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

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Multiple Choice

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

Research with human subjects is a systematic investigation that involves living individuals and collects data through intervention, interaction, or identifiable private information to generate generalizable knowledge. The classroom study fits this definition most clearly because researchers actively alter a real instructional variable (the time spent on reading instruction) across twenty 4th grade classrooms and then collect weekly assessments from the students over time. This is a planned, ongoing protocol that aims to produce findings applicable beyond the specific classrooms, with direct interaction and data collection from identifiable participants. The other scenarios are less clearly aligned with the regulatory definition as described. A study described as examining gender-related stereotypes and subsequent performance could involve participants and data collection but isn’t as explicitly framed as a prospective, systematic intervention across a group of living subjects. A medical-record study may or may not involve identifiable private information, and its status under human-subjects regulations depends on whether data are identifiable or de-identified. Videotaping toddlers and caregivers would also involve living subjects and data collection, but the description here doesn’t specify the researchers’ plan as a formal intervention study aimed at generalizable conclusions, making the classroom example the clearest match to the definition.

Research with human subjects is a systematic investigation that involves living individuals and collects data through intervention, interaction, or identifiable private information to generate generalizable knowledge. The classroom study fits this definition most clearly because researchers actively alter a real instructional variable (the time spent on reading instruction) across twenty 4th grade classrooms and then collect weekly assessments from the students over time. This is a planned, ongoing protocol that aims to produce findings applicable beyond the specific classrooms, with direct interaction and data collection from identifiable participants.

The other scenarios are less clearly aligned with the regulatory definition as described. A study described as examining gender-related stereotypes and subsequent performance could involve participants and data collection but isn’t as explicitly framed as a prospective, systematic intervention across a group of living subjects. A medical-record study may or may not involve identifiable private information, and its status under human-subjects regulations depends on whether data are identifiable or de-identified. Videotaping toddlers and caregivers would also involve living subjects and data collection, but the description here doesn’t specify the researchers’ plan as a formal intervention study aimed at generalizable conclusions, making the classroom example the clearest match to the definition.

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