Forensic Corner; Informed Consent

Lee H. Haller, M.D.

I recently had the good fortune of attending an excellent presentation on pediatric psychopharmacology given by Drs. John Walkup and Mark Riddle. As part of the conference, informed consent for the "off label" use of psychotropic medications in children was discussed. The importance of this particular topic warranted highlighting it in this column. However, let's start with an overview of informed consent.

There are three essential elements for informed consent. All three must exist before the physician can rely on the validity of the consent and carry out a treatment regimen.

The first component is knowledge about the treatment. The child's guardian can give a valid consent only after he has been given information about the proposed treatment. The child psychiatrist must provide data such as the diagnosis, names of medications, intended effects, and possible side effects. Also, the risks involved and alternative treatment options should be presented.

After the guardian has been given the basic information, he must comprehend the material and appreciate the ramifications of each of the alternative choices. Understanding the information is the second key element of a valid consent. It is the duty of the child psychiatrist to explain the significance of the often complex, technical, medical data. The guardian needs the opportunity to ask questions until he has a sufficient grasp of the information. Only then can the guardian make a reasoned determination about what treatment direction to take for his child.

The third essential component of an informed consent is that it be given voluntarily. There should not be any degree of coercion involved. For example, if the child psychiatrist were to threaten immediate withdrawal from the case if the guardian did not approve the treatment plan, this would be considered coercive. Threat of abandonment would invalidate any consent which was obtained. A physician does have the right to withdraw from a case where a treatment recommendation is not followed, but it should be done in a non-threatening way, allowing the parent time to find another psychiatrist.

These three elements of informed consent are always necessary. The conference highlighted an additional issue to which the child psychiatrist must attend as part of the teaching/information imparting process. Almost all the new psychotropic medications, which are being recommended in child psychiatry, have not been approved by the FDA for use in children. Thus, the use is considered "off label". This does not mean the physician cannot or should not use the medications. Rather, it means that the child psychiatrist must be sure to inform the guardian of this fact. The meaning of "off label" use must be clearly explained for the guardian. Hopefully, a thorough discussion of all aspects of the proposed treatment, culminating with an informed consent, will lead to good rapport and a smooth treatment process. It will serve to protect the child psychiatrist legally as well.

Dr. Haller is in the private practice of forensic psychiatry in Potomac, MD

AACAP News/May-June 1999