HEC Forum DOI 10.1007/s10730-015-9275-7

Duty to Inform and Informed Consent in Diagnostic Radiology: How Ethics and Law can Better Guide Practice Victoria Doudenkova • Jean-Christophe Be´lisle Pipon

 Springer Science+Business Media Dordrecht 2015

Abstract Although there is consensus on the fact that ionizing radiation used in radiological examinations can affect health, the stochastic (random) nature of risk makes it difficult to anticipate and assess specific health implications for patients. The issue of radiation protection is peculiar as any dosage received in life is cumulative, the sensitivity to radiation is highly variable from one person to another, and between 20 % and 50 % of radiological examinations appear not to be necessary. In this context, one might reasonably assume that information and patient consent would play an important role in regulating radiological practice. However, there is to date no clear consensus regarding the nature and content of—or even need for—consent by patients exposed to ionizing radiation. While law and ethics support the same principles for respecting the dignity of the person (inviolability and integrity), in the context of radiology practice, they do not provide a consistent message to guide clinical decision-making. This article analyzes the issue of healthcare professionals’ duty to inform and obtain patient consent for radiological examinations. Considering that both law and ethics have as one of their aims to protect vulnerable populations, it is important that they begin to give greater attention to issues raised by the use of ionizing radiation in medicine. While the situation in Canada serves as a backdrop for a reflective analysis of the problem, the conclusions are pertinent for professional practice in other jurisdictions because the principles underlying health law and jurisprudence are fairly general.

V. Doudenkova
J.-C. Be´lisle Pipon (&) Programmes de bioe´thique, De´partement de me´decine sociale et pre´ventive, E´cole de sante´ publique, Universite´ de Montre´al, C.P. 6128, succ. Centre-ville, 7101 Avenue du Parc, Montre´al, Que´bec H3C 3J7, Canada e-mail: [email protected] J.-C. Be´lisle Pipon Institut de recherche en sante´ publique de l’Universite´ de Montre´al (IRSPUM), Montre´al, Que´bec, Canada

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Keywords Duty to inform
Health law
Informed consent
Professional ethics
Radiation protection
Radiology

Preamble: Risks Related to Ionizing Radiation in Diagnostic Radiology Exposure risk to low doses of ionizing radiation—whether associated with diagnostic tests such as plain radiographs (‘‘X-rays’’) or examination scanners (e.g., CT, PET-CT, SPECT-CT)—is stochastic (e.g., random, probabilistic). This risk is medically and socially accepted despite the fact that there is consensus on the fact that radiation can cause harm. The ionizing nature of X-ray radiation can create DNA lesions (Sankaranarayanan 1991) and lead to mutations that will result in a cancer in 5–20 years depending on the type of cancer (Upton 1991). Yet, this stochastic risk cannot be demonstrated using empirical data. Instead, the risk is based on calculations, assumptions and extrapolations from epidemiological data related to effects from much higher dosages (associated with risk that is said to be deterministic), such as data from survivors of the Hiroshima-Nagasaki atomic bomb (Life Span Study Cohort). For example, according to one theoretical study (Brenner and Hall 2007), nearly 2 % of all cancers in the United States are due to computed tomography (CT) exams (commonly known as CT scan or scanner). It becomes easy to understand, then, why there are controversies among researchers as to the quantification of these risks (Einstein 2009; Modan 1991). Reflecting upon stochastic risk is particularly relevant, from an ethical and legal perspective, as any dose of radiation is cumulative and not all people are equal with respect to risk. In fact, women are more radiosensitive than men and children more than adults. Considering that both law and ethics seek to protect vulnerable populations (especially children), these two fields should pay greater attention to the issues posed by the medical use of ionizing radiation.

Introduction Medical imaging has revolutionized modern medicine (Hricak et al. 2011), allowing physicians to make faster and more reliable diagnoses or avoid surgery in favor of less invasive methods. Patients, for their part, can avoid prolonged hospitalization and have better health monitoring throughout their medical care. Moreover, medical imagery can help patients to change their perspective on their condition by allowing them to see their disease (Pierret 2003). The underlying risks associated with medical imaging (i.e., due to exposure to ionizing radiation), while put into the background for several decades, are now the subject of increasing concern in the medical and scientific communities, and are also attracting the attention of policy makers (Hricak et al. 2011). For example, many studies have noted that physicians lack awareness of and are poorly informed about the risks related to ionizing radiation, as well as the basics of radiation protection (e.g., the dosages associated with common procedures) (Brown and Jones 2013; Gervaise et al. 2011; Krille et al.

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2010; Thomas et al. 2006). The increasing use of medical imaging technologies, and an overuse (i.e., unnecessary examinations that do not provide any health benefits) trend estimated at between 20 % and 50 % (Hendee et al. 2010), seem to confirm the hypothesis that there is a widespread trivialization of radiological investigation in contemporary Western medicine. It is acknowledged, as in most other forms of medical practice, that the patient should be informed of radiological risk (Karsli et al. 2009; Nievelstein and Frush 2012; Richardson 2010). However, the risks are rarely mentioned by radiology technicians or radiologists (Richardson 2010) and the issue of informed consent is far from being developed and articulated in radiology practice (Malone 2008). The difficulty lies in the communication of a risk that cannot be characterized with certainty, which leads to intense debates among health professionals and researchers (Paterick et al. 2012). There is no consensus about need for informed consent to such a risk in contemporary radiological practice, which explains why only a minority of doctors intentionally inform their patients about these risks (Robey et al. 2014). In light of this situation, our aim is to initiate reflection on how to address the lack of professional consensus on the duty to inform and on a patient’s right to consent in diagnostic radiology. This reflection will necessarily involve contributions from both health law and professional ethics in order to establish benchmarks and principles that should guide clinical practice. Health law will be presented through a set of charters, codes, judgments and legal doctrine from the Canadian context, while professional ethics will be detailed using the principles of Beauchamp and Childress (2012) and professional responsibility (notably, the ethics of responsibility of Hans Jonas). While the situation in Canada serves as a backdrop for a reflective analysis on the professional duty to inform and on a patient’s right to consent to diagnostic radiology, the conclusions can be applied to other jurisdictions because the principles underlying health law and jurisprudence are fairly general. For the purposes of this article, and in order to clearly differentiate between law and ethics, we consider that health law operates entirely on a hetero-regulation mode (i.e., rules imposed by an external authority), while professional ethics is primarily about self-regulation1 (Boisvert 2012). This will then allow us to examine the feasibility of integrating various modes of legal and ethical regulation as a starting point for a broader professional discussion about what should be best practices in radiology.

Background At present, there is no clear consensus regarding the need to obtain consent—or even what consent would entail—from patients who are exposed to ionizing radiation in radiological examinations (Mendelson 2010). There are several communication barriers for radiological risk. For example, it is now known that 1

Hetero-regulation relates to behavior regulation imposed by a third party (prescription), while selfregulation is based on the ‘‘responsible management of the levels of autonomy’’ (Boisvert 2012).

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radiology practice is particularly influenced by the subjective risk perception of both doctors and patients (Freudenberg and Beyer 2011). Thus, the risk may be underestimated or overestimated (Freudenberg and Beyer 2011). In this context, a patient’s decision may be influenced insofar as perception, for the perceiver (i.e., doctor or patient), is the reality (Berlin 2011). For simple procedures such as plain radiographs (‘‘X-rays’’), implicit consent is considered sufficient (Berlin 2014); i.e., the patient consents simply by being present at an examination. With regards to complex procedures that are more invasive and may require a significant radiation dose (depending on the duration of the procedure), such as those used in interventional radiology (biopsy, cardiac catheterization, angiography, etc.), informed consent is considered the norm because there are obvious and known risks for the patient (Berlin 2014). But what about all the procedures that fall between these two extremes; i.e., from being slightly radiated to highly irradiated? As Picano (2004) shows quite clearly (see Fig. 1), different radiological examinations may be associated with highly variable risk of cancer; and while most of these exams may be situated between negligible and low risk, the associated risks are not non-existent. In this grey area of negligible to low risk, several questions arise about the issue of consent and the duty to inform. Starting at what level of risk—and by consequence, what type of examination—should healthcare professionals begin asking for patient informed consent? Further, knowing that during an episode of

Fig. 1 Graph showing the risk of cancer and radiation dose (in multiples of the dose of a chest X-ray) for some common radiological examinations (Picano 2004)

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care patients may undergo repeated examinations, should these professionals also disclose the effects of examination frequency with the other information given to patients (considering that the dose is cumulative throughout life)? Finally, how should professionals provide information about those risks that are difficult to quantify, that are long-term and probabilistic, alongside those risks that are definable, short term and observable and that are generally communicated to the patient (e.g., regarding infection, bleeding, hemothorax, pneumothorax)? A study by Lee et al. (2006) concluded that ‘‘Although most academic medical centers currently have guidelines for informed consent regarding CT, only a minority of institutions inform patients about possible radiation risks and alternatives to CT’’ (p. 282). Whether from an ethical or legal perspective, this lack of clarity on the issue of informed consent is problematic, particularly given ethical and legal standards and current medical practice surrounding patient decision-making and risk communication (Picano 2004).

Legal Framework: A Top-Down Approach as a Guide to Medical DecisionMaking Before turning to the specific case of informed consent for radiological exams, it will be helpful to review the charters and laws, and then more specifically codes of ethics and legal doctrine, that inform general medical practice, using Canada—and more precisely, the province of Que´bec—as an example. Integrity and inviolability, as principles underlying human rights and dignity, are at the very basis of human rights bills or charters. For example, the Charter of Human Rights and Freedoms of the province of Que´bec states in Article 1 that ‘‘Every human being has a right to life, and to personal security, inviolability and freedom’’ (Government of Que´bec 1975). Similarly, from an international perspective, in the UNESCO Universal Declaration on Bioethics and Human Rights, Article 8 Respect for human vulnerability and personal integrity states that ‘‘In applying and advancing scientific knowledge, medical practice and associated technologies, human vulnerability should be taken into account. Individuals and groups of special vulnerability should be protected and the personal integrity of such individuals respected’’ (UNESCO 2005). From these principles is directly derived the notion of free and informed consent, as is evident in reading Article 10 of the Civil Code of Que´bec (or CCQ): ‘‘Every person is inviolable and is entitled to the integrity of his person. Except in cases provided for by law, no one may interfere with his person without his free and enlightened consent’’ (Government of Que´bec 1991b). Article 11 of the CCQ then specifies the notion of consent related to the nature of ‘‘harm’’ referred to in Article 10: ‘‘No person may be made to undergo care of any nature, whether for examination, specimen taking, removal of tissue, treatment or any other act, except with his consent’’ (Government of Que´bec 1991b). This article explicitly informs us that the nature of the infringement may involve an examination, and radiology obviously falls into this category. The Code of Ethics of Physicians of Que´bec details the practical application of the CCQ’s brief and prescriptive statements.

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Governing the conduct of all physicians (including radiologists), Article 28 states that it is the duty of the physician to obtain free and informed consent: ‘‘A physician must, except in an emergency, obtain free and enlightened consent from the patient or his legal representative before undertaking an examination, investigation, treatment or research’’ (Government of Que´bec 2002). The ‘‘informed’’ aspect of consent brings to the fore the notion of an information duty on the part of professionals vis-a`-vis their patients.2 The information duty arises directly from a patient’s right to be informed before consenting, a right found in Article 8 of the Act Respecting Health Services and Social Services of Que´bec: ‘‘Before giving his consent to care concerning him, every user of health services and social services is entitled to be informed of his state of health and welfare and to be acquainted with the various options open to him and the risks and consequences generally associated with each option’’ (Government of Que´bec 1991a). Finally, a physician’s obligation to inform is specified in Article 29 of the Code of Ethics of Physicians of Que´bec: ‘‘A physician must ensure that the patient or his legal representative receives explanations pertinent to his understanding of the nature, purpose and possible consequences of the examination, investigation, treatment or research which he plans to carry out. He must facilitate the patient’s decisionmaking and respect it’’ (Government of Que´bec 2002). These different legal requirements show how from the concept of ‘‘dignity’’, a concept that is difficult to define unequivocally, the law manages to specify general duties of practice, such as the obligation to inform, which becomes a ‘‘legal obligation imposed on anyone who wants to pose an intrusive act to the integrity of another’’ (translation by authors) (Kouri et al. 2005, p. 238). This duty is definitely suitable for the medical profession, considering that intervening in an individual’s integrity is a daily activity.3 The lack of consensus in practice with regards to the consent of patients in diagnostic radiology thus seems to be in direct conflict with accepted legal standards in contemporary medicine (Picano 2004). That being said, the law gives certain guidelines that can perhaps make it possible to inform practice about what is required of a health professional. According to Kouri et al. (2005), leading authorities on Canada’s legal doctrine, the content of the information that should be given to patients must meet a number of criteria: the test of objectivity; information on adverse effects; and the characteristics of the risk (nature, severity and frequency). The test of objectivity pertains to the criterion of reasonableness for a patient. The usefulness of such a standard is that it defines the content of the information given 2

For the purposes of this article, the concept of freedom is left aside in order to focus on the information provided to patients.

3

Integrity is a broad concept that involves several dimensions (physical, psychological, etc.), so we use the definition in the UNESCO declaration: ‘‘In the biomedical context, ‘integrity’ is presented as a right that all people hold, a negative right or a right of non-interference which, as such, demands respect from others; i.e., others’ non-interference in the private sphere of the self. … The multidimensional nature of the individual is clearly stated in the idea that physical, psychological, social and spiritual dimensions cannot be separated or extracted without the loss of all that the individual understands’’ (Ten Have and Jean 2009).

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by the healthcare professional on the basis of the potential risks that a reasonable person in the patient’s position would like to know to make an informed decision (Paterick et al. 2012). In Reibl v. Hughes (Supreme Court of Canada 1980), a milestone in Canadian jurisprudence about informed consent and invasive treatments, the Supreme Court of Canada found that the content of the information provided to a patient does not have to state in detail a risk if it is generally ‘‘known or presumed to be’’ known (Kouri et al. 2005). Why then should there be an obligation on the part of professionals to inform patients of the particular risks associated with the means (examination by ionizing radiation) for creating diagnostic images when this means is very common, widely used, generally accepted and known to the public? For radiological examinations involving the most commonly prescribed tests (e.g., standard radiography using X-rays), this is an argumentative shortcut that aligns with the idea that the patient knows the risk in question. Indeed, diagnostic imaging is common, but it is known to the public only in the general sense that these are routine tests; this common knowledge does not mean that the public knows about the associated risks or how these tests actually work. Moreover, upon closer inspection, the literature tells us exactly the opposite about the ‘‘presumed’’ known risk. In fact, information provision and patient education vis-a`-vis the risks associated with medical imaging have been found to be largely unsatisfactory (Sin et al. 2013). Regarding the aspect of ‘‘desire to know the risk’’ for allowing an informed decision, the literature provides evidence that is contradictory with the Reibl v. Hughes judgment, which aimed to determine whether there had been a case of medical malpractice or negligence. Whether for a risk considered very low (1/ 100,000) of anaphylactic shock by injection of iodinated contrast agent used for certain diagnostic radiology examinations, or for the risks associated with imaging scanner (CT) and with single-photon emission computed tomography coupled to the scanner (called an hybrid SPECT-CT imaging modality), respectively 86 % and 90 % of patients in two studies wished to be informed of these risks (Busey et al. 2013; Debray et al. 1991). What then should healthcare professionals (or even the legislator) take away from such findings? On what should be based judgments about which patients would like to know what type of risk information? And what do we ultimately know of the risks that a reasonable patient would want to know to make an informed choice? In light of these questions, the standard test of objectivity seems to be a highly subjective assessment that does not really inform us, from a legal standpoint, of the raison d’eˆtre of the duty to provide information on the risks associated with ionizing radiation in the context of diagnostic radiology practice. The second criteria, information on adverse effects, states that the content of the information to be given should also incorporate the negative effects of a successful intervention (Kouri et al. 2005). In the case of ionizing radiation, this is particularly relevant insofar as the vast majority of radiological exams are successful (it is usually possible to have the desired image, making diagnosing possible). It is not the possibility of a failure that causes adverse and long term consequences (unlike surgery, for example, where the success of the intervention normally means fewer

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health concerns), but it is the very means for producing the image (e.g., X-rays) that is the cause of the harmful effects. Finally, each characteristic of a certain risk (i.e., its nature, severity and frequency) influences the type and amount of the information that should be given to the patient. As mentioned in the preamble, exposure to ionizing radiation is associated with a risk of a stochastic nature. It is quite understandable (considering the elusive nature of stochastic risks) that the law does not take a clear position on that issue and therefore tends to exclude stochastic risks from the information that should be given to patients due to the fact that the risk is not quantifiable (because it is based on calculations and hypotheses) and unpredictable in the long-term. The gravity of a risk that needs to be disclosed can take three forms: (1) particular and unusual; (2) rare, but serious; or (3) frequent and minor (Kouri et al. 2005). The risk of ionizing radiation is a particular and unusual risk because of the stochastic nature, integrating an important long-term aspect (i.e., cumulative impact). In addition, it can also be considered a rare but serious risk, to the extent that having radiationinduced cancer means theoretically having a one in two chance of dying (Berrington de Gonza´lez et al. 2009), and so while uncommon, has a very serious consequence. As a result, the frequent and minor characteristic does not apply to ionizing radiation. The criterion of severity of risk tends to require the inclusion of risk information to be disclosed to the patient because two criteria appear applicable. As for the frequency of risk, in the health law literature there is a consensus on the threshold of mandatory disclosure of a risk starting from 1 % (Kouri et al. 2005). A standard abdominal scanner (using CT-scan) has a risk of 1/2000 of radiationinduced cancer development (Picano 2004). This criterion frequency of 1 % systematically excludes the mention of such a risk with respect to the information given to the patient, while remaining silent about issues of risk communication and consent in radiology (Berlin 2011, 2014; Nievelstein and Frush 2012; Robey et al. 2014). In light of these legal guidelines, it becomes easy to understand why there is no clear consensus in the practice of radiology when it comes to informing patients about the risks related to ionizing radiation. In fact, the law supports arguments both in favour of and against such information provision. When the law prescribes in general terms through laws or codes, it does not contain the same idea as when it tries to be specific to medical practice using different criteria for evaluating risk, such as the standard of the test of objectivity. A quandary is then observable in the law itself. This could explain the insufficiency of law—that is to say, the requirement of hetero-regulation—to effectively regulate a certain practice in responding to the issues raised by a rigid prescription.

Ethical Framework: Basing Reflection on the Context and Practice Let us now address the potential implications, with respect to the patient, resulting from contemporary radiology practice using the four ethical principles proposed by Beauchamp and Childress (2012). These principles are widely accepted, underlie much of general medical ethics in North America, and are implicit or explicit in the

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provisions and the spirit of most healthcare professional codes of ethics. The duty to inform in the practice of radiology concerns key ethical principles such as respect for autonomy, beneficence and non-maleficence, as well as the ethics of responsibility. Each principle will be briefly presented and contextualized through specific examples relevant to the radiological context. These ethical guidelines form the ethical framework on which will be based our subsequent discussion about the interface between ethics and law. Respect for autonomy is reflected in medical practice by obtaining free and informed consent from patients for things that could potentially undermine dignity, inviolability and integrity (Beauchamp and Childress 2012). Informed consent allows a patient to knowingly make a decision about care, even though the original intent of the professional (by prescribing radiological examination, for example) was beneficial. Respect for autonomy entails that physicians must properly inform their patients, but to do so they must themselves be fully informed. However, this may not always be the case (e.g., physicians may know little about the risks of particular radiology exams); it is thus difficult to properly foster patient autonomy if a professional is under-informed, thus jeopardizing the informed consent of patients. As mentioned previously, there is an important overuse trend in radiology practice (20 %–50 % of estimated non-required exams). The infringement of the duty to provide information, through overuse, raises ethical issues insofar as the imaging test has an inherent risk and is not necessary to ensure patient health. Although an examination has been prescribed (and one might think that it is medically required), it may not have been adequately justified by the professional. The mere fact that it has been prescribed by their doctor may impede a patient’s ability to properly understand the implications (and the associated risks) of the medical intervention. Once prescribed, the inadequate justification is forgotten and only the imperative for the exam remains. Due to persistent medical and social views of radiology as a service (Caille´ 2008), it minimizes the importance to inform and to be informed about this risk, thereby jeopardizing the principle of autonomy (i.e., the routine nature of radiology induces a certain tolerance or blindness toward risks). Many aspects of radiology are unknown to patients, for example, the quest for the best quality image (higher level of diagnostic information) with high-dose technologies is an imperative stronger than patient protection (Moores and Regulla 2011). By consenting in a general sense to the medical act, the patient is expressing agreement with a procedure, but not to the specifications of the imaging procedures per se. Another example showing that patients are consenting only in the general sense has to do with the age and maintenance of radiological equipment. Should the patient be informed if the test is done using older equipment that delivers greater doses than newer technology for a similar examination, where the patient could benefit from a significant dose reduction? But even if newer technologies have the potential to minimise the dose of radiation (because they are more efficient and specific in focus), studies have shown that the introduction of digital systems in radiology (a major innovation of the last decade) actually contribute to an increase in radiation dose (ICRP 2004). Despite its obvious advantages (better diagnostic data, dynamic contrast, pre/post-processing functionality, electronic transfer, to

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name but a few), radiographers are largely unaware that digitalization has contributed to overexposure (which can occur without negative effects on image quality in comparison with traditional film-based exams). Even where professional guidelines exist, they are not always routinely applied, and radiology experiences a great deal of variability in its practices (Abramson 2012). In such circumstances, do we have to inform the patient that a particular clinic pays special attention to the value of reducing unnecessary exposure (due to the quality of their equipment and their practices) every time it is possible, in comparison with another clinic? These elements raise important issues considering that the information leading to the consent of a patient (in the office of her treating doctor) is never that detailed. It is possible that, without the patient being aware, there is an unfavorable shift in the balance of risks and benefits (Brenner and Hall 2012). The principles of non-maleficence and beneficence thus become important avenues through which to conceive of a more respectful and effective practice, notably with regard to informed consent. Non-maleficence is based on the maxim primum non nocere (Jouanna 1992), that is to ‘‘do no harm’’, or at least not cause undue harm to others when it can be avoided (e.g., overuse of radiology and thus over-exposure). Compliance with this principle means that health professionals and their patients must weigh the risks and benefits of an intervention, in order to make an appropriate choice, and this entails a clear understanding of the risks associated with procedures and related technologies. This risk–benefit assessment can take different forms. For example, it may be appropriate to submit an elderly patient to a radiodiagnostic exam for a condition that may have serious consequences (e.g., cancer or cardiac arrhythmia), considering that the radiation-induced adverse effects would likely appear only in the long term (i.e., the radiation-induced effects occurring in 20 years are less important for an 80-year-old versus a 30-year-old patient). By contrast, from a population health perspective, it would be inappropriate to submit younger people to mass screening for a condition (e.g., mammography before the age of 40) except if there are symptoms, signs or a family predisposition. But the principle of ‘‘do no harm’’ also concerns examinations that are potentially harmful and commonly involve risks that are underestimated by patients. For example, whole-body screening is often marketed to asymptomatic individuals (healthy people) as a procedure to scan for undiagnosed (or hidden) abnormalities or cancers. The main purpose is to reassure people of their good health. However, a cost-effectiveness study revealed that whole-body scans trigger too many false positive results: 90 % of the scans find at least one ‘‘abnormality’’ of which only 2 % are clinically significant (Beinfeld et al. 2005). These ‘‘abnormalities’’ have an anxiogenic effect on patients, prompting them to embark on a series of unnecessary examinations. Furthermore, the procedure clearly brings with it more harm than (radiation-related) benefits. For instance, the associate risk of fatal cancer due to full body scans is between 1 in 1200 and 1 in 600 (the latter by making a series of images using contrast agents) (Faulkner 2009), and so has been banned in some countries (such as Switzerland and Germany), but is tolerated in the United States (Richardson 2010). This kind of scan raises important concerns because the medicalization of healthy people brings with it undue and potentially unknown

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risks, transforming otherwise healthy people into victims of modern imaging technology (also known as VOMIT) (Hayward 2003). Professional practice is key in this misuse of full body scans and so should be questioned, especially in a context where up to 76 % of the whole-body scans have been self-referred (Albert 2013), an indicator that other incentives than patient protection are present. Promoting and defending non-maleficence reinforces a professional’s duty to focus on patient wellness (to properly weigh the benefit-risk ratio in a shared decision-making process) and requires them to inform and educate patients on the associated risks. Beneficence, or ‘‘doing good’’, is at the very heart of medical practice and requires that patient welfare be fostered and protected. In the particular context of overuse, this principle implies not performing an act when it is not necessary. Unfortunately, in the current medical culture, particularly with the issue of defensive medicine (where we see how law can influence and modulate practice), not performing an act seems to require more justification than performing an unnecessary act (Hall 1991; Malone et al. 2012). In this context, who is the actual recipient of the benefits of care: the doctor who protects himself from litigation or the patient for whom diagnostic examination is needed? And without involving other key actors (radiologists, imaging technicians, etc.), how can physicians actually engage in a process of shared and informed decision-making with their patients? Doing good in the patient’s best interest should involve seeking less irradiating alternatives where possible (especially for children, who are particularly radiosensitive). As this good is patient-centered, it should involve providing appropriate care for the patient and not more convenient methods for the professional (e.g., favoring a CT scan for a child because it is faster and easier than doing an MRI), something that necessitates professional ethical sensitivity (Weaver et al. 2008). To do good entails going further than do no harm, by seeking the best solution for each patient, especially for patients for whom alternative diagnostic solutions exist. Beneficence is thus an important ethical landmark that entails the justification of the choice of radiological examinations, and their practice in a manner that is both respectful and benevolent. Underlying the clinician-patient interaction is a fiduciary relationship. Because of this trusting relationship with their patients, clinicians have obligations and, thus, the responsibility to act in their patient’s best interests. So, in addition to Beauchamp and Childress’ four principles, professional responsibility is an important consideration in the context of radiology practice, especially when dealing with the issue of the duty to inform. To what extent is such a responsibility actually taken into consideration by radiology professionals? This question clearly integrates notions of professional ethics present in the various codes of ethics (e.g., physicians, imaging technicians, nurses). But beyond professional responsibility, the ethics of responsibility of Hans Jonas (1998) is also a relevant point of reference to consider, within a self-regulation perspective, to address the implications of the duty to inform and patient consent in radiology. Jonas discusses the risk of jeopardizing future generations due to the unceasing development of modern technology. An important aspect of his principle of responsibility is the place he gives to prospective aspects: responsibility is not based

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solely on the impact of past actions, but needs to take account of future (and potential) consequences. This is particularly relevant to radiology practice because the risk in question is, as noted above, in the long-term (moreover, it concerns not only the patient but also any offspring). In this view, professional responsibility must also include duties toward future generations, considering that little is known about the implications of the hereditary effects of ionizing radiation (UNSCEAR 2001). Because the trivialization of imaging technologies in medicine is a reality, there is an ethical imperative to address the question of responsibility to address the lack of clinician and patient awareness regarding the medical use of ionizing radiation. In that sense, information provision can be seen as the first step to a more responsible radiology practice. The ethics of responsibility is also important in the doctor-patient relationship, because this relationship implies, by its very nature, an information asymmetry. Even if a patient is not always vulnerable, the lack of information and the burdens of illness may induce a state of vulnerability, reinforcing the physician’s role: ‘‘One who knows things that a vulnerable person ignores is accountable towards him’’ (Me´tayer 1997). The literature shows that patients are often poorly informed about the risks of ionizing radiation (Sin et al. 2013). As a patient undergoes a treatment with an inherent risk (without necessarily being aware), their confidence in the expertise and the professional judgment of their physician plays an important role. Indeed, to inform ‘‘the person on the different interventions or treatments, the health professional must be knowledgeable about them’’ (Kouri et al. 2005, p. 267) and the risks of treatment should be part of this knowledge, although it is always possible to question the extent of the knowledge required to justify ‘‘good practice’’. Unfortunately, it is now recognized that there is a general lack of awareness on the part of clinicians in all medical specialties about the risks of ionizing radiation (Krille et al. 2010).

Discussion From an ethical point of view, should the current situation be worrying and should it raise questions about what constitutes ‘‘good clinical practice’’? The issue is complex insofar as information provision is only one part of an episode of care. However, if a duty to inform were better established in radiology, it could address both the problem of overuse and the lack of information that can be found in current radiology practice. Greater awareness on the part of both professionals and patients about the risks of radiological examinations would help, to some extent, counter the problem of overuse. Doctors could better exercise their profession in alignment with fundamental ethical principles and the ethics of responsibility, while patients would receive care that preserved their dignity and integrity. The principled approach of Beauchamp and Childress, as well as the ethics of responsibility of Jonas, lead one to recognize the importance of fostering the duty to provide patient informed consent regarding the risks of ionizing radiation. This conclusion is consistent with Berlin (2014) who argues that providing information to the patient about the harmful effects of ionizing radiation is an ethical duty.

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There is increasing discussion in the medical and scientific literature about the duty to provide information and obtain fully informed consent in radiology (Karsli et al. 2009; Lewars 2004; Mendelson 2010; Nievelstein and Frush 2012; Picano 2004). One possible explanation for the lack of consensus vis-a`-vis the duty to inform and obtain consent in radiodiagnostics is that insofar as law and ethics do not use the same reasoning to determine whether or not to require the provision of risk information, they are continually feeding the debate and thus impeding any resolution. After exploring the contribution of law and ethics, it is justified to conclude that neither a purely legal nor ethical approach is sufficient. As previously discussed, although legal hetero-regulation has an important role and is generally accepted with regards to regulating the behavior of professionals, it does little to account for the particular context of clinical practice. The statements of the laws cited above work on a prescriptive mode and remain very general; they are not tailored to specific professional practice, such as radiology, and leave unresolved more specific issues to do with the stochastic nature of risk relating to ionizing radiation. The law provides necessary but insufficient guidelines to help regulate professional practice. In the context of radiology, law can be seen as an entity that imposes strict benchmarks to a certain reality (while remaining outside), in agreement with its hetero-regulation logic. This is evident, as previously discussed, in the tension found in the law itself which, on one hand, states that professionals should ‘‘always’’ inform, and on the other hand, uses criteria for risk characterization and what information should be provided. The standard of the test of objectivity leads to a more nuanced argument by making the duty to inform mostly non-required and an implied consent wholly acceptable in the practice of radiology. However, as Fig. 1 showed, the various imaging examinations are strongly associated with highly variable risk and, in that context, a lack of comprehensive guidelines raises more questions; i.e., over what dosage (or risk) would implied consent no longer be sufficient? Considering the high number of annual examinations performed (e.g., 72 million CT examinations in the United States in 2007 (Berrington de Gonza´lez et al. 2009)), a fixed and arbitrary standard (such as 1 %) would be an inadequate guide, since the impact can be significant from a population standpoint. In addition, there is the question of taking into account the cumulative doses in the information to be given. Each patient is not equal with regards to the risks at hand (because there are gender and age differences in radiosensitivity), and the care pathway for each patient is unique (e.g., the sequence of imaging tests, different treatments). It is thus hard to conceive that the heteroregulation could be sufficient to handle such variability. Yet, the law takes into account this concern for contextualization by specifying professional practice through codes of ethics (although the Code of Ethics of Physicians is not specific to the particular reality of radiology). While this approach tends to be closer to a practical reality, it still operates mainly on a hetero-regulation or top-down model, remaining thus largely decontextualized and so unable to respond to very specific issues, such as those raised by radiological practice. Another example that shows the insufficiency of the hetero-regulation approach is the lack of clear guidance regarding the definition of the object of the laws

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themselves. The laws surrounding the issue of duty to inform and obtain consent are founded on the principles of respect for the dignity of the person, and articulated as integrity or inviolability. However, it is possible to query the definitions of ‘‘dignity’’, ‘‘integrity’’, and ‘‘inviolability’’ on which they are based. Is accumulating ionization in the DNA of a cell a potential violation of the physical integrity of an individual? The answer must take into account the mutations that may occur and their long-term effects on health, even if this remains quite vague when compared to invasive and observable treatments (such as surgery). Many questions arise and it is difficult to determine whether their analysis should be in the courtyard of law, applied ethics, or philosophy (or of the three). Professional ethics, based on the principles discussed above (autonomy, beneficence, non-maleficence, and responsibility), assumes that these principles are engaged on the side of the professionals or patients and suggests that risk information should be given in order to allow a better, more informed, consent. It is possible to see that the responsibility of a physician to his patient has significant consequences when the issue is seen from a population perspective. For instance, a totally utilitarian ethic could endorse the practice that seems to be the norm today (i.e., denying a duty to provide information on the risks related to ionizing radiation), simply because the use of imaging technologies would probably always result in greater benefits than harms, at least in the short-term and at the individual level (e.g., the patient not worrying about the technologies’ potential negative health effects and professionals not being required to invest time and effort to fully inform the patient). However, this perspective (and contemporary practice) is highly questionable given the context, because with the increasing use of imaging tests, including scanner examinations and dosage accumulation, low individual risk spread across a population could nonetheless become a major public health issue (Brenner and Hall 2007), and an important source of concerns by public health decision-makers (Moore 2014). Professional self-regulation, in collaboration with ethical reflection, allows—in the context of a professional practice such as radiology—the taking into account of and searching for potential solutions for issues and problems, whether it is the increasing use, overuse, or lack of information, and even in a prospective manner (thus meeting the dictates of Jonas). Unfortunately, it seems that this prospective aspect has been largely restricted or even discarded in radiology. Medical practices are affected by technological evolution, but although there is a fairly rapid evolution of the equipment (i.e., every 5–10 years) (Holmberg et al. 2010), practices and attitudes do not evolve at the same pace and are infrequently reconsidered over time. Considering that the reflexivity made possible by ethics (without imposing or sanctioning), a self-imposed change of culture (first and foremost on the part of health professionals and medical practice in general) would be more consistent to addressing the issues at stake and, so, be better integrated into professional practice. In other words, the radiology community should engage in a broader collective reflection that integrates their core ethical principles, in order to decide upon appropriate (and more respectful) practice guidelines. However, it would still require a significant investment on the part of different stakeholders and would take time to be accepted and effective. It is therefore not surprising to see

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how this mode of regulation (self-regulation) seems to have a limited role in actual practice. It is necessary to clarify that this limited role is not so much due to the fact that self-regulation is limited in itself, but more because the structural and organizational constraints that govern radiology activities are not favorable (e.g., labour hierarchy, intensive workload, high efficiency expected). It is also important to add that ethical requirements can be difficult to operationalize. Although ethics takes into account the challenges present in the professional environment, and confronts them with the principles of bioethics, it is not always able to counter the structural constraints that leave little room to change in practice. For example, it is ethically justifiable to inform and seek consent for any act that uses ionizing radiation. However, to do this systematically for simple procedures such as standard radiographies is unnecessary and even the source of harm (i.e., by producing unnecessary/unjustified anxiety), given the negligible risks and the high number of examinations. In a professional health care context marked by increasing demand and limited resources, giving information to and obtaining the consent from patients may require significant additional resources, whether in terms of time or staff (Lewars 2004), that could lead to an increase in costs to the health care system, potentially creating other injustices. The solution does not lie in increased resources, but in a better use of what is available. This can be accomplished by assessing the role of each actor, the medical and sociological context and the particular role of radiology within medical practice in order to understand what ‘‘doing better’’ means. For instance, if 20 %–50 % of the activities are considered as overuse, these services (and associated workforce) could instead be used to better inform and educate, thus resulting in no additional cost. Another way to counter this problem would be to redefine radiology service compared to the rest of the medicine, what its function is within the episode of care, and what the roles are of the professionals practicing radiology. The radiological sciences are neither coherent nor consistent in terms of how they define their role, whether in medicine or more generally in society (Moores and Regulla 2011). The resources wasted by overuse, such as workforce, time and money (Armao et al. 2012), could be invested differently so that the key actors—whether policy-makers or radiology professionals—might work together to solve the problems associated with information provision and patient consent. Due to the variability of existing procedures, reaching a consensus regarding the need for informed consent for a particular type of examination remains a challenge; but this does not make it ethically acceptable for this issue to have received so little attention from radiology professionals. As with hetero-regulation, the self-regulation characterized by an ethical approach is insufficient in itself to meet the challenges that arise in professional practice. So it is through the gaps in professional ethics that the law can have an important role to play, and vice versa. Giving greater room for self-regulation could be a starting point to what is called the ‘‘reflective professional practice’’ (Scho¨n 1983), which would mean including the duty to inform the patient—depending on the context—and to guide, frame and prioritize activities and tasks at the foundation of radiology practice. In a context where information and awareness on the part of healthcare professionals and patients are incomplete, it appears even more worrying, in the light of professional

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responsibility, to read the following in the Reibl v. Hughes judgment (1980): ‘‘[to determine] what are the significant risks and, therefore, those who should be disclosed, and what risks are not important is equivalent to hand over to the medical profession the whole question of the extent of the duty of disclosure, including the issue whether there has been a breach of that duty.’’ It is important that practice improves through self-regulation alongside the establishment of formal rules and surveillance of compliance; this must be done both bottom-up (self-regulation) and top-down (hetero-regulation). Hence, it is appropriate to adopt an approach integrating the two modes of regulation, thus allowing a better relationship between law and ethics as a guide to practice. This could be conceivable and efficient, for example, for codes of conduct, for the definition of the information to be given according to the type of examination (and regarding the associated dosage), or for detailing the nature of professional responsibility. This last point is particularly interesting to explore insofar as, in the context of specialized medicine, tasks are shared within multidisciplinary teams. This is particularly relevant as ‘‘science is progressing faster than law, the traditional normative framework governing responsibility in the context of multidisciplinary medicine does not seem to fit reality’’ (Leroux 2011). Although the law has an important place in terms of governing the professional-patient relationship, we find that this is insufficient; hence, there is a need to add other guides, including the ethics of responsibility.

Conclusion In light of the statement of laws, legal standards, principles and ethical guidelines (each of them supporting and fostering respect for patient dignity and integrity), it is possible to highlight a certain number of arguments supporting the fact that the duty to inform should be better framed in radiology. After briefly analyzing the character of each mode of regulation from a critical perspective, it is clear that both the hetero-regulation and self-regulation models have strengths and weaknesses. But the integration of both in the practice of radiology can potentially provide interesting and efficient solutions to address the problem of information provision and patient consent. Despite the many challenges identified, it remains pertinent to undertake deeper reflection on the contribution of each regulation mode to redefine what should be the duty of information provision in radiological practice. Our aim has not been to claim that professionals are irresponsible (since the practice is not adequately framed), but rather to encourage and promote professional ethics as a means to improve practice and better protect patients. Professionals have a crucial role to play in the management of radiation protection, in educating patients and, thus, in the protection of public health (Nickoloff and Alderson 2001). A better articulation of the requirements of law and ethics would help these professionals make better decisions for a more effective and accountable practice, while reaffirming and enhancing their role in this regard. It is worth noting that the particular risk involved in exposure to ionizing radiation, in

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relation to the increasing use of imaging technologies, deserves to be specifically addressed due to its stochastic nature and long-term effects. As ethics cannot, by itself, ensure an ideal professional practice, the law—with its certain level of rigidity—cannot continue to ignore issues at a population level on the pretext that the risk cannot be demonstrated by facts. The challenge, then, is one of instigating a paradigm shift in radiological practice, which has ‘‘experienced difficulty to change from a logic of proven risk prevention to precautionary approaches to hypothetical risks’’ (translation by authors) (Godard and Lochard 2005). Adjustments are necessary, even if they are difficult to implement because they require multidisciplinary collaboration (law, ethics, but also medicine and other fields of expertise) and a change in professional culture that needs to take place (to be effective and well accepted in practice) in parallel with the shift toward a risk management paradigm. Funding Doudenkova is supported by a graduate scholarship from the Bioethics Program and the Faculty of Graduate and Postdoctoral Studies of Universite´ de Montre´al. Be´lisle Pipon is supported by PhD scholarships from the Institut de recherche en sante´ publique de l’Universite´ de Montre´al (IRSPUM), the Centre de recherche en e´thique (CRE´) and the Fonds de recherche du Que´bec—Sante´ (FRQS) & Unite´ SUPPORT du Que´bec. Conflict of interests None.

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