#1
In research involving minors, what is the term for the process of providing information about the study to the participants before obtaining their consent?
Informed consent
ExplanationInformed consent involves providing participants with information about the study, including its purpose, risks, and benefits, before they decide whether to participate.
#2
What is the term for the psychological or emotional harm that may result from participation in research, particularly in minors?
Harm
ExplanationHarm refers to the negative effects, including psychological or emotional harm, that participation in research may cause.
#3
What is the term for the process of concealing the identity of research participants to protect their privacy?
Anonymity
ExplanationAnonymity involves ensuring that the identity of research participants is not known or disclosed.
#4
What ethical principle emphasizes the fair distribution of the benefits and burdens of research, particularly among minors?
Justice
ExplanationJustice emphasizes the fair distribution of the benefits and burdens of research, ensuring that no group is unfairly disadvantaged.
#5
What is the term for the extent to which research results can be generalized to other populations, beyond those directly studied?
Generalizability
ExplanationGeneralizability refers to the extent to which research results can be applied to other populations or settings.
#6
Which of the following is considered an essential element of informed consent in research involving minors?
Ensuring complete understanding of the research
ExplanationEnsuring that participants, including minors, fully understand the research is an essential element of informed consent.
#7
Which ethical principle emphasizes the importance of obtaining informed consent from minors in research?
Autonomy
ExplanationAutonomy emphasizes the right of individuals, including minors, to make their own decisions.
#8
What is the primary purpose of an Institutional Review Board (IRB) in research involving minors?
To ensure ethical conduct and protect participants
ExplanationIRBs are responsible for reviewing and approving research protocols to ensure they are ethical and protect participants.
#9
In the context of research involving minors, what is assent?
The willingness of a minor to participate in research
ExplanationAssent is the affirmative agreement of a minor to participate in research, even though they may not have legal capacity to give informed consent.
#10
Which of the following is an example of a vulnerable population in research involving minors?
Teens with parental consent
ExplanationTeens with parental consent are considered vulnerable because they may not fully understand the risks and benefits of research participation.
#11
Which ethical principle emphasizes the obligation to maximize benefits and minimize harm in research involving minors?
Beneficence
ExplanationBeneficence emphasizes the obligation to maximize benefits and minimize harm in research.
#12
What is the term for the intentional deception of research participants about the true nature or purpose of a study?
Deception
ExplanationDeception involves intentionally misleading research participants about the true nature or purpose of a study.
#13
Which international guideline provides a framework for the ethical conduct of research involving minors?
The Declaration of Helsinki
ExplanationThe Declaration of Helsinki is a set of ethical principles for medical research involving human subjects, including minors.
#14
Which regulatory document in the United States provides guidance on the protection of human subjects in research, including minors?
The Code of Federal Regulations (CFR) Title 45, Part 46
ExplanationThe CFR Title 45, Part 46, provides regulations for the protection of human subjects in research funded by the U.S. government, including minors.
#15
In the context of research involving minors, what is the purpose of a Certificate of Confidentiality?
To protect identifiable research information from being disclosed
ExplanationA Certificate of Confidentiality protects identifiable research information from being disclosed, even under legal compulsion.
#16
Which document outlines the ethical principles and guidelines for conducting research involving human subjects, including minors?
The Belmont Report
ExplanationThe Belmont Report outlines the ethical principles and guidelines for conducting research involving human subjects, including minors.
#17
In research involving minors, what is the term for the voluntary, written agreement to participate in a study, provided by the participant or their legally authorized representative?
Informed consent
ExplanationInformed consent is the voluntary, written agreement to participate in a study, provided by the participant or their legally authorized representative.
#18
What is the term for the obligation to report the results of research to the participants, community, or scientific community?
Dissemination
ExplanationDissemination is the obligation to report the results of research to the participants, community, or scientific community.