Guidance and Application for Course Instructors
Guidance for Student Projects Conducted to Fulfill Course Requirements
Is IRB Review Required for Student Course Projects?
SCSU uses the definition of “research” provided in the Federal Regulations about the protection of human research participants to govern the scope of the IRB. This definition of “research” is: §46.102(d) Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Student projects that are conducted solely for a course grade are not considered to be "designed to develop or contribute to generalizable knowledge" and are not subject to IRB oversight. As the intent of such activities is to educate students in the methods and techniques of research and are not intended to add to the body of generalizable knowledge in the discipline, they do not meet the definition of research defines the purview of the IRB, and need not be presented to the IRB for review.
Instructors who incorporate such class assignments into their courses must complete the Course Instructor Notification Form and file it with the IRB. This serves not only to notify the IRB of the projects, but also confirms that the projects do not require IRB review. An instructor must complete this form for each course taught in which students collect data from people for classroom research projects. Once filed with the SCSU IRB, the notification for that course will remain in effect until changes in the course are made. At that point, the instructor must renew notification for that course. This process is not appropriate for undergraduate honors theses, MA theses or special projects. These types of research do qualify for IRB review and should be submitted for review prior to recruitment of participants.
Instructors wishing to submit Course Instructor Notification must complete an on-line tutorial presented by CITI (see the IRB website for the link). A certificate of completion will be issued on-line (which may be printed and downloaded) when the tutorial has been successfully completed. This certificate must be submitted with the SCSU IRB Course Instructor Notification Form. Once approved, a copy of the form signed by the SCSU HRPP IRB chair will be returned to the instructor.
The form can be accessed here: Course Instructor Notification
Class assignments often are also not intended for distribution of the results outside the classroom. Such distribution, if done, should be limited in scope, and clearly marked as a course assignment. An example would be an on-campus forum highlighting the scholarly excellence of the work done in a course. This is different from a professional conference where the advance of knowledge in the field is highlighted. If a project is intended for professional distribution, it indicates that it is being conducted to create generalizable knowledge, and therefore should be submitted for IRB review prior to its initiation.
Guidance for Course Instructors
As course assignments are not considered research, and academic freedom prevails, the IRB has no oversight on what happens in courses unless the projects meet the definition of research above. However, the IRB is uniquely positioned to offer insight and advice for faculty who assign such projects in their courses. This guidance is intended to assist faculty who teach courses which involve training in human subjects research. To this end, course instructors are invited to use any and all IRB education and guidance as course materials.
The fact that IRB review is not required for class assignments does not mean that no rules apply. Education on the ethics of research should be part of any research training. Any student class project should adhere to the ethical standards of the discipline as well as any university policy state law, or federal regulation. In the case of course assignments, the responsibility to ensure that ethical standards are followed falls to the instructor. That is, the course instructor must provide oversight and guidance as needed. This is consistent with a course instructor’s role regarding any course assignment.
Suggested practices for the protection of all involved include.
- Student course projects should be limited to the research methods that are taught in the course and in which the instructor is expert.
- Class projects should present no more than minimal risk to participants. A risk is minimal when the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical, educational, psychological examinations, tests or surveys.
- Class projects should not be done with “vulnerable” populations.
- Consent or permission should be secured from participants. Participants should be made aware of the purpose of the project.
- The project should clearly be identified as a class project and include contact information for the instructor.
- Information about the anonymity of the participants and the privacy and confidentiality of data collected should be conveyed to the participants.
- Students should complete CITI training deemed relevant to the course by the instructor.
- Instructors should document their review of the projects and issue explicit approval.
- Instructors of research courses may wish to develop a student IRB as part of course activities. Students conducting research in the class submit a protocol to the student IRB thereby making the ethical review process part of the course content. A “practice” IRB protocol application is available on the IRB website for this purpose.
- It is strongly recommended that course assignments NOT include topics which participants may find traumatic or anxiety-provoking. While such topics can and should be investigated, students may not possess the resources and experience to counter negative reactions by participants.