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Informed Consent and Patient Rights: Key Points to Consider

• Informed consent is the agreement or permission accompanied by full notice/explanation about the care, treatment, or service that is the subject of the consent.
• The patient must be apprised of the nature, risks, and alternatives of a medical procedure or treatment before the physician or other health care professional begins any such course.
• Challenges to implementing an effective informed consent process include patients frequently not understanding the risks, benefits, and alternatives involved in their course of treatment or surgical procedure.
• Informed consent is a process of communication between a clinician and a patient that results in the patient’s authorization or agreement to undergo a specific medical intervention.
• Communication issues are the most frequent root cause of serious adverse events reported to The Joint Commission’s sentinel event database.
• Barriers to patient understanding and communication challenges include a lack of basic information on the consent form, ineffective provider-patient communication, lack of consideration of the health literacy and cultural issues of patients.
• Ways health organizations can better serve their patients during informed consent include promoting informed consent as a process of effective communication between provider and patient, having clear written policy on informed consent for care, providing a formal training program to physicians, simplifying the content, length, and language of informed consent documents, and providing communication models for physicians to evaluate patient understanding.
• Patient rights include considerate and respectful care, information, privacy and confidentiality, and the right to ask to see and get a copy of your health records, have corrections added to your health information, receive a notice that tells you how your health information may be used and shared, and decide if you want to give your permission before your health information can be used or shared for certain purposes.
• The informed consent process consists of seven elements, including discussing the patient's role in the decision-making process, describing the clinical issue and suggested treatment, discussing alternatives to the suggested treatment, discussing risks and benefits of the suggested treatment, discussing related uncertainties, assessing the patient's understanding of the information provided, and eliciting the patient's preference.
• Patients have the right to refuse treatment or examination, even after informed consent is signed.
• Terminally ill patients have the legal right to request aid in dying under certain conditions, and a Do Not Resuscitate (DNR) order and/or a Do Not Intubate (DNI) order indicated the patient’s choice that neither resuscitation nor intubation is to be undertaken.
• Patient medical records can be in paper format, electronic format (e-charts), or both, and diagnostic images are legally considered to be part of the medical record and belong to the institution in which they are made, not to the patient.
• Any patient’s or visitor’s or staff’s fall, accident, or occurrence that results in injury or potential harm must be reported immediately to the department supervisor or radiologist or both by completing an Incident Report or Unusual Occurrence Form.