Class Projects that are Not IRB-Regulated Research

Summary

If you are an instructor who is assigning a class research project that does not meet the definition for regulated research, please use this document to help guide your students in the development of their projects, including teaching your students what to say when communicating with people involved in their non-IRB-regulated project.

Full Description

For complete definitions of "human subjects research" under the IRB regulations, please review:

"Research" (opens new webpage) defined under 45 CFR 46 (opens new webpage)
"Human Subject" (opens new webpage) defined under 45 CFR 46 (opens new webpage)
W&M Guidance document, “Is it Research?” (opens new webpage)
W&M Guidance document, “Is it Human Subjects Research?” (opens new webpage)

Class-assigned projects using humans as subjects “purely for educational purposes" do not meet the criteria in the federal definition of research. “Purely for educational purposes” means that the class-assigned activities are conducted for pedagogical or evaluative reasons only, and information from the activities or results of the activities are not intended to be used or disseminated outside of the class or organization. Please refer to Appendix (Word doc) for examples of regulated research that may look like non-regulated research.

The primary goal of class projects is to provide students with experiential learning in research methods, including study design, data collection, and analysis. Class projects and research methods classes may involve data collection activities for training purposes that do not require IRB review and oversight because the intent is to teach methods or complete evaluation, not to develop or contribute to generalizable knowledge. The intent of class projects may be to provide the student with real world experiences, information gathering techniques, and report writing. There is no intent to develop or contribute to generalizable knowledge. In these cases, these projects do not require IRB review and approval.

Student class assignments include activities that are:

Conducted during, or outside of class, with students enrolled in an official course (for credit or not for credit).
Conducted in fulfillment of class assignments, extra credit, or required evaluation or assessment.
Typically initiated and completed within a single term
Designed to teach research methods through student interaction with individuals or information about individuals or designed to help students practice or understand concepts covered by the course.
Generally not intended to create new knowledge or to lead to scholarly publication, presentation, or widespread dissemination.

Class Projects and IRB-Regulatory Definition of "Research"

Student class assignments, generally, are not systematic data collection efforts intended to develop or contribute to generalizable knowledge and, thus, do not meet the federal regulatory definition of research. Therefore, as a rule, student class assignments do not fall under the jurisdiction of the IRB and do not require IRB application, approval, or oversight.

However, some projects have an additional goal, the intent of developing or contributing to generalizable knowledge (opens new webpage), or presenting publicly or otherwise disseminating data from the project that will be stored and used by researchers as data. These class projects constitute research with human subjects’ and IRB review and approval is required before recruitment, consent, data collection, or analysis of identifiable data may commence.

Course instructors are responsible for determining whether a project qualifies as research involving human subjects and, therefore, requires prior IRB review. You may contact the IRB office (opens new webpage) for consultation for a determination and guidance.

Instructors and students must be aware that IRB approval cannot be granted retroactively if the class project was designed to contribute to generalizable knowledge from the outset (with an intent to disseminate findings broadly). Additionally, instructors and students must be aware that seeking IRB approval may inhibit a project from completion in the timeline of one semester. This is because the IRB’s review is focused on participant protections, ethics, and compliance, not completion of an assignment.

Instructors who assign a class project that involves human subjects but is not intended for dissemination beyond the classroom are encouraged to engage their students in a discussion of the ethics of human subjects’ research as appropriate to their discipline and the methodology employed in the project. Students and instructors may find human subjects’ research training (opens new webpage) a helpful starting point for discussing research ethics and compliance.

Guidelines for Class-Assigned projects not Requiring IRB approval

If the student designed their class project with the intent to contribute to generalizable knowledge and IRB approval was not sought before implementation, data obtained from class-assigned projects cannot be used outside of the class.
For example, if the student intended to disseminate their findings broadly through publications, presentations at professional association meetings, applications for funding, or independent, honors, thesis, or dissertation research (including activities preparatory to such research, such as collecting pilot data), but they did not seek IRB approval before implementation, then the IRB cannot retroactively approve the use of this information as data for research.
If the student did not design their class project with the intent to contribute to generalizable knowledge, but yielded unexpected results that warrant further investigation or additional analysis in preparation for use outside the class setting to contribute to generalizable knowledge, IRB approval for the use of that class project information may be sought and granted by requesting the use of secondary information to be used as research data.
Approval under such circumstances is not guaranteed, and any information collected under a class project may not be accessed for analysis as research data prior to IRB approval.
IRB approval may require consent or re-consent for the use of the class project information as research data.
Sharing Results/Findings/Conclusions of Class Projects
- Some class projects have students working with companies or outside organizations as consultants or interns. In this case, since the student is not intending to share the findings outside of the class, internship, or outside organization, they do not need IRB approval.
  - It is permissible for the company or organization to share the information from the project with members of their company or organization, just like usual evaluation information can be shared within an organization or group without it being regulated by the IRB. Additionally, if the company or organization wants to use the provided information for research, they can as long as they follow their own IRB related procedures.
- Some classes invite external guests to the session when class projects are presented. The presentation of the data under this circumstance is not considered research with human subjects.
- Some class projects are displayed in a more communal way, such as in the hallway of an academic building at W&M. The presentation of the class project in this manner does not constitute research with human subjects
Students who intend to conduct research to meet the requirements for the class as well as to contribute to generalizable knowledge through dissemination in a conference presentation or publication, as a pilot for theses or dissertations, or through other avenues, must obtain IRB approval prior to beginning the project. Please refer to the “Is it Research?” guidance (opens new webpage) regarding what outlets may constitute dissemination of findings.
- The student's faculty advisor may wish to serve as the PI for the project, rather than the class instructor. This should be addressed between the advisor and the instructor.
- IRB approval may take time, so instructors and students should work together to develop appropriate timelines to incorporate IRB review and the requirements for the class project.
The participants must volunteer to participate; there can be no coercion or pressure placed on them by the researcher.

Faculty member responsibilities:

If you are the course instructor, you have the responsibility to:

Bear the primary responsibility for the class-assigned project activities and for ensuring the rights and welfare of the people involved in the project are maintained.
Guide students on project scope, such as:
- Can the project be feasibly completed in the selected timeframe (e.g., one semester)?
- Are the people being targeted as participants for the project at higher risk or more vulnerable for participating? If so, what considerations need to be taken into account, and should they be exposed to this risk for a course project?
- Discuss any legal, regulatory, contractual issues, such as HIPAA, FERPA, GDPR, international laws, contractual obligations, and W&M regulations.
Ensure that the project is not considered regulated by the IRB, IACUC, or IBC, and guide the student on how to find this out.
Take into consideration any export control or conflicts of interest issues.
Take into consideration any issues related to compensation that your departmental research office or accounting office may need to regulate.
Guide the student on the project design, including participant selection, methods employed, analysis, and responsible handling of information relating to people.
Work with the student to have an emergency plan in place if something goes wrong during information collection or during information handling/analysis, such as data security issues.
Review all communications that are sent to people regarding the student’s project.
Be available should anyone involved in the student project have questions or concerns.
Keep all paperwork associated with the class projects for one calendar year.
When required, document that students have received permission to conduct project activities at institutions other than W&M (e.g., letter of support from a school principal).
Discuss mandatory reporting and any legal obligations that may arise as related to the project and the people involved in the project.

Structuring Non-IRB Regulated Research Projects

If the student’s project is not subject to IRB review and approval, then the students can use the templates below to structure the project. Important tips for students when designing the class project:

Students must be very clear in all communications with team members, teachers, advisers, and people participating in the project that the project is being completed for a class and is not considered regulated research requiring IRB review and approval.
If the instructor or the student are unsure if the project requires IRB approval, contact the IRB Office (opens new webpage) and they will let you know if you need IRB approval in written form. Provide the following information in an email:
- Is the project systematic? Is the project answering a question; is the study design rooted in literature; is there a systematic way of collecting and analyzing the data; are the findings being synthesized within the current literature?
- Is the intent behind the project to develop or contribute to generalizable knowledge including but not limited to:
  - Presenting at university events (e.g., senior design day), symposia or conferences (refer to IRB guidance for regulated research (opens new webpage)).
  - Written reports that will be used outside the project team, publications, thesis or dissertation
- Is the intent to have the findings available for use by others to make policy decisions or other choices? Is the intent to do something else with the findings other than submit a project to the instructor?
- Does the project involve living people? If so, how?
  - Describe who the target participant group is and how the student plans on getting information from them. Will the student implement surveys, interviews, focus groups, observations, collection of secondary identifiable data, manipulation of the person’s environment (and how), provide something for the participating person to interact with and get feedback on?
If the instructor and student are sure that the project does not require IRB approval, please see the following pages for suggested language to use when involving people in your project.

Appendix: Template Language for Recruitment and Permission (word)