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Principles of Informed Consent in Healthcare

blog_InformedConsent_ConsentFormSignHospitalPatientDr_260x200px.jpgMany practitioners view the process of informed consent in healthcare to be a nuisance and a hindrance. It is often simply one more hoop to jump through so that the patient can get the care he or she needs. This is not true. If the provider was negligent in providing the service and a bad outcome occurred, the patient has a cause of action for medical malpractice. If the provider was not negligent but a bad outcome still occurred, the patient may have a cause of action if the provider did not disclose the risk of the bad outcome (complication) ahead of time. This is where informed consent comes in; if the patient was aware of the risk of the complication and agreed to have the procedure anyway, the patient cannot be allowed to complain afterward. Informed consent can immunize the provider from liability for a known complication that occurred in the absence of negligence.

There is a difference between general consent and informed consent.

  • General consent is required before the patient can be examined or treated or before minor testing (such as lab work or routine imaging studies) can be done. No explanation of the contact is necessary, but consent to touch the patient is required.
  • The patient’s informed consent is required (generally) before an invasive procedure that carries a material risk of harm can be performed. State laws vary on the details of the requirement for when informed consent is required, but the foregoing is the general rule.[i] Invasive procedures can include anything from a root canal to major surgery. If the patient’s informed consent is required, the provider must discuss the risks and benefits of as well as the alternatives to the proposed procedure.

website_author_westThe determination of what constitutes a material risk of harm falls into two distinct classes:

  1. In the reasonable patient school, the question is: “What would a reasonable patient want to know about the risks of the procedure before agreeing to undergo it?”
  2. In the reasonable provider school, the question is: “What risks would a reasonable provider disclose to a patient under the same or similar circumstances?”

It is important for providers to understand the law in their jurisdictions regarding the principles of informed consent.

As a general rule, the risks of the procedure do not include the risk that the provider may be negligent in performing it. Thus, the disclosure of a history of or current substance abuse, disciplinary actions against licensure, failure rate with the procedure, etc., are not normally required to obtain the patient’s informed consent, although this too can vary by state law. As noted, if the provider performs the procedure negligently, the patient can sue for medical malpractice. A patient cannot waive the right to sue before the negligence has occurred.

Informed consent, when done properly, can be a strong shield against liability. Providers who perform procedures that carry a material risk of harm are well-advised to undertake these discussions with patients carefully and thoughtfully. Providers must recognize that this process requires a meeting of the minds about the risks, benefits and alternatives to the procedure; it is more than just a signature on a piece of paper.

Read more about the Informed Consent Process & Documentation here.


[i] Oklahoma, for example, requires informed consent for non-invasive and invasive procedures.


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Categories: General Risk Management, Medical-Legal Issues, Patient Safety


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