Government-scripted consent: when medical ethics and law collide.
Subject: Decision-making (Laws, regulations and rules)
Medical ethics (Laws, regulations and rules)
Ethics (Laws, regulations and rules)
Authors: Minkoff, Howard
Marshall, Mary Faith
Pub Date: 09/01/2009
Publication: Name: The Hastings Center Report Publisher: Hastings Center Audience: Academic; Professional Format: Magazine/Journal Subject: Biological sciences; Health Copyright: COPYRIGHT 2009 Hastings Center ISSN: 0093-0334
Issue: Date: Sept-Oct, 2009 Source Volume: 39 Source Issue: 5
Topic: Event Code: 930 Government regulation; 940 Government regulation (cont); 980 Legal issues & crime; 290 Public affairs Advertising Code: 94 Legal/Government Regulation; 91 Ethics Computer Subject: Government regulation
Accession Number: 220561111
Full Text: Informed consent lies at the heart of the physician-patient relationship. It is grounded in the principle of respect for persons, which affirms an individual's consequent right to autonomous decision-making. Informed consent requires voluntariness--freedom from coercion, undue influence, or bias--on the patient's part, and accurate, good faith disclosure of information by the physician. These are minimal but essential conditions by which the patient as a person and her exercise of autonomy are respected. The twin tenets of voluntariness and adequate disclosure are not independent silos, but rather mutually dependent fundamentals for the exercise of individual choice. The selection of data to be shared, the values that frame the facts, and the emotional perspective by which they are proffered all contribute to a context that either animates or degrades a person's autonomy.

A recently enacted policy in South Dakota threatens to abrogate the process described above; a consent discussion grounded in dogmatic and uncompromising ideological speech is now the de jure standard in that state. Several articles have focused the medical community's attention on these newly implemented requirements, which include a script that must be given to a woman prior to abortions. (1) The script asserts, among other things, that the fetus is "a whole, separate, unique, living human being." It also requires the physician to give the patient a description of all known medical risks of the procedure and statistically significant risk factors to which the pregnant woman would be subjected, including depression and related psychological distress and increased risk of suicidal ideation and suicide--none of which has been scientifically substantiated. In addition, a statement is required that sets forth an accurate rate of deaths due to abortions, including all deaths in which the abortion procedure was a significant contributing factor, and all other known medical risks to the physical health of the woman, including the risk of infection, hemorrhage, danger to subsequent pregnancies, and infertility. The probable gestational age of the fetus at the time the abortion is to be performed and a scientifically accurate statement describing the development of the fetus at that stage must be shared as well.

This litany of required "facts" includes many that are untrue. It replaces the concept of informed consent as a discussion of risks, benefits, and alternatives with a coercive process focusing almost exclusively on risks, misinformation, and implied governmental opprobrium. By mandating "ideological speech" on the part of physicians, use of the legislated script forces them to commit an untenable ethical and professional wrong: deceiving their patients by providing false information and withholding empirically derived, evidence-based clinical data. (2)

Legal arguments against this approach and its infringement on the first amendment rights of physicians continue to be eloquently sounded. (3) First amendment protections for scientific speech should inform, if not govern, the disclosure elements of the informed consent process. The failure of appellate courts to prevent such infringements on patient's and physician's rights has resulted in situations, de facto and de jure, in which medical ethics and the law are in direct con flict. (4)

The American College of Obstetricians and Gynecologists' (ACOG) Committee on Ethics has noted that "free consent is an intentional and voluntary choice that authorizes someone else to act in certain ways ... Consenting freely is incompatible with [a patient] being coerced or unwillingly pressured by forces beyond herself. It involves the ability to choose among options and to select a course other than what may be recommended." (5) Though physicians' beliefs may be legitimate bases for recommendations, physicians are expected to avoid manipulation or coercion. However, potential for undue bias exists even when physicians frame their counseling carefully, since their choice of words, of emphasis, and even of body language unwittingly transmits bias.

Legislated counseling is even more fraught with the risk of coercion than physician counseling. While manipulation by physicians is often subtle, unconscious, and unintentional, the South Dakota script is an overt attempt to dissuade patients from seeking a particular course of action. Imagine if another state or nation with a conflicting ideology proposed an alternative script with an equally "factual" base. Women at a first prenatal visit would be presented with a script detailing their risk of death in childbirth, and if they were in a group at particular risk--for example, minority, living in poverty, or obese--they would be told how much greater their particular risk of dying would be. All women would then be informed of the increased chance of subsequent incontinence in later life, as well the increased risks of other later life morbidities, like myocardial infarction, (6) that have been associated with having children. Finally, before being offered a termination of pregnancy, they would be informed that the fetus they are carrying is not a human being--the latter assertion being no less credible than the converse, which is currently contained in the South Dakota script. Indeed, as Zita Lazzarini has pointed out, (7) the dissent in the case that allowed the South Dakota script opined that "'human being' has no specific scientific or medical meaning, and that whatever meaning it has varies with context. Although it may refer to purely biologic characteristics, especially when distinguishing humans from other species, 'it may also represent a value judgment indicating entitlement to the moral or political rights shared by all persons.'" (8) Legal scholar Robert Post notes that the question of "whether the fetus is a human being is thus understood by all sides to the abortion controversy to be a contested moral proposition." (9)

ACOG's Committee on Ethics also noted that the disclosure of information elements during the informed consent process, "insofar as it is possible, is governed by the ethical requirement of truth-telling. The adequacy of disclosure has been judged by various criteria, which may include: 1. The common practice of the profession; 2. The reasonable needs and expectations of the ordinary individual who might be making a particular decision; and/or 3. The unique needs of an individual patient faced with a given choice." (10)

The Committee on Ethics went on to observe that although the patient's unique or subjective need for information has generally been difficult to acknowledge within the legal arena, its practical and ethical force is, nonetheless, robust. The South Dakota script achieves none of the established professional or ethical norms for disclosure of information as a component of the informed consent process. It stands in stark contrast to--and violation of--the common and accepted practices of the profession, as well as the ethical norms that inform those practices.

It falls even further from the standard of meeting the expectations of the ordinary person, or certainly of the person faced with the specific choice under discussion. A woman who seeks to terminate a pregnancy may reasonably be assumed to have already wrestled with the difficult moral issues inherent in her decision. When she requests an abortion, the informed consent process should be constructed to familiarize her with the foreseeable risks and benefits of the procedure and with alternative courses of action. Unfortunately, in lieu of that approach and the respect for women it shows, the South Dakota script imposes bias and sophistry that will inevitably compromise voluntariness and disrespect patients.

The fact that the script is value-laden is not necessarily incompatible with the ethics of counseling. In fact, salient values should animate counseling; physicians' professional values and patients' personal values have legitimate standing in the process. The values of the government have, for good reasons, not been considered suitable for inclusion in counseling. For example, while it is the appropriate purview of government to consider health care rationing, it would be inappropriate to try to effect change in the utilization of health resources by having governmentally sanctioned consent scripts that encourage patients to request "do not resuscitate" orders.

While governmental or ideological values aren't natural constituents of the informed consent process, patient comprehension is. According to ACOG, "Comprehension includes awareness and understanding of the patient's situation and possibilities. It implies that she has received adequate information about her diagnosis, prognosis, and alternative treatment choices, including the option of no treatment. Comprehension in this sense is necessary for freedom in consenting." (11)

If comprehension as so defined is a vital component of the informed consent process, then the South Dakota script falls short by yet another measure. It is counterintuitive to think that lay women (in this case laity is defined in regards to constitutional law) should be expected to understand the meaning of a law stating that a pregnant woman has an existing relationship with an unborn human being, that this relationship enjoys protection under the U.S. Constitution and under the laws of South Dakota, and that by having an abortion, her existing relationship and her existing constitutional rights regarding that relationship will be terminated. Nor can the pseudoscience bolstering the state's brief against abortion contribute to a woman's comprehension of the information that she is being asked to consider. The script mandates that women be informed of a putative association between abortion and depression even though recent reviews demonstrate that only the most methodologically flawed studies link abortion with any psychological consequences. (12) Just as it is unreasonable to expect lay women to understand legal and scientific data regarding abortion, it is likewise unreasonable to expect legislators to understand scientific standards of evidence. This is yet another reason why legislators should not be engaged in crafting consent documents.

Given that informed consent is essentially a process to insure that information animates free choice, South Dakota's transparent attempt to undermine the latter through a corruption of the former must be seen as antithetical to the norm of respect for persons and, thus, to the proper practice of medicine. By virtue of their fiduciary obligation to their patients, physicians should perceive any participation in an unedited rendering of the South Dakota script as an abdication of their professional obligations. A central tenet of professionalism is the primacy of patient welfare that is "based on a dedication to serving the interest of the patient.... Market forces, societal pressures, and administrative exigencies must not compromise this principle." (13) South Dakota's law, which grants primacy to governmental interests over the patients' free exercise of consent, is inimical to this principle.

What, then, is the recourse for the physician who is legally obligated to participate in a consenting charade that requires her to recite a script which does violence to the core ethic of counseling? Beyond joining in appeals to reverse the legislation, physicians can, when called upon to counsel a patient, contextualize the script, separating medical fact from legislative conjecture. Similarly, risks should not only be cited but also considered more broadly in terms of all options available. And those assertions that are debatable at best--those that fall shy of grounding in the level of evidence that would have justified their inclusion in counseling in the first place--should be debunked, even if they must, by statute, first be transmitted to the patient. In essence, it is the physician's burden to rehabilitate a counseling process that has been debauched by the South Dakota legislature. For not only will the physician's first amendment rights be imperiled if South Dakota's script stands unchallenged, but--more importantly--so will women's rights to a process of consent that is unfettered and informed, rather than ideological and imposed.

Acknowledgments

We would like to thank Britt Johnson and Grace Fleming for their assistance with this manuscript.

(1.) Z. Lazzarini, "South Dakota's Abortion Script--Threatening the Physician--Patient Relationship," New England Journal of Medicine 359 (2008): 2189-91.; G.D. Curfman, S. Morrissey, M.F. Greene, and J.M. Drazen, "Physicians and the First Amendment," New England Journal of Medicine 359 (2008): 2484-85.

(2.) R. Post, "Informed Consent to Abortion: A First Amendment Analysis of Compelled Physician Speech," University of Illinois Law Review 3 (2007): 939.

(3.) Lazzarini, "South Dakota's Abortion Script"; Curfman, Morrissey, Greene, and Drazen, "Physicians and the First Amendment"; Post, "Informed Consent to Abortion"; C.P. Guzelian, "Scientific Speech," Iowa Law Review 93 (2008): 881-928.

(4.) H.J. Tobin, "Confronting Misinformation on Abortion: Informed Consent, Deference, and Fetal Pain Laws," Columbia Journal of Gender and Law 17, no. 1 (2008): 111-153; L.P. McKenzie, "Federally Mandated Informed Consent: Has Government Gone Too Far?" Journal of Law and Health 20 (2006--2007): 267-96.

(5.) Committee on Ethics of the American College of Obstetricians and Gynecologists, "Ethical Dimensions of Informed Consent," ACOG Committee Opinion 108, May 1992, revised 2004.

(6.) J.R. Palmer, L. Rosenberg, and S. Shapiro, "Reproductive Factors and Risk of Myocardial Infarction," American Journal of Epidemiology 136, no. 4 (1992): 408-416.

(7.) Lazzarini, "South Dakota's Abortion Script."

(8.) Planned Parenthood Minnesota v. Rounds, 530 F.3d 724 (2008).

(9.) Post, "Informed Consent to Abortion."

(10.) Lazzarini, "South Dakota's Abortion Script."

(11.) Ibid.

(12.) V.E. Charles, C.B. Polis, S.K. Sridhara, and R.W. Blum, "Abortion and Long-Term Mental Health Outcomes: A Systematic Review of the Evidence," Contraception 78, no. 6 (2008): 436-50.

(13.) American Board of Internal Medicine, American College of Physicians--American Society of Internal Medicine, and the European Federation of Internal Medicine, "Medical Professionalism in the New Millennium: A Physician Charter," Annals of Internal Medicine 136, no. 3 (2002): 243-46.

Howard Minkoff and Mary Faith Marshall, "Government-Scripted Consent: When Medical Ethics and Law Collide," Hastings Center Report 39, no. 5 (2009): 21-23.
Gale Copyright: Copyright 2009 Gale, Cengage Learning. All rights reserved.


 
Previous Article: Misgivings.
Next Article: Saturday morning in the clinic.