Informed Consent: A Process of Communication

Informed consent is more than a form; it is a process that includes:

1)      Discussion  

Frank and open dialogue with patients is the most important step in the informed consent process, providing an opportunity for physicians to establish rapport and engage patients in making decisions about their own care.  

The discussion should emphasize the physician-patient team in the decision-making process and include the following information:

  • Differential diagnosis,
  • Description and purpose of proposed treatment,
  • Benefits and expected outcome of proposed treatment,
  • Risks associated with treatment,
  • Alternatives to treatment (including risks and benefits), and
  • Consequences of no treatment.

2)      Education  

Educational pamphlets, videos, handouts, and pre/post-treatment instructions will help patients make an informed decision and remember what they have consented to should any complications occur. Moreover, these materials are usually much easier for patients to understand and are less intimidating than most consent forms.              

3)      Obtaining written consent  

The consent form provides written information that will help patients remember the risks, benefits, and alternatives that have been discussed. It also serves as documentation of the discussion should the physician ever need to establish a defense against an allegation of medical malpractice.

In Texas, physicians are required to obtain written consent for procedures or treatments indicated by the Texas Medical Disclosure Panel (TMPD). The TMDP has created two separate lists of those medical treatments and surgical procedures that do and do not require disclosure. Or, contact the TMA Knowledge Center at (800) 880-7955 or (512) 370-1550 to request a copy of the panel's disclosure requirements; you also may request a copy of a standard consent form.

4)      Chart documentation  

As is the case with all patient interactions, the informed consent process should be documented in the medical record. The following is a sample entry:

Advised patient of need for _____ due to ________. Discussed risks, benefits, and alternatives.  Gave ____ handout. Patient stated he/she understood, signed consent, and agreed to proceed. It is my judgment that the patient does understand the treatment plan.  

Tips for Obtaining Informed Consent  

  • Consent discussions should take place before patients are admitted to the hospital.
  • Remember, patients are in a heightened emotional state. In addition to not feeling well, they probably are experiencing a great deal of anxiety about the upcoming procedure.  
  • The physician who sits down during discussions with patients displays a caring and concerned attitude and appears to be willing to spend adequate time to ensure that all patient questions and concerns will be addressed. 
  • Choose a quiet setting for the discussion where patients aren't likely to become distracted.
  • Use descriptive, simply stated terminology to ensure patients understand complicated medical procedures. Use key repetitive phrases and then ask patients to repeat what you have said. Draw diagrams if necessary. 
  • When a recommendation is made based on your assessment and then patient then refuses to comply, document this action in the medical record! In these circumstances it is crucial that you document the fact that the patient has received adequate information stressing the importance of compliance.
  • Anesthesiologists and radiologists often make the mistake of relying on the primary or attending physician to handle the informed consent process on their behalf, making an assumption that the primary physician has addressed adequately the risks associated with the intended anesthesia or radiological procedure. The only person who is truly qualified to respond to a patient's questions satisfactorily is the physician specialist who is to perform the procedure.
  • Informed consent is no longer limited to surgical, invasive, or diagnostic procedures.  Written consent also should be obtained for drugs that involve potentially significant complications or side effects.

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