Many cases are won and lost on the issue of informed consent. The procedure may have gone well, or the outcome may be perfect. But, if the patient wasn’t aware of the risks, other treatment options, etc., (or can claim there was no awareness of the risk, etc.) a cause of action for negligence can still be brought against the physician.
What is Informed Consent? Informed consent is an event involving two things – it is an act of informing the patient of all the required items, and then obtaining the patient’s agreement (or consent) to the planned course of treatment or procedure. The patient must have all information necessary to allow for a truly informed decision. Typically, the event involves an in-depth discussion between doctor and patient, which often entails questions and answers between physician and patient.
What Information Should Be Provided to the Patient? The best “rule of thumb” to apply here is: provide all the information that you would want to know? If you think it would be important to accept, reject, or even understand, your treatment recommendation, then the chances are high that you should include it as part of the informed consent process.
The patient should be provided with at least the following information:
- The nature of the recommended treatment or procedure
- Reasons for the recommended treatment or procedure
- Other options/alternatives that may exist
- The benefits and consequences of all options
The last element includes the risks associated with the recommended treatment plan or procedure, as well as the risk of all other options.
Both the Information Provided and Consent Should Be in Writing. It is not uncommon for patients to forget (whether legitimately, or as a matter of “selective memory”) that they were provided with information relative to their treatment, and gave the necessary consent. Defending a physician who relied on oral informed consent in these instances is a 50/50 proposition at best – it will inevitably revolve around a “he said/she said” scenario, with the trier of fact (jury) being left with the responsibility of determining who to believe.
No physician wants her practice and reputation or livelihood to hinge on such odds. Disclosing all relevant information to the patient in writing, and documenting that disclosure with the patient’s signature, is the only way to avoid this situation. (It is important to remember that, in the case of minors, the parent or guardian must sign the form.) Copies of the information and signature should be retained with the patient’s chart, and a copy should be provided to the patient.
Use of Informed Consent Forms. There are many good, standard informed consent forms available. These can frequently be obtained from trade or professional associations. However, it is imperative to recognize that each case is different, and thus, it is risky to employ a “one size fits all” approach. A good compromise can be to use an informed consent form as a “base” document, and to then add to it separately – with the patient signing all of the documents.
Pharmaceutical companies and hospitals also frequently have their own forms that they may use, or recommend that the physician use. While they can be part of the informed consent process, it is important that the physician be comfortable with all of the information that has been provided to the patient (as well as the patient’s responses and agreements relative to accepting or rejecting the proposed procedure or treatment).
Where Possible, Obtaining Informed Consent Should Not Be Delegated. As a general proposition, if the procedure or treatment option rises to the level of necessitating informed consent, then the informed consent process should be handled by the physician personally. Not only does this increase the likelihood that all of the relevant information will be presented and discussed, but it looks much better to a jury or judge relative to indicating a more “hands on” approach to treatment.
It is also best if the informed consent process is handled in an office setting, as opposed to telephone conversation.
Delegating the informed consent event to a nurse, or handling it by phone, can render an otherwise good informed consent suspect.
Further, in situations where the procedure or recommended treatment has comparatively more significant consequences, it is a good idea to have a third witness to the conversation (i.e. a nurse or office manager). Either the presence of this individual should be noted in the chart, or the third-party should also execute the same informed consent form as a witness.
When to Update an Informed Consent Document? Frequently, the course of treatment for a given patient can change, or new issues may arise. If the patient has already given informed consent, then it may be necessary to update and complete a subsequent informed consent process. The central test here is whether the initial or former informed consent covers the secondary issue or situation. If it does not, then a new informed consent process should be undertaken, and it should be undertaken in the same manner, i.e. as if it were the first informed consent, in writing, etc.
Informed consent is one of the most valuable tools in the physician’s armamentarium of risk management. It is also one of the simpler and effective ways of avoiding an unnecessary claim, and it should be utilized consistently with all patients.