If there is one single issue besides the patient's right to self-determination upon which the Patient Self-Determination Act is built it is informed consent. The notion of informed consent has come a long way from the Hippocratic notion of keeping patients ignorant of their conditions and allowing physicians to make all decisions on their behalf.⁽¹⁾ When informed consent finally became an issue in healthcare ethics the physician was still the one who determined its conditions. Prior to Canterbury v. Spence the criterion was that patients were to be informed about matters which the "reasonable physician" thought they should know.⁽²⁾ After Canterbury the criterion shifted to giving patients information that a "reasonable patient" would want to know.⁽³⁾ Currently, approximately half the states in the United States use the former criterion and half the states use the latter.⁽⁴⁾

    The historical shifts in the informed consent dynamics have very likely occurred as a result of better information being available about healthcare conditions and the accessibility of the information to patients in forms which the patient could understand. Another likely reason for the shifts may very well lie in an increased awareness that the principle of self-determination, so essential to a democracy, ought to operate in the healthcare setting as well as in the political arena.⁽⁵⁾ Adequate information to make choices lies at the heart of self-determination.

    The President's Commission, in setting the parameters for informed consent, identified two basic values which underlie it: personal well-being and self-determination.⁽⁶⁾ These two values are the foundations for the Patient Self-Determination Act, as well as for informed consent in the healthcare setting. Patients are in the best position to make decisions which affect them and they are equally in the best position to determine what will contribute to their well-being. The use of the term "personal" to qualify "well-being" conveys the intimate character of such judgments, their subjective character, and private nature. No one can make such judgments about an individual's well-being as well as she. But the judgments cannot be made without adequate information, thus underlining the "informed" part of informed consent.

    The Commission goes on to affirm that there is a dimension of mutuality in the informed consent exchange which cannot be ignored. At first glance it would seem that informed consent is directed only to the patient. In some ways this is the case. For the Ethics Manual of the American College of Physicians clearly states that the patient who is entitled to complete explanations about her healthcare condition possesses full decision-making authority with regard to her medical care.⁽⁷⁾ But the President's Commission sees a more participatory model in informed consent. It becomes a relationship precisely because each partner ------ physician/caregiver and patient ------ has a stake in the outcome of the therapeutic relationship under consideration.⁽⁸⁾ The patient's stake clearly results from the fact that the patient is the one to bear, in the most personal way, the outcomes of the decision. The caregiver has a stake insofar as she has a keen interest in engaging in the best form of healthcare practice possible according to the standards of her profession.

    As suggested in chapter 3, the dynamics of informed consent constitute a relationship of mutual empowerment because the mutuality of informed consent gives true power to each of its participants.⁽⁹⁾ The patient does not have the power to make a proper healthcare decision and consent to a course of treatment without having the information necessary as a resource for giving consent. By giving the patient information which is adequate for making a sound decision, the physician is empowering the patient. One of the greatest areas of patient vulnerability is that of ignorance.⁽¹⁰⁾ Patients often come to the healthcare setting ignorant of the problem which they are facing and of the measures which will help them overcome that problem. In giving the patient appropriate information, that vulnerability is reduced. If pertinent information is withheld the patient's vulnerability is perpetuated and often magnified.

    The other side of the relationship is equally important. The initial power of the physician lies in her expertise. The knowledge which the physician brings to the clinical setting gives her the power to diagnose, render a prognosis, and recommend treatments. But this all remains distant from the patient until the patient gives consent because the physician may not engage in any non-consented to touching of the patient.⁽¹¹⁾ Thus, while the physician has power and some measure of authority granted by society, she cannot exercise that power and authority without the patient's consent to do so. Thus, the patient empowers the physician by giving consent, in much the same way as the physician empowers the patient by giving information.

    There are many components to the information package which patients must know if they are to be truly empowered to make wise decisions about their healthcare.⁽¹²⁾ The most obvious element is that they should know the nature of the problem which they are facing and the outcome of the problem if it is left untreated. The practice of fully disclosing this sort of information, particularly in cases of critical illness, became common only in the last two generations of medical practice.⁽¹³⁾ Prior to this practice many practitioners thought that it was more beneficial to patients to keep them ignorant of their problem, thinking that knowledge would only exacerbate their plight and create additional problems of depression, despair, and inappropriate refusals of treatment.⁽¹⁴⁾ This silence has come to be known as "therapeutic privilege."⁽¹⁵⁾ While some patients still may wish to remain ignorant of their problem, the suppression of information is often now the result of the patient's conscious desire rather than a default to the clinician's judgment.

    The next component of the information package is the nature of the treatment which the clinician is recommending. The patient will have to know what the treatment can accomplish, i.e., the benefits of the treatment for the patient and the likelihood of its success.⁽¹⁶⁾ The patient will also need to know the risks which are involved with the treatment, i.e., the detrimental effects which may accompany the treatment.⁽¹⁷⁾ None of these elements can be communicated to the patient with absolute certainty. This kind of certainty is not possible in the art of medicine.⁽¹⁸⁾ The patient will need to know about this limitation in medical knowledge. The information will have to be couched in the language of probabilities, for medicine is largely the management of probabilities in the design and administration of treatments.

    Finally, patients need to know a reasonable range of alternatives to the treatment which is recommended. Patients do not always find a recommended course of treatment to their liking because the side-effects of the treatment might interfere with their lifestyles. Or, they might weigh the risks and benefits of a course of treatment differently from their clinicians.

    Giving patients information is not as simple as it may sound. It involves a complex dynamic which has as its base the use of language which the patient can understand.⁽¹⁹⁾ It is easy for practitioners to fall into the trap of using professional jargon in communicating with patients because it is their language of everyday use. Unfortunately, essential information often escapes the comprehension of the patient because of the use of technical language. A case can be made that the use of technical language may actually violate the patient's dignity by keeping this critical information from her.⁽²⁰⁾

    Beyond the use of understandable language three levels of working with information can be identified in the dynamics of informed consent.⁽²¹⁾ The first level is the communication of mere facts.⁽²²⁾ At this rudimentary level the patient is merely acquainted with a body of factual knowledge, the parts of which may be fairly discrete and unrelated. For example, "there is a cancer. Cancer of such and such a type often responds to chemotherapy in the following way. Radiation therapy is sometimes an alternative to chemotherapy." At this level the patient has information but the elements are generally disconnected from each other. So they are "floating" independently of the patient.

    The next level beyond simple communication of facts is the level of understanding. Here the patient possesses mastery of the facts and is able to establish some meaningful connections. For example, "there is a cancer and it is responsive to this form of therapy in the following way. The therapy has the following benefits but also poses the following risks. If the therapy is pursued the results for the cancer in six months will be significant remission of the growth of the tumor or shrinkage of the tumor. The therapy even has X% probability of actually destroying the tumor." Here the patient can see the relationship clearly between the various pieces of information. The causal relationship of the elements has been understood and the outcomes explicitly projected. But there is still a significant dimension lacking which becomes possible only at the next level.

    The final level of managing information in informed consent can be call the level of "processing" information, which may include both patient and physician sharing in the processing.⁽²³⁾ The emphasis here is on the patient's integrating everything she knows at the first two levels into her own value framework. She personalizes it. For example, the cancer is no longer "a" cancer, it is "my" cancer. The therapy is no longer a therapy for "the cancer," it is a therapy for "me." "My therapy" no longer affects the cancer in such and such a way; "my therapy" affects "me." And it does not affect "me" as an abstraction but "me as a living, breathing subject with a particular lifestyle and particular goals which I wish to accomplish and particular values which I wish to pursue. I may or may not wish to consent to this regimen." Thus, the patient has seen the disease as an intimate part of herself about which she must make some significant decisions which will flow from the value life which she has generated over the years. Thus, the disconnected information communicated in the first level is finally integrated with the patient's innermost values and preferences. Processing information in this way is not the result of an automatic decision to have therapy (the technological imperative). Rather it requires considerable reflection on the part of the patient and often some extensive assistance on the part of the caregiver who shares in the processing of information.

    Three authors, Lidz, Appelbaum, and Meisel, have structured the issues of informed consent a bit differently but with similar results for understanding the implementation issues related to the Patient Self-Determination Act.⁽²⁴⁾ An examination of their analysis would be most helpful. They point out that the standard way of approaching informed consent in the clinical setting follows what they call the "event" model. Here the communication between clinician and patient occurs as a discrete act in their relationship. The information is given and is seldom revisited. The patient signs a consent form as a symbol of the "communication event."⁽²⁵⁾ While this transaction may satisfy the legal requirements for informed consent there are two lingering questions: How much does the patient truly understand and how can the patient open a discussion about reconsidering her decisions?

    The alternative approach to informed consent which the authors suggest is the "process" model of informed consent.⁽²⁶⁾ In this model, information is exchanged and consent reconsidered and reaffirmed over the entire course of treatment. Whereas the event model allows the patient to be passive about consent after the consent form has been signed, the process model is structured around continuing conversations between the clinician and the patient about both the patient's condition and treatment.⁽²⁷⁾ The process model is predicated on the active participation of the patient in decision-making, thereby emphasizing the patient's responsibility. The patient's personal and value history are viewed as important backdrops for the dialogue between the parties in the clinical setting. Both patients and physicians articulate their expectations of their own roles as well as those of each other. This allows them to negotiate any differences as they arise and resolve them quickly.

    One of the most significant features of the process model is the continuous dialogue which takes place. Nothing is considered to be automatic and everything is open for reappraisal. A mutual monitoring between the partners in the clinical relationship involves on-going reflection on, and reordering of, knowledge, both new and old, in light of further information and experience. This approach opens the pathways of discussion about the patient's feelings about what is being faced and the processing of those feelings throughout the experience.⁽²⁸⁾

    The strategies which reinforce the process model help to define more carefully the parameters of the problems which the patient faces and help the patient select the appropriate approach to treatment. By using the strategy of soliciting the patient's reflections, caregivers can more immediately address the patient's concerns before they become overwhelming and an additional obstacle in the therapeutic relationship.

    The major advantage of the process model of informed consent is that it enhances both the patient's autonomy and responsibility. The patient is not considered a spectator but rather an active participant in the therapeutic process and a primary source in decision-making. And this is precisely the objective of the Patient Self-Determination Act. For the law intends to place some measure of control in the hands of patients by letting them know some broad features of their rights in the therapeutic relationship. The Patient Self-Determination Act confers on patients a cluster of interrelated rights flowing from the dynamics of informed consent in medical situations: (1) the right to be informed upon admission to a healthcare facility or organization of their right to consent to or refuse treatment; (2) the right to know the policies of the institution regarding the withholding or withdrawing of life-sustaining treatments; and (3) their rights under current state laws regarding advance directives. Failure to implement fully the Patient Self-Determination Act means that an institution is neglecting its obligation to patients under the canons of informed consent as well as federal law.

    The advantages of informed consent have become increasingly obvious over the past generation. The first, and perhaps most important, advantage is that informed consent creates a bond of trust between the patient and the caregiver by opening avenues of communication between them.⁽²⁹⁾ Without the expectations and dynamics of informed consent, there could be a measure of mistrust between the patient and the caregiver. There could be a suspicion that, even though the caregiver is giving the patient some information, other important information might remain hidden. There could also be a suspicion that the information might be weighted in such a way that consent could be the result of manipulation or coercion rather than free choice. The bond of trust has always been central to the physician-patient relationship. But for a large part of the history of medicine it has been asymmetrical, i.e., the patient was supposed to trust the physician. Informed consent adds a measure of symmetry to the relationship which it never before possessed by challenging the physician to trust the patient.

    The second advantage of informed consent can be found in the way it opens the possibility for patients to take greater responsibility in the course of their treatment. Thus, informed consent is intimately connected to the practice of autonomy.⁽³⁰⁾ If patients do not have information about their healthcare conditions they will be at the mercy of others in the decision-making process. The responsibility for what happens to the patient will fall upon those who have the information and who make the decision on that basis. If it is desirable for patients to be responsible for their healthcare, it will be necessary for them to have the information which will act as a foundation for their decisions.⁽³¹⁾

    But patients are not the only ones to be benefitted by the dynamics of informed consent. Physicians and other caregivers also benefit. And the third advantage of informed consent can be significant for them. Physicians can be more effective in the care they give to their patients if they spend time discussing the patient's healthcare condition with her. This dialogue will allow the patient to reveal the value basis which underlies her decisions and set particular decisions within the context of those values. Beneficence is well served by any strategy which gives patients a significant advantage in participating in decisions about their healthcare. In this case, physicians are being beneficent by cultivating this advantage in patients through the process model of informed consent.

    A special advantage of this exchange is that it averts a very significant conflict in the physician-patient relationship. All too often, when a conversation is brief and the information imparted is limited, sharp disagreements emerge about a healthcare decision. The friction often arises because the decisions take the form of conclusions which have been reached without extensive conversations. If there is a true dialogue in the informed consent relationship, reasons for decisions will arise. Then physicians will not feel compelled to argue with patients about the decisions which they have reached. Instead, there is a good chance that they will see the reasons behind the decisions and will be able to channel their therapeutic energy and expertise toward helping patients within the patient's value context, rather than argue with them because of conflicts in their tacit value agendas.

    The last major advantage of informed consent can also be directed toward physicians and other caregivers as well as patients. Informed consent reduces the liability exposure of physicians by maintaining avenues of communication between caregivers and patients. Many malpractice claims occur because patients and caregivers have not communicated fully enough and such claims can be avoided if effective communication occurs.⁽³²⁾ Consent should never be a perfunctory exercise and should only be given when the patient has received adequate information. A thorough conversation about the issues which the patient faces can give the patient the information which she needs to make a decision reflective of her values and goals. Often courts are called into a case when such a conversation has not occurred. When there is sound communication between the physician and the patient, contentious issues can be resolved without the need of judicial intervention and resolution. It is interesting that a number of courts, including Quinlan,⁽³³⁾ have indicated the reluctance of judges to become involved in cases which could have been resolved in a more extensive interchange between the caregiver and the patient.

    Just as informed consent in the therapeutic relationship can be carried out in a perfunctory manner which simply goes through the motions or in an enriched manner which works with the patient's value system and the patient's reflective abilities, so also the Patient Self-Determination Act can be mechanical or enriched in its implementation. In both cases, i.e., informed consent and the implementation of the Patient Self-Determination Act, the latter approach takes patient dignity seriously and refuses to yield to the temptation of considering the convenience of caregivers as the highest priority. The Patient Self-Determination Act reinforces informed consent in the clinical setting and is positioned to guarantee its fulfillment if it is taken seriously. But this can only be accomplished if the spirit as well as the letter of the law is followed.

1. Lloyd GER (ed). Hippocratic writings. London: Penguin Books, 1983, page 67. Cf. also Lidz CW et al. Informed consent: a study of decision-making in psychiatry. New York: The Guilford Press, 1984, pages 3-5.
2. Katz J. Informed consent in therapeutic relationships: law and ethics. In Reich, WT (ed). Encyclopedia of bioethics. New York: The Free Press, 1978 , pages 770-778.
3. Canterbury v. Spence. 464 F.2d 772, 150 U.S.App.D.C. 263 (1972).
4. Meisel A, Kuczewski M. Legal and ethical myths about informed consent. Arch Intern Med 1996;156:2521-2526.
5. Appelbaum PS et al. Informed consent: legal theory and clinical practice. New York: Oxford University Press, 1987, pages 35-36.
6. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Making health care decisions: The ethical and legal implications of informed consent in the patient-practitioner relationship. Washington, D.C.: U.S. Government Printing Office, 1982, page 41.
7. American College of Physicians. Ethics manual. 1st edition. Philadelphia, PA: American College of Physicians, 1984, page 25.
8. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Deciding to forego life-sustaining treatment: a report on the ethical, medical, and legal issues in treatment decisions. Washington, D.C.: US Government Printing Office, 1983, pages 43-44.
9. Bok S. Personal directions for care at the end of life. N Engl J Med 1976;295:367-369.
10. Hotchkiss WS. Doctor as patient advocate. JAMA 1987;258:947-948.
11. Schloendorff v. Society of New York Hospital. 211 N.Y. 125, 105 N.E. 92 (1914).
12. Katz J. Informed consent in the therapeutic relationship. In Reich WT (ed). Encyclopedia of bioethics. 2nd edition. New York: Macmillan Library Reference USA - Simon and Schuster Macmillan, 1995, pages 1256-1265.
13. Meisel A, Kuczewski M. Legal and ethical myths about informed consent. Arch Intern Med 1996;156:2521-2526.
14. Oken D. What to tell cancer patients. JAMA 1961;175:1120-1128. Patient response to information was often quite the opposite of what physicians feared. Patients object if they are not given appropriate information and often respond very positively to physicians who are honest and open with them. (Cf. Alfidi R. Informed consent: a study of patient reaction. JAMA 1971;216:1325-1329.)
15. Katz J. Disclosure and consent in search of their roots. In Milunsky GJ (ed). Genetics and the Law. Vol. 2. New York: Plenum Press, 1980, pages 121-129.
16. Jonsen AR et al. Clinical ethics; a practical approach to ethical decisions in clinical medicine. 4th edition. New York: McGraw-Hill, Inc. 1998, page 55.
17. There is much discussion about how far physicians should go in giving information about risks to patients. Clearly every risk cannot be communicated. The clinical judgment of the physician is central to determining how much information in the area of risks should be communicated. Certainly clinicians should be sensitive to the clues sent by the patient regarding the amount of information she wishes. In general, one might think in terms of mortality and morbidity. When the risk is mortality, then even low probabilities should be communicated. However, when the risk is morbidity then, depending on the seriousness of the morbidity, there may be a higher tolerance for not disclosing extensive information. (Cf. Beauchamp TL, McCullough LB. Medical ethics: the moral responsibility of physicians. Englewood Cliffs, NJ: Prentice-Hall, Inc., 1984, pages 74-75. Cf. also Gorovitz S. Doctors' dilemmas: moral conflict and medical care. New York: Macmillan Publishing Co., Inc., 1982, pages 35-54.)
18. Kassirer JP. Our stubborn quest for diagnostic certainty. N Engl J Med 1989;320:1489-1491.
19. American Hospital Association. A patients' bill of rights. In American Hospital Association. Values in conflict: resolving ethical issues in hospital care. Chicago IL: American Hospital Association, 1985, pages 77-79.
20. Cousins N. A layman looks at truth-telling in medicine. JAMA 1980;244:1929-1930.
21. While the following three levels may often overlap in practice to some extent, they are distinguishable with regard to the focus of the information transfer, the response of patients to the information given, and the participation of patients in appropriating and integrating the information.
22. When informed consent occurs at all, this is often what is likely to happen.
23. Meisel A, Kuczewski M. Legal and ethical myths about informed consent. Arch Intern Med 1996;156:2521-2526. "A shared process approach does not restrict the physician to providing facts and insists that the patient supply all the values. The physician and patient each have access to interrelated facts and values." (page 2522)
24. Lidz CW, Appelbaum PS, Meisel A. Two models of implementing informed consent. Arch Intern Med 1988:148;1385-1389.
25. It is an error to think that a signed consent form is informed consent. (Cf. Meisel A, Kuczewski M. Legal and ethical myths about informed consent. Arch Intern Med 1996;156:2521-2526.)
26. Here the term "process" functions in much the same way as it was used previously in identifying the three distinct levels of informed consent. In both usages patients' beliefs, values, and wishes are intimately connected to the facts of the medical situation.
27. The ease with which Lidz, Appelbaum, and Meisel draw the distinction between the event and the process model may neglect some of the positive aspects of the event model. Stephen Wear, in Wear S. Informed consent: patient autonomy and physician beneficence within clinical medicine. Dordrecht: Kluwer Academic Publishers, 1993, calls them to account for this deficiency. Wear contends that the event model is quite sufficient in the majority of cases provided the groundwork in the physician-patient relationship has been adequately laid. "An overall atmosphere of trust, candor, information provision, assessment and feedback is surely essential to the effectiveness and success of any physician-patient encounter" (page 82). His contention is that the atmosphere of the relationship will take care of the issues that Lidz, Appelbaum, and Meisel without having to return time and again to assess the therapeutic intervention after it has been initiated (pages 81-82). Wear may be right in many cases. However, one must always remain open to the possibility that the process model may have to be employed as therapy continues. (Cf. White BC. Competence to consent. Washington, D.C.: Georgetown University Press, 1994, pages 27-28.) Moreover, when addressing the matter of the stipulations in the Patient Self-Determination Act, the issues may frequently have to be addressed on an on-going basis because of their complexity and the changing life situations which patients experience.
28. Callahan S. In good conscience: reason and emotion in moral decision-making. New York: HarperSanFrancisco, 1991, pages 95-113.
29. Zaner RM. Ethics and the clinical encounter. Englewood Cliffs, NJ: Prentice Hall, 1988, page 54.
30. Childress JF. Who should decide? paternalism in health care. New York: Oxford University Press, 1982, pages 77-80.
31. Strull WM et al. Do patients want to participate in medical decision making? JAMA 1984;252:2990-2994.
32. Levinson W. et al. Physician-patient communication: the relationship with malpractice claims among primary care physicians and surgeons. JAMA 1997;277:553-559.
33. In re Quinlan, 70 N.J. 10, 355 A.2d 647 (1976).