Classroom research and independent research projects

Overview

The University encourages novel and innovative classroom activities in support of its teaching mission. Many student class assignments, such as those commonly used in research methods courses, do not meet the federal regulatory definition of ‘research.’ Therefore, student class assignments ordinarily do not fall under the jurisdiction of the IRB and do not require IRB application, approval, or oversight.

A student class assignment, in general, is:

• An activity designed as part of a course requirement for purposes of learning research methods, such as the consent process or data collection;
• An investigation that a student conducts as a class assignment designed to teach human subject research methodology; and
• A project not intended to produce findings that will be applied more broadly to the population at large.

Parameters for class assignments

• NO VULNERABLE POPULATIONS: The project cannot include minors or any other vulnerable populations such as pregnant women, prisoners, those who lack the capacity to consent, non-English speaking individuals, etc.
  • Exception: Projects conducted in established or commonly accepted educational settings, involving normal educational practices, such as: work on regular and special education instructional strategies, or work on the effectiveness of, or the comparison among instructional techniques, curricula, or classroom management methods.
• NO MORE THAN MINIMAL RISK: “Minimal risk” means 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. This also precludes the study of any illegal activities or the collection of private information that could put the participants at risk through a breach of confidentiality.
• Projects involving drugs and/or medical devices always require IRB review and approval.

Guidance for instructors

Whenever class activities involve ‘human subjects’ but do not meet the federal definition of ‘research,’ course instructors and their students must be aware of and understand their responsibilities. Course instructors have ultimate responsibility for assuring that the rights and safety of participants are not violated and for the ethical behavior of students when conducting the project. Students need to take personal responsibility and have accountability for their actions, as well. The course instructor must personally evaluate each class project and provide supervision and guidance during its conduct.

Course instructors should ensure the following when evaluating a class project and advising a student:

• The purpose of the proposed project and the procedures to be carried out is practicable and has merit;
• The process by which participants will be recruited does not unfairly target a particular population unless proper justification has been made to do so;
• The participants will be treated with respect;
• The privacy of the participant and confidentiality of the date will be protected;
• The potential risks to individuals are minimized;
• The data collected from participants does not contain identifiable private information when it is not required for completing the class project; AND
• Informed consent must be obtained. The consent should clearly identify the following:
  • The project is being conducted as part of a class project and not identified as a research project
  • The extent of where/how the information will be used
  • A description of the procedures involved
  • That participation is voluntary
  • Contact information for the instructor

Training requirements for class projects

It is recommended that all students complete the appropriate CITI course if they will be conducting a project during the course of a class.

• Instructors assigning class projects are required to complete the required human subjects training program.
• It is recommended that instructors require students to complete the IRB training tutorial as part of the learning experience, even in cases when student projects do not require IRB approval.

Independent research projects

Independent research projects, such as scholarly projects, internships/practica, theses/dissertations, and honors projects, may fall under the jurisdiction of the IRB if the information is collected in a systematic manner and there is intent by the student researcher to apply the research findings and conclusions from the study to the population at large.

In the case of the scholarly project, internship, or practicum, the student may complete a project on behalf of an organization that would involve interaction with human subjects. The student’s primary goal, however, is educational, whereas the organization for which the student is volunteering may use the information collected for quality improvement or publication. For purposes of the NAU IRB, these projects do not constitute research. Activities conducted at another site in connection with the internship or scholarly project are subject to the review and approval of the specific site.

Note: Please contact the HRPP if federal funding is involved.

Conclusion

If a student class assignment or an independent research project is collected in a systematic manner and is intended to be applied more broadly to the population at large, this is Human Research and an IRB application must be submitted for review and approval prior to conducting the study.

For student class assignments that constitute Human Research, the instructor must be listed as the PI, and the student(s) may be listed as Co-PI. For independent research projects that constitute Human Research, the student’s advisor/mentor must be affiliated with the NAU.

Version 2019-8