As part of the consent process, what must researchers provide to potential subjects?

Providing information at an appropriate reading comprehension level is fundamental in the consent process because it ensures that potential subjects fully understand the study, its purpose, the procedures involved, and any risks or benefits. This aligns with ethical research principles, as informed consent must be based on a clear comprehension of what participation entails. When information is conveyed at a suitable reading level, it increases the likelihood that participants can meaningfully engage with the material, ask questions, and make informed decisions about their involvement in the research.

Potential subjects need to grasp complex concepts, especially in studies that may involve their health or legal rights. Ensuring the provided information is accessible promotes ethical standards in research, allowing individuals to make informed choices that are aligned with their values and circumstances. This consideration is especially critical in vulnerable populations, which often include prisoners or other groups with limited access to education or health literacy.