Why You Need Medical Informed Consent.
A fter seeing an ear, nose, and throat doctor for ear pain and congestion, my 21-year-old son was told to come back 2 hours later for “some testing.” When he returned, no physician was present, and he received no explanation of why the testing (which turned out to be allergy testing) was ordered, how it would be conducted, possible side effects, or available alternatives. Had that discussion—which is called informed consent—taken place, my son would have simply told them that he’d had allergy testing two weeks earlier. Informed consent is important to consumers’ health for many reasons. Unfortunately, it’s also one of the most abused and misunderstood concepts in medical care today. That’s why it’s important to be truly informed about informed consent.
What Is Informed Consent?
It’s intended to be a conversational process when your clinician explains the risks and benefits of a specific test, procedure, surgery, or other treatment. During this talk, your doctor should also outline other available options and make it clear that you are helping make decisions about your care. You then confirm your understanding of what you’ve been told and agree to—or reject—the doctor’s recommendation. Today, however, some doctors have become far too casual about this process. Instead of a shared discussion, the goal in some cases has shifted to getting you to sign a piece of paper called a release. With your signing, a doctor or hospital feels legally protected in case something goes wrong. For your consent to be considered valid, it must be voluntary. But most people feel uncomfortable—even intimidated or coerced—when a doctor asks them to sign a release. So they might not speak up, even if they have concerns.
When It Should Happen
Your doctor should initiate an informed consent discussion if he or she recommends anesthesia, surgery, or any invasive procedure (one that “invades” the body, usually by piercing the skin), or if you are asked to be in a clinical research trial. There is no national consensus on when informed consent is required. It varies from state to state and can be influenced by a doctor or hospital’s interpretation of recommendations from professional and specialty groups. Those interpretations are not always correct. For example, the American Academy of Allergy, Asthma & Immunology’s sample informed consent form for allergy skin testing notes that a physician or other healthcare professional will be on hand because “occasional reactions may require immediate therapy.” That didn’t happen in my son’s situation.
How the Discussion Should Go
During informed consent, your doctor should explain the procedure, test, or treatment in plain words and without medical jargon—and tell you which roles each healthcare provider plays. This should be a thorough verbal discussion—a release form should serve as a supplement to this, not a replacement. In fact, the form should merely confirm that the discussion took place. A good informed consent discussion also uses decision aids, interactive media, or digital tools. It should include information from medical studies, best practices, and clinical guidelines. Your doctor should pull in a qualified medical interpreter, if needed, and allow for assistance for limited English proficiency or hearing or visual impairment.
Making Sure You Understand
During an informed consent talk, you should be able to take notes, bring along a friend or family member, ask questions, get clarifications on anything that’s unclear, and have time to consider your options before you decide. Afterward, it’s useful to summarise back the highlights of what you heard. If you feel rushed or ignored, ask whether the decision on the proposed test or treatment can be delayed until your doctor can answer your questions fully. (In emergencies, or if you are unable to communicate, informed consent may not be necessary.)
Remember, if you’re uncomfortable, you have the right to say no.
Credit: Dr Orly Avitzur for Consumer Reports 7 August 2017.