need IRB approval if my protocol is already
approved by another IRB?
- Does the IRB continue to review
research once it has been approved?
- If I make changes in my protocol
does the IRB have to review and approve again?
- What is an identifier?
- Are any special steps required
to protect data collected on film, photographs, and audio or videotape?
- How can I speed my proposal through
the IRB?
Consent
- When do projects require consent?
- Does the project require written
consent?
- Is it necessary to explain to
the subjects ahead of time how data from the study will be used?
- Can deception or misrepresentation
be used in studies with human beings?
- What consent materials are required
for research with minors?
- What is assent?
- Is assent always required?
- What do I do with the consent
forms once they are signed?
CITI FAQs
- Who is required to take the CITI Human Subjects Protection Training?
- When will this training requirement begin?
- Which CITI training modules should I take?
- If my research area or subject population changes, do I need to complete additional learner groups of CITI ?
- How long will it take to complete the course?
- What is the passing score on the quizzes?
- How do I access the quiz for the module?
- How will the IRB know my training is complete?
- Will the IRB review an initial application if all key personnel are not trained?
- Will training of all key personnel be required before IRB approval of Continuing Review or Amendment?
- Where do I find the on-line CITI training modules?
- Do I have to renew my training?
- I forgot my username and/or Password. What do I do?
- Is there a fee?
- Are CME /CEU credits available for CITI ?
- What if I have more questions?

General Human Subjects Questions
1. What is the University's
policy for the use of human subjects in research?
The University Policy on activities involving
Human Subjects is to fully comply with regulations and follow guidelines
defined by the Office for Human Research Protections and to implement
principles outlined in the Belmont Report. Any research activity
that involves human subjects, whether such activity is undertaken
on a large or small scale, whether it is preliminary or fully designed,
whether it is conducted by students or faculty, whether it is externally
funded or not, and whether it involves minimal risk or more than
minimal risk, is subject to the IRB review.
For additional information regarding UGA Human
Subjects policy and procedures see the IRB
Guidelines for Investigators.
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2. What is the Institutional
Review Board (IRB)?
The IRB is the University of Georgia's committee that reviews
and approves protocols for the use of human subjects in research.
Federal regulations require that the IRB membership represent a
variety of backgrounds, training and experience. At least one IRB
member must have no formal or family connection with the University.
At least one member must be a non-scientist.
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3. What are the responsibilities
of the IRB?
The IRB reviews research protocols to ensure that the rights and
welfare of subjects are protected and that the proposed use of
human subjects is in compliance with Federal regulations, state
laws, and the UGA policy.
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4. How does the IRB function?
The Board meets monthly. Meetings are typically
held on the last Friday of each month. Board approval requires
a majority vote of a quorum of members. The Board may require additional
information or modifications as conditions for approval. The Board
may also "table" the application until more information
is provided or until significant changes are made. You will be
notified of the Board's decision.
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5. What is the distinction between the Human
Subjects Office (HSO) and the Institutional Review Board (IRB)?
The
HSO is an administrative office, provides support for the IRB
and is responsible for the review and approval of applications
for certain categories or research with human subjects/participants.
The IRB is a committee of researchers and community members that
review human subjects research.
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6. Does my project involve
human subjects?
Human Subject refers to an individual, living
or dead, about whom a researcher obtains:
- Data through intervention
or interaction with the individual, or
- Identifiable private
information.
Intervention
includes both physical procedures, by which data are gathered
(for example, venipuncture), and manipulations
of the
subject or the subject's environment that are performed for
research purposes. Interaction includes communication or interpersonal
contact between researchers and subjects.
Private information
includes information about behavior that occurs in a context,
in which an individual can reasonably
expect that
no observation or recording is taking place, and information,
which has been provided for specific purposes by an individual
and which
the individual can reasonably expect will not be made public
(for example, client or medical records or information
obtained in an
interview).
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7. What is research?
Research is defined as a systematic investigation that contributes
to the larger body of knowledge of any given discipline. This includes
collection of scholarly materials for theses and dissertations
done by students, and investigations carried out by faculty and
staff for publication and/or presentation.
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8. What are some examples of
research with human subjects conducted at the UGA?
Examples include psychological experiments, questionnaires,
in-person and telephone surveys, interviews and focus groups, educational
and behavioral tests, review of medical or other records, observation
of public or private behavior, including classroom observations,
and taste tests. Also included are physical procedures like blood
tests, MRIs, DEXAs and X-rays. Please refer to Section
1 of the Guidelines for further information.
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9. What is the difference between
practice and research?
"Practice" consists of interventions designed to enhance
the well being of a patient or client. "Research" is
designed to test hypotheses, permit conclusions to be drawn and
thereby develop or contribute to the larger body of knowledge.
Research and practice can be carried out together. However, as
a general rule, if there is any element of human subject research
in an activity, then that activity should be described in an application
for submission to the IRB.
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10.
What is the difference between anonymous and confidential?
By anonymous the IRB means that the researcher
cannot link the data to the participant. Confidential means that
the researcher may be able to identify a participant’s data
but will not reveal the participant’s identity to anyone
else. Person-to-person interviews, for instance, are never anonymous.
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11. Can the Board stop me
from conducting my research?
Yes. The IRB has the authority to disapprove,
suspend or terminate research that is not carried out according
to its requirements or may be associated with unexpected serious
harm to subjects. Any such step shall include a statement of the
IRB's reasons for its action and will be reported promptly to the
principal investigator, the Vice President for Research, and the
funding agency.
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12. Does the IRB serve as
a scientific review panel?
No, but if a proposed project appears to lack scientific merit
or rigor, or duplicate existing work with more than minimal risk
to subjects, the Board is required to consider whether the benefits
to individual subjects and society outweigh the potential for harm
to them.
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13. My research with human
subjects is not funded. Do I still have to submit an application
to the
Human subjects
Office?
Yes. All research that involves human subjects/participants must
be reviewed and approved by the HSO or the IRB. For more information
on UGA policy and procedures for research with human subjects/participants
read the IRB Guidelines.
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14. I believe that my study
is eligible for exempt status. Do I still need to complete the
entire
application?
Yes. The federal regulations allow six specific categories of human subjects research to be exempt from continuing IRB review. However, the UGA IRB requires that such activities be reviewed and approved. Only the IRB/HSO can make a determination if any of the exemption categories may apply. Approval is granted for five years; any modifications must be submitted through an Amendment Form, reviewed, and approved prior to implementation.
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15. Do student research projects
have to be submitted to the IRB?
Course instructors who assign human subjects related
class projects receive a research exemption from the HSO/IRB. For
additional information please read the "Class
Projects Exemption" Section XII of the Guideliness.
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16. Is IRB approval required
for graduate level research involving human subjects?
Yes. Master’s thesis or a Doctoral dissertation
research is considered research and must be approved by the IRB.
Failing to obtain approval may result in disqualification of these
activities in application towards a degree program.
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17. Is anyone available to
speak to classes and/or groups about the IRB process?
Yes, the Human Subjects Office staff is available
to discuss the importance of protecting human subjects/ participants
and the procedures with any group on campus.
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18. Who is responsible for
reporting any problems that may occur during the conduct of approved
Human
Subject Activities?
Researchers and Department Heads are responsible
for reporting promptly to the IRB any serious or continuing noncompliance
with federal regulations, or university policies, or injuries to
subjects, unanticipated problems, and changes proposed in research
activities. Research related problems should be reported to the
IRB Chair at 542-3199 or e-mail at IRB@uga.edu
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19. What should I do if I
know of research that has violated ethics?
You should notify the chair of the department
and/or the Human Subjects Office. If you have any concerns or are
uncertain about what constitutes a violation, please contact the
HSO at 542-3199 or e-mail at IRB@uga.edu.
For more information read Section XI
of the Guidelines.
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20. What is considered minimal
risk?
Minimal risk means that the probability and magnitude of harm
or discomfort anticipated are not greater in and of themselves
than those ordinarily encountered in daily life or during the performance
of routine physical or psychological examinations or tests.
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21. How can an investigator
obtain further information or advice regarding the use of human
subjects?
Contact the Human Subjects Office at 542-3199 or e-mail at IRB@uga.edu
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Submittal and Review Procedures
22. What materials
should I submit to the Human Subjects Office?
1. An original, fully completed Application.
Each researcher must sign the application, and for students,
the signature of a faculty advisor is also required.
2. All applicable attachments, including
consent forms, surveys, interview guides, instruments, recruitment
flyers, and letters of authorization from each institution involved
other than the UGA.
3. One additional copy of the application
and all attachments are also required.
4. For more information, see Section
II of the new Guidelines.
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23. Where can I get
an application?
Application
forms are available
on the web. If you are unable to download the application from
the web please contact the webmaster at forms@ovpr.uga.edu.
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24. May I submit my
HSO/IRB application before I have obtained my letters of authorization
from participating institutions?
It is always a good idea to submit
your application as soon as possible. You may submit before obtaining
written approval from other institutions. Your application will
go through the review process without the letter(s) of authorization;
however, the IRB cannot give final approval until all letters are
on file in the HSO.
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25. Can applications
be sent through e-mail?
Yes. New IRB applications, continuing reviews, and amendments may be sent as email attachments to irb@uga.edu. However, all of the following criteria must be met to qualify for an electronic submission.
- Total number of pages for the complete application must be 100 pages or less.
- Application and all supporting materials (e.g., consent document/s, instrument/s, letter/s of authorization, etc.) must be submitted in electronic form (i.e., HSO cannot accept an application via this method if some materials can only be submitted as paper copies).
- Signature page/s must be sent by mail, fax (706.542.3360), or scan to email with the electronic submission.
Word format is preferred except for other documents (e.g., authorization letters, instruments) that must be scanned and attached as a pdf file.
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26. Are handwritten
applications acceptable?
No. The cover page may be legibly handwritten. All
other pages must be typed on the application form or prepared on
computer by the applicant following the designated format. Handwritten
applications will be returned to the researcher or faculty advisor
without being reviewed. The entire application is available on the web and can be completed before
being printed.
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27. How long does the
approval process take?
The Institutional Review Board strives to review and approve every application as quickly as possible, but the process may take from a few days or weeks, depending on the individual project and the work load of the Human Subjects Office and the IRB. The researcher has a significant influence on the approval time, i.e., a complete and well-prepared application, and a prompt response by the researcher on any request for modifications and/or additional information will help speed the approval process. For more detailed information regarding review levels and approximate processing times see Section III of Guidelines on time considerations for review. It is the researcher's responsibility to submit an IRB application as far in advance as possible in order to meet research deadlines.
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28. May I call about
my study?
Yes, you may call the Human Subjects Office at 542-3199
to learn the status of your application after you have submitted
an application. You may learn where your proposal is in the review
process. If any changes are required, you will receive an email detailing
the changes. Your study can only be approved after all the changes
have been made and submitted. When your study is approved you will
receive written notification from the Human Subjects Office. Do not
begin data collection until you receive written approval from the
HSO. If you do not hear from the personnel at the Human Subjects
Office, it is your responsibility to inquire about the status of
your application before you begin your data collection.
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29. Will the Human
Subjects Office personnel help researchers complete the applications?
Yes, the HSO personnel are pleased to give advice
and guidance. Please feel free to call us at 542-3199 or e-mail at IRB@uga.edu if you have questions. You will not be penalized for
incomplete or incorrect answers on your application; you will be
asked to correct them.
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30. What about meeting
the Chairperson of the IRB?
The IRB Chairperson will be pleased to meet with
you, but we recommend that you make an appointment. Please call 542-3199
for an appointment.
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31. Does the project
require full IRB Review?
Some projects may meet the criteria set forth by the federal regulations for administrative (exempt) or expedited review, and will not require full IRB review. All research that involves more than minimal risk and/or does not clearly fall into one of the administrative (exempt) or expedited categories will be reviewed at a convened meeting of the IRB. The vulnerability of the targeted population is also a determining factor in the type of review. Please refer to Section I of the Guidelines for a detailed explanation of the different levels of review.
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32. What kinds of
activities are considered "normal educational practice"?
Generally, normal educational practice
means activities that would occur in a given educational setting
regardless of whether or not a study was being conducted. Such
activities must not be disruptive to the normal classroom routine
and do not require students to undertake any tasks specifically
designed for a particular project.
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33. Do projects involving
students in the Department of Psychology require any additional
information in the consent forms?
Yes. If students are required to participate
in the subject pool you must make clear the terms under which they
will receive credit for full or partial participation, their freedom
to not take part in all or any part of the research, and the alternative
ways in which they might fulfill their course requirements. In
all human-subject activities where sensitive issues of personal
behavior, depression, addiction, substance abuse, dietary disorders,
suicidal tendencies, sexual disorders might be revealed, you must
include on the consent form sources of professional consultation
and care. In addition, efforts must be made to insure that all
participants are legally adults.
Because many human subject activities,
particularly in Psychology, are conducted in the context of both
teaching and research, you must provide the subjects with an oral
or written explanation (debriefing) of the nature, design, and
implications of the project even if deception is not a part of
the experiment. A debriefing script or form must be submitted with
the application as an attachment.
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34. May deception
or misrepresentation be used in studies with human subjects?
Yes, if the benefits outweigh the risks to the subjects
for participating in such a study, and if the researcher provides
a compelling scientific justification for such experimental manipulation.
For research where deception or misrepresentation is involved, the
subjects must receive an explanation (a debriefing) about the nature
of the experiment and why such manipulation was critical to its success.
Such a form should be included with the materials submitted for IRB
review and approval. All research that involves deception must be
approved by the HSO.
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35. May I begin my human subjects activity before I receive IRB approval?
No. All research involving human subjects must be reviewed and approved by the IRB before the research can be conducted.
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36. If I do begin my human subjects activity before I receive IRB approval, what action may be taken against me?
Any extramural study may be terminated/suspended by the IRB, which could lead to the loss of funding. Graduate students who begin human subjects research before the IRB has approved the research may be denied permission to graduate by either their department or by the Graduate School. For additional information refer to Section XI of Guidelines.
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37. Do I need IRB
approval if my Human Subjects Activities will be conducted someplace
other than the University campus? Do I need IRB approval if my
protocol is already approved by another IRB?
Yes. To ensure that the UGA's researchers comply
with federal and university regulations, it is important that the
University, through the IRB, be aware of where and by whom such activities
are being done, even if conducted in a foreign country. In many cases
the researcher must provide written authorization from that locale.
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38. Does the IRB continue
to review research once it has been approved?
Yes. The Board is required to conduct
continuing reviews of applications at intervals appropriate to
the degree of risk, but not less than once a year. The Board also
has the authority to observe or have a third party observe the
consent process and the approved activities. Most continuing reviews
are conducted through a questionnaire reporting the status of the
project, completed by you and returned to the HSO. For additional
information refer to Section IX of
Guidelines.
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39. If I make changes
in my protocol does the IRB have to review and approve again?
Yes. Any changes to your protocol must be reviewed
and approved by the Board. In most cases, however, this can be done
quickly through an expedited review by the IRB chair and/or selected
members of the Board. For additional information, refer to Section
V of Guidelines on Researcher Responsibilities.
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40. What is an identifier?
The term "Identifier" refers
to any information that could be used to match the data with the
individual subject. Some examples are the subject's full or partial
name, initials, social security number, and phone number.
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41. Are any special
steps required to protect data collected on film, photographs,
and audio or videotape?
Yes. The subject must be informed
that the data is being collected through such recordings unless
approval for deception has been granted by the IRB. Consent forms
must describe specifically who will use these recordings, how they
will be used, for what purposes, how long they will be stored,
and how they will be disposed of at the end of the study. Use of
such data for other purposes must be disclosed and permission obtained
for subsequent use in a special part of the consent.
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42. How can I speed
my proposal through the IRB?
The IRB is responsible for reviewing and approving
your application to use human subjects, but is not responsible for
meeting research deadlines and cannot predict or guarantee approval
dates. Fill out forms accurately and completely, and submit an original
plus one copy of all materials as early as possible to meet your
deadlines.
CAREFULLY read all of the Guidelines
for Researchers.
- Complete
each section of the application form fully and accurately. Leave
no blanks in your application; type and answer all questions.
If a question is not applicable, answer "not applicable." This
includes the question concerning funding. If the IRB must call
or write for additional information, or wait for a second copy
of your
application, approval of your study will be delayed. Be sure
the phone number and/or e-mail address you provide on the application
form is one where you can be reached during the day or a message
can be left for you. If you do not understand an item in the
application
form, call the Human Subjects Office at (706) 542-3199 or e-mail
at IRB@uga.edu
- Carefully write your consent form(s) or cover letter(s).
Tell the research participants as much as possible depending
on their
level of understanding and without compromising your study.
If you cannot give them all the details, let them know you are
withholding certain information, and that you will provide a full
explanation
at the end of the study. Do not make your final copies
until the IRB has approved your research.
- Don't forget to sign the application form. All researchers must sign the application cover sheet, not just the Primary Investigator (PI). If you are a student or non-faculty, it is necessary that a UGA faculty member supervise the research and sign in the space designated for faculty oversight.
- The IRB and its staff work
very hard to approve your projects as quickly as possible.
However, there are instances when
they are unable to reach you to discuss some point
in your study.
If you do
not receive some word from the Human Subjects Office
within a reasonable period of time (4-6 weeks), call the office
at 542-3199
or e-mail
at IRB@uga.edu to learn the status of your study.
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Consent
43. When do projects require
consent?
Consent is required from any human subject in research unless informed
consent has been specifically waived by the IRB. The IRB may waive
consent if the project involves no more than minimal risk; the waiver
doesn't adversely affect subjects; the research couldn't practicably
carried out without the waiver; and, where appropriate, subjects
are given information about the project afterwards. Otherwise consent
must be obtained. For additional information on Consent requirements
see Section VIII of Guidelines.
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44. Does the project require
written consent?
The IRB may waive written consent if:
1. Signed consent is the only record linking the
subject to the research and the greatest risk of the research is
a breach of confidentiality; OR
2. The research presents no more than minimal risk and involves procedures
for which consent wouldn't normally be obtained outside of the research context.
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45. Is it necessary to explain
to the subjects ahead of time how data from the study will be used?
Yes. If data obtained will be made available to
any person or organization other than the subject, the researcher,
and the researcher’s staff, the informed consent must disclose:
the person or agencies to whom information will be furnished; the
purpose of the disclosure; and the nature of the information to be
furnished.
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46. Can
deception or misrepresentation be used in studies with human
subjects?
Yes, if
the benefits outweigh the risks to the subjects for participating
in such a study, and if the researcher provides a compelling
scientific justification for such experimental manipulation.
The participants must be informed that some information is
being withheld until the end of their participation. See the consent form guidelines for the recommended wording for this
deception statement. If deception or misrepresentation is involved,
the subjects must receive an explanation (a debriefing) about
the nature of the experiment and why such manipulation was
critical to its success. Such an explanation should be included
with the materials submitted for IRB review and approval.
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47. What consent materials are
required for research with minors?
Human Subject Activities with minors requires completion of a parental
consent form and an assent form. To avoid delays in the approval
of your application, follow the guidelines for informed consent (see Section
VIII). For additional information for research with minors refer
to Section VI.
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48. What is assent?
Assent refers to agreement by a minor or incompetent adult to participate
in Human Subject Activities. Assent must be accompanied by consent
form a parent or guardian. The assent form must be written in the
simplest terms possible. The participants must be able to comprehend
what they are being asked to do. See Section
VIII Part F.
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49. Is assent always required?
Assent must be sought from the child unless: 1) the child is incapable of providing
assent (due to age or condition), or 2) the intervention holds out the prospect
of direct benefit to the child and the intervention is available only in
the context of the study. In these two situations, consent from parent(s)
is sufficient.
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50. What do I do with the consent
forms once they are signed?
You must keep the signed consent forms in a secure location. These
consent forms must be retained for a period of three years after
the study is complete. For some disciplines the forms and data must
be kept longer. For example, the American Psychological Association
requires forms and data be kept for six years.
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CITI FAQs
1. Who is required to take the CITI Human Subjects Protection Training?
The CITI training is mandatory of all key personnel identified on any human subjects research protocol. Key personnel is defined as individuals who will play a substantial role in the human subjects research. This includes all faculty, staff, and students who are engaged in the planning, conduct, or analysis of research (including individuals responsible for obtaining informed consent and those with a major authorship role when work is reported), whether the research is funded or not. If you are working on a human subject research project in which some of the other investigators are not affiliated with UGA, these other individuals are still required to complete the CITI training. It is the principal investigator's responsibility to ensure that all key personnel have taken the tutorial.
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2. When will this training requirement begin?
The training will be required of all key personnel beginning January 1, 2006 .
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3. Which CITI training modules should I take?
Researchers should select the track that is most appropriate to the type of research that will be conducted. The Social and Behavioral Research Module (S&BR) relates to studies on sociological, psychological, anthropological, or educational investigations including observational and survey research and work with population and/or epidemiological studies. There are also specific S&BR tracks if your research involves children, foreign countries (international), internet, or prisoners. The Biomedical Research Module would apply for medical, physiological, or pharmacological studies.
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4. If my research area or subject population changes, do I need to complete additional learner groups of CITI ?
There are instances when your research area or subject population may change, and certification in your initial Learner Group is no longer sufficient. For instance, a researcher initially conducted basic behavioral studies (i.e., completed Group 1 - Social and Behavioral Research) and later wishes to conduct a study with children in public elementary schools. Two additional modules - Research with Children and Research in Public Elementary and Secondary Schools - must then be completed.
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5. How long will it take to complete the course?
Each CITI module has text to read and a quiz to complete. The average learner spends approximately 2 to 3 hrs in the Basic Course site. You may use multiple log-ins to complete the course but you should take the quizzes immediately after completing each module.
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6. What is the passing score on the quizzes?
A passing score of 80% is required. If you are not satisfied with your score, you can retake the quiz.
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7. How do I access the quiz for the module?
The links to the quizzes are at the bottom of each module in the footer of the page. You may access the quiz by logging on to the site and going to the Learners Menu. Once you are at the Learners Menu, click on either the Basic Course or the Refresher Course to access your Grade Book. There are links in the Grade Book to provide you access to all the modules. You must complete the first required module before you can access the next module. As you complete modules, the next module in the sequence will become available. After all required modules are completed, the optional modules will become available for you to review.
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8. How will the IRB know my training is complete?
The software will track your progress through the course. The Grade Book will provide a list of the modules you have completed, and those remaining to be completed in your required course of instruction. When all required modules have been completed with a passing aggregate score, the software will provide you with a link (at the bottom of the Grade Book page) to print or download your course completion report. This report is like a transcript and will provide a detailed record of the completed modules. You should save an electronic or hard copy (or both) for your records. An electronic notification will likewise be sent to our office.
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9. Will the IRB review an initial application if all key personnel are not trained?
Yes, the IRB will review the initial application. However, the protocol will not be approved until all key personnel are trained. So it is highly recommended that training be completed at the time of protocol submission, and a copy of the Course Completion Report attached to your human subject protocol application.
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10. Will training of all key personnel be required before IRB approval of Continuing Review or Amendment?
As with initial reviews, the IRB cannot reapprove protocols at the time of their continuing review unless all key personnel have been trained. If the IRB cannot complete the reapproval process because key personnel have not been trained, the protocol will be suspended and subject accrual must cease immediately. When new personnel will be added to a project, this is considered an Amendment that must first be approved by the IRB. Training certificates for any new key personnel must also be submitted with the submission of the IRB Request for Continuing Review or Amendment.
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11. Where do I find the on-line CITI training modules ?
The training site can be found at https://www.citiprogram.org/default.asp.
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12. Do I have to renew my training?
Certification will be valid for five (5) years from the date of initial training completion. CITI offers a refresher course which must be completed every 5 years.
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13. I forgot my username and/or Password. What do I do?
You may utilize the automated username/password retrieval system by clicking on the "Forgot Username and Password" link located on the left of the Welcome page. If you made an error in providing your email address or there are firewalls to prevent HTML attachments, your request will not be filled and you will need to contact CITI Support at 305.243.7970.
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14. Is there a fee?
There is no fee for individual users. The University pays a flat annual fee regardless of the number of users.
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15. Are CME /CEU credits available for CITI ?
Yes. The main CITI website provides links to apply for Continuing Medical Education/Continuing Education Units ( CME /CEU) credits through the University of Miami CME office.
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16. What if I have more questions?
Please contact the UGA IRB at IRB@uga.edu if you have any questions about the training requirements. If you are having technical problems with the CITI site or course, contact the CITI Office at citisupport@med.miami.edu or at 305.243.7970 .
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