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St. Cloud State University

St. Cloud State University

Institutional Review Board: Student Research Involving Human Subjects

Most student projects or assignments do not require review by SCSU's Institutional Review Board for the Protection of Human Subjects (IRB).

Faculty Sponsors are responsible for both:

  • evaluating students' proposed projects to determine whether the projects fall under the definition of "research" and meet the criteria for IRB review (see below)
    AND
  • providing supervision and guidance to students during the execution of all projects involving human subjects--regardless of whether the projects require IRB review.

When faculty sponsors are uncertain about whether their students' projects constitute research and require IRB review, they should contact the Office of Sponsored Programs (OSP). If OSP believes that a particular project is subject to IRB review, the student researcher must submit an application to SCSU's IRB and receive written approval before recruiting human subjects.

I. Criteria Requiring Review of Student Projects

As defined in the Federal Policy for the Protection of Human Subjects (45 CFR 46) , "research" is "a systematic investigation designed to develop or contribute to generalizable knowledge." Most undergraduate and graduate student assignments/projects are unlikely to lead to "generalizable results" and thus do not require IRB review.

Student projects involving human subjects should be submitted for IRB review only if:

  • The research involves physically or psychologically invasive, intrusive, stressful procedures or, in the judgment of the instructor/faculty sponsor, has the potential for placing subjects at more than minimal risk, as defined below.

II. Definition of Minimal Risk

Minimal risk, as defined in 45 CFR 46, subpart A , exists when "the risks of harm anticipated in the proposed research are not greater considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."

Student projects that fit the categories below are usually considered minimal risk and do not require IRB review:

  1. Research conducted in an educational setting involving normal education practices, such as research that examines or compares regular and special education including but not limited to instructional strategies/techniques, curricula, or classroom management methods.
  2. Research involving the use of educational tests, survey procedures, and interview procedures.
  3. Observation of public behavior if confidentiality or anonymity is maintained.
  4. Research with subjects who are elected or appointed public officials or candidates for public office-regardless of whether the subjects may be identified or the information is sensitive.
  5. Research on individual/group characteristics or behavior or research employing oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies on areas such as perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, social behavior, etc. if confidentiality or anonymity is maintained.
  6. Collection of data from voice, video, digital, or image recordings made for research purposes.
  7. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if one of the following is true: the sources are publicly available or information is recorded by the investigator in a way that subjects cannot be directly or indirectly identified.

III. Additional Circumstances Requiring IRB Review of Student Projects

Student projects involving human subjects that meet either of the criteria below must always be submitted for IRB review-even if the projects do not meet the criterion in section I above.

  • Externally-funded projects
    OR
  • Projects involving vulnerable populations, including minors* (except when engaged in public activities in which the investigator does not participate, such as non-participatory observations of playground or classroom interaction), pregnant women, fetuses, prisoners, people with mental or cognitive handicaps, or individuals who cannot communicate in a language known by the student conducting the project.

*Officially registered SCSU students under the age of 18 who participate in minimal-risk classroom research activities are not considered a vulnerable population.