IRB Research Guidelines
The purpose of an IRB is to review research conducted using human subjects. For the purposes of APUS IRB, research is defined as being both:
Systematic research includes research development, testing, and evaluation, and it is designed to create generalizable knowledge. Generalizable knowledge involves the creation of new knowledge that may be the basis for scholarly publication, including a capstone thesis or project. In summary, if the project is designed to include human subjects, create new knowledge and may be published, an IRB review will be required prior to conducting any research.
Class Assignment vs. Research
A class assignment may not need IRB approval if it does not fit the above definition of research. An assignment may involve collection of data from human subjects when the data is used solely for the purpose of teaching course content and is not intended to be used to develop or contribute to generalizable knowledge. For instance, interviewing an individual for a specific course assignment may not require IRB approval if the interview is only used as the basis for a single assignment and does not contribute to a research study.
Once something is classified as a class project, it is always a class project. In other words, retroactive approval for data collected during or after a class is not allowed. All data collected for research purposes must have received IRB approval prior to data collection.
All projects where human subjects may be involved must have the explicit approval of the course instructor prior to submitting the application for IRB review.
Please note: IRB approval cannot be provided retroactively.
If students (or instructors) think the data may be used for research purposes beyond the in-class assignment, then an IRB application must be completed and submitted for IRB review, prior to conducting any research. A student who does not secure IRB approval for the class project, but wishes to present their project to their course of colleagues, can do so as a classroom research project, but not as a research study. Keep in mind when making the data from the project public via a blog, conference presentation, etc. does constitute a research study.
Any research conducted prior to IRB approval will be considered a violation and may not, under any circumstances, be used for the research study assignment.
Principal Investigator Responsibilities
Because most graduate level projects are very time sensitive, graduate students are encouraged to begin discussing the nature of their research design plan and its potential for IRB review with their instructor as soon as possible. Students should expect the IRB process to take at least one month. All IRB applications MUST have instructor approval.
- Complete the required CITI training: Social and Behavioral Research Investigators course. Visit the Research Ethics Training page for more information.
- Follow the IRB step-by-step process.
- If IRB approval is received, it is the investigator's responsibility to ensure appropriate human subject protection while conducting research.
- Once the IRB has approved the research, the investigator will need to contact the IRB if there are changes in the study protocol, adverse events (should any occur), and/or project renewals. Visit the IRB Application Process page for forms needed to complete any of these situations.
For an in-class assignment that requires an IRB review, instructors have an obligation to ensure that students understand their ethical obligations in carrying out their research design plan. Instructors will need to provide guidance to students collecting human subject data in order to minimize any unwitting or unintentional harm to their subjects or other students, especially if students will interact with or collect private information about vulnerable individuals.
Suggested options for instructors:
- Review and confirm if the student’s classroom or group project involves human subject research and requires IRB approval.
- Review and suggest improvements in design, spelling, grammar and protections for confidentiality.
- Confirm students have taken the CITI online training on human subject protection.
- Review and confirm students have completed all required support documentation, prior to signing the IRB application.
- Course instructors who require such assignments are encouraged to undergo CITI IRB training in order to ensure that their assignments and the work their students produce comports with federal rules and guidelines.
- Suggest, whenever possible, anonymous data collection so the data is not linked to the subjects identifying information.
- Suggest that information identifying participants be kept separately from the information collected from the subjects.
- Instruct students about the privacy and security vulnerabilities associated with networked computers.