Informed Consent and Duty to Follow Protocols

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; under- 2. That the patient or legal guardian of the patient stands: 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 estab- clinical training program, preceptee, or intern has lished 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. Historical Note New Section made by final rulemaking at 8 A.A.R. 3702, effective August 9, 2002 (Supp. 02-3). Amended by final Supp. Code AND OCCUPATIONS PHYSICIANS MEDICAL BOARD 32-1560, 32-1561 30 days 60 days 90 days 32-1504(A) 30 days 60 days 90 days 30 days 60 days 90 days 32-1559 30 days 60 days 90 days 32-1559 30 days 60 days 90 days Note 3702, effective August 9, 2002 (Supp. 02-3). rulemaking at 19 A.A.R. 1302, effective July 6, 2013 (Supp. 13-2).