Risk Management GEM (Volume III): Informed Consent: A Procedure Specific Consent Form is a Best Practice

Documentation of patient-specific and procedure-specific risks is often crucial in successfully defending malpractice claims and suits containing allegations of informed consent deficiency.

The optimal approach would be to use the procedure-specific consent form and include a note in the patient’s record detailing questions asked by the patient and showing a discussion of the risks, benefits, and alternatives.

Procedure-specific informed consent is recommended/required when the care requires specific medical treatment or invasive medical intervention and should be developed and used wherever practical.

Click here for a sample consent form template.

Informed consent is an essential part of the patient care process and is often cited as lacking or improper in medical professional liability claims. A recent call to the MPIE Risk Management Hotline shows there can be some ambiguity about when it is advisable to use a specific consent form rather than relying on a general consent to treat. Providers should be familiar with the consent policy and attestation form(s) used in their organization or at the healthcare facility where treatment is provided. The following scenario and discussion aim to provide guidance on this topic.

The scenario involved a patient taken to the Emergency Department for an arm dislocation after a fall. She was given Propofol and had her humerus reduced to put back into place. During the reduction, a portion of her humerus fractured. This required transfer to a higher level of care and an unexpected surgical procedure. The patient raised concerns that she did not fully appreciate her treatment’s risks, benefits, and alternatives. Although a general hospital consent form was used, the patient’s allegation would have been more easily defended had a procedure-specific consent form or a progress note entry been used. A properly developed, patient-signed consent form is compelling evidence that a patient was adequately informed before a medical procedure. If that is not possible, a progress note summarizing the detailed informed consent discussion with the patient and family if involved is helpful. Documented, detailed informed consent acknowledged by the patient, parent, guardian as applicable often deters claims or helps the healthcare providers prevail against allegations of improper or inadequate informed consent. Informed consent may also aid a patient to be more responsive to advice and is associated with a patient’s ability to recuperate more quickly, require fewer analgesics, and feel less anxiety if experiencing complications.

The informed consent process is documented in two separate ways:

  1. Consent form: Obtain the patient’s signature on an appropriate consent form following the necessary disclosure of information upon which a patient can give their informed consent.
  2. Patient’s medical record note: Document the specific detail of the informed consent discussion in the patient’s medical record and note who was present, if applicable, besides the patient.

The optimal approach would, of course, be to use both a procedure-specific consent form and include a note in the patient’s record detailing questions asked by the patient and showing a discussion of the risks, benefits, and alternatives. The documentation of patient-specific questions ensures that consent was truly informed and would be challenging to refute should a claim be brought.

When is a specific consent form recommended from a risk management perspective?

The American Medical Association states, “[t]he process of informed consent occurs when communication between a patient and physician [or provider performing the procedure] results in the patient’s authorization or agreement to undergo a specific medical intervention.”

A general consent to treat form may be sufficient for basic care or assessment—such as routine lab tests or diagnostic screenings. The general consent should be in place before the patient is examined or treated or before minor testing is done. However, procedure-specific informed consent is recommended/required when the care requires specific medical treatment or invasive medical intervention and should be developed and used wherever practical. Sufficient time to read and discuss the consent form should be afforded to patients or their medical decision-makers. Consent forms are the most comprehensive tool for communicating risks associated with specific treatments and documenting the patient’s consent. Consent forms are not only intended to be used as an adjunct to a provider-patient discussion but as a tool to memorialize the discussion. Personalizing the consent form by adding risks, benefits, and alternatives is a best practice demonstrating that an informed consent discussion occurred and completing the document was not just a cursory task.

During the informed consent discussion, address the most severe risks, the less severe risks that have a high likelihood of occurring, and any other risks that the patient may consider significant. Documenting any questions asked and answered may also become a significant factor in defending allegations of lack of or improper informed consent. The provider performing the procedure is the most appropriate person to obtain the consent and document the discussion on either the form or the patient’s medical record progress note. Documentation of patient-specific and procedure-specific risks is often crucial in successfully defending malpractice claims and suits containing allegations of informed consent deficiency. The patient’s informed consent, which entails discussing the risks, benefits, and alternatives to the specific, proposed procedure or treatment, is required before any medical procedure or treatment that carries a material risk of harm. Obtaining thorough and specific consent is a powerful deterrent to claims challenging informed consent and may head off litigation altogether.

Click here for a sample consent form template.

If you are an employed provider of a healthcare system and have questions on this subject, please consult your organization’s risk management department for advisement as to system policy or protocol.


Disclaimer: This information is provided as a risk management resource and should not be construed as legal, compliance, technical, or clinical advice. This information may refer to specific local regulatory or legal issues that may not be relevant to your organization. Consult your professional advisors or legal counsel for guidance on issues specific to your organization. Medical or clinical information presented is offered for educational and informational purposes only and does not replace independent professional judgment. The information is intended to guide the clinician in patient care management and is not intended to establish a standard of care. The clinician shall defer to applicable prevailing medical authority. This material may not be reproduced or distributed without the express, written permission of MPIE.