There is the possibility that researchers may choose to study students in their own classrooms. This can occur with university faculty members with their undergraduate or graduate students, or student teachers with their K-12 students. The IRB met with a group of Norman Campus researchers in October of 2016 to discuss input on reviewing these studies. All suggestions and recommendations were discussed at the October Executive Committee Meeting (made up of IRB Chairs, Vice Chairs, and the Director of Compliance). The following guidance is a result of these meetings.
1. There is the possibility that researchers, especially if they are faculty members, may have supervisory relationships with students outside of the classroom. Undue influence is a concern for those individuals.
2. If the researcher is also collecting peer evaluations, assurance must be made that the course instructor did not promise that the evaluations would not be shared with other parties.
3. If the researcher is only including a small number of participants, there is the risk of deductive re-identification.
4. If the coursework includes sensitive information, this would elevate the level of risk.
5. If the researcher is obtaining retroactive consent after the course has concluded, the students may have a reduced memory of the assignments. Over time, this possibility increases.
- Key Study Personnel: Any role in the classroom (faculty, teaching assistant, student) is acceptable for the Principal Investigator Role. However, the IRB reviewers will be more cautious with student researchers obtaining data from other students. Similar to other student-led research projects, these studies would require the listing of a faculty advisor and consent/permission/assent forms.
- There are studies across multiple classes in a department, where the study is being conducted to both benefit the department and to be used for research purposes. If there is a relatively large number of participants making the likelihood of deductive re-identification low, and sensitive information is not included in the data, then a member of the key study personnel (such as a departmental staff member) could de-identify the data and give it to the Principal Investigator. However, the researcher will need to provide a letter of support from the Department Chair.
- The researcher cannot have any supervisory relationship with a participant. Students with whom the researcher has this supervisory relationship should not be recruited.
- Participants cannot be current students in any class taught by the researcher at the time of recruitment. If they are, somebody other than the researcher must recruit and consent participants, and the researcher cannot know who participated until final grades are posted.
- The IRB will develop a list of questions that PI’s will answer to assess whether there is a supervisory relationship, potential for coercion, or elevated level of risk based on the access to identifiable or deductively re-identifiable data. These questions will be included in either the online application or as a study attachment to be completed and submitted by the researcher.
- In studies with an elevated risk level, the IRB may require that the participants be willing to provide the data directly to the researcher from their own records.
- Modifications can be submitted; however, depending on what is being modified and the potential for new risks to be introduced by the modification, the IRB reviewer may require re-consent.
- The following rules apply to the noted forms:
- The researcher must clearly indicate which course, what semester, and what data will be used for research purposes.
- Follow-up recruitment will not be allowed. In order to avoid coercion, researchers may only contact students once as part of the recruitment process.
Protocol Description Form:
- The researcher must describe his/her plan for data management. The IRB needs assurance that the data will be matched to consent forms and non-research data gathered from students (who do not consent) will be stored separately from research data. Maintaining an up-to-date “Enrollment Log” will be important for routine quality improvement (QI) evaluations. The QI Coordinator must be able to trace research records directly to consent/assent /permission forms.
- If there are multiple data collection activities, each must be noted and described in the application materials. This includes accessing education records, completing a survey, conducting interviews, classroom observations, etc.
Data Collection Instrument:
- The course syllabus, assignment instructions, and/or explanation and details about the kinds of information that were submitted in the assignment must be submitted for review. If there is not enough detail to determine the risk level, the IRB will ask for samples of assignments.
- If the researcher will gather additional information (such as demographic information), s/he will need to submit a separate data collection instrument for this information.
- The “Risks” section must note how coercion will be addressed and what steps will be taken to reduce it.
- This statement must be included in the form: “All members of the research team, including will have access to your academic records and/or assignments. We have created a data management plan to protect the identity of participants; however, there is a risk that others may be able to deduce which data may be yours.”
- The consent form(s) may need to include the “Will my identity be anonymous or confidential,” “Audio Recording of Research Activities,” “Video Recording of Research Activities,” and/or “Photographing of Research Participants/Activities” sections, as appropriate.
- The consent form(s) must contain the “Will my personal records be accessed” section.
- A specific list of the courses, semesters, and types of data being collected for research purposes must be included.
As always, please contact us if you have questions about any of these concerns or rules! Email email@example.com or call 405-325-8110.
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