Informed consent requires a physician or other health care clinician to furnish a patient with information sufficient to allow the patient to understand and give approval for a proposed medical treatment or the performance of a particular medical procedure. Health care providers have a duty before performing a procedure to provide adequate explanation to assist the patient’s decision-making process.
The clinician should provide a written or oral explanation about the proposed treatment or procedure, explained in a way the patient fully understands, which generally includes the following:
When considering whether a patient can give informed consent, the legal requirements including capacity and information must be considered.
Important note: Having an intellectual disability does not automatically preclude an individual from being able to give informed consent, nor does the lack of a guardian or conservator automatically mean an individual is capable of giving consent.
This tool can provide additional useful information about promoting a patient’s capabilities:
A. DETERMINE CAPACITY
Capacity refers to a patient’s ability to understand the significant benefits, risks, and alternatives to proposed health care and to make and communicate a health care decision. It is question- and decision-specific and should be documented relative to each decision. Capacity to consent should be assessed and documented for each treatment or plan of treatment. An individual is presumed to have capacity to make a health care decision, to give or revoke an advance directive, and to designate or disqualify a substitute.
Capacity is not static but can change over time or require distinct abilities depending on the nature and complexity of the specific treatment decision. Specific capabilities may be lost or gained at different times during the life of a patient with IDD. Capacity may even vary from day to day. For example, a patient in a postictal state may not be able to give consent but could several days later. Situations may arise where consent to a treatment has been given or refused on a patient’s behalf. However, if that patient then becomes capable of consenting to the treatment in the opinion of the health care practitioner, the patient’s own decision would take precedence over that of the SDM.
Assessed capacity can vary according to the supports provided. Involve the patient wherever possible by adapting the level and means of communicating to him/her; patients require functionally appropriate means of communication and support to realize their capacity for informed consent to, or refusal of, treatment. Offer information in a form you believe the patient will understand (e.g., pictures, symbols, gestures, vignettes). (See also Communicate CARE.)
Involve others who know the patient best, such as family members or paid support staff, to obtain information or to facilitate the patient’s understanding and communication.
If the patient is incapable of giving consent, or if there is uncertainty in this regard, follow appropriate legal procedures and ethical guidelines for assessing capacity. If incapable, delegate authority for decision-making, which should be based on the patient’s best interests in the circumstances. Whenever possible, even when consent is obtained from a substitute decision-maker, assent should be sought from the patient and be documented.
B. OBTAIN AND DOCUMENT CONSENT
Consent must be given voluntarily: Allow sufficient time for the patient to understand, consider the information, and ask questions. If the patient requests additional information, provide a timely response.
Consent must be related to a proposed treatment and be informed by adequate disclosure: The person obtaining consent should be knowledgeable and well-informed about the condition and proposed intervention.
Consent must not be obtained through fraud, coercion or misrepresentation: The patient should not be under any duress or pain. It is important to be familiar with how the individual usually exhibits pain (e.g., normal or unique pain responses), which may affect decisions.
C. IDENTIFY THE CURRENT SUBSTITUTE DECISION-MAKER
A patient who lacks capacity to make or understand health care decisions cannot give consent, and the clinician must get consent from someone else before rendering medical care except in an emergency. In this situation consent must be obtained from a health care agent or substitute appointed by the patient while still competent in an advance directive. Consent may also be obtained by a judicially appointed conservator having authority to make health care decisions.
If the patient lacks capacity, and if an agent, patient-designated substitute, or conservator has not been appointed or is not reasonably available, the clinician may identify a substitute to make health care decisions on behalf of the patient. The physician should choose someone who:
Preference for the selection of the substitute is given in the following order:
If none of the individuals eligible to act as a substitute are reasonably available, the designated physician may make health care decisions for the patient after the designated physician either:
A substitute must make health care decisions in accordance with the patient’s instructions, if any, and other wishes to the extent known to the substitute. Otherwise, the substitute makes decisions in accordance with the substitute’s determination of the patient’s best interest.
D. WHEN IS INFORMED CONSENT REQUIRED?
As a general rule, informed consent should always be obtained. However, there may be situations where treatment can be administered without informed consent. The following guidelines generally apply when determining whether informed consent is required. These are guidelines and you should always check with your facility’s legal counsel if you have concerns.
Treatment/Procedures Requiring Informed Consent
Treatments and procedures requiring informed consent include, but are not limited to, the following:
Treatment/Procedures Not Requiring Informed Consent
A patient’s legal representative(s) or family members should be consulted regarding routine medical procedures, illness, or injury. The following procedures generally do not require a client’s formal consent:
Original tool: © 2011 Surrey Place Centre.
Developed by Gillis, G & Developmental Disabilities Primary Care Initiative Co-editors.
Adapted with permission of Surrey Place. Revised by Disability Rights Tennessee, Nashville, TN.