Updated 2014
Introduction to IRB at UW-Stout
General Overview:
If you involve human subjects as part of your research, you need to follow the Institutional Review
Board (IRB) process. A human subject is any living individual about whom an investigator
(whether professional or student) conducting research obtains either data, through intervention or
interaction with the individual, or identifiable private information. The IRB exists to protect the
rights and welfare of human research subjects.
The process for conducting research involving human subjects at UW-Stout involves the following
steps:
1) The Researcher takes the online Human Subjects Training:
All faculty, staff and students must complete the UW-Stout Human Subjects Training before
submitting a Protection of Human Subjects Protocol Form to the IRB for review. The
training can be found at the Human Subjects webpage:
https://uwstout.qualtrics.com/SE/?SID=SV_9miEKZTmUCMJSPb.
2) The Researcher submits a Protection of Human Subjects in Research Form (the “Protocol”):
Complete the Protection of Human Subjects in Research Form online,
http://www.uwstout.edu/rs/upload/humnsubjform-doc.docx. Once you have gathered all
required signatures and necessary attachments (consent forms, surveys, training certificates),
you may email the completed protocol to Research Services at IRB@uwstout.edu, or bring a
printed original to Research Services, 152 Voc. Rehab. Bldg. Keep a copy of what you
submit for your records.
3) The IRB reviews the Protocol:
Typically, expedited review will be completed within ten working days. If a full board
review is required, it will be placed on the agenda for the next monthly IRB meeting.
4) Research Services notifies the Researcher:
Upon completion of the review, the investigator(s) will be notified of the outcome
electronically. The student’s research advisor (who signed the Protection of Human Subjects
in Research Form) will also be notified of the review outcome.
5) The Researcher starts collecting data:
Upon notification of approval from the IRB, research can then begin.
The IRB exists to ensure that research be done safely, and works to help researchers get their
research approved. Researchers help themselves by submitting their protocols well in advance of
their intended dates of gathering data, so that any necessary revisions or modifications to their
research plan will not delay their project. Successful researchers also write their protocols in clear,
non-technical language so that the reviewer, regardless of background, can evaluate the proposal.
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Helpful Hints:
Human Subjects Training (https://uwstout.qualtrics.com/SE/?SID=SV_9miEKZTmUCMJSPb)
Take the Human Subjects Training as soon as possible so that you are prepared when you identify
your research topic. The training will take approximately an hour to complete. It explains what
constitutes human subjects research, and it delves into the history and principles that guided the
development of current rules. After completion of the training a certificate is emailed to you. This
certificate must be attached to your research protocol to show that you have learned what your
responsibilities are.
Protection of Human Subjects Form (http://www.uwstout.edu/rs/upload/humnsubjform-doc.docx)
Successful researchers write their protocols in clear, non-technical language so that the reviewer,
regardless of background, can evaluate the proposal. Remember that you MUST wait to collect data
until the IRB has approved your research.
The most basic issue that a reviewer will consider is whether the benefits of your research outweigh
the risks to your subjects. The reviewer will pay close attention to the questions on the form relating
to selection of subjects, procedures regarding how the subjects are utilized, methods of keeping the
subjects’ participation confidential, and the risks and benefits to the subjects and to society.
Consent
All protocols involving human subjects must be submitted to the IRB with a consent form.
Even when the researcher uses an online survey or a verbal interaction, the researcher must provide
their subjects with the opportunity to understand what the research entails and the potential risks
and harms associated with the research. This basic standard is called “informed consent” and can
only be waived in certain circumstances.
Sample consent forms are available online at the Research Services website. These include Signed
Consent, where the subject or their legal guardian signs the form to show they will participate
(http://www.uwstout.edu/rs/upload/cformsi.docx), and Implied Consent, where the subject does not
need to sign (http://www.uwstout.edu/rs/upload/cformim.doc).
Risks and Benefits
Risks may be physical, psychological, or social. For instance, a study may place a participant at risk
of embarrassment or they may face termination from a job if their responses became public. It is
important to acknowledge these risks in order to demonstrate that you are planning to minimize
them.
Benefits may be to the individual who is participating, such as when they are trying a drug that
could cure a disease they have. Often, the participant will not enjoy a direct benefit other than the
satisfaction of participating in a study that may help others in the future. Again, by thinking
thoroughly about the benefits (or lack of benefits), you design a better protocol.
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Revising or Extending a Research Project
Approved research may be conducted for one year. If at any point you need to change your protocol
or extend it beyond the expiration date then you MUST submit one of the following forms to the
IRB:
 Modification/Revision Request Form (change in survey, investigators)
 Extension Request Form (extending research approval beyond approved date)
 Adverse Event Form (unintended effect participants may have encountered)
These forms allow the reviewer to re-evaluate the risks and benefits of your research.
Paying Human Subjects involved in Research
Generally speaking, research should be conducted without need for compensation or reward. Any
use of payments may constitute coercion and may make it more difficult for the IRB to approve the
research.
If research is to be conducted involving payment, several policies and regulations must be followed.
For details, see the “Procedure for the Payment of Human Subjects when Involved in Research”
(http://www.uwstout.edu/rs/paymentofhumanresearchsubjects.cfm).
Other Issues
The IRB and Research Services are available to answer questions in order to help research be
conducted safely. The full list of current board members and staff members is online at
http://www.uwstout.edu/rs/humansubjects.cfm.
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