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The Oncologist, Vol. 10, No. 8, 636-641, September 2005; doi:10.1634/theoncologist.10-8-636
© 2005 AlphaMed Press

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Informed Consent for Medical Treatment and Research: A Review

Marcela G. del Carmena, Steven Joffeb

a Division of Gynecologic Oncology, Vincent Obstetrics and Gynecology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA; b Department of Pediatric Oncology, Dana-Farber Cancer Institute, Children’s Hospital, Harvard Medical School, Boston, Massachusetts, USA

Correspondence: Marcela G. del Carmen, M.D., Gillette Center for Women’s Cancers, 55 Fruit Street, Cox Building, 5th Floor, Boston, Massachusetts 02114, USA. Telephone: 617-724-4800; Fax: 617-724-6898; e-mail: mdelcarmen{at}partners.org


   ABSTRACT
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Introduction
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The practice of informed consent has historical roots in various disciplines, including medicine, moral philosophy, and the law. It is closely tied to philosophical notions of respect for persons and respect for individual autonomy. Consent to treatment is rooted in case law. Consent to research, in contrast, has its basis in ethical codes, statutes, and administrative regulations, with the courts playing a lesser role. In this article, we define the elements of informed consent in the treatment setting, outline its ethical and legal foundations, and explore some of its limitations. We contend that informed consent plays a critical role in clinical medicine but that other models of decision making deserve consideration under particular circumstances. We also delineate the current federal regulatory schemes guiding human subject research in the U.S., highlight how consent to research differs from consent to treatment, and explore the difficulties that arise in research involving cancer patients and certain vulnerable populations.

Key Words. Informed consent • Treatment • Autonomy • Ethics • Law


   INTRODUCTION
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 Abstract
 Introduction
Conclusions
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The practice of informed consent has roots in multiple disciplines, including the health professions, the law, and moral philosophy. In this article, we first explore the ethical and moral basis, the legal grounding, and the limitations of informed consent to treatment. We then consider informed consent in the research setting.

Informed Consent for Medical Treatment
The discourse of informed consent has been framed primarily through the languages of law and of moral philosophy [1]. The legal doctrine of informed consent to treatment has evolved largely through the medium of case law [1]. In particular, courts have addressed patients’ claims that physicians failed to obtain proper authorization for the actions they undertook. Because of the retrospective and adversarial nature of the legal system, the notion of informed consent to treatment has taken on a defensive flavor. This plays out, for example, through heightened attention to disclosure of risks. While the risk-management aspects of informed consent cannot be ignored, informed consent has had fundamental and positive practical and moral consequences for the practice of medicine.

In contrast to the courts’ emphasis on judging retrospectively a physician’s actions, moral philosophy has focused on ensuring the patient’s right to make autonomous choices [1]. Bioethicists view informed consent as the practical embodiment of respect for persons and for individual autonomy. Autonomy includes notions of self-governance, liberty rights, and privacy [2]. This moral framework holds the patient’s right and ability to make choices that are consistent with his or her values and preferences to be the main rationale for informed consent [1–4]. From an ethical perspective, the physician’s disclosure obligation is a prerequisite for the exercise of patient autonomy rather than the central focus of informed consent [1].

Informed consent can be seen through at least two lenses [2]. The first relates to the concept of autonomous authorization of a medical intervention. This position is in direct contrast to the paternalistic conception of the physician as acting in the patient’s best interest, independently conceived [3, 4]. This notion of informed consent is exemplified in Mohr v. Williams [2, 5]. In this case, the physician obtained the patient’s consent to perform surgery on her right ear. During the procedure, the surgeon recognized that it was the patient’s left ear that needed the surgical procedure and proceeded to operate on that ear. The court determined that the surgeon had violated the terms of the informed consent, stating that the patient "enters into a contract authorizing the physician to operate to the extent of the consent given, but no further" [5]. In this context, the patient consents if she intentionally authorizes a professional to perform a procedure, after expressing understanding and in the absence of control by others [2].

An alternative conception mandates that a legally valid consent be obtained prior to a medical procedure, thereby locating informed consent in the realm of social rules and institutional contexts [2]. This definition deals with the institutional rules of consents and does not necessarily insist on consent as an autonomous act. Rather, informed consent is defined as the patient’s institutionally or legally effective authorization [2]. The consent is valid if it occurs within the rules that govern specific institutional practices [2].

Elements of Informed Consent
What makes a patient’s authorization of a medical procedure valid? Valid informed consent incorporates five elements: voluntarism, capacity, disclosure, understanding, and decision [1–4, 6].

Voluntarism requires that the patient be free from "coercion and from unfair persuasions and inducements" [6].

Coercion refers to morally inappropriate pressures from individuals or institutions that constrain patients’ exercises of choice; serious illness by itself does not compromise voluntarism [7–9]. Also, physicians’ attempts to influence patients’ decisions need not undermine voluntarism [3]. Rather, physicians should be encouraged to clarify patients’ goals, present the appropriate options in light of these goals, and make recommendations within the "deliberative model" of the doctor–patient relationship [10].

Capacity can be defined as the patient’s ability to make health care decisions [2, 3]. In practice, we assume that adults are capable of making decisions unless there is strong evidence to the contrary [3]. Several criteria can be used clinically to assess a person’s capacity, including the ability to make choices, to understand the relevant information, to appreciate the situation and its consequences, and to rationally process the information [3, 4, 9]. The stringency of the standard varies according to the significance, complexity, and consequences of the decision [10]. Competence, a related notion, refers to the patient’s legal standing to make health care decisions. For example, a 17 year old may have the capacity to make decisions for him- or herself, but not be competent from a legal point of view.

Disclosure involves providing the patient with the information needed to understand a procedure [2, 3]. This information includes the nature and purpose of the treatment, as well as its risks, potential benefits, and available alternatives [2, 3]. Information should be disclosed using simple explanations [3]. Common complications, irrespective of severity, should be described, as should less frequent but potentially serious or irreversible risks [1, 3, 4].

Understanding requires that the patient comprehend the information given and appreciate its relevance to her individual situation [2, 3]. There is little consensus in either law or ethics about what constitutes sufficient understanding [1, 2]. The courts have not generally held that failure of understanding invalidates informed consent [4]. Instead, they have relied on evidence of disclosure when determining if a patient was adequately informed [3, 4].

Decision refers to the patient’s authorization allowing a physician to execute the proposed treatment [2, 3]. Consent forms facilitate and document this authorization but should be seen as secondary to the process through which the patient and the physician discuss and negotiate the proposed treatment [3].

Limitations of Informed Consent
Although informed consent is intimately linked to the deontological notion of respect for persons, it also plays an important and positive instrumental role within medical care. Informed consent can lead to better patient–physician relationships, better physician understanding of the patient’s illness, and better patient adherence to treatment recommendations. However, it is possible to overstate the benefits of informed consent [4]. Two limitations of the informed consent paradigm bear mention. First, although informed consent facilitates communication and decision making between physicians and patients, it cannot create opportunities for autonomous choices when such choices are absent in reality. Second, informed consent has developed within a particular cultural context. As a result, it may not fit perfectly in the context of certain societies or cultures.

The first limitation is related to the absence of choice. Informed consent usually enhances autonomy by making real the possibility of individual choice. But circumstances too often inappropriately constrain the available choices [4]. This scenario is exemplified by the patient with an illness that is amenable to a wide variety of treatment options but who lacks medical insurance. For this patient, autonomous deliberation about which option to choose, in the absence of resources allowing fulfillment of each choice, is irrelevant. Another example is the lack of choice available for nursing home residents. To function as organized social institutions, nursing homes limit residents’ choices and thereby risk undermining residents’ autonomy. These social structures have rules that dictate when residents wake up, eat, and how they spend their leisure time. Such choice-limiting regulations also characterize other medical institutions, such as intensive care units. The limits that such institutions place on autonomy cannot be resolved through the exercise of informed consent.

Informed consent also exists in particular cultural contexts [3, 4]. The concept of informed consent finds its roots in the U.S., a country with a long tradition and history of commitment to individuality and rights. While this model may fit comfortably in most Western societies, some other cultures may not consider informed consent to be a universal ideal. In certain parts of the world, preserving community norms and family relationships is more important than individual autonomy. In some cultures, such as traditional African communities, a young patient’s choice over medical treatment may be in opposition to the preference or opinion of older family members [4]. In other societies, women may not be deemed capable of making medical decisions for themselves; instead, that right is given to their husbands [4]. In Arab culture, decisions are made at the collective, family, tribal, or community level, not by individuals [4]. Some Hispanic communities in the U.S., especially those led by older members who may be less acculturated, are also primarily guided by family-based health care decisions. Treatment choices may be viewed as the province of the family rather than the individual patient [3, 4, 11, 12]. The degree to which we should respect or challenge such cultural norms is a recurring tension in our multicultural health care context.

Attitudes about truth-telling may also vary across cultures [3, 4]. In certain cultures, positive thinking and speaking are favored over negative discussions, even at the expense of truth-telling [3, 4]. For traditional Navajos, open and direct end-of-life discussions may be deeply offensive [13]. Many Chinese place a similar value on positive thinking and speaking, and physicians in China are supportive of the practice of not informing patients of bad news [14]. In another study, although 88% of African Americans and 87% of European Americans who responded to a survey stated that patients should be told of a metastatic cancer diagnosis, only 47% of Korean-American and 65% of Mexican-American respondents agreed [12].

Even absent cultural differences, some patients may prefer to avoid bad news or to delegate decision-making responsibilities to family members [3, 15]. It is possible to resolve the tensions that arise in such circumstances by returning to the underlying purpose of informed consent, namely, respect for a person’s autonomy [3]. Respect for autonomy may mean allowing a person to delegate certain decisions if that is his or her wish [3, 4]. In practice, negotiating the balance between respect for autonomy and a patient’s desire for information or decision-making authority can be difficult [3]. The physician can facilitate this sensitive process of "offering truth" by asking the patient to describe the current medical problem in his or her own words [3, 16]. The physician can then ask, gently and indirectly, what information and decision-making role the patient desires [16]. The patient is given leeway to lead or to limit the dialogue. Such a nondirective exchange can help reconcile respect for a person’s autonomy, which underlies the principle of informed consent, with his individual desire to receive less information or to delegate decision-making responsibility [3].

Informed Consent to Research
Formal obligations and requirements for informed consent evolved from the standards governing both clinical medicine and human research. Informed consent in the context of research has evolved in parallel with but largely separate from informed consent to medical treatment. In the U.S., the practice of informed consent to research, as well as the procedures that must be followed when obtaining consent is problematic, is governed by federal regulations.

Current U.S. Federal Regulatory Scheme
In 1991, the Department of Health and Human Services issued the Common Rule, listing regulations for human subjects research that apply to almost all federal departments funding research [17]. This document requires that eight elements of information about the research study be provided to the patient or his or her legally authorized representative. These elements include a statement that the study is investigational along with a description of the research and its objectives, a description of foreseeable risks, a description of foreseeable benefits to participants as well as to others, information about reasonable alternatives, a statement clarifying the implications of research participation for the subject’s confidentiality, a statement about compensation if injury occurs (for investigations involving more than minimal risk), information about how the subject can obtain answers to pertinent research questions, and a statement about the voluntary nature of study participation and the subject’s right to withdraw [17]. The Common Rule also defines "optional" elements of informed consent that should be described when appropriate, including: (a) the possibility of unforeseeable risks, (b) circumstances under which the subject may withdraw from the study, (c) the possible consequences of withdrawal, (d) additional costs the subject may incur, (e) the provision of information obtained during the study that may affect a subject’s willingness to continue, and (f) the approximate number of subjects [17]. The Common Rule requires that informed consent be documented in writing for virtually all research involving greater than minimal risk and delegates the primary responsibility for research oversight to institutional review boards (IRBs) [17].

The Therapeutic Misconception
One critical notion in discussing consent to research is the "therapeutic misconception" [18]. Obtaining consent from research subjects differs in important ways from obtaining consent to ordinary clinical care [19]. In a study, the investigator has ethically legitimate commitments to the scientific goals of the research project. Because research subjects in clinical trials are generally also patients, these obligations may be in tension with the investigator’s responsibilities as a clinician [19]. For example, the trial’s structure and the requirements of the scientific method may constrain the physician’s ability to render individualized care [19, 20]. Research participants may have a difficult time differentiating between the physician–patient and the investigator–subject relationships [20]. Many research subjects believe that their clinical trial is designed with the individual benefit of participants as its primary objective. This can occur despite the investigator’s careful explanation that the nature of the trial is to generate new scientific knowledge and improve treatments for future patients [19]. Because such a misconception can obscure the risk–knowledge tradeoffs inherent in clinical research, it represents a potential threat to the validity of informed consent [19].

Though the data are imperfect, there is evidence that many oncology trial participants hold therapeutic misconceptions [21, 22]. In an effort to minimize therapeutic misconceptions, investigators should describe for prospective subjects how being enrolled in a trial differs from receiving ordinary clinical care; how the procedures, risks, and benefits in the particular trial differ incrementally from those the patient might receive outside the trial; the nature of uncertainty within the trial; and how trial participation contributes to the altruistic mission of advancing treatment over time [20].

Informed Consent to Research and Vulnerable Populations
The concepts of voluntarism, capacity, disclosure, and understanding structure informed consent in research as well as in medical treatment. Concerns about these concepts—especially voluntarism and capacity—underlie the additional regulatory protections for "special populations" [1]. Subjects can be deemed vulnerable due to circumstances or as a result of cognitive disability [1]. The categories may overlap, but prisoners are considered vulnerable as a consequence of circumstances, whereas children and mentally disadvantaged persons are considered vulnerable as a result of cognitive disability [1].

Prisoners
Research involving prisoners challenges the requirement of voluntarism [1]. Many have argued that prisoners, by virtue of circumstances, might feel compelled to agree to do things that nonprisoners might not [23, 24]. The concern is that incarcerated individuals may have an impaired ability to make choices that are free of coercion [1]. IRBs are required to ensure that study participation is not unduly encouraged by inducements such as improvement in general living conditions, quality of food, medical care, amenities, or opportunities [1]. IRBs must also ensure that nonprisoner volunteers would deem the risks involved to be acceptable; subject selection is fair; information is disclosed in understandable language; parole boards do not base release decisions on subjects’ decisions to participate; and follow-up plans consider subjects’ varying lengths of incarceration [1]. To ensure that the prisoner’s perspective is heard, IRBs must include at least one prisoner or prisoner representative when reviewing such research [1].

Individuals with Life-Threatening Illnesses
Some have argued that patients suffering from life-threatening illnesses, such as advanced malignancies, are a potentially vulnerable research population [25]. This view, for example, might preclude their participation in phase I trials. In contrast to the regulations that guide research involving prisoners, no special regulations govern research activities among this group of patients. In our view, designating patients suffering from life-threatening illnesses as vulnerable, and therefore in need of special protections, would unjustifiably undermine respect for such patients’ liberty and autonomy.

Children
In research involving children, federal regulations mandate that parents or guardians give permission and that, in most cases, the child assents (i.e., gives "affirmative agreement") when capable of doing so [1, 26, 27]. Parental permission is one element of the "special protections" afforded this vulnerable population, while the requirement to obtain assent conveys respect for the developing autonomy of children and adolescents [1, 26].

Educationally or Socioeconomically Disadvantaged Persons
The ethical concerns regarding research in these two populations are not entirely identical, although some overlap exists. Safeguards in place to help those who are educationally disadvantaged aim at ensuring that the information needed to decide about research participation be delivered in understandable language and that investigators allow the time needed to facilitate appropriate comprehension [1]. A major concern for socioeconomically disadvantaged persons is the compensation offered for study participation [1, 26]. Many have argued that protective guidelines should be in place to prevent subjects from participating in high-risk studies to receive substantial financial compensation [27]. This issue is also pertinent for those who lack health insurance coverage, for whom study participation may be the only venue for access to health care [27]. The Belmont Report highlights the principle of justice and the corollary requirement for fair subject selection, which implies that no population should disproportionately bear the burden of research or gain from the benefits [1, 28, 29].

Cognitively Impaired Subjects
Concerns regarding research among subjects with cognitive impairment, such as persons with a mental illness or dementia, revolve around their capacity to give consent [1, 30]. Currently, federal regulations do not specifically address research activities involving adults who lack decision-making capacity [31]. The Common Rule permits investigators to obtain consent from a subject’s "legally authorized representative" [32]. However, whether an incompetent patient’s proxy has the right to authorize research participation is a function of state law, which varies and is often unclear or silent on this point [33].


   CONCLUSIONS
Top
 Abstract
 Introduction
 Conclusions
Disclosure of potential...
 References
 
The concept of informed consent is founded on the principle of respect for autonomy and the notion that individuals have a right to control their medical care and research participation [2–4]. This principle has both an ethical and a legal basis. The doctrine of informed consent has evolved from its roots in ethical theory and has been integrated into contemporary American law [4]. As evidenced by the results of a study by the President’s Commission for the Study of Ethical Problems in Medicine, most patients want to know about their medical conditions and value the option of influencing the course of their medical care, even if they do not always exercise that option [4, 34]. Protecting patients’ interests in this decision-making process accords well with the American societal respect for individual integrity [4, 34]. These goals cannot, however, be fully realized through legal initiatives alone [2, 4]. Rather, they require respectful dialogue with patients about their circumstances and their care, coupled with sensitivity to the practical limitations of and tensions inherent in patient-centered medical decision making [35]. Finally, irrespective of the law of informed consent, informed decision making is compromised when institutional structures and processes fail to facilitate adequate opportunities for physician–patient communication [4].


   DISCLOSURE OF POTENTIAL CONFLICTS OF INTEREST
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The authors indicate no potential conflicts of interest.


   REFERENCES
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Received April 19, 2005; accepted for publication July 15, 2005.




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