How does the consent process work in helping patients to make an informed decision?

Informed consent is described by the Joint Commission as being an agreement between a healthcare professional and their patient. The agreement describes the nature of a treatment, as well as the risks of treatment, and alternatives.

For people who have had any type of surgical procedure, they are most likely already familiar with the common signed consent form. The form, an informed consent document, describes the proposed treatment and how it relates to the patient’s medical care.

Surgical consent forms are often scary descriptions of the many possible negative outcomes that may occur. There are risks of infection, scarring, tissue damage, nerve damage, and even death.

It is common for a surgeon to put the patient at ease, pointing out that many of the risks outlined in the form are rare. Yet, patients should still take the risks seriously, because medical treatment always carries real risks. The decision making process should be taken seriously.

Is verbal consent enough to meet the requirements for informed consent?

Do doctors have a legal obligation to implement an informed consent process? Is it required for a healthcare provider to give the patient a written consent form?

In the case of procedures, such as surgeries, an informed consent form is a legal requirement. Health care institutions hire legal teams to help design the forms to meet the requirements of state and federal laws.

What about other medical treatments other than surgeries? Is a doctor required to provide informed consent when they write a prescription for medication?

Laws regarding informed consent may vary from state to state, so if you are a concerned doctor, wanting to comply with informed consent laws, I recommend looking at your state’s laws and consulting with a healthcare attorney. Legal lectures are a required part of continuing medical education for doctors, and informed consent is a topic that is usually covered in such lectures.

When a doctor writes a prescription, they should inform the patient verbally of the risks of side effects and adverse reactions. Prescription medications can be quite dangerous to a certain percentage of patients.

By informing a patient of the risks, they are able to make an informed decision. Verbal consent is important, because it provides an aspect of informed consent that goes beyond an informed consent template presented as a written consent form or electronic informed consent.

In some cases, verbal consent may be enough, yet, to be safe, healthcare professionals may want to require explicit consent in writing for any medical treatment. It would not be unreasonable to ask patients to sign an informed consent document for all treatments, even the prescribing of medication.

Informed consent is not all about following the laws and rules.

There is another important reason for doctors to provide informed consent to their patients, beyond following state and federal laws. Doctors should offer informed consent because it is the right thing to do.

Recently, there has been an increase in attention to the dangers of many prescription drugs. We are discovering that the pharmaceutical industry has been deceptive in the way that it educates healthcare professionals on the safety profiles of their products.

We now know that opioids, such as OxyContin, are not as safe as we were told by the industry, two decades ago. The pharmaceutical industry is very involved in healthcare education and healthcare administration.

Why were more patients not told of the addictive potential of OxyContin? Purdue, the company that manufactured the drug, presented false data to doctors, and to the rest of the healthcare industry.

We are now discovering that many psych drugs used to treat mental health conditions, from benzodiazepines to antidepressants, are not as safe as we previously believed. These drugs may cause serious harm to the human nervous system, and they may increase the risk of suicidal ideation and suicidal attempts.

Fortunately, product information has been updated for many of these drugs. Doctors should review the latest literature regularly, because there are new warnings for various drugs, including new black box warnings for benzodiazepines, as of 2020.

Should a doctor tell a patient of the risk of suicidal ideation and suicidal attempts that may occur if they take a prescription drug? I believe that doctors should have this discussion with their patients.

Should a doctor offer informed consent for a medical treatment started long ago, by another doctor?

Regarding medications, what if a doctor starts working with a new patient who is taking a benzodiazepine, without any negative consequences? Should the doctor recommend that the patient start a tapering process, reducing their medication with the intent of stopping it?

This is an excellent question. Just because a medication may be dangerous to a large percentage of people does not mean it is bad for everyone.

Yet, the doctor may still engage with their patient by providing informed consent, even if it has not been offered before. The doctor can explain that benzodiazepines are now known to potentially cause serious long-term consequences, such as toxic encephalopathy and akathisia.

While it is possible that not all patients will suffer these consequences, the patient, now understanding the risks, can make a better informed decision. Now, the patient has the information they need to decide if they want to start the tapering process, or maintain their current treatment plan.

I believe that this type of informed consent can be considered a form of harm reduction. Harm reduction means to protect a person’s safety until they can get out of harm’s way.

Harm reduction is usually a term used in association with addiction recovery, but it may be used in areas beyond addiction treatment. Informed consent may be considered a form of harm reduction.

Should informed consent be used in human research?

In clinical research, informed consent is critically important. Historically, there have been instances where each human subject was uninformed of the risks of a study, or they were not even informed that they were in a study.

Not providing informed consent in a research study is a civil rights violation. Human beings have a right to be informed of all known risks of being a research subject.

There are human research protections to protect public health and to protect individuals from being harmed by dangerous experimental procedures and treatments. A potential participant must be fully informed of all risks before agreeing to be a research participant.

Patient safety should be a primary concern in any research study where human subjects are involved. This is especially true with experimental treatments for diseases such as cancer, where participants may place unrealistic expectations on the outcome of a dangerous and risky experimental treatment.

What if a patient is unable to make an informed decision on their own?

Of course, there are situations where a patient is unable to agree to verbal informed consent, or to sign a written consent form. The patient may be unconscious, in severe pain, or they may not have the appropriate decision making capacity for a variety of other reasons.

In these cases, a legally authorized representative may provide surrogate consent. Informed consent laws do allow for a surrogate to sign on behalf of a patient who is unable to sign an informed consent document for themselves.

People may want to make arrangements ahead of time to prepare for the possibility that they will be unable to sign paperwork for medical procedures in the future. The importance of such arrangements is not only for elderly people or people with existing health conditions.

We never know when we might find ourselves in a situation where we are unable to make decisions for ourselves. If this situation arises, we will want to ensure that the person designated to make decisions on our behalf has our best interests at heart.

Additionally, we would want the person agreeing to informed consent on our behalf to be a knowledgeable, educated, and discriminating person who will ask questions and not agree to unreasonably dangerous procedures. Designating a legally authorized representative is an important decision.

Informed consent should be both verbal and written.

In the film, Medicating Normal, a patient returns to her doctor’s office to complain to the doctor that she was never told of the risks of her medication. She was on a benzodiazepine, and she suffered from a difficult tapering process and severe withdrawal symptoms.

The doctor, who was hidden from camera with his voice disguised, insisted that he had warned her, and that he was aware of the dangers of her medication. The patient persisted in complaining that she had no prior warning.

The major point of the film, as intended by the filmmakers, was that informed consent is critical with the prescribing of medications. Patients should be warned of the risks before starting a medication.

Patients trust their doctors, and doctors should take this responsibility seriously. Doctors should review the risks of treatment with patients, not to deny the treatment to them, but to inform them that there are risks if they decide to go forward with the treatment.

Verbal consent is important, because when a doctor says something verbally, it has more impact than simply signing a form placed in front of the patient. Unfortunately, patients have a tendency to sign any form given to them in a doctor’s office without carefully reviewing and considering the content.

If the doctor explains the details of risks of treatment verbally, the patient will be more likely to think carefully, and make a proper informed decision. Written informed consent is also important, so a patient can be shown later that they did agree to the risks of treatment, if this is necessary.

Should dangerous medical treatments be taken off the market, when they are proven to be dangerous?

In some cases, medications have been found to carry risks that are considered to be excessive. These drugs are removed from the marketplace to protect patient safety.

If this is true, why do drugs, such as benzodiazepines, opioids, SSRI antidepressants, and other dangerous drugs remain available? Should the FDA ban these drugs?

While these medications do carry serious risks, they also have significant benefits for many patients. It would be cruel to not offer opioid analgesics to a person suffering from cancer pain, or other severe pain syndromes.

Benzodiazepines are still considered to be useful for short-term use in certain situations. Many patients benefit from these drugs, so it would not be appropriate to outlaw them.

What we should do is provide better education about the potential dangers of these drugs to both doctors, and to the public. Informed consent is the key to protecting public safety from dangerous medical treatments that are still highly beneficial to patients in certain situations.

Not only should we work to educate doctors and the public about the dangers of medical treatments, we should also educate on the topic of informed consent. Informed consent is important, and it will help to prevent many iatrogenic (healthcare-caused) injuries and tragic outcomes.

What is the best way to bring up informed consent with my doctor?

Next time you are in your doctor’s office, and your doctor sits down to write a prescription for medication, ask about risks and alternatives. What are the side effects and adverse reactions that may occur if you take that medication?

The doctor may brush you off and say that the drug is safe, and you don’t have to worry about any serious side effects. Or, they may run off a short list of vague side effects, and then assure you that they are rare and not serious.

Before filling the prescription, you may want to look up the medication on a reputable and reliable website. Read the literature yourself, and review the list of side effects and adverse reactions that are possible.

Then, when you go to the pharmacy, ask for a consultation with the pharmacist. Ask to review the literature on the medication, and the possible risks involved.

You may even want to investigate support groups for people who have the condition for which you are being treated with the medication. What alternative treatments are being discussed? Have others had problems with the medication being prescribed?

Are there support groups for people who have suffered injuries caused by the medication? For example, there are many support groups for people who have suffered from the consequences of psych drug adverse reactions.

Should you be discouraged from taking the medication after finding that there are serious risks involved? Not necessarily. The next step would be to consider the possible benefit of taking the drug.

For example, antibiotics can have serious risks associated with taking them. Some have neurological risks, others have cardiac risks, and most antibiotics will cause intestinal problems if taken for long periods.

Yet, antibiotics can be life-saving, and sometimes it is important to take the treatment, and take the risk. The risk of infection may greatly outweigh the risks of side effects and adverse reactions from the antibiotic.

Informed consent, which can involve verbal and written consent from your doctor, as well as your own extensive research, can help you to make a proper informed decision. Making an informed decision is an important component of your own healthcare, and it should be a priority for all people who may require medical treatment.