According to federal regulations, “children” are defined as:
A) Persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research was approved.
B) Persons who are under 18 years of age.
C) Persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research will be conducted.
D) Persons who are under 21 years of age
The Correct Answer for the given question is Option C) Persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research will be conducted.
Answer Explanation:
This definition of “children” aligns with the most commonly accepted and legally sound approach to defining children in research settings.
It emphasizes the importance of respecting the legal standards set by the jurisdiction where the research takes place, ensuring that research involving individuals below the age of consent is conducted ethically and legally.
Here’s why this definition is correct in detail:
Legal Consistency:
The definition considers the legal age of consent in the specific jurisdiction where the research is conducted.
Laws related to the age of consent can vary widely from one place to another, and research must comply with local regulations.
Therefore, by referring to the applicable laws, researchers ensure that they adhere to the legal framework relevant to their study.
Protection of Minors:
Research involving minors must prioritize their safety and well-being. The legal age of consent is typically set to protect individuals from making decisions they may not be mature enough to make.
Using the age of consent as the defining criterion ensures that research involving minors is conducted with their best interests in mind.
Ethical Considerations:
Informed consent is a cornerstone of ethical research. Children, due to their age and potential lack of capacity to fully understand research implications, require special ethical considerations.
By using the age of consent as a reference point, researchers can ensure that children’s participation is based on informed and voluntary decisions.
Flexibility:
This definition is adaptable to different research contexts and locations. It acknowledges that what constitutes a child may vary depending on local laws and cultural norms.
Researchers need to be aware of and respect these differences while conducting research.
Now, let’s explore why the other options are not correct:
Option A) Persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research was approved.
This option is not correct because it focuses on the jurisdiction where the research was approved, which may not be the same as the jurisdiction where the research is conducted.
The legal age of consent can vary between these two jurisdictions, potentially leading to inconsistencies and ethical concerns.
Researchers must prioritize the jurisdiction where the research is being conducted to ensure the safety and ethical treatment of participants.
Option B) Persons who are under 18 years of age.
Option B provides a fixed age limit (18 years) as the definition of children. While this age is commonly used in various legal contexts, it may not be universally applicable.
Different jurisdictions may set their age of consent below or above 18.
Using a fixed age limit fails to consider these variations and can lead to ethical and legal issues when conducting research in different locations.
Option D) Persons who are under 21 years of age.
Option D sets an even higher age limit (21 years) as the definition of children. While some jurisdictions may consider individuals under 21 as minors for certain legal matters (e.g., alcohol consumption), this age limit is not universally applicable to all research contexts.
Using 21 as the age limit can significantly limit the scope of research involving young adults and may not align with the local legal standards in many cases.
In summary,
the correct definition of “children” in research, as provided in option C, emphasizes the importance of adhering to the legal age of consent in the jurisdiction where the research is conducted.
This approach ensures legal compliance, protection of minors, ethical considerations, and flexibility across different research contexts.
The other options, while providing fixed age limits or focusing on the jurisdiction of approval, do not adequately address the variability in legal standards and ethical concerns that researchers must navigate when involving minors in research studies.
Federal Regulations Related FAQs
According to the federal regulations, research is eligible for exemption, if:
a) All the subjects are adults, and the risk is minimal.
b) The investigator is experienced in the field of inquiry.
c) Participation in the research will involve 10 minutes or less of the subjects’ time.
d) The research falls into one of eight categories of research activity described in the regulations.
As part of the consent process, the federal regulations require researchers to:
a) Provide potential subjects with information at the appropriate reading comprehension level.
b) Not Provide potential subjects with information at the appropriate reading comprehension level.
According to federal regulations the expedited review process may be used when the study procedures pose:
a) a minor increase over minimal risk and the sponsor needs approval before the next irb meeting.
b) more than minimal risk, but the study replicates previously approved research.
c) any level of risk, but all the subjects are adults.
d) no more than minimal risk and the research activities fall within regulatory categories identified as eligible.
According to the federal regulations which of the following studies studies meets the definition of research with human subjects?
A) An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests.
B) A researcher receives anonymized data for secondary analysis from a survey about gender-related differences in stress levels conducted by a colleague at another university.
C) An organization for women academics in engineering asks a federal agency to provide the number of women investigators funded by that agency to include a report for its membership.
D) A university designs an in-house study to improve the mentoring of women students in its engineering department with the proposed outcome consisting of a report of recommendations for the department.
According to the federal regulations, human subjects are living individuals about whom an investigator conducting research obtains information through interaction or intervention with the individual, and uses, studies, or analyzes the information; or:
A) Observes public behavior.
B) Obtains, uses, studies, analyzes, or generates identifiable private information.
C) Obtains, uses, studies, analyzes, or generates identifiable public information.
D) Obtains, uses, studies, analyzes, or generates de-identified private information.
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