Below are Frequently Asked Questions related to basic policies and procedures that
govern the IRB review and approval process.
While we serve a regulatory function, we take a collegial approach to consultation
with researchers and their staff. Please feel free to call on us as you navigate the
process. We are happy to respond to your inquiries.
What is the role of the IRB?
IRB stands for "Institutional Review Board." The IRB is a committee established to
review and approve applications for research projects involving human subjects, regardless
of funding source. The IRB reviews all projects conducted at or under the auspices
of WCU by WCU personnel. The primary purpose of the IRB is to protect the rights and
welfare of human participants.
How do I know if I'm conducting human subjects research?
Research is defined as a "systematic investigation, including research development, testing
and evaluation, designed to develop or contribute to generalizable knowledge." Generalizable
knowledge is not defined solely as an intent to publish.
Human subjects are "living individuals about whom an investigator conducting research obtains i)
data through intervention or interaction OR ii) identifiable private information
Projects that meet the criteria of both definitions require review by the IRB. If
you are unsure whether your project involves research with human subjects please contact IRB@wcu.edu for help making this determination.
You may also use this Decision Tree to help guide you.
When do I need to submit my project to the IRB?
The IRB must review and approve the project prior to investigators beginning any proposed
research activity (including recruitment of subjects).
Do classroom projects conducted by students require IRB approval?
If students will only be presenting the results of their study in a classroom setting,
then the project does not meet the definition of research because the projects are
not contributing to generalizable knowledge. However, instructors should be aware
that if IRB approval is not obtained prior to study initiation results or data may
not be disseminated outside the classroom for any purpose, even if a project generates
interesting results. Instructors and students should discuss and consider these limitations
prior to beginning a project. If a classroom project does not require IRB review,
it is the responsibility of the instructor to use good ethical judgment in determining
whether a proposed student project is appropriate.
PI Eligibility and Role of Investigators
Who may serve as Principal Investigator (PI) on a project?
All submitted projects must list a PI. Any full-time WCU faculty or staff may serve
as PI. Students may serve as co-PI, but the faculty advisor must be listed as the
PI and must review all proposal documents prior to submission.
What are the responsibilities of the PI?
The PI is responsible for assuming meaningful supervision for other investigators
and each student researcher listed on the protocol. The PI must be reasonably available
to assist in the resolution of and reporting of any problems that may arise during
the course of the research.
The PI is responsible for imparting to students an understanding of the ethical principles
of human research to which the university adheres.
If a student is conducting research or a class activity that falls within the IRB's
purview, the faculty member teaching the course must ensure that the student completes
appropriate training and secures IRB approval before beginning the study or activity.
The PI also has primary responsibility for overseeing and monitoring the conduct of
research in its entirety and for ensuring that students adhere to the approved protocol
(e.g. data storage, retention, and disposal).
Collaborative and Research
I am WCU faculty/staff and I will be collaborating with another institution. Do I
need to submit my project to the WCU IRB?
For unaffiliated investigators that have an institutional IRB: collaborating institutions
may have the option to enter into a Reliance Agreement, (or IRB Authorization Agreement),
which allows one IRB to provide review and oversight for the study. The IRB Offices
will work with investigators to determine if single IRB review is feasible. If a WCU
investigator will rely upon the approval of an external IRB, the investigator should
provide all related study documentation (e.g. application form, consent form, advertisements)
approved by the partnering agency.
Further information about collaborative research can be found on the Collaborative Research website.
I am WCU faculty/staff and I will be collaborating with an investigator who is not
affiliated with another institution. What do I do?
Individuals unaffiliated with WCU who will be listed as members of the study team
must sign and submit an Individual Investigator Agreement in order to perform work on the project. This form does not apply if the external investigator has an institutional IRB. Individual Investigators must also completed WCU's CITI human subjects training requirement.
I am not affiliated with Western, but I would like to conduct research on campus or
with Western faculty/staff/students. What do I do?
Unaffiliated investigators, who wish to conduct research that takes place on the WCU
campus or that involves WCU faculty, students, or staff should submit a copy of the
application and approval letter from their institution's IRB to the WCU IRB by email.
Following review for compliance with WCU policy for researching involving humans,
the IRB will grant permission to begin the research.
How do I apply?
WCU uses an electronic system called IRBNet, to process and review all IRB applications.
All new investigators will need to register for an account in IRBNet. All IRB application
forms and templates are described under the IRB Forms tab and can be downloaded directly
from IRBNet. The fully completed application, study materials, and training certification
must be submitted electronically.
WHAT TYPE OF REVIEW DOES MY PROJECT UNDERGO?
Projects will undergo one of the following types of review: exempt review, expedited
review, or full-board review. Studies that meet one or more exempt criteria will be
reviewed via the exempt review process. Studies that contain no more than minimal
risk and meet expedited criteria will undergo review by one designated member of the
IRB. Studies involving vulnerable or special populations, or involving more than minimal
risk to the subjects will undergo review by the convened IRB.
How long does the review process typically take?
Exempt and Expedited reviews generally take about 2-4 weeks. However, during University
holidays and breaks the process may take longer. Projects requiring full-board review
must be submitted two weeks prior to the next scheduled meeting and will be placed
on the agenda once received.
What happens after submission?
Once you submit your project in IRBNet, the project becomes locked and you will not
be able to make changes until an administrator has unlocked it. The project is received
by the IRB administrative office where your project will undergo an administrative
review for completeness and clarity and the appropriate level of review will be determined.
Studies requiring exempt or expedited review will be forwarded to a designated reviewer.
Studies requiring full-board review will be assigned to a primary reviewer and will
be distributed to the entire IRB committee. The application materials will be reviewed
at a scheduled IRB meeting. Investigators will be notified via IRBNet if revisions
or necessary or when the study has been approved.
How will I know when my study has been approved?
You will received notification of approval via IRBNet and email. Approval letters
and approved study materials will be maintained in IRBNet, and are available for download
by the investigator at any time.
Can my project be disapproved?
Yes, the IRB may elect to disapprove a project. Typically the designated reviewer
will work with the investigators to develop an acceptable protocol. However, if the
investigator and the IRB are unable to establish a protocol that will be supported
by WCU, the Full-Board can vote to disapprove the project.
What is informed consent?
Consent is a continuing process that starts before any forms are signed and continues
until the individual's participation is complete. It involves meeting with a potential
participant, determining whether s/he is capable of giving consent, discussing the
purpose, risks, and benefits of participation, etc. Its goal is to assure that prospective
participants can knowledgeably and voluntarily, without coercion, decide whether to
participate. Consent is required for every participant unless the consent or one of
its elements has been waived by the IRB. If a project is determined to be Exempt,
a consent process is still required if direct interaction with human subjects will
What is the process for informed consent when the research participant is a child?
When the research participant is child (<18 years old), both permission from the parents
using the informed consent process and informed assent from the child must be obtained.
The assent process must be tailored to be age appropriate to the child. For example,
if obtaining informed assent from a 7 year old, the assent form must be written at
their reading level.
What information is required in the informed consent?
There are 8 required elements for informed consent, with other elements required dependent
on the project. Consent form templates can be found in IRBNet. A brief list of the
required elements is below:
1. Statement the activity is research, the purpose of the research, the duration,
a description of procedures and identification of any experimental procedures
2. A description of any foreseeable risks or discomforts
3. A description of any foreseeable benefits to the individual or to society
4. Disclosure of any alternative treatments or procedures that might be advantageous
5. A statement describing the extent to which confidentiality will be maintained
6. For more than minimal risk studies, a description of any compensation or available
treatments in the event of an injury
7. Contact list for who to contact with questions about the research study or treatment
as a subject
8. A statement that participation is voluntary, that refusal to participate involves
no penalty or loss of benefits to which the subject is entitled, and the subject may
discontinue participation at any time with no penalty or loss of benefits
Confidentiality and Privacy
What's the difference between confidential data and anonymous data?
Anonymous data cannot be linked, even indirectly or through a code, back to a subject.
Confidential data may be linked to a code or directly identifiable to the research,
but the subject's privacy is protected and the identity is not disclosed outside the
How long is the approval period?
The approval period for projects undergoing expedited or full-board review is for
no more than a year. Project renewal must be submitted prior to the expiration date.
After the initial approval, an Application for Continuing Review may be submitted
for years 2 and 3 of the research. To begin the 4th year of research, you must submit
an Application for initial review as part of de novo review.
What if I need to make changes or modify my project?
After a research study has been reviewed and approved by the IRB, the investigator
MUST conduct the study exactly as approved by the IRB. No changes in approved research
should be initiated without prior IRB review and approval, except where necessary
to eliminate apparent immediate hazards to participants (these cases must be reported
to the IRB immediately). The Request for Modification form is used to request any
changes to your research protocol including changes to approved documents such as
consent forms, recruitment materials, or instruments to be used in the study. Changes
may not be implemented until approval is received from your IRB reviewer.
What if I encounter problems during the research?
Researchers must promptly report to the IRB any serious or continuing non-compliance
with federal regulations or university policies, any injuries to subjects, or unanticipated
What constitutes a protocol deviation or violation?
Researchers must submit a Report of Protocol Deviation or Violation within 10 business
days of a protocol deviation or violation:
• A Protocol Deviation is an inadvertent act (from the perspective of the PI and study staff) in which the
protocol is not followed. Examples that are reportable to the IRB include the accidental
loss of consent forms, or study materials with participant information, or an accidental
misread of a laboratory value as being within the reference range when it actually
is sufficiently abnormal to preclude study participation by the subject.
• A Protocol Violation is an intentional act (from the perspective of the PI and study staff) in which the
protocol is not followed. Examples that are reportable to the IRB include the PI beginning
the study before IRB approval, the PI prescribing or administering the wrong drug
on the study, or the study subject being scheduled to return for follow-up intervention
outside the protocol-dictated window as a convenience to the PI or the study staff.
What constitutes an adverse event?
The Adverse Event Form should be used as you conduct your research study whenever
you encounter a problem or event that is both unanticipated and indicates that the
research places subjects or others at a great risk of harm (including physical, economic,
or social harm) than was previously known or recognized. Unanticipated is defined as: unexpected (in terms of nature, severity, or frequency) given:
• The research procedures that are described in the protocol-related documents, such
as the IRB-approved research protocol and informed consent document; and
• The characteristics of the subject population being studied.
The adverse event should be reported to the IRB within 3 business days of the event.