What must be included in the informed consent form according to FDA regulations?

Informed consent is a critical component of clinical research, ensuring that participants are fully aware of what their participation entails. According to FDA regulations, one of the key elements that must be included in the informed consent form is a statement regarding the confidentiality of records. This is essential because it assures participants that their personal information and data collected during the trial will be kept confidential and protected from unauthorized access. Participants need to understand how their private data will be handled, who will have access to it, and the safeguards in place to maintain that confidentiality.

This emphasis on confidentiality reflects the ethical obligation researchers have to protect participant privacy, which is a foundational aspect of conducting clinical trials responsibly. The other choices provided do not represent mandatory elements of the informed consent process under FDA regulations. While discussing trial costs and providing rationale for trial approval may be valuable information, they are not universally required. Additionally, not all trials may use specific substances that necessitate a comprehensive list in the informed consent form.