The Institutional Review Board (IRB) is a committee that protects the rights and welfare of human research subjects by reviewing research projects for ethical implications. Researchers from the Park University community must have their research involving human participants approved by the IRB, and the IRB evaluates applications based on principles such as voluntary and informed consent, anonymity, and potential harm. The application process includes various scenarios that determine if the project is exempt, expedited, or requires full review, with outcomes communicated via official letters.

1. What is the IRB?
Short Answer: the Institutional
Review Board

2. What is the IRB?
Long Answer: a committee whose purpose is to
protect the rights and welfare of human subjects
in research, in particular by considering the
ethical implications of proposed research
projects and experiments. The IRB is composed
of faculty members from various disciplines, as
well a member external to the university.

3. What is the governing principle behind our
approach to research?
From Dr. Henry Beecher’s “Ethics of Clinical Research,” 1966:
“A particularly pernicious myth is the one that
depends on the view that ends justify means. A
study is ethical or not at its inception.”

4. What are the main questions an IRB asks of an application?
• Is the research based on voluntary consent?
• Is the research based on informed consent?
• Does the research involve deception?
• Does the research involve vulnerable populations?
• Will the research subjects be paid?
• Are there mechanisms to ensure the anonymity of the
research subjects?
• Will the research provide a clear benefit?
• Does the research contain the potential to enact harm on the
participants?

5. The Belmont Principles
• Respect for persons (recognizes a
person’s right to protection, autonomy, privacy)
• Beneficence (not just “do no harm,” but more
like “do unto others…”)
• Justice (research does not systematically include or
exclude a particular population)

6. Let’s get practical—who should apply?
All research connected with members of the Park
University community must be reviewed and
approved by the IRB. The Park University IRB
defines "research" as a systematic investigation—
including research development, testing and
evaluation—involving a living individual about
whom you obtain:
• data through intervention or interaction,
INCLUDING surveys and interviews, and/or
• identifiable private information in a form
associable with that individual.

7. Can you say that again?
Yes, I’d love to. Here’s another way to think of it:
If you are a member of the Park University community
and intend to conduct research that involves human
participants, either on campus or elsewhere, you must
have your research plans reviewed and approved by the
IRB prior to the initiation of your project. Researchers
who are not affiliated with Park University who intend to
conduct research involving members of the Park
University community as participants are also required to
secure Park University IRB approval prior to beginning
their research.

8. An interesting wrinkle: what about observation?
Observation—that is, a project that involves
watching people, but not interacting with
them—is exempt if the observer focuses on
public behavior.

9. Great—so that means I can observe people
anywhere that’s technically public, right?
• Not really. The Park IRB uses this circumscribed
definition of public behavior: Public behavior is
behavior occurring without the intervention of the
researcher, and which the individual could reasonably
expect to be observed. Observation of reactions to
"staged" events and of behavior occurring in private
settings (e.g., at home, in a bathroom stall) or in
settings in which individuals have reasonable
expectations of a limited audience (e.g., classrooms,
meetings of identified groups) is not exempt. Adapted
from US Department of Health and Human Services
Code of Federal Regulations, 45 CFR 46.101(b)(2)

10. We don’t have a medical school. So how often does
institutional research using human subjects come up?
We process about 100 applications a year, in areas like
• Psychology
• Criminal Justice
• Education
• Sociology
• Legal Studies
• Athletic Training
• Business
• And even Spanish, History, Design

11. How do I apply?
To go to the IRB page under MyPark, click on
“Resources,” and then the “Institutional Review
Board” link. Select “IRB application” on left tool
bar and complete the application. Please review
“Forms” including the Informed Consent
Checklist.
Questions? Contact IRBchair@park.edu

12. Is it really that easy?
Well, usually. In addition to the application, you’ll need
an informed consent form. And in some instances, the
form will direct you to fill out other supplementary
forms. This will happen if
• Your research is funded
• Your project involves international research
• You’re seeking a waiver of informed consent
• You intend to seek the assent of a child

13. What happens then? Scenario One
The Chair will read the IRB application and he/she may
decide that it’s EXEMPT. This happens if the project
• Involves normal educational practices, like classroom
management surveys, comparisons on instructional
technique, etc.
• The research involves the collection and study of existing data
• The research involves basic “taste-testing” style surveys of
products approved by the FDA
• The research is sponsored by governing agencies, and involves
basic survey practices

14. What happens then? Scenario Two
The Chair may read your application and decide it should
be EXPEDITED. This means one member of the IRB will
review your application and make a determination on
behalf of the board. These reviews occur when
• The research presents no more than minimal risk to the subjects
• The collection of data is routine, standard, and non-invasive
• The research continues the research of a project that has already
been approved
• The research involves individual or group characteristics or behavior
• The research does not involve any of the elements of Full Board
Review research

15. What happens then? Scenario Three
The Chair or another member may read the
application and decide that a Full Board Review is
required. This occurs when the research project
• Involves vulnerable populations (children, prisoners,
the mentally handicapped, etc.)
• Involves payment to subjects
• Involves more than minimal risk to subjects
• Does not meet the criteria for exempt or expedited
review

16. Outcomes
In Scenario One, you will get a letter from the IRB stating
that your research is exempt; you will carry on with your
research outside the oversight of the IRB.
In Scenarios Two and Three, you will get a letter from the
IRB stating whether your research project has been
approved or disapproved. If it has been approved, you
may proceed with your project. If it has been
disapproved, you will receive detailed information as to
why that happened, and you will be able to reapply as
soon as you have corrected the necessary elements.

17. And that’s it (pretty much).
Questions? Feel free to e-mail the
IRB Chair at irbchair@park.edu