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Informed Consent Guidelines

Informed consent should be obtained for all major therapeutic, diagnostic and invasive procedures/treatments to be completed in the hospital, surgery center, or physician’s office. Informed consent is a process whereby the patient is informed of the risks and benefits of a potential procedure/treatment and gives consent to proceed. A signature on a form is not sufficient to demonstrate a patient’s informed consent.

Exceptions to the Need to Obtain Informed Consent

If a physician is unable to obtain consent from a patient or surrogate and immediate action is necessary to save “life or limb,” he or she may proceed if they believe that under similar circumstances a reasonable person would consent to the procedure. Documentation should support the decision to proceed based on a medical emergency.

Written policies and procedures should be developed, outlining all important aspects of the informed consent process, including:

  • Which medical procedures or treatments require informed consent
  • Who is responsible for obtaining the consent
  • Appropriate methods of documenting the process, including informed consent forms
  • Periodic review and revision of the policies and procedures

Informed consent should be obtained for all major therapeutic and diagnostic procedures, which carry potential risks. Procedures/treatments requiring consent include but are not limited to:

  • Surgical procedures under anesthesia
  • Biopsies and excisions
  • Cardiac catheterization and angioplasty
  • Major endoscopies
  • Chemotherapy
  • Blood and blood products
  • Major radiologic and/or imaging procedures which include contrast media
  • Medications or other treatments that have a potential for significant side effects

Anesthesia providers should have a discussion with the patient and obtain a separate written informed consent form for the use of anesthesia.
It is the physician’s responsibility to obtain the informed consent from his/her patient. Hospital or office staff may assist in obtaining documentation of the consent, in accordance with the organization’s policies and procedures.

Capacity to Consent

Providers should determine if their patient is competent and has the capacity to engage in a meaningful discussion regarding their healthcare and the proposed treatment. Physical trauma, altered mental status and intoxication can limit a patient’s capacity to provided consent. If the patient lacks capacity due to circumstances that are likely to resolve and the procedure is not urgent, the procedure/treatment should be postponed until the patient gains capacity and can provide consent. Consent discussions and signatures on informed consent forms should be obtained prior to a patient receiving medications that could alter their mental status.

If it is determined that the patient is not competent to make healthcare decisions, consent may be obtained from a surrogate decision maker. These could include:

  • An identified agent based on the patient’s Advanced Directive
  • Power of Attorney for Healthcare
  • Durable Medical Power of Attorney
  • A legally designated guardian

The informed consent discussion should include the following information:

  • Diagnosis and nature of the illness
  • Treatment or procedure to be performed and likelihood of success
  • Side effects of treatment or procedure
  • Summary of risks and benefits. This includes risks an ordinary person would likely want to be informed of
  • Alternatives to the treatment or procedure
  • Patient demonstration of understanding of diagnosis, proposed procedure/treatment, risks, benefits and alternatives (ability to “teach back”)
  • Opportunity for patient to ask questions and have questions answered

Informed Refusal

Patient refusal of recommended treatment should be documented. Documentation should demonstrate that the patient was informed of the risks and benefits of the treatment and the possible risks of refusing treatment. The patient’s demonstrated understanding of the consequences of refusing offered treatments should be documented in the patient’s medical record. In addition, the organization may utilize an informed refusal form.

A patient’s consent for a procedure is considered active/current provided there has been no change in the patient’s condition and that the patient has not raised additional concerns regarding risks and benefits of the procedure.

When more than one treatment or procedure is being performed by separate licensed individuals, each provider should obtain the patient’s informed consent for the treatment/procedure they will be performing.

Obtaining consent by telephone

When informed consent must be obtained from a patient’s legally authorized representative, it is optimal for the discussion to take place in person. If this is not possible and the consent discussion occurs via the telephone, the following measures should be taken:

  • Verify that the representative has the authority to make healthcare decisions on behalf of the patient
  • Designate at least one employee to be present on the telephone to witness the consent discussion and to sign applicable documents
  • All parties on the telephone call should be identified
  • The representative should be provided with the same information that would be provided to the patient
  • When feasible the provider should explain to the patient the treatment/procedure for which the representative has consented
  • Documentation should include the name of the representative, the witness, why consent was obtained via telephone, elements of the consent discussion and the representative’s understanding and agreement to proceed

Documentation in the patient’s medical record should contain enough detail to assure the reader that the patient was provided with sufficient medical information, understood the information and made an informed choice. Documentation should include:

  • Proposed procedure/treatment and the likelihood of success
  • Information provided to patient
  • Major material risks disclosed
  • Disposal and/or use of tissue removed
  • Alternatives to the proposed procedure
  • Patient’s understanding of their diagnosis, proposed treatment/procedure, including risks and benefits
  • Date and time the patient gave consent

Written informed consent forms should include the following information:

  • Facility/practice name
  • Patient name and date of birth or medical record number
  • Diagnosis and nature of illness
  • Treatment and procedure to be performed and likelihood of success
  • Side effects of the treatment or procedure
  • Summary of risks and benefits explained to patient
  • Alternatives to the treatment or procedure
  • A statement that a physician-in-training or representative from the medical device company may be present at the procedure, as applicable
  • A statement that medical photography may be utilized for medical, scientific or educational purposes, provided the patient’s identity is not revealed in the photo or text
  • A statement that the patient was given the opportunity to ask and have questions answered
  • A statement that the patient demonstrated an understanding of the diagnosis, proposed treatment/procedure, risks, benefits and alternatives (ability to “teach back”)
  • Date and time patient gave consent
  • Patient signature
  • Physician signature

Resources

Health Care Risk Management Fundamentals, ASHRM p. 173-179