Question

Federal regulations require that additional safeguards have been included in a study to protect the rights and welfare of these subjects:

A. Children, prisoners, pregnant women, or older adults
B. Children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons
C. Children, prisoners, pregnant women, fetuses, embryos or senior citizens supported by social security benefits
D. Children, prisoners, women of child-bearing potential, or cognitively impaired persons of any age

Answer 1

Federal regulations require additional safeguards in studies to protect children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons. Risks must be minimized and informed consent must be obtained, overseen by an IRB.

Step-by-step explanation:

Federal regulations require that additional safeguards have been included in a study to protect the rights and welfare of these subjects: Children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons. These groups are considered vulnerable populations and require special consideration to ensure their protection during research studies. The main guiding principles are that risks to participants must be minimized, and informed consent must be obtained. Research institutions must establish Institutional Review Boards (IRB) to oversee the ethical conduct of research involving human subjects. IRBs review research proposals to guarantee that the safety, rights, and welfare of participants are respected and that potential coercion or exploitation is avoided.