IRB - Human Subjects
- Clinical Trials
- Internal Classroom Exemption
- IRB Procedure
- Your Rights as a Participant
- Levels of Review
- Paying Participants
- FAQ / Terms
Internal Classroom Exercise Exemption
"Internal Classroom Exercises" refers to any class related project/assignment that involves human participants conducted primarily for the purpose of evaluating learning or teaching students to do research. Even though this work is not defined as research (defined in the federal regulations as a "systematic investigation designed to contribute to generalizable knowledge") the Institutional Review Board must be notified before the exercises begin to ensure that they fall within the parameters given below and do not require IRB oversight. The purpose of this exemption is to improve communication between the instructor and the IRB to determine which projects shall require IRB oversight, and assist the student in completing his or her project in an efficient and effective manner.
Generalizable Knowledge: In order to contribute to generalizable knowledge, the activity’s conclusions are intended to be extended beyond the sample or internal program. The dissemination of findings to an external or scientific audience is a sufficient criterion for identifying generalizable knowledge.
Application materials are to be found in IRBNet.org in the Forms and Templates section. All appropriate Internal Classroom Exercise Exemption forms are marked with “Class Project”. Instructor Exemptions (including surveys and consent forms) should be submitted in word.doc format, and Student Code of Conduct forms are to be consolidated and scanned into one .pdf file.
Parameters for Classroom Projects
No minors or vulnerable populations: The project cannot include minors or any other vulnerable populations like pregnant women, prisoners, and those who lack the capacity to give consent.
No more than minimal risk: The project does not involve any risks of harm that is normally encountered in the daily lives of healthy individuals. Also, this includes the study of any illegal activities or the collection of private personal information that could put the subjects at risk through a breach of confidentiality.
No Deception: The classroom project cannot include deception. Participants must be informed and given the opportunity to voluntarily consent to participation.
No Publication: Data from class projects approved under this exemption cannot be used for publication. This also includes data collection for thesis, capstone, dissertation, and practicum research.
No video or audio taping: To ensure the anonymity and confidentiality of the participating no video or audio taping of the participants is allowed under this exemption.
If a class project does not fall within the above parameters, the instructor will be notified and the student must complete a Human Subjects Research Application that will go through the normal review and approval process.
Responsibility of Instructors
Course instructors have the primary responsibility for ensuring that the rights and welfare of all participants are protected. This responsibility includes: communicating to students the ethical principles for the protection of human subjects, reviewing student class project applications, supervising their activities and consent procedures. All adverse incidents must be reported to the IRB immediately.
- Course instructors are responsible for completing an Instructor Exemption for Class Projects and submitting it, along with the class roster to the IRB. The exemption is valid only for the academic semester and will expire at the conclusion of the class.
- Instructors are responsible for educating and training students in human subjects research ethics and the institutional policies and procedures covering human subjects research.
- Instructors are responsible for prior review of student applications to ensure compliance with the listed parameters of classroom projects. Instructors must review and approve informed consent procedures. It is recommended by the IRB to use the sample informed consent form.
- Instructors must review and approve instruments, methods, and procedures prior to use by students.
- Instructors are responsible for ensuring that students obtain authorization for access to other institutions and organizations.
- Instructors are responsible for any violations incurred in their students' research projects.
- Instructor Exemption for Class Research Projects
Note: documents in Portable Document Format (PDF) require Adobe Acrobat Reader 5.0 or higher to view,
download Adobe Acrobat Reader.
Note: documents in Excel format (XLS) require Microsoft Viewer,
Note: documents in Word format (DOC) require Microsoft Viewer,
Note: documents in Powerpoint format (PPT) require Microsoft Viewer,
Note: documents in Quicktime Movie format [MOV] require Apple Quicktime,