IRB for the Protection of Human Subjects Guidelines for Class Projects
Federal regulations and Simpson University policies require IRB approval for research with human subjects. This applies whether the research is conducted by faculty or students, by individuals or a group. Although many class projects are conducted for educational purposes and do not constitute research, some may. Failure to obtain proper approval in advance for such projects may place your participants at risk for harm, jeopardize your data, prevent you from publishing the results, and place you and the university in violation of federal regulations.
The guidelines below are intended to assist instructors in determining when class projects meet the definition of research with human subjects and require review by the Simpson University Institutional Review Board (IRB). (Please note that the IRB cannot grant “retroactive” approval after research is completed; you should err on the side of submitting research applications to the IRB or consulting with the IRB if there is any doubt.)
If any of the questions below are answered “YES” then IRB review is needed.
1. Does the project meet the official definition of research; a systematic investigation designed to develop or contribute to generalizable knowledge?
Many class projects are intended to provide a learning experience for students, such as to teach research methodologies or techniques, rather than a contribution to the academic literature in a particular area. If the project is intended to be published, presented at a scholarly conference (including the annual Simpson University Research Symposium), or appears to add to generalizable knowledge, then the project must be submitted to the IRB.
If the project will include vulnerable populations, as defined by federal guidelines to include “children or adolescents (individuals under age 18), prisoners, pregnant women, mentally disabled persons or economically disadvantaged persons,” then it must be submitted for IRB review.
Minimal risk is defined by federal guidelines as “the probability and magnitude of harm or discomfort anticipated 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.”
Projects are deemed to be more than minimal risk and will require IRB review if they involve:
- Topics that could lead to significant emotional distress in participants beyond stress that would be experienced in daily life.
- Sensitive information including, but not limited to: sexual attitudes/preferences, psychological health, or the use of alcohol or drugs.
- Exposes participants to the following risks if information is released requires IRB approval: financial damage, a reduction in employability, or any potential damage to their reputation, including criminal/civil risk.
Any senior capstone or master’s thesis involving human subjects needs IRB review. IRB review is needed if the project includes direct interaction with individuals (e.g., in person, or via mail, email, web survey or telephone), or data from human subjects for which the researchers will have access to identifiers. IRB review is also required if the research includes secondary analysis of data where a link exists between data and personal identities.
If the class project meets the definition of research:
- The instructor should meet with the student to prepare the IRB research application.
If the class project does not meet the definition of research:
- It is the responsibility of the instructor to ensure that the student project does not meet any of the criteria above.
- The Simpson University IRB strongly recommends that instructors require all students who will be interacting with human participants to complete the IRB research application as part of the class assignment, even though this application will not be reviewed by the IRB. This will (1) educate students about the research process and the importance of peer review of research ethics in that process; (2) prepare students to complete the IRB research application if and when they conduct independent research projects; and (3) allow the instructor to provide detailed feedback to each student about the ethics of his/her project.
- It is the responsibility of the instructor to ensure that the class project is conducted according to the ethical standards of the relevant discipline. The IRB strongly encourages instructors to refer their students to the Human Subjects Protection Training guidelines on the Simpson University IRB website.
- Remember that from the participant’s viewpoint, giving out personal information does not differ for a class assignment or a research project. Personal information is personal information. Instructors should advise students to identify the project to participants as a class assignment and be sensitive to the personal nature of the obtained information. Labeling the class project as “research” is inaccurate and misleading to participants.
- Students should inform participants that data will be destroyed after their assignment or class project is completed.
- Instructors are advised to tell students that data from human subjects should not contain any personal, identifying information whenever possible. Instructors should ensure that the privacy and confidentiality of participants is protected.
- All class projects must include informed consent language that closely follows the guidelines (see informed consent guidelines in the Simpson University IRB Policy and Procedure Manual or online.
- The IRB is available to give feedback on any proposed class project not meeting the definition of research even though the IRB would not officially review the project.
We would like to acknowledge the use of IRB/HPRB guidelines on class-related projects from Concordia University, Liberty University, Pacific Lutheran University and Pennsylvania State University.