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Medical Ethics

Informed Consent Revisited: A Doctrine in the Service of Cancer Care

^aDivision of Medical Ethics, Weill Medical College of Cornell University, New York, New York, USA; ^bThe Rockefeller University, New York, New York, USA

Correspondence: Joseph J. Fins, M.D., F.A.C.P., Division of Medical Ethics, New York Presbyterian-Weill Cornell Medical Center, 435 East 70 Street, Suite 4-J, New York, New York 10021 USA. Telephone: 212-746-4246; Fax: 212-746-8738; e-mail: jjfins{at}med.cornell.edu

Received April 18, 2008; accepted for publication September 3, 2008; first published online in THE ONCOLOGIST Express on October 10, 2008.

Disclosure: The content of this article has been reviewed by independent peer reviewers to ensure that it is balanced, objective, and free from commercial bias. No financial relationships relevant to the content of this article have been disclosed by the authors, planners, independent peer reviewers, or staff managers.

	ABSTRACT

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Informed consent traditionally has been viewed as a safeguard for the protection of patients' decisional autonomy. While informed consent is a critical means for the protection of the patient's dominion over the integrity of his body, exclusive consideration of the doctrine as a safeguard for patients eclipses the doctrine's significant benefits for the therapeutic endeavor. Undertaking a thorough informed consent process helps the physician avoid the unilateral burdens of paternalism; furthers compliance with the doctor's legal obligations, ethical duties, and clinical responsibilities; and, as importantly, enhances the collaborative treatment enterprise.

When informed consent is viewed narrowly and solely as a protective device for patients' rights, the physician may be less likely to engage the patient in ongoing discussions. Important opportunities may be missed to elicit additional clinical information, assess psychosocial concerns, and reiterate the commitment to collaboration and patient autonomy.

	INTRODUCTION

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Informed consent traditionally has been viewed as a safeguard for the protection of patients' decisional autonomy. While informed consent is a critical means for the protection of the patient's dominion over the integrity of his body, exclusive consideration of the doctrine as a safeguard for patients eclipses the doctrine's significant benefits for the therapeutic endeavor. When the contours of the doctrine are examined comprehensively, it becomes clear that the clinician is effectively motivated to solicit and implement the patient's preferences, thereby avoiding the unilateral burdens of paternalism sometimes assumed by physicians when they withhold information from patients and/or make value choices more properly vested in the autonomous patient.

Instead, we propose a reinvigoration of the doctrine of informed consent in which the physician engages in meaningful and ongoing dialogue with the patient. Ultimately, both the clinician and the patient–physician relationship will benefit as respect for this doctrine serves to facilitate compliance with the doctor's legal obligations, ethical duties, and clinical responsibilities, and, as importantly, enhances the collaborative treatment enterprise.

When informed consent is viewed narrowly and solely as a protective device for patients' rights, the physician may be less likely to engage the patient in ongoing discussions. Important opportunities may be missed to elicit additional clinical information, assess psychosocial concerns, and reiterate the commitment to collaboration and patient autonomy. Framing the informed consent paradigm in terms that highlight the benefits for the physician fosters continuing discussion and thus iteratively affirms reassessment of the patient's condition, confirmation or refinement of the treatment plan, and patient complicity in the therapeutic management.

	REFRAMING INFORMED CONSENT FOR CANCER CARE

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The clinical benefits of the informed consent doctrine are especially significant in the context of the diagnosis and treatment of cancer patients in many clinical settings. Just consider the range of diagnostic and therapeutic choices that a woman with breast cancer faces. At the outset are questions of patient education and the utility of mammography for early diagnosis and treatment. Depending upon family history some women will need—or want—to make choices about genetic testing. Widespread misconceptions about cancer demand careful and meaningful explication of pathologies and prognoses, such as genetic predispositions based on tests like those involving the BRCA-1 and BRCA-2 tumor suppressor genes, as well as about pathological data that are definitive for disease or predictive of an eventual cancer occurrence, such as ductal carcinoma in situ.

Moreover, the treatment of cancer sometimes involves contemplation of a series of therapeutic interventions that involve choices among surgical, radiological, and pharmacologic modalities. Sometimes these choices are even preventive, as in the case of prophylactic mastectomies and oophorectomies in the setting of a burdensome genetic predisposition or some precancerous pathologies. But sometimes, too, there are few options for medical intervention, such as when a patient presents with acute leukemia. In those instances, treatment options are limited by protocol, although a competent patient always retains the prerogative of refusing curative care and opting instead for palliation, a decision also worthy of respect.

All of these decisions require an appreciation of the relative risks and benefits of these options as they relate to likely outcomes. That both the patient's choice is informed and consent is volitional is more than a rhetorical point. It also is a pragmatic one because it helps ensure longitudinal buy-in and patient compliance, frequently in the face of treatments' debilitating side effects that can serve as a disincentive to continue treatment.

Even more critical is how patients understand the choices that were made about care when the outcome is not favorable. If a robust process of informed consent was part of the discussions about treatment options, and if this dialogue was truly reciprocal and engaged [1], the patient and physician will have established a relationship that can help to sustain them in more difficult moments and ensure ongoing follow-up and the formulation of goals of care. This can be crucial in both curative and palliative contexts [2], and in instances when the patient requests a treatment that the physician must decline to administer because it is medically unsound.

	FROM HISTORIC TO CURRENT PERSPECTIVES

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Paternalistic approaches historically were at least implicitly legally authorized in medical practice until judicial decisions beginning in the late 1950s began to endorse a landmark decision on informed consent first articulated by Benjamin Cardozo, when he was Chief Judge of the New York Court of Appeals in 1914 [3]. In that forward-looking opinion, before Cardozo ascended to the U.S. Supreme Court, he articulated the modern notion of informed consent that, "Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient's consent commits an assault, for which he is liable in damage" [3]. Since then, the imprimatur of the doctrine of informed consent has so widely displaced predilections of paternalism that it helped "advanc[e] the centrality of informed consent and patient autonomy" [2]. The American Medical Association Code likewise focuses on "[t]he patient's right of self-decision... . The patient should make his or her own determination on treatment" [4].

Disproportionate emphasis on legal consequences sometimes has caused many clinicians to "treat informed consent as a legal hurdle to be leaped rather than an opportunity to communicate with their patients" [5]. However, the predominant focus on satisfying the legal obligation to secure informed consent can obscure the prospect of accruing benefits for the physician that far exceed the avoidance of legal liability.

Legal requirements focus on minimal prerequisites and on the amount of information that must be conveyed, a task that can at times become merely procedural and bureaucratic, even formulaic. By contextualizing the process of securing informed consent as one that serves physicians' interests and develops a climate of collaborative healing, these concerns can be mitigated, viewing the bolstering of autonomy through the informed consent process as an effective way to turn legal rhetoric into tangible, pragmatic clinical benefit. But to achieve this, we need to better articulate the clinician's role and offer a richer perspective on the clinical utility of fostering a climate of patient self-determination through a deeper respect for the process of informed consent.

	INFORMED CONSENT: BEYOND BENEFICENCE TO COLLABORATION

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Unilaterally dispensed paternalism, in which clinicians make extramedical determinations that invoke personal values, casts a moral and psychological burden on the practitioner. Displacing decisional autonomy with paternalistic directives, no matter how well-intentioned or subtle, is contrary to the self-interest of the physician. If the course the doctor recommends does not achieve the patient's goals of care, the doctor may, emotionally at the very least, bear the burden of those consequences. This reaction may be especially acute when the doctor advocates a treatment plan that the patient disfavors or about which she harbors reservations. Consider the oncologic surgeon who subsequently recommends a more extensive mastectomy and the patient who encounters debilitating lymph edema. Or, conversely, consider the physician who deems a lumpectomy and radiation sufficient treatment for a patient who retains doubts but goes along with her doctor's recommendation. Years later, as the disease progresses and becomes metastatic the doctor may harbor significant doubt about whether a subsequent lymphatic spread might have been avoided had a mastectomy been performed instead.

In both scenarios, physicians may, justifiably or not, have reservations about their decisions and question whether lymph edema or metastatic disease might have been averted by a different set of initial choices. Although an alternative course may not necessarily have had a better physiological outcome, both the patient and the physician may be left wondering if the plan of care pressed by the physician was mistaken, even when compliant with practice guidelines. Our point is that for each of these patients, the guidelines, which might have accommodated a range of therapeutic choices, needed to be translated into actions that were patient centered and patient specific through a well-articulated process of informed consent.

If that process had taken place, the deleterious emotional effects of the physician's unilateral beneficence would be mitigated through a collaborative analysis of comparative risks and benefits of therapeutic regimens. The weight of the decision on the physician is lessened by vesting the treatment decision in the patient from the outset, of course with proper guidance from her oncologist about medically sound options. Informed consent facilitates autonomous decision making, which itself has intrinsic value in the furtherance of personhood and self-determination. This point is well rehearsed in the ethics literature. What we are pointing out here is that informed consent, when properly implemented, alleviates the physician from usurping patient autonomy and assuming a burden that the physician cannot properly or effectively assume alone.

Effectively implemented informed consent is not just predicated on clinical indications, but also incorporates the patient's personal goals and objectives [2]. As Yale physician and ethicist Robert Levine observed:

The key to effective communication is to invite active participation by patients or subjects in the context of an informational exchange... . Professionals would do well to end their traditional preoccupation with disclosure and instead ask questions, elicit the concerns and interests of the patient or subject, and establish a climate that encourages the patient or subject to ask questions. This is the most promising course to ensure that the patient or subject will receive information that is personally material—that is, the kind of description that will permit the subject or patient, on the basis of his or her personal values, desires, and beliefs, to act with substantial autonomy [6].

Formulation of a treatment plan without both explanation to and receipt of relevant information from the patient is morally suspect and as inappropriate as the prescription of a drug before the physician has taken a proper history and physical that takes into account any drug allergies or other contraindications. Unilaterally imparted disclosure without solicitation of the patient's perception of salient facts precludes assurance that either the patient or doctor has been adequately informed.

This is particularly significant in the context of treating cancer, a diagnosis that is fraught with misunderstanding and apprehension. One study of patients with a cancer diagnosis found that 41% of adults believed that surgery could cause the disease to spread throughout the body [7]. Mere disclosure of the surgical risks and benefits to the patient considering surgery for the removal of a tumor would fail to unearth this hidden concern, which might lead to a decision to refuse surgery, or more likely lead to avoidant behavior and delay a decision to get timely care. The study's investigators concluded that the prevalence of certain misconceptions about cancer outcomes was unacceptably high, and that erroneous beliefs may increase the risk for cancer morbidity and mortality because of poor adherence to treatment regimens [7].

Other investigators concluded that a notable percentage of participants held beliefs about cancer risk that are at odds with prevailing scientific evidence, and opined that inaccurate beliefs may contribute to inadequate adherence to recommended screening and prevention guidelines [8]. Explications by clinicians that actively engage patients can identify and clarify misunderstandings and educate patients in acute and chronic care. This helps induce greater solicitation of medical attention, elicits compliance with treatment modalities, and possibly provides emotional reassurance about improved prognoses and the efficacy and availability of palliative care.

By engaging in a dialogue with the patient, the physician is positioned to explain why a particular treatment requested by the patient is contraindicated or inconsistent with acceptable medical practice, while making recommendations in such a way that the patient remains free to decline an option. This helps foster the prudential use of the power inherent in the doctor–patient relationship [9].

A negotiated plan also enables the doctor to learn about the patient's misapprehensions about his physiological state or the course of treatment. This helps ensure that the patient has accurate and material information necessary to provide consent. The oncologist's patient who misapprehends the severity of a cancer diagnosis may decline aggressive treatment based on a misperception of his prognosis and the estimated therapeutic value of the proposed treatment plan.

Ultimately, dialogue positions the health care provider to appropriately view the patient's needs holistically, enhancing the objectives of taking into account relevant considerations and fashioning a tailored approach of care for the patient [10, 11].

In this way, the patient becomes part of the treatment team, displacing the anachronistic role of the patient as a passive recipient of care bestowed by health care providers, and rendering the patient an integral component of the healing process. The physician becomes a catalyst for healing, enticing the patient's participation and support in his care. Collaboration—or literally, laboring together—in the process of devising the treatment plan and an accurate understanding of the rationales for the selection inevitably does more than protect patients' rights; it builds consensus and elicits complicity by the patient, who likely will be more compliant with therapeutic management [7, 12] (a hypothesis that is worthy of empirical study).

The physician's engagement in the selected course of treatment likewise is enhanced. To the doctor, consenting to a proposed course of aggressive chemotherapy may seem a highly desirable option in light of the empirically supported data on efficacy for the patient's malignancy. The doctor's reaction of frustration and confusion when his patient refuses chemotherapy may be dissipated when the patient's rationale is explored by the doctor; the patient's priority in deferring treatment until after the birth of her grandchild would be better understood. Even if the doctor would not have made the same choice for himself, the properly implemented process of informed consent positions him to understand his patient's decision and continue to provide needed support and guidance. In this way, the physician neither abandons his patient nor abdicates his professional responsibility.

Lest we be misunderstood, we point out that the physician's support of the patient does not necessarily mean that the physician agrees with the patient's choice. This distinction becomes especially clear when the patient requests physiologically futile treatment.

The critical aspect of any response lies in recognizing and acknowledging the patient's goals of care and the value system attendant to the patient's decision-making process. A rational and appropriate response would be to point out distinctions that are relevant to the decision. For example, the doctor who outlines the risks and benefits of a lumpectomy to a young mother might explicitly acknowledge that he hasn't suffered the loss of a parent at a young age and therefore may not appreciate how she is contextualizing her diagnosis against the specter of her childhood loss of a parent. To meet the needs of the patient, this patient, the doctor must overtly acknowledge that her analysis of these factors might still lead her to a different conclusion than that reached by the patient, and confirm that the latter's decision will be respected if it is clinically sound.

	CONCLUSION

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Hippocrates famously observed that, "[l]ife is short, and the Art long; the occasion fleeting; experience fallacious, and judgment difficult. The physician must not only be prepared to do what is right himself, but also to make the patient, the attendants, and externals cooperate" [13]. But notwithstanding Hippocrates' exhortations, he also counseled his students to listen to their patients and hear their stories. Millennia before the advent of patient autonomy or an appreciation of the doctrine of informed consent, he knowingly wrote, "‘Let your best means of treating people be your love for them, your interest in their affairs, your knowledge of their condition, and your recognized attentiveness to them’" [14]. This advice is not inconsistent with the collaborative informed consent process we have advocated.

Empathetic and attentive interest in patients facilitates an understanding about patients' physiological and psychological needs. Significantly, it enables the physician to contextualize the patient's decision within the patient's moral and values framework. If there is a paradox in all of this, it is that the ideal of informed consent rests as much in the physician educating the patient as it does in the patient educating the physician.

	AUTHOR CONTRIBUTIONS

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Conception/design: Madeleine Schachter, Joseph J. Fins

Admin support: Madeleine Schachter, Joseph J. Fins

Collection/assembly of data: Madeleine Schachter, Joseph J. Fins

Data analysis: Madeleine Schachter, Joseph J. Fins

Manuscript writing: Madeleine Schachter, Joseph J. Fins

Final approval of manuscript: Madeleine Schachter, Joseph J. Fins

	REFERENCES

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1. Fins JJ. In: Bruera E, Portenoy RK, eds. Topics in Palliative Care. Truth telling and reciprocity in the doctor-patient relationship: A North American perspective. NY: Oxford University Press, 2001:81-94.
2. Fins JJ. A Palliative Ethic of Care: Clinical Wisdom at Life's End. Sudbury, MA: Jones & Bartlett Publishers, 2006:1-281.
3. Schloendorff v. Society of New York Hosp. 211 N.Y. 125, 126, 105 N.E. 92, 93 (N.Y. 1914).
4. American Medical Association. Code of Medical Ethics. 2006–2007 Edition, American Medical Association, 2007. 8.08 at 227.
5. Dworkin RB. Getting what we should from doctors: Rethinking patient autonomy and the doctor-patient relationship. Health Matrix Clevel 2003;13:235–296.[Medline]
6. Faden RR, Beauchamp TL, King NMP. A History and Theory of Informed Consent. NY: Oxford University Press, 1986:307, quoting Levine R.
7. Gansler T, Henley SJ, Stein K et al. Sociodemographic determinants of cancer treatment health literacy. Cancer 2005;104:653–660.[CrossRef][Medline]
8. Stein K, Zhao L, Crammer C et al. Prevalence and sociodemographic correlates of beliefs regarding cancer risks. Cancer 2007;110:1139–1148.[Medline]
9. Brody H. The Healer's Power. New Haven, CT: Yale University Press, 1993:1-324.
10. Ahronheim JC, Moreno JD, Zuckerman C. Ethics in Clinical Practice. Second Edition. Sudbury, MA: Jones & Bartlett Publishers, 2004:1-508.
11. Lidz CW, Appelbaum PS, Meisel A. Two models of implementing informed consent. Arch Intern Med 1988;148:1385–1389.[Abstract/Free Full Text]
12. Groopman LC, Miller FG, Fins JJ. The patient's work. Camb Q Healthc Ethics 2007;16:44–52.[Medline]
13. Oath of Hippocrates. Cerca 400 B.C. Available at http://www.cirp.org/library/ethics/hippocrates/. accessed September 24, 2008.
14. Levine RJ. In Bulger R, ed. In Search of the Modern Hippocrates. Medical ethics and personal doctors: Conflict between what we teach and what we want. Am J Law Med 1987;(13):351–364, citing Bulger R. The search for a new ideal. Iowa City, IA: University of Iowa Press, 1987:1-256, quoting Hippocrates.

This Article Abstract Full Text (PDF) All Versions of this Article: theoncologist.2008-0101v1 13/10/1109    most recent eLetters: Submit a response to this article Purchase Article View Shopping Cart Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Services E-mail this article link to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Reprints/Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Schachter, M. Articles by Fins, J. J. Search for Related Content PubMed PubMed Citation Articles by Schachter, M. Articles by Fins, J. J.