Liability Prevention Through Informed Consent: Some New Approaches for the Clinician

By Thomas G. Gutheil, M.D., Harold Bursztajn, M.D. and Archie Brodsky, B.A.

The Massachusetts Mental Health Center Program in Psychiatry and the Law has been at work for several years studying malpractice case law and performing clinical research on decision-making as it relates to the issue of informed consent [1]. We have found that one of the most serious errors commonly committed by clinicians in their attempt to reduce the risk of suit is their practice of "defensive medicine." Typical examples of tactics designed to defend oneself against "the enemy" include mindless and prolific documentation, and overuse of technology, e.g. repeated or unnecessary laboratory testing. This approach is regrettably as ineffective a deterrent against liability action as it is cumbersome to implement. Furthermore, it may provide the very danger it aims to prevent by jettisoning the most powerful liability preventive device, the therapeutic alliance.

As part of an ongoing research effort, the Program has been attempting to devise methods of liability prevention that avoid the trap of defensive medicine. These are summarized in an article [2] entitled, "Malpractice Prevention Through the Sharing of Uncertainty: Informed Consent and the Therapeutic Alliance." In it we suggest that patients come to their physician with preconceived wishes for magical certainty and the security that accompanies this belief. When these wishes are inevitably unfulfilled, some patients sue their physician to express their disappointment at the absence of this magic. We recommend that doctor and patient frankly face, and thus share, the UNcertainty inherent in medicine, and that the patient be "weaned" from wishes for magical certainty. We suggest that the concepts of informed consent and the therapeutic alliance offer a framework from which the clinician may collaborate with the patient in ways that diminish the actual risk of liability.

Pro Forma Consent

Informed consent as a concept is often regarded with suspicion by clinicians as a burden, a snare, or legalistic charade [3]. For many clinicians informed consent implies no more or less than the patient's signature on a form. Obtaining informed consent then, means persuading the patient to sign the consent form, preferably but not necessarily after reading it and/or understanding it. Not uncommonly the form is offered to the patient by the nurse who may feel that no more elaborate explanation is required than, "The doctor needs you to sign this so you can have the operation (medication, treatment, procedure)." In a "worst-case" scenerio, the patient has already received his or her preoperative medication and is thus tendering "informed consent" from a state of twilight sleep — a condition not known for its inherent competence. We have termed this procedure "pro forma informed consent" [4].

Use of the consent form to represent the totality of the informed consent process presents several problems:

Comprehension Level

In the natural order of things, consent forms perch upon the horns of a dilemma. If they are long enough to be comprehensive, they are in imminent danger of being incomprehensible. If short enough to be comprehensible, they can be faulted as insufficiently comprehensive. In most cases, moreover, the consent form is designed by the hospital's attorneys who often employ that curious legal argot known as "boilerplate:" a form of expression that resembles no human speech but is designed to "cover all bases". It is the kind of language that expresses the concept, "give", as "give, devise, bequeath, assign and otherwise convey," for example.

More problematically, it is a fact not widely recognized that most of these forms require a reading comprehension level comparable to that required for reading "Scientific American" — a level that only a fraction of the average physician's patients can possibly have.

Patient Responses

The responses of patients to these forms when the chips are down, so to speak, is not very rewarding or reassuring for the clinician who held hopes that the patient's signature would solve all problems and guard against liability. In the courtroom patients might say, cheerfully, "The form? Oh, that. Yeah, I signed it; I had to because the doctor refused to even look at me until I did, but I sure didn't understand it." If the attorney for the patient is sufficiently astute, he or she may simply read the form aloud in court as a very effective way to get the jury to identify strongly with the patient's reported bewilderment. Needless to say, this difficulty is only amplified when the patient suffers from intellectual deficits, has an illness that affects cognition, speaks English as a second language, or — most confoundingly — speaks no English at all as some physicians have discovered rather belatedly.

Closure of Process

From our point of view in the Program in Psychiatry and the Law, the major problem with the consent form transcends its language, the patient's reaction to it and the circumstances of its signing. The problem with the form is that it tempts the clinician to consider the process of informed consent as a discrete event that is over when the signature graces the dotted line. The clinician is thus lulled into thinking that informed consent is a hurdle that has already been cleared, never to cross the path of medical care again. Whether the clinician intends this or not, the patient may read in this manner an inhibiting deterrence from asking questions and a discouragement from sharing his or her fears and concerns with the clinician. The "discovery phase" of a lawsuit (in which the medical records and related documents are requested and reviewed by attorneys and experts) is a rather late point in the game for answering questions.

The Bipersonal Field

In the Program we suggest that a remedy for these difficulties can be derived from viewing the consent process as a two-person field which encompasses doctor and patient and extends indefinitely over time. We once stated it in this way:

"...physicians must stop thinking of informed consent as a formality (the recital of options and the signing of the form) and enter into it with their patients as a process of mutual discovery. Informed consent as we envision it here is not an empty gesture toward liability reduction but an interaction between physician and patient, a dialogue intended not only to satisfy this legal requirement but to do more as well. The real clinical opportunity offered by informed consent is that of transforming uncertainty from a threat to the doctor-patient alliance into the very basis on which an alliance can be formed. This is particularly important, since a sense of working together with the doctor may be one of the major elements in avoiding negative reactions to treatment [e.g., a lawsuit]." [5]

While some hospitals have eschewed consent forms for these reasons (using progress notes instead), other institutions require their use; clearly, if your hospital requires use of a consent form, it is folly not to use it. But the liability-reducing principles of the ongoing dialogue, within a relationship based on frank confrontation with uncertainty, should be used as an essential supplement to the sheets of paper. This shift of perspective moves pro forma informed consent to informed consent as process.

Informed Consent as Process

By use of this term we mean to imply that informed consent is not an event but an ongoing dynamic interchange between doctor and patient that evolves as the two confront the vicissitudes of illness and treatment. An essential aspect of this process is the open discussion of risks and benefits of each phase of intervention. This has two advantages.

First, the translation of risks and benefits into language that the patient can understand is itself supportive and fosters the patient's trust as well as a commitment to active engagement in follow-up care. Second, such discussion provides the clinician an additional opportunity to review the reasoning which underlies the recommended intervention in explicit risk-benefit terms. This approach actually represents an informal clinical version of decision analysis. [6] Such a review, moreover, helps to challenge overly facile hindsight reasoning ("You should have weighed the risks and benefits") in case of a tragic outcome leading to litigation.

The Open Door Policy

The last element of this model might be styled the "open door policy" of informed consent. Simply stated, this means that the clinician's aim is to convey to the patient that "the door [of communication] is always open" to discussion of side effects, newly arising questions or concerns and the like. Especially given the well-demonstrated absence of reliable retention of clinical information by patients in the stressful situation of contemplated medical procedures, this policy is more effective than mere information overload, as it is sometimes practiced.

The power of this model is best demonstrated by the realization that surprise at unanticipated outcomes (e.g., side effects, unwanted sequelae), more than the bad outcomes themselves, is the major trigger of animosity. The knowledge that the door is open markedly decreases the experience of being alone with one's calamity from the unreachable caretaker whose apparent failure now confronts the patient.


We have suggested several approaches to the thorny problem of informed consent in the realities of clinical practice. We suggest that informed consent is not a legalistic snare and pitfall but an occasion and opportunity for the practice of sound liability prevention as opposed to the specious practice of defensive medicine.

By approaching informed consent as a process, as a bipersonal field wherein an open-door policy prevails, the clinician turns a potential legal constraint to distinct clinical advantage: improved care, better relationship with patients and decreased risk of liability. ■


  1. Bursztajn H, Feinbloom K Hamm R, Brodsky A: Medical Choices, Medical Chances: How Patients, Families and Physicians Can Cope With Uncertainty. New York, Delacorte Press, 1981.
    Gutheil TG, Appelbaum PS: Clinical Handbook of Psychiatry and the Law. New York, McGraw-Hill, 1982.
  2. Gutheil TG, Bursztajn H, Brodsky A: Malpractice Prevention Through the Sharing of Uncertainty: Informed Consent and the Therapeutic Alliance. N Eng J Med 311: 49-51,1984.
  3. Id.
  4. Bursztajn H, Gutheil TG, Cummins B: Medicolegal Issues in Inpatient Psychiatry. In: Sederer L (ed), Inpatient Psychiatry: Diagnosis and Treatment, 2nd Ed. Baltimore, Williams and Wilkins, 1986.
  5. Gutheil TG, Bursztajn H Brodsky A, Supra n.2.
  6. Bursztajn H, Hamm K, Gutheil TG, Brodsky A: A Decision-Analytic Approach to Medical Malpractice Law: Formal Proposals and Informal Syntheses. Med Decis Making 4:401-414,1984.

Thomas G. Gutheil, M.D. and Harold Bursztajn, M.D. are co-directors of the Program in Psychiatry and the Law at The Massachusetts Mental Health Center, and both serve on the faculty of Harvard Medical School Archie Brodsky, B.A., is Senior Research Associate for the Program in Psychiatry and the Law, Massachusetts Mental Health Center. Dr. Gutheil has consulted on malpractice cases in 24 states and has written extensively on liability prevention in national and international professional literature.