What is one key element that must be included in the informed consent process?

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One key element that must be included in the informed consent process is information about the risks and benefits of participation. This is crucial because informed consent is designed to ensure that participants are fully aware of what they are agreeing to when they decide to take part in a study. By providing clear and comprehensive information about the potential risks that might arise from participation, as well as the possible benefits they might gain—either personally from the study or to society at large—participants can make an educated decision regarding their involvement. This ethical obligation protects their autonomy and right to make choices that align with their values and interests.

While summarizing the research team's qualifications, detailing funding sources, and explaining data usage are also important aspects of research transparency and ethical considerations, they do not directly pertain to the individual's personal decision-making regarding their participation, which is central to informed consent. Hence, the emphasis on risks and benefits is paramount for ensuring that participants are fully informed and can weigh the pros and cons of their involvement in the study.

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