In previous blog posts, we explored the various categories of Expedited review. Expedited review may not be used if the risks related to the invasion of privacy and breach of confidentiality are greater than minimal. Additionally, research that meets the requirements for Exempt review would not be considered under Expedited review categories. Federal regulations permit the IRB to review and approve proposed research through an Expedited review process if...
- The research constitutes a minor change in a previously approved research project during an approved period; or
- The research is not greater than minimal risk and falls into one of the categories listed under the New Common Rule (45 CFR 46.110 or 21 CFR 56.110).
For help determining your review category, please download our guide: Does my human subjects research fall under the expedited review category?
Researchers new to the IRB may be unfamiliar with the different activities within each Expedited review category. This post will provide examples of research that typically falls under Expedited Review type, Category 6 - Collection of data from recordings made for research purposes.
Research that meets the criteria for Expedited Category 6 includes “data collected from voice, video, digital, or image recordings made for research purposes.” This may include:
- Audio or video recordings of interviews or focus groups
- Video recordings of participants completing an intervention or task
- Digital recordings of Zoom meetings or interviews.
We will review a few research scenarios to see if they meet the requirements for Expedited Category 6.
Example A: Researchers in the education department would like to compare the methods college professors use to teach linear regression during class. The researchers recruit university professors who teach asynchronous, online courses. The researchers will receive one lecture on linear regressions from each professor. These lectures are pre-recorded and are uploaded into the researcher’s secure TC Google Drive folder. Students are not included in the asynchronous lecture and the researcher will not access any of the class rosters or student information. Thus, no students will be included in the video recording and no student data will be shared with the researcher. The researchers outlined their data security plan for storing the videos following TC IT and TC IRB’s guidance.
- Is it Expedited Category 6? As the video recordings do not include students or any of their identifiable data and were initially made for non-research purposes, this study would likely qualify as Exempt rather than Expedited. This study would likely be reviewed under Exempt Category 1 because the researchers did not ask the professors to modify their lecture in any way and student data was not included in the video recordings.
Example B: A researcher is interested in studying how expectant parents attain skills in a parenting class. The class focuses on how to care for an infant, how to properly use a car seat, and how to use a crib. The class meets one hour each week for 6 weeks. The class is regularly led by one of the researchers who is trained in child development and infant care. The research team will video record each class, and they will code the recordings to compare the participants’ skill development over the six weeks. The videos will only be used for analysis purposes and will not be used outside of the research study. As the researchers will analyze patterns of how the parents improve (or diminish) in their skill attainment over time, participants must consent to be audio/video recorded in order to participate.
- Is it Expedited Category 6? Yes, this study would likely be considered Expedited Category 6. The researcher cannot guarantee that the other group members will maintain confidentiality. As such, the researcher should include the following language on the consent form: “Your identity will be known to other group participants and the researchers cannot guarantee that others in these groups will respect the confidentiality of the group. We will ask you to keep all comments made during the group sessions confidential and not discuss what happened during the session with anyone outside the group.”
Example C: A team of researchers wants to know what facial features people focus on when interpreting emotions. For their study, the researchers will ask adult participants with no known eyesight ailments to look at stock photos of people displaying a variety of emotions (anger, sadness, joy) and write down the emotion that they think is being displayed. They will use eye-tracking software and hardware to track the participant’s eye and determine the direction and concentration of a participant’s gaze on the computer screen. The software utilizes a small video camera on a tripod to generate data about eye movement in the form of heat maps and saccade pathways. Participants do not have to wear or interact with any devices. In previous studies, the eye-tracking software demonstrated an only minimal risk to participants. Additionally, the research team has a safety plan in case a participant becomes distressed or uncomfortable when viewing the images.
- Is it Expedited Category 6? Yes, this study meets the criteria for Expedited Category 6, as the team is collecting video data for the purpose of their research study. Researchers proposing the use of new software or application should always consult with TC IT prior to submitting a protocol to the IRB. If the recording software is not regularly encountered in daily life, the research team should provide participants with an information sheet detailing a description of the software, the type of data it will record, and any possible risks associated with the software or hardware.
Research activities may fall into one or more review categories depending on a variety of factors, including the study population, researcher expertise, coinciding events, etc. Researchers can access the Expedited review categories on TC IRB’s website or from the Department of Health and Human Services (HHS). TC IRB administrators will always review research on a case-by-case basis.