First take home point from this post would be to understand that "even if you perform a procedure that was necessary without any complications, you can still be held liable for not obtaining the consent." Therefore, it is vital to have a clear understanding about "informed consent" to avoid miscommunication and bad outcomes.
So what does "informed consent" mean?
Informed consent is the process by which the treating health care provider discloses appropriate information to a competent patient so that the patient may make a voluntary choice to accept or refuse treatment (informed refusal). It originates from the legal and ethical right the patient has to direct what happens to their body and from the ethical duty of the physician to involve the patient in her health care. Informed consent may not be applicable only to procedures, but also to other significant management decisions.
- Nature of the decision/procedure
- Reasonable alternatives to the proposed intervention (regardless of there costs)
- The relevant risks, benefits, and uncertainties related to each alternative
- Assessment of patient understanding
- Acceptance of the intervention by the patient
Concept of Battery
- Physician failed to disclose adequate information regarding benefits and risks of proposed treatment, as well as alternative treatment options
- Patient need not prove negligence in the performance of the treatment; liability arises solely from inadequate disclosure (Physician is liable even if treatment was medically appropriate and performed skilfully right to damages arises from unauthorized contact)
What is informed refusal?
Waivers to informed consent:
- If the patient does not have decision-making capacity. Find the proxy, or surrogate decision-maker
- Implied consent in emergency
- When the patient has waived consent
- When a competent patient designates a trusted loved-one to make treatment decisions for him or her
There are three ways to look at it:
- Reasonable physician standard: What would a typical physician say about this intervention? This standard allows the physician to determine what information is appropriate to disclose. This standard is generally considered inconsistent as the focus is on the physician rather than on what the patient needs to know.
- Reasonable patient standard: What would the average patient need to know in order to be an informed participant in the decision? This standard focuses on considering what a typical patient would need to know in order to understand the decision at hand.
- Subjective standard: What would this particular patient need to know and understand in order to make an informed decision? This standard is the most challenging to incorporate into practice, since it requires tailoring information to each patient.
It is fine to have consent forms signed by the patients before the procedure/major treatment (tPA for stroke), making sure that they are aware of the process and understand it. In the ED, patients are distressed and sometimes they just want things to move quickly. This can be one reason for signing the consent form without going through it in detail. The way these forms are designed is scary. For a minute, if you read it through the patients eyes, it can give you goose bumps for sure.
This is what a typical consent form says:
I confirm the following:
When obtaining an informed consent:
- Have a meaningful, unhurried conversation with patient.
- Make the patient an active participant in the shared decision-making process.
- Provide supplementary information, such as brochures or videos.
- Disclose the most severe risks and the most common risks.
- Don't forget to mention about the alternatives.
- Obtain signed informed consent form.
- Avoid giving casual answers e.g This surgery is as risky as any other major surgery or I have done dozens of such surgeries. Be a little sensitive.
- Be professional.
- Avoid quoting exact numbers or percentages.
- Most important: Never ask a colleague or junior physician to obtain an informed consent on your behalf. This leads to confusion, chaos and miscommunication. Person doing the procedure (Yes, even the the senior physicians) must take the consent. It is important to make sure that the patient and family have the capacity, are clear on the facts and have their concerns addressed by an experienced physician before getting to YES,.
- Appelbaum PS. Assessment of patient’s competence to consent to treatment. New England Journal of Medicine. 2007; 357: 1834-1840.
- Moore, Gregory P., et al. "What Emergency Physicians Should Know About Informed Consent: Legal Scenarios, Cases, and Caveats." Academic Emergency Medicine 21.8 (2014): 922-927.