Informed Consent: What is Required by Health Care Providers

Informed Consent

What is Required by Health Care Providers

Informed Consent issues have generated more articles, legal opinions and Court decisions than most other medical malpractice. It is a very common secondary allegation in claims that involved complications from surgery, invasive diagnostic studies, and medications. Many physicians and healthcare providers erroneously regard “informed consent” as something they give to patients. Doctors and healthcare providers receive informed consent from patients who give their permission to proceed after they have been advised of the proposed procedure’s risks, alternatives and their risks, and expected outcome.

The discussion of risks and possible complications of surgery, diagnostic tests, and certain medicines can be uncomfortable for the doctor, and perhaps alarm the patient, unless the task is approached with compassion and good judgment. When possible, the consent discussion should take place well in advance of the procedure. Approaching the patient at bedside a short time before surgery, which was planned much earlier, heightens the patients anxiety and may not give ample time to make a clear decision. Further, patients tend to have “selective memory” if discussion concerning informed consent occurs shortly before the procedure. The ideal time for the discussion is in the physicians office, when the need for surgery, the diagnostic test, or the medicine is first disclosed. With the patient’s permission, a close family member might be asked to join the discussion . If there is some concern about a wary patient, it may be best to have a second healthcare provider present as a witness. Be candid with the patient about the reasons for having the discussion. Some doctors tell patients “just as there are risks associated with driving your car or flying, there are risks associated with many medical procedures, including surgery. To help you better understand this surgery and enable you to give your informed consent, I would like to tell you about the possible complications of your surgery, unless you don’t want me to.”

When the patient indicates he does not wish to know the risks, the physician should document the patient’s decision in the medical records. If the patient does wish to know, consider the following approach: “The entire surgical team will do our best to anticipate and avoid problems. But, because there are many variables in medicine due to the different way patients respond to the same treatment, no doctor can guarantee a perfect result, although that is our goal. Although serious complications are rare, they can occur no matter who does the surgery. I want to assure you we will do everything to prevent these complications. If one does occur, we will move quickly to manage it. I am well trained and experienced in performing this procedure or diagnostic test. The most serious complications that can occur with this surgery or this test are death, bleeding, infection, reactions to drugs or anesthesia, or damage to adjacent organs or tissues. Sometimes we have to re do all or part of the surgery (with your surgery other complications occasional have been reported such as ).”

How to Make Informed Consent a Benefit for Physicians and Patients

Understand your State’s informed consent laws. Contact a liability insurer or medical society for assistance. Get advice if you are in doubt about what the law requires in specific situations.
Ask colleagues in your specialty what they disclose to patients about specific procedures, physicians in group practices should know how their colleagues obtain and document informed consent.
Use plain language when explaining medical procedures to patients. The law does not require physicians to give patients a mini-course in medicine or to disclose every esoteric problem that could occur. Put yourself in the patient’s position. How much information would you want to know if you or a loved one were the patient?
Encourage patients to ask questions. Don’t be offended if a patient seeks a second opinion about the surgery or tests you recommend. Third-party payers often require second opinions; support for your recommendation is a plus. Be sensitive to the fact that many people fear surgery and are anxious when they learn of adverse test results. Speak and relate to patients as you would want other doctors to speak and relate to your family.
Train your staff to assist you to educate patients generally about treatment or surgery. Use written materials models and audiovisual aids to supplement discussions with patients and family. Document educational efforts.
At the conclusion of an informed consent discussion, ask the patient to sign a consent form, even if the hospital requires its own. Sign the form yourself and give the patient a copy.
Document a summary of your informed consent discussions in your office chart and in the hospital admitting history and physical report; include the name and relationship of others who were present; include the name of foreign or sign language interpreters who participated in your discussions with the patient.