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Examples of vulnerable populations in the Final Rule no longer include?

User Erel
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Final answer:

The Final Rule has shifted from using broad categories to a risk-based approach to determine if a population is vulnerable, focusing on potential for coercion or undue influence rather than predefined categories.

Step-by-step explanation:

The question refers to the Final Rule related to the protection of human subjects in research as outlined in the Common Rule. Specifically, it asks for examples of populations that are no longer considered vulnerable under the updated regulations. Previously, populations such as pregnant women, human fetuses, neonates, prisoners, and children were broadly categorized as vulnerable. However, the Final Rule updates have focused on a risk-based approach to identify vulnerability, emphasizing the potential for coercion or undue influence rather than assuming vulnerability solely based on population categories.

This change in policy requires researchers and Institutional Review Boards (IRBs) to consider the specific context of research participants and the potential for coercion or undue influence, rather than applying blanket designations of vulnerability. It aims to ensure protections are provided where they are truly necessary and to facilitate appropriate access to research benefits.

User NingLee
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