Delta Pre-internship workshop
Addressing approval of the Institutional Review Board (IRB) to use
human subjects in your Teaching-As-Research project
As a Delta Intern, you are REQUIRED to take the University's Human Subjects Protection
tutorial and submit an IRB protocol for your internship project. Both activities must be completed
prior to initiating the project and any data collection. This handout includes the following:
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IRB Timeline for Delta interns– steps you need to take to begin data collection in your project
Overview of the IRB review process
Information about IRB Certification
Information about IRB Review of your protocol
o Exemption from IRB review
o Expedited review
o Full review
o Inclusion of minors (e.g. K-12 outreach projects)
Accessing the IRB Webkit
o Consent for wizard
Example IRB forms and relevant text
o General Protocol Information form
o Project Sponsorship Information (current or planned) form
o Review Type form
o Study Description Form
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Additional Text examples
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Created on 3/25/2011 3:57:00 PM
revised: 3/7/16
Pre-internship workshop - IRB Process
IRB Timeline for Delta interns
Action
Date due
Obtain Certification by taking the University's
Human Subjects Protection tutorial on-line.
(NOTE: both Interns and partners must do this)
Print out and save a copy of your IRB
Certification.
Submit an IRB protocol for your project.
Prior to submission of an IRB protocol
Turn into the Delta Internship Program during the
seminar
A minimum of 4-8 weeks prior to the
beginning of any data collection for your
project
Upon receiving notification of approval or
exemption from the IRB
Turn into the Delta Internship Program during the
seminar
Begin data collection for your project.
Submit a copy of your IRB Certification and
protocol approval to the Delta Internship
Program.
Note: You should plan on the approval/exemption process taking a minimum of four weeks, so you
will need to plan accordingly. If, for example, you want to collect data about student learning through
a pre-survey at the beginning of the semester, you will need to have IRB approval or exemption in
place before that time.
Overview of the IRB review process:
IRB Certification via on-line tutorial
Write IRB protocol
General Protocol Information form
Project Sponsorship Info form
Review Type form
Study Description form
Upload relevant
assessment instruments
(e.g. surveys)
Use consent form wizard
& create project-specific
consent form; upload
Submit protocol for IRB review
Upon notification of exemption
or approval:
- begin data collection
- notify Internship Pgm
Note: Both Delta interns and their faculty/staff partners are required to complete the online IRB
Certification prior to creation and submission of a project protocol.
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Information about IRB Certification
You can access the University's web site at
http://info.gradsch.wisc.edu/research/compliance/humansubjects/ for more information on this
subject. There is a link to an on-line version of the tutorial at Step #2: Take required training
(Human Subjects Tutorial (on-line) link). See below for anticipated changes to the Certification
process that may affect you in the future.
As detailed in the above table, you and your internship partner MUST complete the tutorial BEFORE
initiating the project and any data collection. You will also need to complete the tutorial in order to
submit your protocol to the IRB.
Once you have taken the on-line IRB certification, you will need to send the following information to
the current Education IRB Program Associate. Check here:
http://www.grad.wisc.edu/research/hrpp/edirb/ed.ContactInfo.html
1.
2.
3.
4.
5.
Your name
UW net ID
Campus address
Campus phone #
E-mail address
Tell him/her that you need to be added to the webkit database. Your Internship partner can give you
security clearance in a protocol once you have been added to the database.
You should also plan to print out a copy of your IRB Certification to turn into the Delta Internship
Program.
Information about IRB Review of the protocol
Most Delta Internship projects will involve research conducted in established or commonly accepted
educational settings, involving “normal educational practices”, such as:
1. research on regular and special education instruction strategies, or
2. research on the effectiveness of or the comparison among instruction techniques, curricula, or
classroom management methods.
Exemption from IRB review
Because you will likely be doing what constitutes normal educational practices, your IRB protocol is
likely to be classified as exempt by the IRB. This status is applied to protocols that are determined to
pose no more than minimal risk to study participants. If a protocol is determined to be exempt from
review, it is not subject to continuing review or other rules governing human research, such as the
rules on informed consent.1
Even if you believe that your project falls into this category, you will still need to submit an IRB
protocol.
1
Go to: http://www.grad.wisc.edu/hrpp/view.php?id=10024&f=htm for the categories of research that may
be exempt from IRB Review, information downloaded 7/5/07.
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Expedited review
If your protocol is not exempt, but still uses primarily normal educational practices, it may qualify for
expedited review. An expedited review procedure consists of a review of a research protocol by the
IRB chair or by one or more experienced IRB members. Categories of research that may be reviewed
through this procedure include2:
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Collection of data from voice, video, digital, or image recordings made for research
purposes.
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Research employing survey, interview, oral history, focus group, program evaluation,
human factors evaluation, or quality assurance methodologies
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Research on individual or group characteristics or behavior (including, but not limited to,
research on perception, cognition, motivation, identity, language, communication, cultural
beliefs or practices, and social behavior)
Full review
Few, if any, Delta Internship Projects require full IRB review. Information about this process can be
found at the UW IRB website at: http://www.grad.wisc.edu/hrpp/view.php?id=10083&f=htm
Inclusion of minors (e.g. K-12 outreach projects)
Projects that involve informal science education and outreach in the schools or other settings will face
the issue of collecting data from children. Most commonly, children participate in research only if there
is no greater than minimal risk to them and the IRB finds adequate provisions are made for soliciting
the consent of the parents or guardians of children and the assent of the children. 3
These projects may still qualify for exemption from IRB review, particularly if they involve normal
educational practices. A protocol must still be submitted.
Accessing the IRB Webkit
The Wisconsin Center for Education Research has prepared a thorough “IRB WebkitTutorial”. This
document will step you through the UW Human Research Protections Program web page and the initial
steps of the on-line submission process. This resource can be found at:
http://www.wcer.wisc.edu/grantServices/propPrep/tutorial_1.php
If you have additional questions after reading through the material that follows, the IRB has also
created a thorough “Webkit Instructions Reference Manual”. This document can be found at
http://www.grad.wisc.edu/research/compliance/humansubjects/WebKitInstructions.pdf
Note: for an intern to create a protocol using the on-line forms, the PI on the project will have to
grant them access. 1) From the list tabs of available Forms, select “Security” (step 9 in the WCER
handout). To grant another person access to this protocol, click the "Grant Access" button. If they
have been certified, their name and contact information should appear in your search. If not, contact
the Delta Program at internship@delta.wisc.edu for help.
2
Go to: http://www.grad.wisc.edu/hrpp/view.php?id=10092&f=htm for the categories of research that may
undergo expedited review, information downloaded 7/5/07.
3
Go to: http://www.grad.wisc.edu/hrpp/view.php?id=10096&f=htm for information about collecting data from
children, information downloaded 7/5/07.
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Consent form wizard
There is an on-line consent form wizard that will allow you to create an informed consent form for
your project. You can access it via a link at “7. Plan for Informed Consent and HIPAA Authorization” on
the main IRB page, or by going to the following URL:
https://rcr.gradsch.wisc.edu/cfwizard/start.asp?wisc
Note: Delta interns and their partners have typically submitted proposals through the
Education IRB.
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Example IRB protocol
Text from an example IRB protocol is included here to help you think about language you
might want to use to frame your project. Look to the text boxes throughout for specific comments
about individual forms. This form can be accessed on-line at the University's web site at
http://info.gradsch.wisc.edu/research/compliance/humansubjects/
General Protocol Information form
Make sure that you give yourself 4-6
weeks after you submit to the IRB office
before your project starts.
Also, give yourself at least 1-2 years to
complete the project (under duration).
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Pre-internship workshop - IRB Process
E-mail the Internship
Program coordinator if you
plan to collaborate with
researchers from a
different campus.
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Pre-internship workshop - IRB Process
The internship partner
will serve as the PI
The intern will serve
as the co-investigator
Once you complete this form, go on to the
Project Sponsorship Information form.
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Pre-internship workshop - IRB Process
Project Sponsorship Information (current or planned) form
Consider using text similar to what follows for Question #4 above about funding.
“The instructional materials will be developed by INTERN’S NAME during an
internship with the Delta Program in Research, Teaching and Learning (Delta;
www.delta.wisc.edu) at UW-Madison. This program provides teaching
professional development activities for graduate students. INTERN’S NAME will
participate as an intern as part of his/her Delta Certificate requirements.
More information on the Delta Internship Program can be found at the following
URL:
http://www.delta.wisc.edu/programs/internship/internship_guide/intern
ship1.html
Once you complete this form, go on to the
Review Type form.
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Pre-internship workshop - IRB Process
Review Type form
Projects are typically exempt.
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Yes, if a K12-focused project
You will likely be checking
“Yes” to Question #7a.
Yes, for example, if your project is
situated in a class that you are TA-
Once you complete this form, go on to the
Study Description form.
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Pre-internship workshop - IRB Process
Study Description Form
Note: Text examples, particularly where the fields have been truncated in the image below, can be
found following this recreated form.
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Additional Text examples:
ABSTRACT (Be sure to include specific aims of your study)
As new technologies arise and become commonplace, new curricula must be designed
to teach students about these technologies. To increase student exposure to
renewable fuels topics, new lecture and laboratory materials were created for general
chemistry classes at Madison Area Technical College (MATC). These materials were
developed during an internship with the Delta Program at UW-Madison. Stephanie
Britton worked in collaboration with Ken Walz and Holly Walter Kerby, faculty
members at MATC, to produce and test these materials. The effectiveness of the
materials was tested by giving students pre- and post-tests to gauge what they
learned from the lecture and lab materials - all normal educational practices to
improve classroom teaching and student learning. All students participated in the
laboratory activities, which were mandatory. Students who elected to complete the inclass activities based on the lecture material and fill out the pre- and post-test surveys
were awarded points. All students were given equal opportunity to earn these points.
The pre- and post-test surveys will be studied with any identifying information
removed, so as to protect student confidentiality. Because pre- and post-test and
laboratory activity results will be compared, student identifiers will be replaced with
random numeric identifiers. We expect that the results will be aggregated prior to
publication.
The specific aims of this study are to: 1) Analyze the correctness of the existing data
(e.g. student responses in the pre-test to the post-test responses); 2) Use this
analysis to revise the afore-mentioned instructional materials; 3) Prepare a manuscript
for peer review, or a presentation of data for disciplinary meetings, based on our
analysis, that details these instructional materials and their benefits for student
learning.
STUDY DESIGN AND METHODS
Inclusion Criteria
Participants included all students registered for the courses taught by Ken Walz and
Holly Walter Kerby at MATC (a class for science majors and a liberal arts chemistry
class, respectively) during the fall semester, 2006.
Justify the number of participants (sample size) entered above.*
Of the two classes involved in testing the educational materials, one has a registration
limit of about 30 students, and the other has a registration limit of 20 students.
Role of Participants
This study will use existing data. The data was collected during the fall of 2006.
Normal educational practices were in use to improve instruction about biodiesel. The
laboratory exercise asked students to synthesize biodiesel, characterize it, and
compare its properties to those of other compounds. This activity took place in the
regularly-scheduled laboratory during the fall semester, 2006. The lab activity required
only as much time as any normal laboratory exercise would. The students were asked
to read a one-page document and complete a few questions as a pre-lab exercise in
preparation for the class period. The students then completed a two- or three-hour lab
activity depending on which class they were enrolled in. The length of time varied for
the liberal arts chemistry class versus the class for science majors. The post-lab
analysis was also typical in difficulty and length for the class. The lecture materials
varied by class. The materials developed for a chemistry class for science majors
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Pre-internship workshop - IRB Process
included a hands-on activity where the students manipulated molecular models to
work through the biodiesel reaction and more fully understand what occurred during
the lab activity. This took place during a regularly scheduled lecture period in the usual
classroom. The pre- and post-test surveys were completed out of class but did not
require more time to complete than a typical class assignment. The lecture materials
for the class for liberal arts majors included an online learning object about renewable
fuels. The students were asked to complete the post-test worksheet while working
through the learning object and then to fill out a survey about their satisfaction with
the learning object. Those students who did not attend class on the day the learning
object was administered were given the website address and worksheet so they could
complete the activity on their own time. In this way, all students had the opportunity
to earn the points from the post-test and satisfaction survey. These materials were
completed in one 50-minute class period. Those students who completed the learning
object on their own time would not have required more than 50 minutes to complete
the exercise. The satisfaction survey was completed by most students in five minutes
or less. No deception was involved in any of these activities. Students were given clear
instructions for completing the pre- and post-tests and the lecture and lab activities.
Confidentiality will be maintained by removing any identifying markers from the preand post-test results and the results of the satisfaction survey. This will be done by
the supervising instructors at MATC, Ken Walz and Holly Walter Kerby, before the
existing data is given to Stephanie Britton and Don Gillian-Daniel to be analyzed and
the results aggregated for publication.
Compensation
The students received points that were factored into their final grade for turning in the
pre- and post-tests and the satisfaction survey, if they were asked to complete one.
The laboratory pre-lab and analysis questions were graded on the same scale as all of
the other laboratory exercises for the course.
Sites
The project that produced the data that will be used in this study occurred in
classrooms and laboratories at the Madison Area Technical College during the fall of
2006.
Measurement Procedures
The teaching materials will be evaluated, and their success determined or measured
by comparing the correctness of the student responses in the pre-test to the post-test
responses.
Steps to Minimize Risks
All identifying markers will be stripped from the pre- and post-test data. Results, when
they are presented, will occur in aggregate.
Possible Benefits to the Participants
Future students who are exposed to these or similar educational materials will learn
about renewable fuels and will be able to make informed choices about buying
renewable fuels for their own use.
Benefits to Society
Disseminating objective information about renewable fuels and their benefits and
drawbacks will help to counteract the misinformation being distributed by groups with
an interest in encouraging or dissuading renewable fuels use.
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