What groups are recognized as vulnerable populations under the Belmont Report?

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The Belmont Report identifies certain groups as vulnerable populations primarily due to their increased risk of coercion or undue influence, and the fact that they may have limited capacity to provide informed consent. Among these, pregnant women, prisoners, and children are explicitly recognized.

Pregnant women may face unique health risks and ethical considerations related to both their health and the health of the fetus. Prisoners are considered vulnerable because of their restricted liberty and potential coercion in decisions regarding participation in research. Children, due to their developmental stage, may not have the maturity or understanding to provide informed consent independently, making them particularly susceptible to exploitation in research settings.

In contrast, non-enrolled individuals, pet animals, and adult volunteers with consent do not fall under the same categories of vulnerability acknowledged in the Belmont Report, as they typically possess the autonomy or decision-making capacity required for informed participation. Therefore, the correct focus on pregnant women, prisoners, and children addresses the need for special protections in research to ensure ethical treatment and respect for their rights and welfare.

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