The Process
A patient’s consent to treatment is more than simply getting the patient to sign a form.

It is a communication process between the patient and all healthcare providers involved.

In many cases there are several care providers involved with the patient’s care, including nurses, physician assistants, technicians, and physicians.

Each of the care providers will likely take part in the discussion with the patient at some point, but the physician who is providing the treatment holds full responsibility for properly obtaining consent.

If the patient is unable to understand and make decisions, there will be decision makers involved in the communication process, also.

The process for obtaining consent requires of a two-way conversation between the care provider and the patient or representative.

This conversation is an opportunity to clarify medical history and identify concerns, as well as inform the patient on procedures.

The patient and physician should discuss any factors that may cause the patient to refuse or the physician to reconsider treatment options.

Once there is a full understanding and agreement between the patient and physician, the consent can be put into writing on a form or in the patient’s electronic medical record.

Core Elements
Laws and best practices for obtaining consent vary slightly from state to state, but they all include a 2-way conversation between the patient and care provider.

The conversation should contain these essential core elements.

Those elements include:

• Description of the reason for treatment;
• Explanation of the test or treatment;
• Explanation of possible benefits and risks;
• Description of alternative treatments with their benefits and risks;
• Description of consequences if treatment is declined.

Along with these core elements for discussion, the physician must also obtain:

• A full medical history on the patient to avoid ordering tests that can harm the patient or duplication of tests.
• The patient’s full medication list, including over-the-counter, vitamins, and homeopathic remedies to avoid contraindications.
• Current social or economic status of the patient to gain a full understanding of the financial stress, personal constraints, and other factors that may affect their decision to consent or decline treatment.

The physician presiding over the patient’s test or treatment is responsible for ensuring that each element is covered during the discussion with the patient or representative.

The Art of Communication
The communication process will vary from patient to patient.

Each individual has a different set of circumstances that will affect their ability to make an informed decision.

The consent process should address the needs of the patient.

Providers must take into consideration all of the aspects of the patient’s life and the best way to communicate with them.

Decision Making Tools: Tools may be used, including brochures, videos, websites, or other learning aids, to educate the patient.

This is often a good way to communicate details about the treatment, the benefits, and the risks.

Carefully gauge the patient’s abilities and personality before choosing a learning tool to avoid insulting the patient’s intelligence or confusing the patient with the wrong tools.

The “One Voice” Approach: Use caution when more than one care provider is involved.

Patients often assume that one provider has given all information to the other providers.

Typically, this is not the case.  When several providers are involved, there is opportunity for misunderstanding by the patient and miscommunication between providers.

The “One Voice” approach simplifies the conversation by assigning one person to deliver the information and ask the questions.

Usually, the physician in charge is the best person to conduct the entire consent communication.

Keep it Simple: While speaking with the patient, use understandable language that is not condescending.

Avoid medical jargon.

Ask questions during the conversation to assess the patient’s comprehension of what was just said.

Provide other sources of information for the patient to research on their own, such as a book, brochure, website, or video.

Remain available to answer questions after the initial conversation.

Informed consent is not a signed piece of paper –

It is the process of obtaining an agreement that is the result of a discussion that includes an exchange of information.

The discussion must be specific to the patient and the process of obtaining consent must directly address the needs of the patient.

Healthcare providers have a legal and ethical duty to follow the process of obtaining consent without leaving out any of the core elements.

Every patient has the right to consent or decline treatment after they have been properly informed.