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What Is Informed Consent?

Max Freedman
Max Freedman

You must obtain and document patients' consent before beginning certain treatments. Learn when and how to do this.

  • Patient consent – most often informed consent – encompasses educating the patient on their condition as well as treatment options, benefits and risks. 
  • State laws govern informed consent, as does The Joint Commission, the national board that accredits medical facilities. 
  • Implied consent differs from informed consent and may be suitable for small-scale checkups. 
  • This article is for medical practitioners looking to understand informed consent versus implied consent and know when they must obtain and document patient consent.

If you have a medical practice, it’s easy to think that once you’ve described a treatment route to a patient, they fully understand why it’s appropriate for their healthcare. It’s also easy to think the patient realizes the procedure comes with an established set of risks. But you can’t know that’s the case unless you obtain patient consent. In fact, obtaining the patient’s informed consent is legally required for many types of procedures, with laws varying by state. 

We’ll explain informed consent, what a medical consent form should include, how to properly document patient consent, and more. 

Patient consent, primarily informed consent, describes the process of educating a patient about a particular medical treatment. This education should occur before the patient agrees to the treatment so they can make an informed decision. 

You must be certain your patient fully understands their condition and treatment options. The patient should also comprehend the benefits and risks of the treatment, as well as any alternatives.

Key Takeaway

Patient consent encompasses educating a patient on their treatment, its alternatives, and the benefits and risks of each.

For starters, it’s ethical to obtain informed consent before treating a patient. Just as importantly, informed consent is also often a legal requirement.

Many states have their own laws governing informed consent. For example, in Pennsylvania, a June 2021 law affirmed the legal requirement of obtaining patient consent while allowing physicians to delegate who obtains this consent. Under this law, physicians can task several other types of qualified medical personnel with obtaining informed consent. 

Technically, at the federal level, no laws explicitly govern informed consent outside clinical research settings. In reality, the national nonprofit The Joint Commission – which accredits healthcare facilities – requires all practitioners to document a patient’s informed consent. Failing to do so could result in your accreditation being revoked. That makes this requirement the national equivalent of a law requiring you to obtain patient consent.

It’s also a good practice to obtain informed consent if your practice faces a lawsuit for medical malpractice. Your consent document could prove the patient’s medical outcome falls within the risks you explained to them. On the other hand, your consent document could prove that what you were sued for falls beyond the purview of the risks you described. In that case, you might make yourself more liable for the patient’s adverse outcome.

Did You Know?

The threat of a malpractice lawsuit is why medical practices must obtain professional liability insurance as part of their overall business insurance coverage.

While patient consent is a legal requirement, it doesn’t apply to all procedures. Often, a patient’s presence in your facility constitutes their consent to essential treatments, such as having their heart rate checked. But you must obtain and document informed consent for the following procedures:

  • Most vaccinations
  • Certain advanced medical tests, including biopsies
  • Certain blood tests, including HIV testing
  • Chemotherapy
  • Radiation
  • Most surgeries
  • Anesthesia
  • Blood transfusions

The above list of procedures requiring patient consent might not account for state-by-state variations. Consult a medical lawyer or other medical professionals in your region to determine when you must obtain informed consent.

There are three types of patient consent you should know about for legal purposes: oral, written and implied consent.

  • Oral consent: This type of consent comprises any verbal permission a patient gives you to conduct treatment. Oral consent isn’t enough if you must produce formal documentation – in that case, you’ll need written consent.
  • Written consent: You obtain a patient’s written consent, also known as express consent, when they sign a form agreeing to treatment. This form must extensively document the knowledge you’ve shared with the patient. It should also indicate that the patient understands the benefits and risks of the treatment and its alternatives.
  • Implied consent: For some procedures, a patient’s actions can imply consent without any verbal or written statements. For example, if you need to collect a throat swab and your patient opens their mouth when you ask them to, you can infer their consent.

Informed and implied consent aren’t one and the same. For basic checkups, implied consent can stand in for the former. But you can’t rely on implied consent before providing high-risk treatments such as surgery or chemotherapy. 

If you’re ever in doubt about when you need informed or implied consent, ask a medical lawyer or another practitioner in your region.

All your medical consent forms should include the following information.

  • A formal statement of the patient’s diagnosis: You don’t need to include medical billing codes alongside your diagnoses. The Joint Commission isn’t a medical billing entity.
  • The treatment you’re administering: Name the treatment and describe the desired outcome. For example, let’s say you’re operating on a patient to remove an overactive parathyroid gland. In that case, the desired outcome could be a successfully removed gland and, in due time, lower calcium levels in the blood.
  • The benefits and risks of the treatment: Continuing with the above surgery example, benefits could include lower blood calcium levels and a decreased likelihood of kidney stones. Risks could include those of any surgery – pain, allergic reactions to anesthesia, infection, and, of course, death.
  • The benefits and risks of all alternatives: Could pills solve the parathyroid problem instead of surgery? If so, you should clearly state that in your informed consent document. But maybe the risk of these pills is that they don’t do quite enough to lower the patient’s calcium levels. State that as well.
  • The patient’s understanding of all the above: It’s one thing if you know the condition, treatment, alternatives, benefits and risks – that’s your job. It’s another thing for the patient to understand it all. That’s why your consent document should clearly indicate that the patient is fully aware of everything regarding their treatment. 

When you implement an electronic health records system, you can store medical consent forms digitally.

For any procedures that require you to obtain consent, you must document this consent to begin treatment. If the patient hasn’t signed a consent form, you can’t start treatment even if the patient has given oral consent. 

Obtaining and distributing patient consent forms is typically quite easy with the best medical software. For example, AdvancedMD automatically loads consent forms into your patient charts. You can also customize AdvancedMD’s consent forms to fit your front-office workflow and reflect your medical specialties. 

Read our review of AdvancedMD to learn more about this software, or check out our reviews of some other top medical software solutions: 

Key Takeaway

Choose the right EMR software for your practice to make obtaining patient consent forms as straightforward as possible.

Occasionally, someone other than the patient can provide informed consent on their behalf. You can obtain informed consent from another party if the following is true:

  • The patient is under 18 years old. Most states require parents of minors to give consent, rather than the minor. In some states, exceptions exist for married or emancipated minors, as well as those who are parents or in the military.
  • The patient defers responsibility to another party. A patient can sign an advance directive to empower another person to make medical decisions for them. That person can then make decisions for the patient no matter their condition.
  • The patient cannot give consent. A comatose patient or one with dementia may be unable to make medical decisions even without having previously signed an advance directive. In that case, someone else can provide informed consent on their behalf.
Image Credit: PrathanChorruangsak / Getty Images
Max Freedman
Max Freedman
Contributing Writer
Max Freedman is a content writer who has written hundreds of articles about small business strategy and operations, with a focus on finance and HR topics. He's also published articles on payroll, small business funding, and content marketing. In addition to covering these business fundamentals, Max also writes about improving company culture, optimizing business social media pages, and choosing appropriate organizational structures for small businesses.