Any time a patient is preparing to undergo a surgery, the practitioner must provide an informed consent document. The informed consent document can range anywhere from a few pages to larger than 25 pages. The intent of the informed consent document was originally to inform the patient about the risks associated with their procedure, to allow the patient to ask any questions about the procedure, and to generally make sure that the patient is mentally prepared for the procedure.

However, the current intent of the informed consent document is to protect doctors from medial malpractice cases by making sure the patient has “signed-off” on what can go wrong. Fortunately for the patient, merely signing the informed consent document does not automatically give away any of your rights to sue.

Proving an informed consent document is inadequate requires three standards to be applied to the case:

1. Reasonable Physician Standard - What would a typical physician say about this informed consent document? This standard allows the physician to determine what information is appropriate to disclose.
2. Subjective Patient Standard - What would this patient need to know and understand in order to make an informed decision? This is the most challenging to incorporate into practice as it requires the information to be tailored to the individual patient.
3. Reasonable Person Standard - Would the average patient (not you) have undergone the procedure if they had been fully informed?

The most basic informed consent document should contain these sections:

1. An explanation of the medical condition for which the proposed procedure is warranted
2. An explanation of the purpose of the proposed procedure or treatment
3. A description of the proposed procedure or treatment including known and/or anticipated side-effects
4. A discussion of the known risks (including all known conditions which might render the surgery inappropriate for a particular patient) and benefits of the proposed procedure or treatment and a presentation of alternatives to the procedure being contemplated and their known side effects, risks, and benefits
5. A discussion of the consequences of not accepting the proposed procedure or treatment
6. A statement that the procedure may involve risks to the patient which are currently unforeseeable
7. A statement of the individual’s right to withhold their consent to the proposed procedure and a statement that such refusal will not impact on the individual’s current or future right to receive continuing health care
8. A statement that the individual may withdraw consent to the procedure at any time and that such withdrawal will not impact on the individual’s right to receive continuing health care.

A physician has several responsibilities in the presentation of the informed consent document, as well. He should provide it to you in a timely manner, and you should be given adequate time to process the information and formulate questions. This amount of time varies for different patients. Some may come to the office ready for the procedure having gotten their information and answers to their questions from the Internet or a family doctor.

Others will arrive without any knowledge of the procedure beyond what an advertisement has told them. A key problem in this area is doctors presenting the informed consent document just prior to the procedure’s scheduled time to rush the patient into signing it. First, and foremost, a doctor’s responsibility to the patient is to make sure that the patient fully understands what the doctor is going to do.

Thus, the informed consent document must be present in “plain English” avoiding most technical terminology in favor of Layman’s terms. The explanations should be clear and concise, and informed consent document should also be presented in the patient’s first language. If the doctor or any of his staff is unable to speak fluently in the patient’s primary language then a translator should be provided. This should not be someone who knows the patient.

Since medical procedures are intended to be private and confidential matters, an informed consent document should always be presented in a private area where only the patient and the doctor (and possibly a translator) are present. Presenting the informed consent document to a patient in a public area like a lobby or cafeteria may make the patient nervous, confused, or embarrassed.

The informed consent document should also be present by a medical professional capable of performing the procedure. There are certain questions a patient may have that only a qualified professional can answer. An office worker or a nurse are probably not qualified to present the informed consent.

Quite often if an office worker or non-qualified person presents the informed consent document, that person will negate the informed consent with such phrases as “just something we have to get you to sign” or “Don’t worry. None of this ever happens. We just have to put it in.”