QQuestionOther Exams & Certifications
QuestionOther Exams & Certifications
Which of the following statements most accurately describes the requirement for the documentation of minors' assent to participate in research?
To protect minors documentation is always required.
Federal regulations do not require the documentation of minors' assent.
Documentation is required unless waived by an IRB.
Parents must approve written documentation.
4 months agoReport content
Answer
Full Solution Locked
Sign in to view the complete step-by-step solution and unlock all study resources.
Step 1: Understand the problem
We are asked to identify which statement most accurately describes the requirement for the documentation of minors' assent to participate in research. The options provided are: A) To protect minors documentation is always required. B) Federal regulations do not require the documentation of minors' assent. C) Documentation is required unless waived by an IRB. D) Parents must approve written documentation.
Step 2: Recall relevant regulations and concepts
In the context of research, minors are individuals who have not yet reached the legal age of majority (18 years old in most states). The assent of a minor refers to their agreement to participate in a research study. The documentation of minors' assent is generally required to ensure that the minor has voluntarily agreed to participate and understands the nature of the research. The requirement for the documentation of minors' assent is outlined in federal regulations, such as the Code of Federal Regulations (CFR) Title 45, Part 46 (45 CFR 46). However, these regulations also allow for the waiver or alteration of some requirements if certain criteria are met.
Final Answer
The correct answer is C) Documentation is required unless waived by an IRB.
Need Help with Homework?
Stuck on a difficult problem? We've got you covered:
- Post your question or upload an image
- Get instant step-by-step solutions
- Learn from our AI and community of students