According to federal regulations, what must researchers provide to potential subjects as part of the consent process?

Providing information suitable for the appropriate reading comprehension level is essential in the consent process to ensure that potential subjects fully understand the research study and their participation in it. This practice aligns with ethical guidelines and federal regulations which emphasize informed consent. Participants should be able to grasp the key elements of the research, which include purpose, procedures, risks, benefits, and their rights as subjects. Using accessible language promotes clarity and ensures that individuals can make informed decisions based on their comprehension of the information provided.

In contrast, the use of complex legal terminology would hinder understanding, making it difficult for potential subjects to grasp important details of the study. Additionally, only providing information upon request does not adequately ensure that all individuals have the necessary information to understand their participation. Similarly, using specialized academic terms can alienate or confuse potential subjects, making it less likely they will be well-informed about their involvement in the research.