Certified Clinical Research Associate (CCRA) Practice Exam

What specific element must be included in informed consent regarding risks?

1. A statement of identifiable risks

2. A statement that unforeseeable risks may exist

3. A declaration of all known benefits

4. A summary of potential medical costs

The correct answer is: A statement that unforeseeable risks may exist

The inclusion of a statement that unforeseeable risks may exist in informed consent is crucial because it addresses the inherent uncertainty associated with any clinical research. Informed consent is designed to provide potential participants with a comprehensive understanding of what they might encounter in a study, including risks that are not fully understood or anticipated at the time of enrollment. Participants must be made aware that while all known risks are typically outlined and explained, there may be unforeseen risks that could arise during the course of the study. This acknowledgment ensures that participants can make a fully informed decision regarding their involvement, as they gain insight into the unpredictable nature of scientific research. This element of informed consent helps to uphold ethical standards in research by fostering transparency and allowing subjects to weigh the potential for unknown risks against the benefits of participation. While statements of identifiable risks and known benefits are also important components of informed consent, they do not capture the broader scope of uncertainties that may not be immediately apparent. Thus, highlighting the possibility of unforeseeable risks is essential for ensuring that potential participants understand the complete landscape of their involvement in a study.