INFORMED CONSENT in adults with intellectual or developmental disabilities

Informed consent requires a physician or other health care provider 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.  Physicians and health care providers have a duty before performing a procedure to provide adequate explanation to assist the patient’s decision-making process.

The physician or health care provider 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:

  1. Diagnosis for which the treatment is proposed;
  2. Nature of the treatment, procedure, medication, etc.;
  3. Name, dosage and frequency of any prescribed medications;
  4. Expected benefits;
  5. Possible risks and side effects;
  6. Availability of alternatives; and
  7. Prognosis without proposed intervention.

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.

 steps involved in the consent process

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 surrogate.
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 Communicating Effectively.)
Involve others who know the patient best, such as family members or paid caregivers, 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 surrogate 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 Surrogate Decision Maker (SDM)

A patient who lacks capacity to make or understand health care decisions cannot give consent, and the physician 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 surrogate 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 surrogate, or conservator has not been appointed or is not reasonably available, the physician may identify a surrogate to make health care decisions on behalf of the patient. The physician should choose someone who:

    • knows about the person’s disability and condition,
    • is actively involved in the person’s life,
    • is willing and able to make the decision,
    • will make the decision in the person’s interest,
    • has no conflict of interest with the person.

Preference for the selection of the surrogate is given in the following order:

    1. The patient’s spouse (unless legally separated)
    2. The patient’s adult child
    3. The patient’s parent or step-parent
    4. The patient’s adult sibling
    5. Any other adult relative of the patient
    6. Any other adult who has exhibited special care and concern for the patient

If none of the individuals eligible to act as a surrogate are reasonably available, the designated physician may make health care decisions for the patient after the designated physician either:

  1. Consults with and obtains the recommendations of an institution’s ethics mechanism; or
  2. Obtains concurrence from a second physician who is not directly involved in the patient’s health care, does not serve in a capacity of decision-making, influence, or responsibility over the designated physician, and is not under the designated physician’s decision-making, influence, or responsibility.

A surrogate must make health care decisions in accordance with the patient’s instructions, if any, and other wishes to the extent known to the surrogate.  Otherwise, the surrogate makes decisions in accordance with the surrogate’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:

  1. Emergency or non-routine medical and dental procedures such as surgery, transfusions, and tooth extraction
  2. Elective or therapeutic surgery
  3. Any procedure requiring sedation and/or a general anesthetic
  4. Medications having potential side effects that could create significant health risks
  5. Diagnostic treatment, such as body tissue samples, studies of internal body organs and tissues that involve the injection of a dye or other solutions, and specialized X-rays such as the MRI
  6. Cosmetic procedures involving invasive techniques, such as piercing of ear lobes
  7. Participation in research
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:

  1. The delivery of routine programs and services;
  2. Emergency procedures necessary to address a significant threat to the client’s health when timely consent is not possible;
  3. Routine medical procedures such as, but not limited to, injections, blood draws, sutures for lacerations, insertion of a heparin lock, and administration of medications that do not have potential life-threatening side effects; and
  4. Reporting of HIV, hepatitis, potentially infectious diseases, and other notifiable conditions as required by law.

Also see:

INFORMED CONSENT CHECKLIST 

Original tool: © 2011 Surrey Place Centre.
Developed by Gillis, G & Developmental Disabilities Primary Care Initiative Co-editors.

Adapted with permission of Surrey Place Centre. Revised by Elizabeth Setty Reeve, JD, Disability Rights Attorney/Intake Director, Disability Law & Advocacy Center of Tennessee, Nashville, TN.

This tool was also reviewed and adapted for U.S. use by physicians on this project’s Advisory Committee; for list, view here.

Additional reviewer was Matthew Holder, M.D., MBA, President-Elect, American Academy of Developmental Medicine and Dentistry, and Global Medical Advisor, Special Olympics.

Resources:

  • Tennessee Health Care Decisions Act at T.C.A. 68-11-1801 et seq.
  • T.C.A. Title 33 Mental Health and Substance Abuse and Intellectual and Developmental Disabilities
  • University of Tennessee Health Science Center’s A Guide for Health Care Providers in Tennessee (specifically the Consent and Advance Directives sections)
  • The Arc Tennessee’s Conservatorship Guide
  • Tennessee Medical Association Law Guide