Certified Clinical Research Associate (CCRA) Practice Exam 2025 – Complete Preparation Guide

The answer highlights a particular scenario where the FDA permits verbal consent without a signature, which reflects a unique aspect of informed consent regulations. In certain research situations, especially those involving minimal risk, the FDA recognizes that obtaining written consent may not be feasible or necessary. This provision allows researchers to conduct their studies more flexibly while still maintaining ethical standards by ensuring that participants are informed about the study and voluntarily agree to participate.

The allowance of verbal consent emphasizes the importance of communication and understanding in the consent process, supporting the ethical obligation to ensure that participants have adequate information. This practice is more likely to occur in emergency research settings or where circumstances necessitate immediate action.

In contrast, bypassing consent entirely or waiving all informed consent poses ethical concerns and is generally not permitted except in very specific and tightly regulated circumstances that do not compromise participant rights. Using a surrogate to obtain consent suggests a scenario where the individual unable to provide consent due to medical conditions could lead to ethical dilemmas, particularly regarding the autonomy of the participant. Therefore, obtaining verbal consent without a signature is a more accepted practice in certain limited circumstances, ensuring respect for individuals while facilitating important research.