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.
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.
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:
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.
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.
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:
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: