333-010-0770 Dental Pilot Projects: Informed Consent (1) A sponsor must ensure that each patient or person legally authorized to provide consent on behalf of the patient: (a) Is provided written information about the dental pilot project and who will be providing treatment; (b) Gives written consent to be treated by the dental pilot project trainee; and (c) Gives informed consent for treatment by the trainee. (2) Written information about the project and who will be providing treatment must include, but is not limited to: (a) An explanation of the role and status of the trainee, any certification or licenses a trainee may hold, the education and training of the trainee and the availability of the trainee’s supervisor for consultation; (b) An explanation that the patient can refuse care from a trainee without penalty for such a request; and (c) A statement that consenting to treatment by a trainee does not constitute assumption of risk by the patient. (3) At a minimum, the following language must be included on the document that requests consent to be treated by the dental pilot project: "I ____________________ [name of patient or person acting on patient’s behalf] have received information about this dental pilot project and provider type. I have been given the opportunity to ask questions and have them fully answered. I have read and understand the information and I agree to the trainee of this project providing me treatment." _____________________________ ___________ Signature of patient or person acting on patient’s behalf Date (4) Informed consent for treatment: (a) Each patient must give informed consent to the procedure. Informed consent means the consent to a procedure obtained by: (A) Providing a thorough and easily understood explanation to the patient, or patient's guardian, of the proposed procedures, any available alternative procedures and any risks associated with the procedures; and (B) Asking the patient, or the patient's guardian, if there are any questions and providing thorough and easily understood answers to all questions asked. (b) Patient records must document an entry that informed consent for treatment has been obtained and the date the informed consent was obtained. Documentation may be in the form of an acronym such as "PARQ" (Procedure, Alternatives, Risks and Questions) or "SOAP" (Subjective Objective Assessment Plan) or their equivalent; (c) Informed consent for treatment must be obtained in writing for procedures identified by the Authority in the application approval letter, and such consent must be included and documented in the patient’s record; and (d) A trainee may not perform any procedure for which the patient or patient’s guardian has not given informed consent provided; however, in the event of an emergency situation, if the patient is a minor whose guardian is unavailable or the patient is unable to respond, a trainee may render treatment in a reasonable manner according to community standards and in accordance with the trainees approved scope of practice. Statutory/Other Authority: 2011 OL Ch. 716 Statutes/Other Implemented: 2011 OL Ch. 716 History: PH 277-2018, adopt filed 11/30/2018, effective 12/01/2018