Which is an essential component of the informed consent form as per ICH recommendations?

Which is an essential component of the informed consent form as per ICH recommendations?

• A. Details of the research team
• B. A statement of the study's purpose and expected duration
• C. All potential risks involved
• D. Confidentiality of the subject's data

Answer: (B)

The essential component of the informed consent form according to ICH recommendations is a statement of the study's purpose and expected duration. This is critical because prospective participants must clearly understand why the research is being conducted and what their involvement will entail over time. It helps individuals make an informed decision about whether to participate based on their understanding of the research objectives and their commitment duration. Providing this information complies with ethical standards and promotes transparency, ensuring that participants know what to expect and how their contribution fits within the larger framework of the study. When participants are informed about the purpose, they are more likely to grasp the relevance and potential value of the research, which can also enhance their engagement and motivation to participate. Informed consent is a foundational ethical principle in research involving human subjects, emphasizing that individuals should have autonomy and agency in deciding whether to partake in a study based on complete and comprehensible information.

The essential component of the informed consent form according to ICH recommendations is a statement of the study's purpose and expected duration. This is critical because prospective participants must clearly understand why the research is being conducted and what their involvement will entail over time. It helps individuals make an informed decision about whether to participate based on their understanding of the research objectives and their commitment duration.

Providing this information complies with ethical standards and promotes transparency, ensuring that participants know what to expect and how their contribution fits within the larger framework of the study. When participants are informed about the purpose, they are more likely to grasp the relevance and potential value of the research, which can also enhance their engagement and motivation to participate.

Informed consent is a foundational ethical principle in research involving human subjects, emphasizing that individuals should have autonomy and agency in deciding whether to partake in a study based on complete and comprehensible information.