Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

Which of the following is NOT required to be included in an informed consent form?

1. A summary of expected side effects

2. A listing of all site personnel involved in the research

3. The purpose of the trial

4. Contact information for trial coordinators

The correct answer is: A listing of all site personnel involved in the research

Informed consent forms are designed to ensure that participants fully understand the trial in which they are about to engage, including its potential risks and benefits. While the other options outline critical information that must be provided to participants, the listing of all site personnel involved in the research is not a requirement of informed consent forms. Including a summary of expected side effects is essential so that participants can make informed choices based on potential risks. Similarly, articulating the purpose of the trial allows participants to understand the research context and what the study aims to discover or demonstrate. Providing contact information for trial coordinators is important as it gives participants a way to ask questions or seek further clarification about any aspect of the trial. While having a list of all site personnel may be beneficial for participant awareness and communication, it is not mandated by regulatory requirements for informed consent. Instead, the focus is on ensuring that participants grasp the crucial elements of participation, such as the objectives, risks, and points of contact for queries.