If the research is subject to Subpart D, which type of research activity with children qualifies for an exemption under Category 2?

If the research is subject to Subpart D, which type of research activity with children qualifies for an exemption under Category 2?

• A. Aptitude testing research
• B. Medical records review
• C. Drug trial participation
• D. Genetic information analysis

Answer: (A)

Research activities involving children that qualify for an exemption under Category 2 of Subpart D specifically pertain to research that by its nature poses minimal risk to the subjects. Aptitude testing research falls within this category as it typically involves assessments of cognitive skills or abilities that do not interfere with a child’s rights or welfare and do not involve invasive procedures. These tests are well-established, widely used, and generally considered non-intrusive, thus aligning with the criteria for Category 2 exemptions. In contrast, other types of research mentioned would not qualify for an exemption under Category 2 due to their potential for greater risk. Medical records review may involve sensitive information that could pose privacy risks. Drug trial participation typically involves administered substances that can have physiological effects on children, thus presenting a higher level of risk. Genetic information analysis can involve complex ethical considerations and privacy concerns, making it a more sensitive area that doesn't meet the low-risk criteria set out in Category 2. Therefore, aptitude testing research is appropriately identified as the correct response in this scenario.

Research activities involving children that qualify for an exemption under Category 2 of Subpart D specifically pertain to research that by its nature poses minimal risk to the subjects. Aptitude testing research falls within this category as it typically involves assessments of cognitive skills or abilities that do not interfere with a child’s rights or welfare and do not involve invasive procedures. These tests are well-established, widely used, and generally considered non-intrusive, thus aligning with the criteria for Category 2 exemptions.

In contrast, other types of research mentioned would not qualify for an exemption under Category 2 due to their potential for greater risk. Medical records review may involve sensitive information that could pose privacy risks. Drug trial participation typically involves administered substances that can have physiological effects on children, thus presenting a higher level of risk. Genetic information analysis can involve complex ethical considerations and privacy concerns, making it a more sensitive area that doesn't meet the low-risk criteria set out in Category 2. Therefore, aptitude testing research is appropriately identified as the correct response in this scenario.