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

Providing information at an appropriate reading comprehension level is crucial to ensure that potential subjects fully understand what their participation entails. This aspect of the consent process is designed to respect the autonomy of potential participants by making sure they can comprehend the details of the study, including its purpose, procedures, risks, and benefits. If the information is too complex or presented in a way that is difficult to understand, potential subjects may not make informed decisions about their participation.

Ensuring that the information is accessible also helps to safeguard the ethical principle of informed consent, which mandates that participants are adequately informed before agreeing to participate in research. This approach is especially important in research involving vulnerable populations, including prisoners, who may face additional challenges in comprehending complex information. Providing information at an appropriate reading comprehension level serves to empower individuals to ask questions and make decisions that are in their best interests based on clear understanding.