Dickinson State University IRB Classroom Research Project Policy
*** If you are doing research in the classroom you MUST consider the following. ***
The Dickinson State University IRB’s policy is to review all human subjects research
conducted by faculty, staff, and students. The IRB must determine if studies meet the
Code of Federal Regulations definition of “Research,” which requires a formal IRB
application. Many class-assigned projects using humans as subjects do not meet the criteria in the
federal definition of research (i.e., “a systematic investigation, including research development,
testing and evaluation, designed to develop or contribute to generalizable knowledge”). In some of
these cases, classroom projects may not require an IRB application.
To minimize administrative burdens on instructors and students, the IRB offers instructors an
alternative to requiring each student to submit an IRB application, provided NONE of the conditions
in A below are met and the instructor agrees to fulfill ALL responsibilities in B.
A. An IRB application is required when the study meets one or more of the following conditions:
1. Use of vulnerable populations or minors.
The project(s) cannot involve minors (under 18), prisoners, or persons lacking the capacity to
give informed consent or other vulnerable populations as defined by Title 45 CFR, Part 46.
2. Publication or presentation outside of Dickinson State University.
Data obtained from this class project can NEVER be used for public dissemination, senior
thesis research, presentation outside of DSU including to any media outlets.
3. Risk more than “Minimal Risk.”
“Minimal risk” is when “the probability and magnitude of harm or discomfort 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.” [45CFR
46.102(i)]. More than “Minimal Risk” can include any activity that might create discomfort for
the student conducting the project or for students taking part in the project, including but
not limited to sexual attitudes, behaviors, or situations; confrontational situations;
involvement of an authority figure such as an instructor, coach, etc.; illegal behaviors; and/or
the use of alcohol or drugs.
4. Use of deception.
The class project may not include deception of any kind. All subjects must be fully informed
of the nature of the project, its risks and benefits, and give voluntary consent to participate.
5. Use of videotaping, audiotaping, or photography.
The collection of video, audio, or photographic data is not allowed under the IRB waiver.
B. Instructors granted a classroom research project waiver must accept primary responsibility for
ensuring the rights and welfare of the human subjects. Instructors must also:
1. Submit an Application to use Human Subjects in Research if the instructor is doing research in the
classroom.
If the instructor is either collecting data from the students in their class or will be using data
students have collected from other subjects, an appropriate application must be submitted
DSU IRB/Classroom Research Project Policy
for approval to the IRB. Once data collection has begun, the instructor cannot change their
mind and submit an application after the fact. Retroactive IRB approval will not be granted
under any circumstance.
2. Train students in the proper conduct of research and the protection of human subjects.
To supplement classroom instruction on research ethics, the IRB requires instructors to have
students complete the NIH Protecting Human Research Participants online training program
prior to beginning the classroom research project.
3. Review Student Class Project Applications and determine if each project qualifies for a
waiver.
The IRB does not review these applications. Instructors are responsible for keeping all
paperwork associated with the course for a period of three calendar years, in compliance
with federal regulations.
4. Review all methods and instruments used in each project.
All written materials presented to human subjects must be at an appropriate reading
comprehension level (generally defined as 8th grade) and/or be a certified translation for
non-English-speaking participants.
5. Document that students receive official permission to conduct research at organizations
or institutions other than Dickinson State University.
This includes letters from a facility official authorized to approve such activities, for example.
6. Instructors are responsible for ensuring students obtain informed consent from all human subject
participants.
Procedures
1. Instructor submits Request for Classroom Research Project Waiver of IRB Application to IRB office
for review.
2. IRB reviews, requests clarification (if necessary), and issues approval or denial notice.
3. Students must provide a complete description of their proposed project to the instructor, who
reviews for waiver compatibility and retains for three calendar years, in compliance with federal
regulations. The student description must include:
a) Project title, name(s) of student(s) conducting the project, course number and name,
instructor name, and semester.
b) Expected sample demographics, including age range, gender distribution, and inclusion or
exclusion criteria.
c) Where subjects will be recruited from and how they will be recruited (direct contact, email,
phone call, etc.).
d) Data collection procedures.
e) Facilities and equipment to be used.
f) A complete description of the project.
g) Privacy and confidentiality procedures, including how and where data will be stored.
h) A copy of the informed consent document that will be used.
i) A description of the project’s risks and benefits.
j) A description of any compensation offered for participation in the project.
k) A statement that all information provided is complete and accurate.
l) The signature of all student investigators with the date signed.
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DSU IRB/Classroom Research Project Policy
m) A copy of the NIH Protecting Human Research Participants online training certificate of
completion for all students involved as “researchers” in the project.
No class project can be conducted until the instructor has submitted the “DSU Application for
Classroom Project Waiver of IRB Review Requirement” form and it has been approved by IRB. No
group or individual student class project can be conducted before the required description of the
proposed project has been submitted to and approved by the instructor. Group or individual student
class projects that do not meet waiver criteria as given on the “DSU Application for Classroom Project
Waiver of IRB Review Requirement” form cannot be conducted until the IRB Application to Use Human
Subjects in Research is submitted to and approved by the IRB.
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DSU IRB/Classroom Research Project Policy
Dickinson State University
Application for Classroom Project Waiver of IRB Review Requirement
Instructor Information
Name:
Department:
Email:
Phone:
Course Information
Course Number and Title:
Academic Term:
Describe the class project:
Describe steps that will be taken by the instructor to maintain confidentiality and minimize risk:
Waiver Checklist (All of the following must be checked to qualify for IRB waiver):
1.
2.
3.
4.
5.
6.
7.
8.
The project will not involve vulnerable populations/minors
The project will not be published or presented outside of DSU
The project involves no more than “Minimal Risk”
The project does not involve sensitive topics or confidential information
The project does not use any type of deception
Subject confidentiality will be maintained
The project will not involve collection of video, audio, or photographs
Informed consent will be collected from participants; participants
will be informed they do not have to take part in the project and can
withdraw at any time
9. The instructor and students have completed Human Subjects
Research Training
10. The project is a requirement for a DSU course
11. The instructor insures the students will adhere to ethical principles
12. The instructor has read and understands the Dickinson State University
IRB Classroom Research Project Policy
This waiver has been
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IRB Chair
Date
Waiver ID Number
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