IRB approval is not required if the course-related student project meets all of the following criteria:

1. The purpose of the assignment or activity is to teach research methodology.
2. The results of the assignment do not develop or contribute to generalizable knowledge because the activities are course assignments/projects conducted by a student to satisfy the curriculum requirements of a course, and are typically concluded at the end of the relevant semester(s), AND either:
   • The results of the project do not at any time leave the University of Iowa campus, OR
   • The project involves gathering data from or about a company, agency or organization and the data/results are either (i) shared only with that company, agency or organization to be used for internal quality assurance or quality improvement purposes, or (ii) owned or controlled by that company, agency or organization under the terms of an agreement to conduct the project such that it is unlikely the data/results will be widely disseminated.
3. The project is limited to surveys, questionnaires, interview procedures, observation of public behavior, or standard educational exercises.
4. The project does not include prisoners, children, or their data.
5. The information is recorded by the researcher without any direct or indirect identifiers (code numbers or pseudonyms) linking anyone to his/her data, OR, if direct identifiers are used when recording the data, the information gathered could not reasonably harm a person’s reputation, employability, financial standing, or place a person at risk of criminal or civil liability.
6. University of Iowa faculty, staff and students do not receive monetary compensation or any type of support from an external company, organization, or agency for collecting, analyzing or reporting the results of the project.
7. The project is not conducted on Iowa City Veteran’s Administration Health Care System (VAHCS) premises and does not use VAHCS resources.
8. The project is not conducted or supported by a federal department or agency that has adopted the Common Rule (45 CFR 46 subpart A).

NOTE: Honor’s, Master’s, and Doctoral thesis and dissertation projects that involve research with human subjects always require IRB review and approval.

The IRB provides a Course-Related Student Project Checklist to assist instructors and student researchers with determining whether the project can be conducted without IRB approval. Based on the responses to the questions in the checklist, students may be instructed to submit a Human Subjects Research Determination (HSRD) form in the eResearch application system (HawkIRB) to ask if IRB approval is necessary. Student researchers should submit the form along with a project proposal to the instructor for review prior to the start of the project. Instructors should review the student proposal and the completed checklist and determine if IRB review may be necessary.

The course instructor is authorized to decide whether the project meets the requirements for a Course-Related Student Project. We strongly encourage instructors who assign course-related research projects to use the Course-Related Student Project Checklist and consult with the IRB Education & Outreach Program prior to the beginning of the semester to make sure the groundwork is laid for student projects to comply with all applicable federal human subjects research regulations and University of Iowa policies. 

Guidance for the course instructor:

1. Review student research plans prior to subject recruitment and data collection.
2. Use the Checklist for Course-Related Student Projects to determine if IRB approval may be required. (You may need to download to your desktop for full functionality) The Checklist collects information about study design and procedures to help the course instructor determine if the project can be conducted without IRB oversight or if the student researcher should consult with the IRB about whether approval is required.
3. Review any revisions to the students’ project to ensure it still meets the criteria for course-related student projects.
4. Ensure that classroom assignments are carried out with due consideration of the UI ethical and legal responsibility to protect individuals who participate in these activities.
5. Determine if a classroom project warrants enhanced oversight:
   1. Due to potential physical, psychological, social, economic, or legal risk to participants, or
   2. Because the project involves vulnerable populations, such as cognitively impaired individuals, or
   3. When students have a supervisory role in their work life over the people they want to recruit for their classroom project.
6. Educate students about the potential for harm, as listed above, and take all possible steps to eliminate risks to these individuals.
7. Provide guidance and oversight about the use of data collected in a classroom project, in a manner that is consistent with UI policy.
8. Assume responsibility in the event of a breach of confidentiality involving data collected for the project, or if data are released outside the parameters of this policy.
9. Address all complaints regarding course-related student projects.
10. Ensure that student researchers provide the following information to participants (See Student Responsibility, below)
11. Carefully consider whether students are qualified to adequately safeguard the rights and welfare of research subjects. (UI Ops Manual, Section II, Ch. 27.4) 

Students who conduct research as a course requirement, without IRB approval, must comply with the policy regarding this type of research. That includes consulting with the course instructor about whether IRB approval would be required. The results of a course-related student project may not be used for a thesis or dissertation project. If the results indicate the need for further research, the student researcher should obtain IRB approval to conduct the project outside the context of a class project.

Student researchers should conduct the project exactly as described in the Course-Related Student Project Checklist. If the project design changes, complete a new checklist and consult with the course instructor about whether IRB approval may be required.

If IRB approval is not required, provide potential subjects with the following information:

• Student name and the name of the course.
• Course instructor name and contact information 
• Who will have access to the individual data or summarized results (e.g. instructor, members of a group project team, the whole class, an outside company/organization/agency)
• Participation is voluntary; they may stop participating at any time.