R4-18-802. Informed Consent and Duty to Follow Protocols

A. A physician, medical student engaged in an approved clinical training program, preceptee, or intern who conducts research involving an experimental procedure, medication, or device, shall ensure that all research subjects give informed consent to participate, which states: 1. Whether a physician, preceptee, or an intern is treating the patient; 2. That the patient or legal guardian of the patient understands: a. The type of treatment the patient is to receive; b. Each procedure that will be provided to the patient; c. The risks and benefits of each procedure, medication, or device to be provided; d. That the patient can withdraw at any time; and e. That the patient is voluntarily participating; and 3. The physician, medical student engaged in the approved clinical training program, preceptee, or intern has established a protocol as required by subsection (B) that meets the requirements of the institutional review board that approved the protocol. B. A physician, medical student engaged in an approved clinical training program, preceptee, or intern, who conducts research on humans involving an experimental procedure, medication, or device shall have a protocol for that research approved by an institutional review board.