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Patients have autonomy to choose what can and cannot be done to their bodies. Therefore, informed consent is required before any treatments or procedures commence. This is a stark contrast to the previously recognized paternalistic approach, which relies solely on the decision-making of the provider.

However, in order for patients to really choose whether or not to submit themselves to a particular healthcare service, they must actually understand what the service is. Therefore, patient consent should help the patient understand the risks and benefits, as well as any alternative treatment options.

Obtaining Consent

Merely having a patient sign an informed consent is not enough for a patient to consent. Rather, providers should have an active dialogue with patients, which starts with explaining a diagnosis, the proposed treatment including its benefits and risks, and any alternative treatment options and their benefits and risks. Providers should allow patients to ask any clarifying questions they may have. Only after this dialogue can a signed consent be obtained.

While some states recognize verbal consents as valid, others require that patients sign an authorization form to show that consent was actually obtained.

Capacity to Consent

Even if a provider engages in a dialogue with a patient clearly laying out the patient’s diagnosis, treatment options, and benefits and risks, some patients still cannot consent due to lack of capacity. If a patient cannot understand or appreciate the benefits, risks, and alternatives, or cannot demonstrate reasoning in their decision-making, the patient likely does not have capacity to give a valid informed consent. One way to determine whether a patient has capacity is to have the patient restate in their own words what they understood about the dialogue with their provider.

Further, while minor patients may seem to have capacity, they are incapable of providing informed consent (although there are some exceptions in states where the minor is emancipated or is being treated for specific illnesses, such as sexually transmitted diseases). Therefore, consent to treat minors will generally require a parent or guardian’s signature. 

Penalties

Failure to adequately obtain informed consent may result in consequences, including but not limited to medical malpractice lawsuits, loss of hospital privileges, or removal from preferred provider lists.

If you have any questions regarding patient consent in general, or whether your current process for obtaining informed consent is compliant with applicable state and/or federal law, please don’t hesitate to contact BMD Health Law Group Member Jeana M. Singleton at jmsingleton@bmdllc.com or 330-253-2001, or BMD Attorney Rachel Stermer at rcstermer@bmdllc.com or 330-253-2019.