Informed Consent: A Process for Building Patient Confidence
Obtaining informed consent is the provider's legal responsibility. Granting informed consent is the patient's exclusive right. According to the National Quality Foundation (NQF): "Although providers often believe that a patient’s signature on a form is sufficient to ensure that he or she provided informed consent, studies show that even after agreeing to or receiving care, 18 to 45 percent of patients are unable to recall the major risks of surgery, many cannot answer basic questions about the services or procedures they agreed to receive, 44 percent do not know the exact nature of their operation, and most do not read (60 to 69 percent) or understand (60 percent) the information contained in informed consent forms, despite signing them. These patients are not truly informed about the choices they make." A fully comprehended informed consent improves patient safety and quality of care and reduces professional liability risk for providers and hospitals. The informed consent process can be the provider's best tool for building patient confidence. A knowledgeable partner often develops more realistic expectations regarding treatment outcomes.
When a patient’s treatment plan has potential risks, benefits, potential side effects and reasonable alternatives, informed consent should be obtained. Written informed consent should be obtained for all major therapeutic, diagnostic and invasive procedures to be completed in the physician office or hospital.
The provider performing the procedure is responsible for obtaining the informed consent of the patient for medical and surgical procedures.
Informed consent should be obtained in a setting that is conducive to patient dialogue and feedback (i.e., physician office), whenever possible. The informed consent process should begin in advance of the proposed treatment to allow patients time to think about their options and make informed choices.
To facilitate decision making and compliance, develop and implement a policy that clarifies which procedures and treatments specific to the organization/practice setting require written informed consent.
Exception to Obtaining Informed Consent
When situations occur that require immediate action to save a patient's life or preserve their health, consent may be considered "implied." In these instances, the provider should support the decision to proceed with medical treatment by a timed, dated provider note indicating the existence of the medical emergency, the requirement of treatment to protect the patient's health, the lack of ability to obtain patient or surrogate consent and the belief the patient would consent to treatment.
In order for the patient's consent to be valid, the patient must be considered competent and have the capacity to make the decision at hand. The provider should determine the patient's capacity to engage in a meaningful discussion regarding their healthcare and the proposed treatment. The patient’s ability to understand medical information can be affected by a number of issues including their level of literacy, hearing impairment and English proficiency. Thirty-six percent of the American population has limited health literacy, which restricts their capacity to make informed decisions about their healthcare. Patient specific information and education about their health is needed to assure a fully informed patient decision regarding their healthcare is accomplished. If a patient has a reduced capacity to understand aspects of the informed consent process, providers must take appropriate steps to ensure comprehension, including hiring qualified interpreters. Patient education regarding their healthcare should be an ongoing component of each patient encounter to enable the patient to make well founded decisions about their healthcare.
The informed consent obtained must be voluntary. A patient determined "incompetent" by the court system may not give informed consent. A patient determined "incapacitated" is one who is unable to take effective action on their own behalf. Lack of capacity may be due to physical trauma, altered mental status, etc. A patient should not be asked to give informed consent or sign a consent form while sedated. An appropriate surrogate should be identified to provide the informed consent for the patient who is incompetent or lacks capacity to provide a fully informed patient consent. In this instance the recommendations below would apply to the surrogate decision maker.
Video-aided Informed Consent Tool
When considering video-aided informed consent tools, the provider should assure the literacy level of the information is appropriate for the patient. There should be an interactive opportunity after each significant sequence in the video requiring the patient to indicate if there are any questions. The information provided to the patient should be consistent with any information given to the patient by the provider. Any special learning needs of the patient should be considered and if necessary, addressed (for example, hearing impaired, visually impaired). The provider should assure that the informed consent process continues to be individualized to the patient's needs and condition. A copy of the video will need to be maintained by the provider for the medical record documentation purposes.
Confirming Patients' Understanding
The provider should ask the patient to explain in their own words ("teach back" to the provider) the diagnosis, a description of the proposed treatment, its risks and benefits and what alternatives to the proposed treatment exist, including the option of no treatment. The process of "teach back" gives the provider an indication of the patient's level of understanding of the proposed treatment. Studies have shown that when patients are asked to "teach back," they have greater recall and comprehension of the risks and benefits of surgical procedures than those who are not asked to recount. "Teach back" is endorsed by the NQF as a tool to improve patient safety.
Documenting Informed Consent
A timed and dated notation documenting the discussion and summarizing its contents should be made in the patient's medical record. Typically, a consent form is also completed. The informed consent form is used to confirm that the disclosure process has taken place to the satisfaction of the patient and that the patient has authorized the provider to perform the procedure. It should be signed and dated by both the provider and the patient. The provider obtains the patient's signature on the form and signs the form at the conclusion of the consent discussion. An appropriate informed consent form is written below the fifth grade level, presently considered the average education level of the patient. The form should also document the provider's satisfaction that the patient understands the proposed treatment and has given a fully informed consent through the "teach back" process.
When Patients Refuse to Consent
If after a properly executed informed consent process, a patient refuses to consent to treatment the provider should document that the patient has been informed of the risks and benefits of the examination and/or treatment, a description of the examination or treatment that was refused by the patient and that the patient has demonstrated the capacity to understand the consequences of the refusal. An informed refusal form may be used to document that the disclosure process has taken place to the satisfaction of the patient and the provider. It should be signed and dated by both the provider and the patient. The provider obtains the patient's signature on the form and signs the form at the conclusion of the discussion. An appropriate informed refusal form is written below the fifth grade level, presently considered the average education level of the patient. The form should also document the provider's satisfaction that the patient understands the proposed treatment and has refused consent through the "teach back" process.
If the patient refuses to sign the refusal form, the physician should record and sign a statement that the patient was offered and refused treatment.
See our Informed Refusal forms
Expiration of Consent
A patient's informed consent for a procedure should be considered active/current provided there has been no change in the patient's condition and that the patient has not raised additional concerns regarding the risks and benefits of the procedure and if more desirable alternatives have not come to light since obtaining the patient's informed consent. Hospital policy and other regulations may dictate the length of time the patient's informed consent is valid. Patient communication and education is vital when time lapses between the informed consent for treatment and the treatment. The patient's informed consent should be confirmed prior to proceeding with treatment.
Is a single informed consent sufficient for a course of treatments/procedures that may be given over an extended period of time, as in blood transfusion therapy or cosmetic therapy?
Informed consent obtained for a series of treatments/procedures is valid for the same episode of care. If the reason for future procedures/treatments differs from the original rationale for the treatments/procedures, if the patient's condition has changed, or if the patient has raised additional questions regarding the treatments/procedures, the physician should discuss the situational changes with the patient, document the discussion and obtain a new written informed consent. The best risk management position for the physician in the instance of a series of treatments/procedures is to validate at each patient encounter no changes in patient condition and ongoing patient understanding of the treatment plan, risks, benefits and alternatives and document continued informed consent in the record. The initial informed consent should also be validated at each patient treatment/procedure by a qualified staff member. Validation should be documented on the original informed consent form with the staff member's initials, date and time of the validation with the patient.
When a patient is receiving more than one treatment or procedure that is being performed by separate licensed individuals, each provider should obtain the patient's informed consent for the treatment or procedure they will be responsible for. Each procedure or treatment will have its own set of risks and benefits and alternatives for the treatment or procedure for the patient to consider. This patient information needs to be explained by the operative provider. The patient discussion and subsequent documentation assures the patient understands the treatment or procedure, its risks and benefits, the alternatives to the treatment or procedure and that the patient has had an opportunity to have their questions answered by the specialist in that field. An example would be when a surgeon is removing malignant tissue and a plastic surgeon is performing a tissue graft repair of the same area. Two separate informed consents (including written consent forms) need to be obtained from the patient for that one surgical setting. Another excellent example is the need to obtain a separate informed consent for anesthesia and a separate inform ed consent for blood transfusion therapy in addition to obtaining the patient's informed consent for the surgical procedure.
The disclosure of medical information, including major risks involved, is necessary to fulfill the requirement of informed consent. The type and number of risks disclosed depend on the significance the patient would attach to those risks in deciding whether to consent to the treatment/procedure. The provider should discuss sufficient information to assure the patient is making an intelligent decision about the proposed treatment/procedure. The provider must be assured the patient is competent to provide an informed consent. The provider must ascertain the patient has the capacity to understand the benefits and risks of the proposed treatment/procedure and the alternatives and give a fully informed consent for treatment.
Documentation of the informed consent process should contain enough detail to assure the reader that the patient was provided with sufficient medical information, understood that information and made an informed choice regarding the proposed treatment/procedure.
- Document the patient's name.
- Document the proposed procedure/treatment and the likelihood of success.
- Document the information provided to the patient.
- Specifically list the major material risks disclosed.
- Document disposal and/or use of tissue removed.
- Document the alternatives to the proposed procedure.
- Document the patient's demonstrated understanding of their diagnosis, the proposed procedure/treatment, its risks, benefits and alternatives. The "teach back" process.
- Document the date and time the patient expressly gave consent.
- Sign the informed consent documentation.
- Obtain the patient's signature.
- Thoroughly complete the informed consent form, if one is to be used, and maintain a copy in the patient medical record.
Use the following list to evaluate the comprehensiveness of your written consent form. In addition to the facility/practice name, the form should include:
- Patient name and date of birth or medical record number.
- The diagnosis and nature of the illness.
- The treatment or procedure to be performed and likelihood of success.
- The side effects of the treatment or procedure.
- Summary of risks and benefits explained to patient.
- Alternatives to the treatment or procedure.
- 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 procedure/treatment, risks, benefits and alternatives (ability to "teach back").
- The date and time patient expressly gave consent.
- Physician signature.
Informed Consent for Immunizations
The National Childhood Vaccine Injury Act of 1986 (NCVIA) established the requirement that Vaccine Information Statements (VIS) be provided to adults or the parent/legal guardian of children receiving vaccinations. The NCVIA does not speak to informed consent (a Vaccine Information Statement does not constitute informed consent it is an adjunct to the process). Therefore, it is important for providers to review state and local laws as well as organizational policies.
- Provide each vaccine recipient and/or their parent/legal guardian with a copy of the most current appropriate VIS before the vaccine is administered.
- Provide each vaccine recipient and/or their parent/legal guardian the opportunity to review the material in the VIS and ask questions.
- Document the date the VIS was given to the patient, parent/guardian and the publication date of the VIS (located on the bottom).
- Discuss with the patient and parent/legal guardian the risks and benefits of the vaccine as described in the VIS. Document in the medical record their understanding of the information provided and their decision regarding vaccination.
American Medical Association, www.ama-assn.org
Centers for Medicare and Medicaid Services, www.cms.gov
National Quality Forum, "Implementing a National Voluntary Consensus Standard for Informed Consent", www.qualityforum.org
Patient Safety and Quality Healthcare, "Informed Consent: Comprehension Is the Key", www.psqh.com
The Joint Commission, http://jointcommission.org/
Temple Health, "Informed Consent Tool Kit", http://www.templehealth.org/ICTOOLKIT/html/ictoolkitpage1.html
The Health Literacy America’s Adults, Results from the 2003 National Assessment of Adult Literacy http://nces.ed.gov/pubs2006/2006483.pdf
Medical Mutual Insurance Company of Maine's "Practice Tips" are offered as reference information only and are not intended to establish practice standards or serve as legal advice. MMIC recommends you obtain a legal opinion from a qualified attorney for any specific application to your practice.