The Informed Consent Responsibility
Informed consent is a process, not simply the collection and documentation of a form.  The consent process requires active, two-way communication between the patient and each healthcare provider involved in the treatment and the decision-making process.  Physicians and patients should exchange information in an interactive way that ensures each party has the full range of knowledge needed to make an appropriate treatment recommendation and make a sound decision on whether or not to consent to follow through with the treatment.  They each have their own set of responsibilities.

Critical steps need to be completed for each patient and for each new treatment recommended, to conduct a proper informed consent process.  Physicians in charge of the treatment are ultimately responsible for the consent process, but other providers, such as nurses, diagnostic technicians, and physician assistants also should clearly communicate with the patient.  Physicians should personally document as the process is completed.

Provider responsibilities during the consent process include:

• Set aside time to communicate with the patient. The process should not be rushed.
• Do not delegate the task of delivering and collecting information from the patient. Too many people in the process can confuse the patient and information can get lost.
• “Get to know” the patient and learn what matters to them. Talk about their current living situation, family, work, and their biggest concerns.
• Consider special needs, including medications, underlying health issues, language barriers, or any factor that may affect their ability to make a sound decision.
• Ask the patient to explain the information they should know, to ensure there are no miscommunications.

Following these simple guidelines gives the physician an opportunity to learn factors that may not have been previously disclosed, as well as lower the patient’s stress level.

Patients also have a set of responsibilities during the consent process.  Information must be exchanged both ways in order to support a proper decision-making process.  When the patient does not interact with the provider, the information only flows one way and this can have catastrophic circumstances if a critical piece of information is not disclosed from the patient.

Patient responsibilities during the consent process include:

• Provide accurate information. Some facts may be embarrassing and the patient may feel that it does not apply to the current situation. This can prevent the provider recommending treatment from making a proper recommendation.
• Speak up when confused. Do not assume the provider knows that there is a misunderstanding or lack of some information. Some patients think they should understand, so they do not inform the provider of their confusion.
• Ask questions. Clarify answers when there is any question of understanding.  Providers should do their best to make sure the patient understands, but it is the patient who needs to let the provider know when they do not.

When the patient effectively communicates with the provider and provider to the patient, both parties can feel confident about the treatment being appropriately recommended and a decision can be made. Documenting the process gives both parties legal

A relationship should be formed between the provider and the patient.  This relationship develops while the information is being shared between the two.  An understanding of religious beliefs, personal finance, and living situations may not seem to apply to the medical care provider’s treatment recommendations, but they can have a profound effect on the treatment plan.

The patient’s religious factors, like not believing in blood transfusions, can cause the patient to refuse one type of treatment based solely on those beliefs.  Personal finance issues may prevent a patient from consenting to a treatment or may alert the provider to come up with an alternative solution. The patient’s family and living situations may be a cause for them to decline a treatment.  The patient may not have anyone to care for them at home or to drive them around during the treatment process.

Once the patient and the provider have done their due diligence by sharing information, making sure each one understands, and building a relationship, collective decision can be made.  Then the “Informed Consent” form can be documented, signed, and stored in the patient’s permanent medical record.