Informed consent can be broken down into two parts.
The informed part of informed consent is the process through which a patient learns about and is led to understand the purpose, benefits, and potential risks of a medical or surgical intervention from their healthcare provider(s). A patient is supposed to be fully informed and made to understand these things for any and all medical treatment, including clinical trials, and experimental medicines and treatments.
The consent part of informed consent is when a patient agrees to receive a suggested treatment, procedure, or surgery, or agrees to participate in a trial, etc. As a legal term, informed consent typically requires the patient, or their conservator or guardian, to sign a statement confirming that they understand the risks and benefits of the medical treatment they are agreeing to undergo.
Any time a patient is going to undergo a treatment that involves any sort of risks, including something as simple as mild side effects of a medication, all they way on up to potential disabilities or death, that may be the result of a particular way to treat your problem, the healthcare provider that is suggesting the treatment is legally obligated to inform you of these things. This is so that you can be fully informed and educated about what you are agreeing to undergo- what you are consenting to.
Patient autonomy is a patient’s right to make decisions about their own medical care without being influenced by their healthcare provider’s bias and opinions. A healthcare provider has the duty to educate their patients but they are not supposed to make decisions for a patient nor are they supposed to try to convince their patients to undergo potentially dangerous treatments because of personal feelings or opinions. Patient autonomy is the moral and legal premise that informed consent is based on.
Informed consent must be voluntary. If a patient is informed about a treatment but is coerced into agreeing to it when this is not what they really wanted, it is not considered to be informed consent. If a healthcare provider or facility fails to obtain informed consent before performing medical tests, treatments, procedures, surgeries, etc., on a patient, it is called battery which is considered to be a form of assault.
There are many interactions with healthcare professionals where explicit, informed consent is not necessary. If a patient makes an appointment with a doctor or goes to an urgent care facility, their consent for this is implied and the healthcare provider does not typically need to get informed consent before performing a physical exam on their patient.
Exceptions to Informed Consent
Similar to some situations of implied consent, there are exceptions to the informed consent rule. These include but are not limited to, emergencies where medical care is needed immediately to prevent serious and/or irrevocable harm, and when a patient is incompetent or refuses to give permission for tests or treatment.
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