Informed Consent

Original Editor - Mariam Hashem

Top Contributors - Mariam Hashem, Kim Jackson, Wanda van Niekerk, Naomi O'Reilly, Tarina van der Stockt, Jess Bell, Robin Tacchetti and Tony Lowe

A brief background

We can track the history of informed consent back to the early years of last century. A doctor in New York was sued for performing a hysterectomy without obtaining patient's consent. The operation initially aimed to investigate an abdominal mass. When the surgeon suspected fibroid he decided to remove the uterus. When informed about the outcome, the patient wasn't pleased and decided to sue the doctor.

Justice Benjamin Cordozo, commented “Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault for which he is liable in damages. This is true except in cases of emergency where the patient is unconscious and where it is necessary to operate before consent can be obtained.”

Simply, informed concept refers to the patient's right to be informed on their condition, risks, benefits and treatment options. It entitles the healthcare professionals to include their patients into their clinical reasoning process to reach a shared- decision. Roles and regulations are different from a country to another. In some circumstances you will find yourself challenged by the available resources, culture and your patient's capacity to make their own decisions.

Ethical framework

Ethically, informed consent is the core of moral practice that justifies autonomy, dignity and respect for our patients.

Understanding the proposed options and voluntarily giving permission without controlled influence are necessities of informed consent.

The emphasis on self-management is widely supported in the evidence. Patients has to show motivation, willingness and active cooperation to the treatment. Adapting a patient-centered practice cannot be validated unless a patient has consented on every aspect of it.

Historically, doctors and medical professionals weren't required to obtain patients' approval to perform a specific treatment as long as it was justified against the professional medical opinion which became known as the Bolam test. Patients weren't expect to understand their conditions or to be given a choice regarding risks and benefits. People trusted their doctors and thought they know the best for them. But what happens when the outcomes weren't exactly the best for the patient, think about the woman who wasn't given the choice on the removal of her uterus? Or a patient who needed an amputation but declined this option so the surgeon decided to perform the operation under her husband's approval and consent?

An example of legal support of informed consent is the UK law stating that medical and healthcare professionals are obliged to inform the patient on risks and benefits of the given treatment and also alternatives and it's up to the patient to choose freely without controlling influence. This is attributed to the famous legal case ''Montgomery Vs Lankarkshire, 2015'' when a short stature woman with type I diabetes weren't informed about the risks of vaginal delivery for her condition and as a result her macrosomic baby sustained shoulder dystocia and brachail plexus injury. The court concluded that she should've been an advised on cesarean section and informed on the risks of vaginal birth.

Why informed consent?

Practicality of informed consent

Effective communication skills are essential to the informed consent. Listening carefully and giving a space for discussion and questions are great tools to empower patients to make their own decisions. It is not meant to be a bureaucratic process, instead it's a process of exercising good communication and showing empathy.

Depending on the nature of intervention and the risks involved, a written consent may be required , such as when deciding to do a grade 5 manipulation.

The following points need to be discussed to ensure patient's dignity and autonomy:

• Clinical condition
• Intervention
• Alternatives with the risk and benefits.
• Assessment of the patient’s understanding and asking them to state their preference.

This information should be delivered in a simple way to the patient. You may choose to support with written materials, involve the relatives or ask the patients some questions that reflects their understanding.

An ideal culture of decision making should reflect a situation where the healthcare professional decides what is best for their patients based on their professional experience and their clinical reasoning skills. However, it's up to the patient to either accept or decline the suggested ''best'' option.

Mills & Epstein argued about the practicality and consequences of the Montgomery case, when the medical workers find themselves challenged to act in the patient's best interest in an attempt to protect themselves. There is no doubt that informed consent and shared decision-making generally have positive outcomes .

A good way of applying informed consent is to ask yourself how to think and what to think instead of what to do?

Limitations to informed consent

There will always be exceptions to any role. Think about the emergency department, where a second can mean life or death. There are some situations where saving a life is the priority and in some cases you cannot take a patient's consent.