Listed below are Frequently Asked Questions on conducting
research involving the use of human subjects at John Carroll University.
If your question is not answered here, or if you have suggestions
for additional helpful information, please email your comments to
Laurie Princiotto, the IRB Administrator.
| 1.
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What is the IRB?
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IRB stands for the Institutional Review Board
for the protection of human subjects. John Carroll University
approved and adopted a policy statement for the IRB in 1997,
applicable to all JCU faculty, staff, administrators, and
students. See the statement of ethical principles, definitions,
and general policy guidelines can be found in the policy
statement. |
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| 2. |
How is research
defined? |
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Based on federal guidelines and as defined
in the JCU IRB policy statement, "research" means a systematic
investigation, including research development, testing and
evaluation, designed to develop or contribute to generalizable
knowledge. |
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| 3. |
What kind of research
projects do I need to file with the IRB? |
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Any research project which involves human
subjects conducted by JCU personnel or conducted on JCU property
should be filed with the IRB. These projects include, but
are not limited to, the use of interviews, surveys, questionnaires,
behavioral analyses, and focus groups. |
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| 4. |
Why do I need approval
from the IRB for my research involving human subjects?
I'm an experienced researcher and I've never had to do this
before. |
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Federal protection of human subjects developed
from international concerns over the unethical treatment of
humans participating in research studies. The Nuremberg
Code responded to Nazi human experimentation. According
to the code, voluntary consent is essential for any human
research and the project should minimize any unnecessary risk
to the subject. As adopted by the World Medical Assembly in
1964, the Declaration of Helsinki made similar recommendations.
In the United States, the National Commission for the Protection
of Human Subjects of Biomedical and Behavioral Research issued
The Belmont Report in 1969 stating basic ethical
principles for biomedical and behavioral research. |
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The Office
of Human Research Protections (OHRP) is the federal agency
responsible for overseeing this area. Visit the
IRB Links page to access
The Declaration of Helsinki and The Belmont
Report , and to explore the OHRP website. IRB approval
is required for federal grants at this point, most notably
for any National Institutes of Health or FDA funding. Like
most universities, JCU has voluntarily mandated IRB approval
for all human subject research. Once JCU receives their federal
assurance, all human subject research on campus will be required
to be approved by the IRB. [1]
Should OHRP have cause to investigate any one
JCU research project after assurance, all federally-received
monies on campus will be in jeopardy. |
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| 5. |
How do I know what
forms to file with the IRB? |
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Our six-page application for new projects
is titled “IRB Application for Human Subject Research.”
Forms are available to request an addendum or to request the
continuation of an approved project. The IRB may ask for additional
information and/or revisions of materials or procedures before
approval is granted. See the
IRB Forms page to download copies of the forms and Types
of IRB Review for additional guidance. |
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| 6. |
What does "exempt
from full board review" mean and how is it different from
an "expedited review"? |
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The federal government has determined that
some minimal risk human subject research may be categorized
either as exempt or capable of receiving an expedited review.
Like many universities, JCU requests full information on possible
exempt or expeditable projects to ensure that the research
is indeed minimal risk. Exempt projects may be examined by
one or two reviewers. Expedited category projects are generally
reviewed by two or three reviewers. Non-minimal risk projects
are reviewed by the entire board. The IRB reserves the right
to make the final determination as to which review is appropriate.
Refer to Information Sheet 1 and Information
Sheet 2 on our forms page
for more information about exempt and expedited projects. |
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| 7. |
What is "minimal
risk"? |
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Based on federal guidelines, minimal risk
means that the probability and magnitude of harm or discomfort
anticipated in the research 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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| 8. |
How long will it
take for the IRB to review my application? |
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It depends. The IRB realizes that many projects,
such as minimal risk student projects, have tight deadlines
and is dedicated to providing a quick turnaround. A faster
response time is dependant, in part, on whether the application
is neatly and completely filled out, easy to understand, includes
copies of all pertinent materials, and the project is of minimal
risk and complexity, and avoids the use of special population
groups. An exempted project review may be completed within
one week of receipt, a expedited review within two weeks of
receipt, and a full board review within four to six weeks of
receipt. Note that the board will make the final determination
as to which category of review is most appropriate, and that
a revise and resubmit decision is frequently given before
an application receives approval. |
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| 9. |
What are the common
reasons for a revise and resubmit decision by the IRB? |
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Additional information is often requested
on the distribution and collection of consent forms and/or
research instruments and on how the data, including the consent
form, will be stored and who will have access to the data.
The consent form may be missing items or may not differentiate
between confidentiality and anonymity. There may be spelling
errors on the consent form or research instruments. |
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| 10. |
Why does the
IRB want to look at the design and analysis for my research
project? |
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Bad science equals bad research and the IRB
is mandated to protect human subjects from bad or unnecessary
research. In the event that the IRB would question the design
or analysis of the project, the researcher would be given
the opportunity to explain or revise the project. |
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| 11. |
What is the difference
between confidential and anonymous and why does the IRB insist
on the correct terminology? |
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Data is confidential if the researcher can
link the data to a particular participant but will protect
the privacy of the participant. The data is anonymous if there
are no identifiers connected to the data and the researcher
is unable to link data to any one individual. Identifiers
may include gender, religion, birth month, salary range, or
ethnicity, especially if the subject pool is small. If the
data is of a sensitive nature, the IRB would carefully examine
the consent form to ensure that the participant is aware of
study design. Projects may collect data in a confidential
manner but analyze and/or report it in an anonymous manner,
or the data may be collected and analyzed on an anonymous
basis. The consent form should make these procedures clearly
understood. |
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| 12. |
Why is the IRB
so concerned with proper wording on the consent form? |
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Informed consent is one of the basic principles
of ethical conduct for human subject research as stated in
the Nuremberg Code , developed in response to human
experimentation conducted by the Nazis. The Code states that
"the voluntary consent of the human subject is absolutely
essential." |
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| 13. |
I've always conscientiously
followed the ethical guidelines in my subject field. Why
do I need to tell the IRB in detail how I will distribute
and collect consent forms? |
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The IRB cannot evaluate a project unless the
protocol is clearly explained. The investigator is expected
to follow the written procedures which were approved. |
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| 14. |
How long should
I keep my consent forms on file? |
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Federal regulations require consent forms
to be kept three years after the completion of the project.
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15. |
How do IRB members
review an IRB application? |
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IRB reviewers pay particular attention to
certain parts of the application as required by federal regulations.
A reviewer will typically look for answers to the following
questions: |
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The subject pool:
Are subjects representative of the general population?
Can you justify narrowing the pool to a select segment
of the population? Can you justify the use of vulnerable
subjects, such as the mentally disabled?
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The protocol:
Is your protocol fully described? Can it be validated?
Can any risk to the subjects be justified by the outcome
of the research? Who will analyze the research and by
what method?
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The consent form:
Does the consent form provide all the information
required? See informed
consent page.
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The data:
Will the data be carefully collected to protect the privacy
of the subjects? Is the data collected in an anonymous
or in a confidential manner? Who will have access to the
data? Where will the data be stored? When and how will
the data be destroyed?
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The results:
What will you do with the results of the data? Who will
have access to results and for what purpose?
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| 16. |
Several of my
students want to conduct a research project involving human
subjects. Do they need to file with the IRB? |
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Individual student projects, including research
for independent study and theses, involving the collection
of data from human subjects (e.g., opinions, behaviors, feelings,
personal information) which will also be generalized (e.g.,
by publishing -- including master’s theses; presenting
outside the class; citing in another paper; poster presentations)
require students to file an IRB application with the IRB.
These projects may be eligible for exempt or expedited review.
The final decision on review category will be made by the
IRB. |
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| 17. |
I generally require
my entire class to conduct research projects involving
human subjects. Does each student need to file an application
with the IRB? |
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In most cases, class projects involving human
subjects are not intended to contribute to generalizable knowledge
and therefore are not covered under the federal regulations
for IRBs.
However, IRB approval should be obtained for class
research projects if (1) data will be collected from a human
subject (e.g., opinions, behaviors, feelings, personal information),
regardless of the sensitivity of the data, AND (2) the results
of the classroom research project will contribute to generalizable
knowledge (e.g., by publishing -- including master’s
theses; presenting outside the class; citing in another paper;
poster presentations). If IRB approval is necessary and a
class will be conducting one basic project, the instructor
can file one IRB application covering the entire class. If individual students
or small groups of students conduct varying types of projects
that require IRB approval, then an IRB
application from each student or group is required. |
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| 18. |
The semester
is really short. My students don't have time to file an application
with the IRB and wait for a response before beginning
their projects. Why can't I just approve the projects since
they will be conducted under my supervision? |
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The IRB's primary charge is the protection
of human subjects in research and is especially concerned
when inexperienced researchers are conducting studies involving
human subjects for those projects which fall under IRB jurisdiction. With a well-designed protocol and a well-written
application, the IRB can quickly and efficiently process an
application. |
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| 19. |
My student is
working off-campus (e.g, at the Cleveland Clinic) on a project
that would fall under the jurisdiction of the IRB and
wants credit for the internship or plans to present the work
in a thesis. Does the JCU IRB need to approve the entire
project before the student begins the internship? |
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No, the JCU IRB does not need to review the
project. However, the project should have received IRB
approval from the host institution; a copy of the IRB approval
letter must be submitted with the request for credit or thesis
approval. |
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| 20. |
I'm working
on a project with faculty from another university. If
my co-investigators receive IRB approval from their university,
do I still need to file with JCU? |
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Yes. The federal guidelines are meant to be
a starting place from which institutions should develop their
own policies and procedures regarding the use of human subjects
in research. Since JCU would not know if another institution's
policy is compatible with ours, the JCU IRB will conduct its
own review of the project. If available, the researcher should
submit the other institution's IRB approval to the JCU IRB.
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| 21. |
The IRB form
at another university is much simpler (or much more complex)
than the one at JCU. Why does JCU have different questions
on their form? |
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Each institution develops their own policies,
forms, and procedures using the federal guidelines as a basis.
Some institutions will take a more stringent look at certain
areas of the project; other will request minimal information.
The policies, procedures, and forms developed by the JCU IRB
will be used to evaluate JCU research projects. The IRB will,
however, continue to revise the forms and procedures as necessary. |
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| 22. |
What happens
if I don't file my research with the IRB? |
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You will be in violation of university policy
and will need to respond to university administration as with
any other serious violation. |
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| 23. |
I've already
started a research project and didn't realize that I needed
to receive IRB approval first. What should I do? |
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Contact the IRB
administrator as soon as possible with information on your
project (216-397-1527). |
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| 24. |
Why can't I begin
my research as soon as I file the application with the IRB?
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The IRB may request that you revise your consent
form or your protocol for selecting subjects. If you have
already started your project, you may have placed your participants
in harm and may need to start the project again using approved
procedures and research instruments. |
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| 25. |
I'm conducting
a project for my department chair where I interview staff
members or students and I don't plan on presenting the
results at a conference or publishing the results. Do I need
to file this project with the IRB? |
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No. Projects done for internal review only
where the results will not be made public (such as those for program
review) do not need IRB review as they are technically not
research. However, the results cannot at a later date be presented
at a conference or published in an article. |
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| 26. |
Why are there
so many biomedical conditions listed on the exempt and
expedited forms? |
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The guidelines created by the federal government
do not separate biomedical issues from social and behavioral science issues.
The exempt and expedited categories cover all disciplines. |
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| 27. |
If my research
project is disapproved by the JCU IRB, what recourse do I
have? Can University Administration override the IRB's
ruling? |
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In the rare event that the IRB would disapprove
your project, it is not possible for university administration
to override that decision according to our policy statement
as mandated by the federal guidelines. However, the IRB would
hope to work with the researcher to come to a mutually agreeable
revision of the project before taking the step of disapproval.
Note that IRB approval does not indicate university administration
approval. The IRB evaluates a project in regard to the
protection of human participants only. University administration
may disapprove a project which is acceptable to the IRB. |
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| 28. |
I just received
notification that my grant has been approved . I don't
have time to file an application with the IRB and wait for
a response before beginning the project and I didn't know
which part of the grant proposal would be funded in advance.
Why should I jeopardize my funding by delaying the project?
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University policy mandates that the IRB oversee
all research involving human participants. The protection
of human subjects takes priority over any monetary awards.
When you develop your grant proposal, you may contact the
IRB in advance to discuss a preliminary application along
general guidelines for your project. The IRB can advise you
on the requirements of consent forms and which areas are likely
to be of concern in your program, which may reduce the amount
of revisions requested when you file your application. With
a well-designed protocol and a well-written IRB
application, the IRB can process your application in a
timely and efficient manner in most cases. Note that you may
not begin your project until you have received IRB approval. |
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| 29. |
Is there a time
limit on IRB approvals? |
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The IRB can approve a research protocol for
one year only. If your project will run longer than 12 months,
you should submit a Continuation
Request Form to the IRB for review before the approval
expires. |
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| 30. |
What happens
if I want the change the protocol for the project after I
receive IRB approval? |
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If you would like to implement a significant
change in your protocol (for example, greatly expanding the
sample size, selecting another subject pool, using a different
survey instrument), you should submit an Addendum
Request Form to the IRB. No significant changes, either
to procedures, methodology, materials, or subject pools, should
be made to your project until you have received approval from
the IRB. |
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| 31. |
What should I
do if I receive a complaint from a participant about the project
or if a participant is injured in some way during the course
of the project? |
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Incidents of complaint or injury should be
reported to your supervisor and to the IRB as soon as possible. |
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| 32. |
All of the horror
stories in the news about research gone bad seem to be
biomedical in nature. Why would the federal government be
worried about behavioral and social science research? |
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Social science/behavioral studies which have
harmed participants include the Milgram Study on obedience
and authority which used deception instead of informed consent
and caused extreme psychological stress to some of the participants.
Participants can also be harmed by revealing personal or sensitive
information. |
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| 33. |
I'm still not
sure if my project should be filed with the IRB or what
form I should use. Who can I talk to about my project?
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If you have additional questions, contact
the IRB Administrator at 216-397-1527.
You may also contact any of the IRB members. |
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