Answer to Question 1
ANS: B
Informed consent for neonates is up to the parents, but they both must sign and must be fully informed as to the nature of the research study.
If the research meets certain conditions, it may be conducted using viable or nonviable neonates. Informed consent for neonates is up to the parents, but they both must sign and must be fully informed as to the nature of the research study.
Studies using neonates must have preclinical and clinical studies to provide information about risks; they do not necessarily need to include a pilot study. Informed consent for neonates is up to the parents, but they both must sign and must be fully informed as to the nature of the research study.
Neonates are certainly extremely vulnerable, but can be involved in research if special care is taken. Informed consent for neonates is up to the parents, but they both must sign and must be fully informed as to the nature of the research study.
Answer to Question 2
ANS: C
There was no indication that their privacy was violated.
The risks portrayed by the research, the subsequent development of hepatitis, did not outweigh the benefits, which was admission into the facility.
Parents had to give permission for their child to be in the study for the child to gain admission to the facility.
The subjects in the Willowbrook Study were coerced into participation.
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