Autonomy, Informed Consent and the Death of Therapeutic Privilege: Lessons Learned from the Jehovah’s Witnesses

An Independent Learning Module for Health Care Workers

Authors [ edit ]

D. John Doyle MD, PhD, FRCPC, June 21, 2005, djdoyle hotmail.com

Purpose of This Learning Module [ edit ]

The purpose of this learning module is to bring readers up to date with some of the more important issues regarding informed consent and patient autonomy, which are discussed from clinical, ethical and legal perspectives. A synopsis of the problem of clinical informed consent is presented, touching on both the ethical and legal issues as well as the various “standards” of consent. The idea that the process of informed consent may occasionally itself be a health hazard is presented. The notion of therapeutic privilege, a concept declining in acceptance, is also discussed. Finally, old and new developments regarding autonomy and informed consent in Jehovah’s Witness patients are discussed.

Specific Learning Objectives [ edit ]

The specific learning objectives for this module are as follows: (1) to understand the philosophical notions of informed consent and patient autonomy, and the relationship between them, (2) to identify the various clinical situations where full informed consent may not be possible, (3) to identify possible clinical situations where informed consent may not be in the interests of the patient’s health, (4) to understand the notion of “therapeutic privilege”, (5) to identify possible clinical situations where conflicting ethical principles which may lead to disagreement between health care workers and patients, (6) to examine several noteworthy legal rulings in the USA and Canada related to autonomy and consent of which health care workers should be aware, and (7) understand how issues related to the care of the Jehovah's Witness patient has influenced our notions of autonomy and consent.

Introduction [ edit ]

Autonomy is one of the four guiding principles of the “Georgetown School” of bioethics, the other principles being beneficence, justice and nonmalfeasance (Beauchamp and Childress 1994). Autonomy implies the right to actively participate in medical decisions concerning oneself without being dictated to or controlled by other parties. Central to the concept of autonomy in this setting is the requirement that a patient understand the various clinical choices available and the risks and benefits associated with those choices. In other words, informed consent is a necessary condition for patient autonomy.



This notion of autonomy implies that individuals should be given adequate means to make their own decisions - decisions made based on their personal value system. This also implies that patients must be provided with appropriate information to make informed decision-making possible. The information that should be supplied to establish clinical informed consent usually focuses on the nature, risks and benefits of the proposed intervention with a discussion of the alternatives to the planned intervention, including their associated risks, benefits, and uncertainties.



Obtaining informed consent also entails ensuring that an adequate degree of patient understanding exists. Thus the clinician must also establish that the patient has sufficient decision-making competence for informed consent to be possible. This is usually accomplished informally, by considering whether the patient appears to comprehend the information presented and establishing that the patient can discuss the issues with caregivers in a reasonable and logical manner. In some cases, however, formal psychological consultation is requested.



Three approaches to the issues of providing informed consent have been described: (Edwards 1999):



• “reasonable physician standard: what would a typical physician say about this intervention? This standard allows the physician to determine what information is appropriate to disclose. However, it is probably not enough, since most research in this area shows that the typical physician tells the patient very little. This standard is also generally considered inconsistent with the goals of informed consent as the focus is on the physician rather than on what the patient needs to know.”



• “reasonable patient standard: what would the average patient need to know in order to be an informed participant in the decision? This standard focuses on considering what a patient would need to know in order to understand the decision at hand.”



• “subjective standard: what would this patient need to know and understand in order to make an informed decision? This standard is the most challenging to incorporate into practice, since it requires tailoring information to each patient.”



In recent years Canada and many states in the USA have adopted the “reasonable patient” standard as their legal model. It is interesting to note that under this model the requirement for informed consent does not necessarily require that the patient be supplied with every imaginable detail. For instance, in a 1980 Canadian Supreme Court decision [Reibl v. Hughes [1980] 2 SCR 880] the court decided that both minuscule risks associated with devastating outcomes (e.g., stroke, death) as well as common but minor risks (e.g., damage to teeth with tracheal intubation) must be disclosed to the patient, but that a detailed disclosure of all possible risks is not a legal requirement.

Therapeutic Privilege [ edit ]

The notion of "therapeutic privilege" refers to the withholding of important information by the clinician during the “consent” process in the belief that disclosure of such information would lead to the harm or suffering of the patient (Meisel et al. 1977). The philosophical basis for "therapeutic privilege" is the notion that beneficence should take precedence over autonomy in cases where a conflict between these two principles exists. Today, with the collapse of paternalism in modern clinical care, and with the widespread adoption of the “reasonable patient” model for legal informed consent, therapeutic privilege is invoked only rarely. This is so both as a result of medico-legal prudence and in response to modern cultural shifts. Furthermore, some clinicians argue that if a person feels that providing a patient with relevant clinical information may be so upsetting to the patient as to cause extreme psychological harm, the patient should be assessed for mental competency.



Still, therapeutic privilege has its cautious supporters. For instance, Etchels et al. (1996), discussing the Canadian situation, make the case that therapeutic privilege may sometimes be appropriate. They write:



The need for sensitivity to cultural norms may potentially support the exercise of therapeutic privilege. In some cultures therapeutic privilege is widely invoked, and it is unclear whether patients from these cultures should always be subjected to Western standards of consent. However, given the legal status of therapeutic privilege in Canada, clinicians should avoid invoking therapeutic privilege. It is better for the clinician to offer information and allow the patient to refuse or accept further disclosure.



Further complicating the issue of informed consent is the recognition that there are a number of circumstances where ensuring that the requirements for full informed consent can be problematic. Such situations include (1) the premedicated patient, (2) the parturient in labor, (3) the “psychologically fragile” patient under enormous emotional stress, (4) the patient with known mental illness, (5) the patient with organic brain disease, (6) the immature adult patient, and (7) the hostile and distrustful patient who is angry at the world and places absolutely no trust in authority figures.



There is also an additional consideration to ponder. Some clinicians would maintain that the process of informed consent has health risks in and of itself, and that these risks should be weighed in discussions of the informed consent process. In particular, consider the case of the patient who is impaired at making judgments involving clinical risk management and who refuses a reasonable intervention involving a relatively small risk even though it would substantially eliminate another, much larger, clinical risk.



The following (edited) posting by a doctor working in the “clinical trenches” illustrates the matter:



I feel that the process of informed consent is not always in the patient's best interests. Many patients clearly need cardiac catheterization and initially agree. But once I inform them of the risks of the procedure, they then refuse. Even when I subsequently inform them that the risk of not doing the procedure is far greater, they persist in their refusal. Thus the process of informed consent has caused the patient to act in a manner deleterious to their health. Many patients cannot understand the concept of risk/benefit ratios. I understand that we wish to avoid medical paternalism and promote patient independence but medical decision making is not the same as a consumer pulling products off a store shelf. Part of what the patient is paying for is our professional judgement. [1]



Another example concerns the administration of blood transfusions. In my own clinical practice as an anesthesiologist, I frequently administer blood transfusions, particularly during surgical procedures with severe blood loss. In fact, anesthesiologists give more than 50 per cent of the nation's blood supply to correct for blood loss during and after surgery. And, associated with every "unit" (about 250 mL) of blood given is a small, but definitely not trivial, chance of transmitting infection or getting some other complication.



I find the decision about giving or not giving blood particularly difficult when a patient asks me to promise not to transfuse during surgery, but has no reason for this request other than an exaggerated fear of becoming HIV infected. So far, I have always been able to convince such patients to allow me to give blood if it is absolutely necessary, usually by asking them about what they would want me to do in the very rare event of unexpected massive blood loss. Typically their response is, "Well, I would die unless I got blood, so of course..."



What should I do, however, if I can't convince a patient to permit me to give blood to save his or her life? One option is to respect the patient's decision. Yet I'm uncomfortable with this position. My discomfort arises from the fact that such people are not making sound judgments about the current risks involved in blood transfusion. Frightened by reports of past blood-transfusion tragedies, people today are inflating the very small risk if HIV or other infection that actually exists. In such an atmosphere of fear, they are making ill-informed decisions about their own health care, decisions by which I fear I must abide.

How Much Information? [ edit ]

It was noted earlier that informed consent under the “reasonable patient” standard does not necessarily require that the patient be supplied with every imaginable detail. Still, there are exceptional patients who ask for far more information than usual. While this may reflect reluctance for the patient to relinquish control, it may also indicative of an analytical coping style in an intelligent, curious patient. My approach to such patients is to systematically provide detailed answers to all questions asked, including pointing out those circumstances where there is no well-established answer to a question because of existing limits to medical knowledge. Also, many patients are familiar with using PubMed and other resources to get information via the Internet, and this too can serve as a means for some patients to get additional information.



Still, some questions may be out of bounds to some practitioners. For instance, some surgeons might be reluctant to disclose the details of their complication rates, or may not even have such information specifically tabulated. As a more extreme example, it would not be considered reasonable to allow a patient considering a particular surgeon to conduct his or her own private chart review of the last 100 cases carried out by that surgeon so as to obtain useful information.



Many health consumers use the Internet to obtain physician profile information, including malpractice claim data. A number of US states now put malpractice data on the Internet. For instance, the State of Virginia makes practitioner information available at http://www.vahealthprovider.com, while the Federation of State Medical Boards of the United States offers a national fee-based service at http://www.docinfo.org. Finally, the Questionable Doctors site at http://www.questionabledoctors.org “contains data on disciplinary actions taken for medical incompetence, misprescribing drugs, sexual misconduct, criminal convictions, ethical lapses and other offences.”



Although many physicians embrace this idea in theory, many are worried about the use of malpractice information as an indicator of competence or quality. Cynics argue that the medico-legal systems in Canada and the USA are so haphazard that good doctors are just as likely to be sued as those who may be practicing below the standard of care. Other opponents of this concept contend that the public may misinterpret malpractice history data and punish capable doctors who happen to treat a large number of high-risk patients.

Drawing on the Jehovah’s Witnesses Experience [ edit ]

A patient has a legal right to decide to forgo “clinically necessary” treatment if the patient is judged to be competent to make that decision. No where is this better illustrated than in the case of the Jehovah’s Witness patient. There are approximately seven million Jehovah’s Witnesses world-wide, with approximately one million in the USA and about one hundred eighty four thousand in Canada. The Jehovah's Witnesses are a Christian religion whose followers believe the Bible to be the true and literal word of God whose name is Jehovah and whose son, Jesus Christ, established true Christianity. Witnesses view Jehovah God as the ultimate moral authority and do not salute flags, join service organizations, enlist in the military, vote in public elections, or take an interest in civil government.





Traditionally, orthodox Jehovah’s Witnesses will not accept homologous or autologous whole blood, packed red blood cells, plasma, platelets and white blood cells, even when “clinically necessary” (Letsoalo 1998, Ridley 1999). The determination that blood transfusions were a violation of God's law was made in 1945 and is primarily based on three biblical passages: Genesis 9:3,4; Leviticus 17:10-16; Acts 15:28, 29.



This prohibition can result in a challenging dilemma for physicians because a routine, safe, and potentially life-saving medical intervention is unacceptable to the patient (Benson 1989, Rothenberg 1990, Mann et al. 1992). Anesthesiologists are particularly affected because they are almost always responsible for intraoperative transfusion management. This sometimes puts anesthesiologists and other clinicians in highly unusual clinical situations (Harnett et al. 2000, Baldry et al. 2000).



It should come as no surprise that this situation has resulted in a number of legal debates, and most legal issues concerning the medical care of Jehovah's Witnesses center on the issues of autonomy and consent. In Canada, the landmark legal case regarding the clinical care of Jehovah's Witness patients was the case of Malette v. Shulman [Malette v Shulman (1990), 37 OAC 281 (CA)]. The courts established that clinicians should not administer emergency treatment without consent if they have reason to believe that the patient would refuse such treatment if he or she were capable. In this case, Dr. Shulman administered a blood transfusion to a patient who was unconscious as a result of hypovolemic shock. The patient carried a signed (but undated and unwitnessed) wallet card indicating that she was a Jehovah's Witness and did not want to receive blood transfusions under any circumstances. Despite this, blood was transfused out of clinical necessity. Although the transfusions were almost certainly responsible for saving the patient's life, the court found the clinician liable for battery. The judge stated: “To transfuse a Jehovah's Witness in the face of her explicit instructions to the contrary would, in my opinion, violate her right to control her own body and show disrespect for the religious values by which she has chosen to live her life.”



In the USA, the case that established the competent adults right to refuse treatment occurred in 1914 in Schloendorff vs. Society of New York Hospital. (Schloendorff vs Society of New York Hospital, 105 N.E. 92, (1914).) A woman agreed to an examination under anesthesia but refused consent for surgery. Despite this, surgery was performed, and serious unexpected complications followed. A lawsuit was launched and resolved in favor of the plaintiff. The presiding judge stated that "Every human being of adult years and sound mind has a right to determine what shall be done with his own body". Despite this ruling the patient lost her case because the hospital was a charitable institution and was consequently immune from liability. Still, the case established the notion of informed consent and of the right of a competent adult patient to choose or refuse treatment. Since the time of the Schloendorff case a large number of American legal decisions have reinforced the right of a competent adult to choose his or her treatment, even when the decision is not medically sound.



A particularly unusual legal case occurred in Pomona, California where a drunken driver rammed his pickup truck into a stationary car, injuring a 55 year old Jehovah’s Witness woman standing by the side of the road (http://www.religiontoday.com/Archive/ NewsSummary/ ). She refused a needed blood transfusion, and consequently died in hospital. Prosecutors said the driver was responsible for the death because he caused the injuries and he was convicted of manslaughter. His lawyers argued that the immediate cause of the woman’s death was her refusal of a blood transfusion, since she very likely would have lived had a blood transfusion been carried out.

Dissent and Consent - The Jehovah’s Witness “Reform Movement” [ edit ]

Since 1996, a number of Jehovah’s Witnesses have anonymously expressed their dissent to the Jehovah’s Witness blood policy and formed a group called the Associated Jehovah's Witnesses for Reform on Blood (AJWRB), with a Web presence at www.ajwrb.org. Their goal is for a “reformation” of existing blood policy, which they see as a “complicated web of contradictory rules and conditions strictly enforced without biblical basis”. Their actions are for the most part conducted anonymously, since experience shows that for a Jehovah’s Witness to express any criticism often results in expulsion from the church (ecclesiastical disfellowshipping). The existence of this movement presents an ethical dimension that I discuss next.



It was implied earlier that the central ethical dilemma in the management of Jehovah’s Witness patients is in the nature of a conflict between beneficence and autonomy, where autonomy is generally given precedence over beneficence, at least in American and Canadian law. But there is another potential dilemma for anesthesiologists who care for Jehovah’s Witness patients: because many Jehovah’s Witness patients are not likely to be fully informed about possible inconsistencies in church doctrine regarding medical issues, should anesthesiologists attempt an in-depth discussion to encourage a rational and truly autonomous decision (for instance, using information provided by the Jehovah’s Witness “reform” movement [www.ajwrb.org]), or should they remain silent regardless of the degree to which they might find the patients’ views to be irrational and misguided, so as to avoid the perception of “religious interference”.



Muramoto (1998a, 1998b, 1999, 2000) and others (Savulescu 1995, Doyle 1998, Elder 2000) have taken the position that truly ethical physicians should inform their patients as fully as possible on all matters affecting their care, seeing any discussions centering on possible religious inconsistencies as merely an attempt to ensure that their patients have the opportunity to be fully informed on an important life-and-death issue. By contrast, Shander (1999) has taken the position that one should remain silent on religious issues and focus on purely clinical concerns, citing the difficulties of what he sees as essentially being an attempt at religious conversion. In short, Shander believes that the anesthesiologist has no business influencing a person’s religious views.



This is not a simple issue since, given that the leaders of the Jehovah’s Witness faith have reversed previous teachings against medical interventions such as vaccination and organ transplantation, and given that some blood products such as albumin, immunoglobulins and clotting factors are already allowed (according to an individual’s conscience) (Bergman 1994), some Witnesses believe that it is only a matter of time and effort before the ban against blood transfusions is removed completely.



The situation is obviously complex and rich in ethical nuances. Perhaps all that can be said is that patients are more likely to be better served by offering all too much information than too little.

References [ edit ]

Beauchamp, T. L., J. F. Childress (1994). Principles of Biomedical Ethics, 4th ed. New York, Oxford University Press

Baldry C, Backman SB, Metrakos P, Tchervenkov J, Barkun J, Moore A. Liver transplantation in a Jehovah's Witness with ankylosing spondylitis. Can J Anesth 2000 47:642-6

Benson KT. The Jehovah's Witness patient: considerations for the anesthesiologist. Anesth Analg 1989; 69: 647-56.

Bergman J. Blood Transfusions. A History and Evaluation of the Religious, Biblical and Medical Objections. Clayton, CA: Witness, Inc. 1994 ISBN 1-883858-27-5

Doyle DJ. Informed consent and "reform" Jehovah's Witness patients. Anesthesiology. 1998 89:537

Edwards KA (1999). Ethics in Medicine Web Site, University of Washington School of Medicine, http://eduserv.hscer.washington.edu/bioethics/topics/consent.html

Elder L. Why some Jehovah's Witnesses accept blood and conscientiously reject official Watchtower Society blood policy. J Med Ethics 2000; 26: 375-380

Etchells E, Sharpe G, Burgess MM, Singer PA. Bioethics for clinicians: 2. Disclosure Canadian Medical Association Journal 1996; 155: 387-391

Harnett MJ, Miller AD, Hurley RJ, Bhavani-Shankar K. Pregnancy, labour and delivery in a Jehovah's Witness with esophageal varices and thrombocytopenia. Can J Anaesth 2000 47:1253-5

Letsoalo JL. Law, blood transfusions and Jehovah's Witnesses. Med Law 1998; 17:633-8

Mann MC, Votto J, Kambe J, et al. Management of the severely anemic patient who refuses transfusion: lessons learned during the care of a Jehovah's Witness. Annals of Int Med 1992; 117: 1042-8

Meisel A, Roth LH, Lidz CW. Toward a model of the legal doctrine of informed consent. Am J Psychiatry 1977; 134: 285-9

Muramoto O. Bioethics of the refusal of blood by Jehovah’s Witnesses: part 1. Should bioethical deliberation consider dissidents’ views? Journal of Medical Ethics. 1998; 24:223-230.

Muramoto O. Bioethics of the refusal of blood by Jehovah’s Witnesses: part 2. A novel approach based on rational non-interventional paternalism. Journal of Medical Ethics. 1998; 24:295-301.

Muramoto O. Bioethics of the refusal of blood by Jehovah's Witnesses: part 3. A proposal for a don't-ask-don't-tell policy. J Med Ethics 1999; 25: 463-468

Muramoto O. Medical confidentiality and the protection of Jehovah's Witnesses' autonomous refusal of blood. J Med Ethics 2000; 26: 381-386

Ridley DT. Jehovah's Witnesses' refusal of blood: obedience to scripture and religious conscience. J Med Ethics 1999; 25: 469-472

Rothenberg DM. The approach to the Jehovah's Witness patient. Anesthesiology Clinics of North America 1990; 8(3): 589-607.

Savulescu, J. Rational non-interventional paternalism: why doctors ought to make judgements of what is best for their patients. Journal of Medical Ethics. 1995; 21:327-331.

Shander A. Informed consent and "reform" Jehovah's Witness patients. Anesthesiology 1999 90: 1787

Appendix 1 [ edit ]

More commentary on informed consent



Source: http://www-hsc.usc.edu/~mbernste/ethics.informed_consent.html (corrections added)



An article in the 1/9/00 NY Times Sunday magazine by Margaret Talbot on Placebos in Medicine also mentioned informed consent and made an interesting point:

"Sometimes our contemporary notions of informed consent, important though they are, interfere with a doctor's capacity to offer hope and comfort. 'When, for example, a patient who is about to undergo a straight-forward surgical procedure anxiously asks the surgeon, 'Doctor, am I going to make it?' what should the surgeon say?' asks Walter Brown. 'Traditionally, the response would be to encourage the patient: 'You're in good hands here, everything will be fine.' Yet I have posed this scenario to a variety of physicians, both residents and attendings, and found that some consider themselves obligated to list the possible complications and risk of death, even if the morality rate from the procedure in miniscule.' Medical training that (rightly) values precise expression and a culture that values full disclosure and protection from liability may spur doctors to tell their patients the uninflected and deflating truths even in the most dire circumstances. But surely telling the whole truth and nothing but the truth is not the most humane or practical of counsel for doctors. Someone I know of, a physician herself, was recently operated on for a brain tumor. Her doctor chose his first postoperative visit in the hospital to tell her she would never work again. It didn't help her recovery much."

This same NYT article made an interesting point about another, related topic- that of patients doing internet research and doing their own medical decision making in lieu of following a doctor's advice. It recounts the bout of Dr. Franz Ingelfinger, former editor of the New England Journal of Medicine, with esophageal cancer. He himself was a gastroenetrologist. He studied all relevant information from the literature and colleagues to make his own treatment decision. This resulted, he wrote, “in he and his family becoming increasingly confused and emotionally distraught. Finally when the pangs of indecision had become nearly intolerable, one wise physician friend said, 'What you need is a doctor.' He was telling me to forget the information I was receiving from many quarters, and to seek instead a person who would dominate, who would tell me what to do." When he found that person, Ingelfinger felt an "immediate and immense relief."

Appendix 2 [ edit ]

Multiple choice questions to accompany [ edit ]

Autonomy, Informed Consent and the Death of Therapeutic Privilege: Lessons Learned from the Jehovah’s Witnesses



[1] Which of the following is NOT one of the four guiding principles of the “Georgetown School” of bioethics

a) autonomy

b) compassion

c) beneficence

d) justice





[2] Which of the flowing standards of informed consent is most commonly employed in clinical care in Canada and the USA:|

a) reasonable physician standard

b) reasonable patient standard

c) subjective standard

d) objective standard



[3] In the case of the Jehovah’s Witness patient refusing a clinically necessary blood transfusion, the principle of beneficence comes into conflict with which of the following principles:

a) autonomy

b) compassion

c) beneficence

d) justice





[4] Obtaining informed consent entails ensuring that the patient:

a) understands the various clinical choices available

b) can discuss the issues with caregivers in a reasonable and logical manner

c) is not being dictated to or controlled by other parties

d) all of the above



[5] Which of the following concerning “therapeutic privilege” is FALSE

a) It refers to the withholding of important information by the clinician in the belief that the information would lead to harm or suffering.

b) The basis for therapeutic privilege is the notion that beneficence should take precedence over autonomy.

c) The exercise of therapeutic privilege is becoming increasing common in modern clinical care.

d) The exercise of therapeutic privilege is considered to be paternalistic



[6] Under which of the following circumstances can the acquisition of informed consent be problematic:

a) the heavily medicated patient

b) the parturient in hard labor

c) the patient with severe organic brain disease

d) all of the above





[7] Some clinicians maintain that the process of informed consent has potential health risks in and of itself. Under which circumstance would this apply:

a) in the case of a patient who is illiterate

b) in the case of a patient who faces a language barrier

c) in the case of a patient is who refuses a intervention involving a very small risk even though it would eliminate another, much larger, clinical risk.

d) in all of the above cases



[8] Which of the following is an unacceptable option for patients who want very detailed risk information as part of the consent process

a) answer every question asked in as much detail as possible

b) refer patients to the peer-reviewed medical literature

c) allow the patient access to the files of patients who have had similar procedures

d) all of the above



[9] Difficulties with using malpractice suit information as an indicator of clinical skill includes which of the following:

a) more experienced clinicians have had more chance to get sued in their career

b) the public may misinterpret malpractice history data and punish capable doctors who happen to treat a large number of high-risk patients

c) friendly and compassionate doctors who are incompetent are sued less frequently than other incompetent doctors

d) all of the above



[10] Which of the following intravenous products will orthodox Jehovah’s Witnesses accept?



a) saline solution

b) packed red blood cells

c) plasma

d) platelets and white blood cells



[11] The determination that blood transfusions were a violation of God's law in the Jehovah's Witnesses faith was made



a) based on concerns about disease transmission

b) based on biblical passages

c) based on a distrust of the medical profession

d) all of the above



[12] In Canada, the landmark legal case regarding the clinical care of Jehovah's Witness patients was the case of



a) Malette v. North York Hospital

b) Schloendorff v. North York Hospital

c) Kramer v. Kramer

d) Malette v. Shulman