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Institutional
Review Board |
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IRB Frequently Asked Questions
[Printable version here]
Note that the guidelines provided below are intended for a broad KSU audience. Some disciplines may require more restrictive procedures.
General Information
Q1: What is an Institutional Review Board (IRB)?
A1: An IRB is a committee established to protect the rights
and welfare of all human subjects who volunteer to participate
in research studies conducted under the auspices of the university.
The purpose of the IRB is to review all research involving
human subjects and to ensure that potential research-related
risks (physical, social, emotional and financial) are minimized
and fully disclosed in order that volunteers can make an informed
decision to participate. All research involving human subjects
is reviewed and conducted according to relevant university,
state and federal regulations.
Q2: What is the IRB definition of research?
A2: If data are collected from human participants and if the results may at some future point be published in a journal or presented at a conference, then the IRB considers it research, and thus, under the guidance of the IRB. Data collected strictly for teaching improvements or for university accreditation (SACS) need not be reviewed by the IRB.
Q3: What types of research must be submitted to the IRB?
A3: Any research activity that to any degree involves using human
subjects as research participants, under the auspices of Kennesaw
State University, whether undertaken on a large or small scale,
whether it is preliminary or full designed, whether it is conducted
by students, staff or faculty, whether it is externally funded
or not, and whether it involves minimal risk or more than minimal
risk, is subject to the KSU IRB regulations. This includes the
collection and/or analysis of data from human beings intended
for publication or presentation or dissemination to an external
audience.
Q4: Do I need IRB oversight even if I am only conducting interviews,
surveys, or simply observing people?
A4: Yes.
Q5: I plan on videotaping and/or recording participants in my research. Are there any special guidelines I need to be aware of?
A5: Yes. The subject(s) 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.
Research involving Other Institutions or Locations
Q6: Do I need IRB approval if my human subjects research will
be conducted some place other than the University campus?
A6: Yes. To ensure that the KSU investigators comply with federal
and university regulations, it is important that the University,
through the IRB, be aware of where and by whom such research
is being conducted.
Q7: Do I need IRB approval if my protocol is already approved
by another IRB?
A7: If your protocol has been approved at another university,
you will need to provide the KSU IRB with a copy of the approval.
Q8: If I obtain human subjects data from other researchers, is
IRB approval required?
A8: Yes. Unless your research is determined by the IRB to be
exempt from continuing review, both you and the other researchers
must have approvals from the IRBs at your respective institutions.
Q9: My research will be done in another country. Do I have to
obtain IRB review and approval?
A9: Yes. Moreover, you may also need to provide the university
(through the IRB) that you have authorization from the officials
in that country to conduct your study there.
Q10: I've heard that the federal regulations make certain categories
of research exempt. If my research fits into one of these categories,
does this mean that I don't have to have it reviewed by the
IRB?
A10: No. The IRB
has the responsibility for determining whether or not a study
is exempt. All research involving the collection
of data from living humans must be reviewed by an IRB.
Scholarship of Teaching
Q11: What about teacher evaluations and other types of assessment we do in our classes and departments?
A11: Projects conducted for routine assessment of teaching effectiveness, curriculum, university processes and procedures, and customer satisfaction may be considered exempt. However, only the IRB can determine if a study is exempt.
Q12: What if I am engaged in the Scholarship of Teaching (SOT)? Should I seek IRB approval before starting to collect data?
A12: Yes. Most SOT projects involving collecting data from students or other human participants. It is important to complete and submit the IRB form for approval before beginning to collect data.
Research By Students
Q13: My students are doing research on human subjects for a class project. Must their proposals be approved by the IRB?
A13: Yes. Any individual conducting research on human subjects
under the auspices of KSU, including faculty, staff, administrators,
and students, must have the approval of the IRB. Students,
and non-faculty staff and administrators must have a faculty
advisor for their research projects. The faculty advisor
is responsible for submitting student project proposals to the IRB
with the exception of M.Ed., Ed.S. and Ed.D. program students. Students in these excepted programs, after faculty advisor review of the study, may submit required documents as long as their email reflects that they are part of an excepted program and the faculty advisor appears as a cc: in the submission email. Classroom projects involving no outside reporting or publication
may be declared exempt by the IRB. For these types of classroom projects, complete and submit the
IRB Approval Request
Short Form. Bagwell College of Education students and
faculty members should also read the related policies.
Q14: As a faculty member, what are my responsibilities to my advisees or students who are conducting research on human participants?
A14: The faculty advisor to a project is responsible for making sure that research projects assigned to students or conducted by non-faculty staff meet KSU IRB guidelines. Faculty advisors are responsible for:
- Informing students/advisees of the ethical principles for the protection of human subjects and applicable polices and procedures;
- Reviewing and approving student/advisees projects PRIOR TO submission of their applications to the IRB to assure compliance with the KSU Instructions for Investigators Conducting Research Involving Human Subjects. Applications which are unreadable, or contain incorrect or insufficient information on which to base a determination for approval/disapproval by the IRB will be returned to the faculty advisor without review;
- Submitting the final application to the IRB
- Monitoring student/advisee projects to ensure proper implementation of project;
- Assuring that end-of-project reports are submitted to the IRB within the timeframe outlined in KSU IRB Instructions;
- Assuring that any adverse effects or changes in protocol are submitted to the IRB as outlined in the KSU IRB Instructions;
- Reviewing and approving student applications that are eligible for faculty review according to the guidelines under “Course Directed Human Subjects Activity” and retaining the completed applications for a period of one academic year.
Q15: What will happen if I, or my students, conduct research on human participants that has not been approved by the IRB?
A15: In the case where research with human participants is in process, without having obtained the prior approval of the IRB, the IRB Chairperson will send a memorandum to the researcher(s) asking them to suspend the research project, and to comply with KSU guidelines by submitting a research proposal to the IRB. The research project should not resume until IRB approval is obtained. If the project has been completed, other considerations exist. Research involving humans that is not approved by the IRB is out of compliance with university regulations and the data may not be usable. This includes research conducted for master’s theses and doctoral dissertations. In addition, peer-reviewed journals often will refuse to print research that was not approved by an IRB.
Research on Students
Q16: Can I recruit students from my own classes to participate
in my research?
A16: If you are the instructor or teaching assistant, or anyone
the students would see as having power and authority over them,
then the answer is "maybe." This is because the students
could perceive the situation as one in which they really cannot
refuse, even if they really didn't want to be in your study.
You must avoid even the perception of coercion. If your students
have special skills that make them particularly valuable as
potential research participants, the IRB may approve your request
to use them provided that you structure your protocol in such
a way that the coercive potential is eliminated. If access to
research subjects, including students, is gained through cooperating
institutions not under the control of KSU, the institution(s)
must be identified on the IRB form and evidence provided that
the authorized official of that institution(s) is or will be
informed of the study. If such subjects are placed at more than
minimal risk, documentation of the institutional approval will
be required.
Q17: If the IRB approves my request to use my own classes to participate
in my research, are there any guidelines I need to follow?
A17: Yes. College students, employees and other persons in subordinate
positions or positions of lesser power/status provide an easily
accessible group with the potential for undue influence to impede
free choice in the consent process. For student subjects, investigators
need to consider the following:
- if course credit is given for participation, alternatives
for receiving equal credit that are no more burdensome than
the participation in research must be offered to those not
participating;
- policies regarding course-related research participation
must be clearly understood;
incentives for participation may not be unduly influencing;
- student subjects must have the ability to decline participation;
- confidentiality must be maintained for self-disclosures
of a personal nature.
Consent
Q18: Do I always have to obtain informed consent?
A18: Investigators involving a human being as a subject in research
must obtain the legally effective informed consent of the subject
or the subject’s legally authorized representative. The
exceptions are few. The IRB has the authority to waive the federal
requirements for informed consent in the following instances:
(1) research in which the only involvement of human subjects
is that of anonymous observation, for example, observational
studies of public behavior when obtaining consent would not
be practicable and in some cases, (2) research that is conducted
in established educational settings, involving normal educational
practices.
Q19: Do research participants always have to sign an informed
consent?
A19: No, not always. The IRB may waive the requirements for the
investigator to obtain a signed consent form for some or all
subjects, if it finds either: (1) that the only record linking
the subject and the research would be the consent document,
and the principal risk would be potential harm resulting from
a breach of confidentiality (as in an interview or survey that
addressed the participant's HIV status). Each subject will be
asked whether they want documentation linking them with the
research, and the subject’s wishes will govern; or (2)
that the research presents no more than minimal risk of harm
to subjects, and involves no procedures, for which written consent
is normally required outside of the research context. If consent
forms will not be used, the researcher must explain in the application
to the IRB how informed consent will be obtained.
Q20: Are there some instances in which oral consent is permissible?
A20: There are several research situations, all involving no more
than minimal risk, where the IRB can authorize you to obtain
consent orally. For example, in the case of phone surveys, consent
may be obtained verbally and recorded by the investigator without
the participant’s actual signature. Or, if your participants
cannot write, the IRB will waive this requirement, provided
that the study presents no more than minimal risk. Otherwise,
you would have to obtain written consent from someone authorized
to act on behalf of the participant. Additionally, if the risk
to your participants would increase markedly because they signed
a consent form (as in an interview or survey that addressed
the participant's HIV status), then the requirement could also
be waived. You'd still need to obtain informed consent, but
it could be obtained orally.
When oral consent is used, there needs to be a witness to
the oral presentation. Also, the IRB must approve a written
summary of what is to be said to the subject or the representative.
Only the short form itself is to be signed by the subject
or the representative. However, the witness shall sign both
the short form and the copy of the summary, and the person
actually obtaining consent shall sign a copy of the summary.
A copy of the summary shall be given to the subject or the
representative, in addition to a copy of the short form.
Q21: What consent materials are required for research with minors
(children, persons under the age of 18)?
A21: Human subject research with minors (children) requires completion
of a parental consent form and a child assent form.
Q22: What's the difference between an Assent Form and a Consent
Form?
A22: An assent form is used to gain consent from minor subjects
(under the age of 18 years old). This form should be either
written or read to subjects in language and terms that they
can understand. A consent form is used to gain permission from
parents or other adult subjects (18 years of age or older) for
participation in the research study. For children, both assent
and parental consent are required.
Q23: Is a child assent form always required?
A23: 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.
Q24: What do you mean by “child assent script"?
A24: When you intend to collect data from children who are capable
of comprehending, after obtaining consent from one or both of
their parents, you must tell the children what to expect if
they agree to participate in your research. You must make as
certain as possible that the child understands that he or she
has a free choice in the matter. The words that you use to present
your study to the children are your "script." The
children must give you a positive affirmation of their interest
in participating. This is their way of exhibiting "assent.” Mere failure to object should not be construed as assent.
KSU Procedures
Q25: When should I submit my application for IRB review?
A25: You may submit your application at any time. You do not
need to wait for the IRB’s scheduled monthly meetings.
In many instances, your proposal may not require review by
the full board. So, you should submit applications to
irb@kennesaw.edu as soon as you have it ready.
Q26: How long will it take for me to obtain approval to do my
study?
A26: It depends on the nature of your study and the characteristics
of the people you intend to recruit.
- Allow 7-10 business days for projects that involve surveys
and interviews given to most adults, providing that you
record the data in such a way that there is no possibility
that the subjects can be uniquely identified by an outsider
and that any disclosure of the their responses outside the
research could not reasonably place the subjects at risk
of criminal or civil liability or be damaging to the their
financial standing, employability, or reputation.
- Allow 4-5 weeks for studies that, in the judgment of the
IRB, involve more than minimal risk to the participants
because your study will need to be reviewed at a monthly
IRB meeting. If the IRB needs you to make extensive changes
to your study and tables further discussion of it for the
next meeting, then clearly the time could be longer. Most
studies that come to this IRB, however, are of such a nature
that they need not be reviewed at a monthly meeting.
Q27: How will I know when my study is approved?
A27: You will receive a letter at the email address that you
provide when you submit your protocol to the IRB. Faculty
members will receive a letter when their students(s)/advisee(s)
study is approved.
Q28: After I download the IRB form from
the Internet and complete it, in what format should I send
it back?
A28: Please save the form as a word document, fill it out,
and send it as an attachment to an email to irb@kennesaw.edu.
Q29: Where should I send my completed form?
A29: Send your forms as email attachments to irb@kennesaw.edu.
Q30: Are handwritten applications acceptable?
A30: No. All pages must be typed or prepared on the computer by
the applicant following the designated format. Handwritten applications
will be returned to the researcher or faculty advisor without
being reviewed.
Q31: What do I do if I make changes to my research protocol after
I've received approval?
A31: Please notify the IRB of any changes you wish to make to
your research protocol before implementation. We will contact
you if we require additional information or review prior to
approving the changes.
Q32: How long is my approval valid?
A32: Student approvals are valid until the end of the current
semester in most cases. Most other approvals are valid for one
year from the approval date. If data collection will not be
completed before your approval expires, you must submit a request
for yearly renewal sufficiently in advance of the expiration
date to permit uninterrupted completion of your project.
Q33: Who do I contact with questions about the IRB?
A33. Contact the IRB Chair, Dr. Ginny Zhan, at gzhan@kennesaw.edu
or at x6679 or you may contact the IRB Administrator, Paula
Strange, at pstrange@kennesaw.edu
or at x2268. |
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