Certified Clinical Research Associate (CCRA) Practice Exam

What must be communicated to subjects about new findings in the research?

1. They should be aware of their rights

2. New findings may affect their willingness to participate

3. They should keep the information confidential

4. They are exempt from follow-up communication

The correct answer is: New findings may affect their willingness to participate

Communicating new findings to research subjects is critical for ensuring that they can make informed decisions about their participation. When new information emerges during a study that could potentially impact a subject's decision to continue participating, it is essential for researchers to share this information. This is rooted in the ethical principle of respect for persons, which includes obtaining informed consent throughout the duration of the study. Informed consent is not a one-time event; it must be ongoing. Subjects have the right to know if new findings could alter their understanding of the risks or benefits involved in their participation. For example, if a new side effect is discovered or if the study goals shift in a way that affects the subjects, this information should be conveyed to ensure that participants can reconsider their involvement based on the most current data. This maintains the integrity of the research and upholds the ethical standards of the clinical research process. The other options do not address the importance of updated communication about new findings in a proactive manner. Understanding rights and confidentiality is important, but they do not specifically deal with the necessity of informing subjects of new discoveries that may influence their participation. The idea of being exempt from follow-up communication contradicts ethical guidelines since ongoing communication is a requirement for ensuring informed consent.