According to the federal regulations, which study meets the definition of research with human subjects?

According to the federal regulations, which study meets the definition of research with human subjects?

• A. An experiment on gender-related stereotypes in math and subsequent performance by males and females on math tests
• B. A medical record study
• C. A study of twenty 4th grade classrooms in which researchers vary the time of reading instruction and collect weekly assessments
• D. A developmental psychologist videotapes interactions between groups of toddlers and their caregivers to determine which intervention methods most effectively manage aggression

Answer: (D)

Understanding the rule: research with human subjects includes systematic investigations that collect data through intervention or interaction with living individuals, or use identifiable private information. The clearest example of this is when researchers directly interact with people and gather data about them. In this scenario, videotaping interactions between toddlers and their caregivers to compare intervention methods is direct interaction with living individuals. The researchers are actively collecting behavioral data from the participants (the toddlers and caregivers) over time to evaluate which interventions work best. That already satisfies the “intervention or interaction with living individuals” criterion and aims to contribute to generalizable knowledge, so it fits squarely under human subjects research and would typically require IRB oversight and informed consent. The other options are less explicit about direct interaction for data collection. They could involve testing or using existing records, but the interaction/collection of new data from living subjects isn’t as clearly demonstrated as it is in the videotaping study.

Understanding the rule: research with human subjects includes systematic investigations that collect data through intervention or interaction with living individuals, or use identifiable private information. The clearest example of this is when researchers directly interact with people and gather data about them.

In this scenario, videotaping interactions between toddlers and their caregivers to compare intervention methods is direct interaction with living individuals. The researchers are actively collecting behavioral data from the participants (the toddlers and caregivers) over time to evaluate which interventions work best. That already satisfies the “intervention or interaction with living individuals” criterion and aims to contribute to generalizable knowledge, so it fits squarely under human subjects research and would typically require IRB oversight and informed consent.

The other options are less explicit about direct interaction for data collection. They could involve testing or using existing records, but the interaction/collection of new data from living subjects isn’t as clearly demonstrated as it is in the videotaping study.