Federal regulations stipulate that certain research activities may be exempt from regulatory requirements of the Common Rule (45 CFR 46), if approved by the IRB Chair and confirmed in writing to the Principal Investigator. Research may be exempt from review when the only involvement of human subjects in research falls into one of the Exempt Review Categories. However, researchers new to the Institutional Review Board (IRB) may be unfamiliar with the different activities within each Exempt category. This post will provide examples of research that typically falls under Exempt Review - Category 1.
Category 1 indicates that protocols may be exempt from IRB review if the research is “conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn or the assessment of educators. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.”
"Research conducted in established or commonly accepted educational settings” - Exempt Review, Category 1
Based on this definition, research on activities that occur naturally in educational settings will likely be exempt from IRB review. Let’s examine a few scenarios to see if the educational research would be exempt from review.
Example A: A researcher wants to compare the outcomes of different types of algebra curriculums for high schoolers. She plans to obtain five different curriculums from high schools for comparison. She will observe a professional development session on how teachers design algebra class curriculum at a time that is convenient to observe their instructional practices.
- Is it Exempt Category 1? As the researcher plans to analyze curriculums that are already in circulation, this would be considered “regular...instructional strategies.” In her IRB application, the researcher should justify how observing a professional development session does not impede normal educational activities.
Exceptions: Some departments or boards of education have their own IRB. Researchers are asked to comply with federal, state, city, and institutional applications of Exempt categories. As a result, the site IRB may determine that the observation of professional development activities may place an additional burden on the teachers.
Example B: A student researcher is interested in test-taking anxiety and how adult General Educational Development (GED) learners and teacher behaviors may exacerbate or reduce student anxiety. He plans to survey adult learners about their opinions on test anxiety and strategies used during tests to avoid or quell anxiety.
- Is it Exempt Category 1? The researcher has introduced new activities that are outside of “normal educational practices.” Specifically, the surveys and interviews would not normally be part of educational activities. This research does not fall under Exempt Category 1.
Exceptions: Depending on the survey measures and interview questions, the research may be exempt under Category 2.
Example C: Online seminars and training simulations are a relatively new and understudied field. An educational company planning to provide online dental training simulation software collaborates with a researcher to help study the effectiveness of their training programs. The researcher will observe online instructional training and adult students' participation in training simulations. Their analysis will be used to support the company’s development of their training program and will be published in a peer-reviewed journal.
- Is it Exempt Category 1? According to the Office for Human Research Protections, the interpretation of “commonly accepted educational settings” expands beyond the traditional K-12 and college classrooms. “Educational settings” have been interpreted by various institutions to include training simulators, medical schools, religious education settings, Scouts meetings, professional development seminars, vocational programs, alternative educational programs, and sports fields. As such, an online dental training simulator may be accepted as an educational setting.
Exceptions: If the researcher plans to video record the students’ training, the students' identities may be ascertained from the video appearance. This presents a confidentiality concern. Video recordings as identifiable data may still fall under Exempt Category 2 depending on the study topic and participant population. However, each study is reviewed on a case-by-case basis. Review categories may be determined based on how the video data information is ascertained and the level of risk to the participants if the data was disclosed outside of the research protocol.
Clarification on the Term, “Exempt”
Federal regulations stipulate that certain research activities may be exempt from regulatory requirements of the Common Rule (45 CFR 46), if approved by the IRB Chair and confirmed in writing to the Principal Investigator. These activities must fall into one of the eight predefined Exempt categories set forth by the Office of Human Research Protections (OHRP).
Researchers may be misled to believe that “exempt” review means that they do not need to submit a protocol to the IRB.
However, studies that are categorized as “exempt” are only exempt from federal regulations stipulated in the Common Rule (45 CFR 46). In other words, this type of research is still subject to state, city, and institutional policies. At Teachers College (TC), all human subjects research must be submitted to the IRB for review.
Once a protocol has been determined to be exempt by TC IRB, it typically is not required to undergo continuing reviews. Principal investigators (PIs) must still alert the IRB of changes to their study by submitting a modification, and must gain approval before implementing changes. The IRB will make a determination if any proposed modifications to a protocol impact an exemption status. Additionally, if an unforeseen event occurs, principal investigators must submit either a protocol deviation or an adverse event, depending on the situation.
Research activities may fall into one or more Exempt categories depending on a variety of factors, including the study population, researcher expertise, coinciding events, etc. TC IRB administrators will always review research on a case-by-case basis.