Through the looking glass—Understanding informed consent

“How can I sign?”

After listening to all the information for surgery for parotid gland tumor, Mr. MN agreed for the surgery. But when consent form was given to Mr. MN for signing, he explained his inability to do so because he is blind. Dr. AB asked his surrogate decision maker.

How important is signing the consent?

In common practice, the consent form is taken as that the patient consented. Communication is important in a physician–patient relationship. A competent patient has to understand the information, make the decision, and then communicate his decision. Communication can be in any form; it can be verbal, written, or gesture, for example, a patient who is on ventilator or intubated can give consent by blinking his eyes or nodding his head. This common practice that signing the consent form is taken as that patient consented instead it should be considered as adjunct to verbal communication.

“I do not want to know” –

Mr. C, a 42-year-old man came to the emergency department with severe abdominal pain, nausea, vomiting, and fever of 12 h. He was diagnosed with appendicitis and an appendectomy was advised. Dr. J, a surgical intern gave the form to obtain informed consent from Mr. C. Mr. C signed the form without reading it. Dr. J tried to give the information verbally but Mr. C stopped him telling that he did not need to know the details and that he trusted Dr. J. In order to obtain informed consent, Dr. J asked who is the surrogate decision maker?

As adequate disclosure by the physician is necessary for informed consent, does the patient require having that information before giving informed consent? Commonly used standards for disclosure are reasonable physician, reasonable patient, and subjective patient standard. The information that a reasonable, sincere, and prudent physician tells the patient about the procedure is considered the reasonable physician standard. The information which satisfies most of the patients to make informed decision is defined as reasonable patient standard. In subjective patient standard, the physician knows the patient’s background and tailors the information according to the specific patient. The reasonable patient standard meets the ethical criteria, but the subjective patient standard is ethically ideal. ³ Hence, it is clear that the patient can demand more information or can restrict the information that he receives. The reason to limit the information can be prior exposure to the procedure, denial to avoid listening to bad outcomes or trust in the physician. Though the physician’s attempts in giving procedure-related information in the above case are commendable, it is not ethically required. The patient remains the decision maker even though he does not want to know by listening or reading the information.

“Hmm, let me think what they said”

Mr. DF, a 56-year-old man was going for tracheostomy, for severe obstructive sleep apnea. The nurse in the preoperative suit asked the patient if he knew how to care for tracheostomy. Two weeks ago, this information was discussed with the patient; Mr. DF understood it and signed the informed consent. Now he was unable to recall the information. The nurse was of the opinion that the surgeon needs to go over the information again prior to surgery as a part of informed consent. The surgeon was already in the operating room, busy at the moment. Should the nurse hold him until the surgeon talks to him and takes informed consent again? How much information should the patient recall and for how long in order to be a valid informed consent?

Understanding is an essential requirement for decision-making capacity. If patient understands and can talk about the relevant information at the time of informed consent, it fulfills the requirement. Complete recall of the information at later date is not a requirement for informed consent. ⁴

“Wait till my wife comes here”

Mr. H, a 65-year-old man, was admitted with symptoms and signs of an abdominal aortic aneurysm and the vascular surgeon recommended surgical repair. When the surgeon came to take informed consent, Mr. H told that he wanted his wife to read the written information in the consent form and then they will make a decision. Since then, the surgeon has been communicating with Mr. H’s wife directly for every other procedure required for him including blood transfusions, radiological imaging, etc.

Should the surgeon be discussing with Mr. H’s wife because Mr. H has asked his wife’s opinion while giving consent? Is informed consent an all or none phenomenon?

When the decision is of high complexity and benefit to risk ratio is not necessarily positive, many patients would prefer to involve their family members in the decision-making process, and this should be encouraged by the physicians. Under the right of informed consent, patient has freedom to take advice or even share decision making with his family or whom he trusts. ⁵ If patient has involved his family member for decision-making process once, it does not imply that he has given permission to that family member to make all his future decisions.

“Can you please sign in here?”

Mr. B, a 56-year-old man was on gurney waiting to be taken for a colonoscopy procedure. The nurse realized that there was no signed informed consent in the patient’s medical record. The nurse gave the informed consent to Mr. B and asked him to sign it.

Are principles of informed consent being followed in above case? What is wrong in this scenario?

Informed consent is a process and not an event. If the details and risks of the procedure have been discussed with the patient earlier and it is only the matter of signing the consent, the above scenario is ethically right. But if this is the first disclosure of details related to the procedure, it is ethically wrong. Gurney consenting is a common phenomenon in medicine today. A patient who is waiting on the gurney is already prepared for the procedure physically and psychologically. He has even made further needful arrangements like taking off from work and arranging a driver. If informed consent is taken when patient is on gurney, he has no option other than to say yes for the procedure.

In this scenario, the nurse is taking consent from the patient; again this is a common practice. The member of the healthcare team who is performing the procedure should take the consent whether it is nurse, PA, or physician. In the above case, the nurse is not ethically eligible to take consent as she is not performing the procedure.

In essence, to obtain informed consent, the patient has to give the consent to physician for the procedure. The patient should have decision-making capacity, receive the information about the procedure and any alternatives, understand it, make a decision, and communicate it voluntarily. The physician should give information about the procedure including its indication, risks, alternatives, and the possible consequences of not having the procedure, in the language that patient can understand. Informed consent has a role only where activity is already subjected to an ethical, legal, or other requirement. We do not have to seek other’s consent to action that we have every right to do or to meet other legitimate expectations. We do not need consent to stop on the road at a red light or sit at our workplace during work. On the other hand, if Mr. Fred is riding a horse in Jack’s ranch, it will be trespassing, unless Jack has waived right to exclude him. ⁶ Informed consent in the present form is representing patient autonomy which should establish good communication between physician and patient, to become a sound in the silent word of doctor and patient.