BJR doi: 10.1259/bjr.

20150713
© 2015 The Authors. Published by the British Institute of Radiology under the terms
Received: Revised: Accepted: of the Creative Commons Attribution-NonCommercial 4.0 Unported License http://
28 August 2015 14 December 2015 17 December 2015 creativecommons.org/licenses/by-nc/4.0/, which permits unrestricted non-
commercial reuse, provided the original author and source are credited.

Cite this article as:

Malone J, Zölzer F. Pragmatic ethical basis for radiation protection in diagnostic radiology. Br J Radiol 2016; 89: 20150713.

FULL PAPER
Pragmatic ethical basis for radiation protection in
diagnostic radiology

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1
JIM MALONE PhD, FIPEM and 2FRIEDO ZÖLZER, PhD
1
School of Medicine, Trinity Centre for Health Sciences, St James’s Hospital Dublin, Dublin, Ireland
2
Department of Radiology, Toxicology and Civil Protection, Faculty of Health and Social Studies, University of South Bohemia in České
Budějovice, České Budějovice, Czech Republic

Address correspondence to: Prof. Jim Malone

E-mail: [email protected]

Objective: Medical ethics has a tried and tested literature contemporary behaviour in radiation protection of
and a global active research community. Even among patients. Application of the system is illustrated in
health professionals, literate and fluent in medical ethics, six clinical scenarios. The proposed system is designed,
there is low recognition of radiation protection principles as far as is possible, so as not to be in conflict with
such as justification and optimization. On the other hand, the conclusions emerging from the ICRP/IRPA
many in healthcare environments misunderstand dose consultations.
limitation obligations and incorrectly believe patients are Results and conclusion: A widely recognized and well-
protected by norms including a dose limit. Implementa- respected system of medical ethics was identified that
tion problems for radiation protection in medicine has global reach and claims acceptance in all cultures.
possibly flow from apparent inadequacies of the In- Three values based on this system are grouped with
ternational Commission on Radiological Protection two additional values to provide an ethical framework
(ICRP) principles taken on their own, coupled with their for application in diagnostic imaging. This system has
failure to transfer successfully to the medical world. the potential to be robust and to reach conclusions that
Medical ethics, on the other hand, is essentially global, is are in accord with contemporary medical, social and
acceptable in most cultures, is intuitively understood in ethical thinking. The system is not intended to replace
hospitals, and its expectations are monitored, even by the ICRP principles. Rather, it is intended as a well-
managements. This article presents an approach to ethics informed interim approach that will help judge and
in diagnostic imaging rooted in the medical tradition, and analyse situations that arouse ethical concerns in
alert to contemporary social expectations. ICRP and the radiology. Six scenarios illustrate the practicality of
International Radiation Protection Association (IRPA), the value system in alerting one to possible deficits in
both alert to growing ethical concerns, organized a series practice.
of consultations on ethics for general radiation protection Advances in knowledge: Five widely recognized values
in the last few years. and the basis for them are identified to support the
Methods: The literature on medical ethics and implicit contemporary practice of diagnostic radiology. These are
ICRP ethical values were reviewed qualitatively, with essential to complement the widely used ICRP principles
a view to identifying a system that will help guide pending further development in the area.

INTRODUCTION ICRP values are most clearly articulated are the recom-
The system of radiation protection in the great majority of mendations of the main commission in publications 26, 60
countries in the world is based on the recommendations of and 103.1–3 With respect to medical uses, publication 105 is
the International Commission on Radiological Protection also important, although it adds little, if anything, to the
(ICRP).1 The publications of ICRP are specifically designed principles.4
for radiation protection, and are based on a solid scientific
evidential base, combined with value judgments that allow In medicine, there is a longstanding system of values
it be applied to practical problems in industry, medicine, stretching back to the Hippocratic Oath, which recog-
education, research and in everyday life. Some of the values nizes the need for care and ethical sensitivity in the
on which ICRP relies are articulated, but many are implied way patients are treated and treatments are delivered.
and not explicitly present. The source documents in which The resultant corpus of knowledge and experience is
 BJR Malone and Zölzer

impressive. Medical ethics has a tried and tested teaching lit- will help issues arising in radiology be judged and reflected on,
erature for undergraduates and postgraduates, as well as an not just against the ICRP principles, but also taking on board
active research community throughout the world. Approaches contemporary thinking on social, medical and ethical
have evolved that are essentially global and are acceptable in concerns.10
most cultures.5–7
The proposed approach in this article is based on a set of
For the most part, scholarship in medical ethics does not at- principles/values that can be applied to problems in medical
tend to the problems in radiation protection. In practice, it radiation protection and that potentially have high recognition
appears there is an unwritten assumption that matters relating in medicine. In our view, the approach to ethical decision-
to radiation are dealt with in a separate system and medical/ making in medicine proposed by Beauchamp and Childress
general ethicists have not engaged with it. In consequence, provides a good basis to this aim.5–7,13 Their Principles of
radiation protection in medicine has enjoyed exceptional in- Biomedical Ethics, first published in 1979, is highly regarded

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dependence, which allowed it unique access to management and reached its seventh edition in 2012.7,13,14 In it, the authors
and resources. The counterpoint is that the ethical issues in suggest that ethical questions in medicine can be addressed by
radiation protection have low recognition in the medical world, referring to four basic principles:
with the exception of a handful of radiation protection spe- • Respect for autonomy (of the individual)
cialists who advise in the area. For example, patients are • Non-maleficence (do not harm)
afforded some protection by advisory diagnostic reference • Beneficence (do good)
levels. This, in our experience, leads to the mistaken belief • Justice (be fair).
among many healthcare professionals that patients are pro-
tected by good practices which include limits on total radiation These principles are rooted in “common morality”. They are of
dose. This illustrates the somewhat isolated position that ra- sufficient generality and flexibility to be widely deployed in
diation protection has, until recently, occupied vis-à-vis con- medicine and, by extension, in radiology.
temporary social and ethical thinking and leaves it exposed on
some important matters. A closer look at ethics traditions as well as social expectations
identifies additional values which are also relevant for ethical
The systems of medical ethics and the ICRP system for radiation decision-making in the radiological context. While these are
protection overlap significantly. However, there is no simple way implied by Beauchamp and Childress’s basic principles, it is
of mapping one onto the other.7–9 Analysis of the ICRP system valuable to give them the additional emphasis of being spe-
identifies different strands of Western utilitarian and de- cifically mentioned. The most important of these, in our
ontological ethics, although the impact of some of these has view, are:
been attenuated with time (Appendix 1). Notwithstanding, it is • prudence: (keep in mind possible long-term risks of
likely that a widely recognized approach to medical ethics may actions) and
prove helpful. • honesty: (share knowledge with those concerned truthfully).
Recently, the global nature of radiation protection has been The notion of prudence is respected across cultures and reli-
explicitly recognized in ICRP Task Group 94 on Ethics of gions. It is generally understood to be at the heart of the Pre-
Radiological Protection.10 This is mandated to identify the cautionary Principle, which is highly valued in dealing with
basic values behind the system and their mutual relation- scientific problems where action is required in the absence of
ships. It is not expected to rewrite the principles of radiation definitive data. Honesty, in the sense used here is often thought
protection but rather show how they are compatible with as “working in an open and transparent manner”.
and rooted in a broadly accepted “common morality”.
The work of this task group has been informed by a series All of the principles are described and explored more fully in
of workshops/consultations held in Asia, Europe and the the Building Blocks section of the Methods and Materials, in
Americas which have looked at the ethical basis of radio- the Pragmatic Value Set section of the Results and in the
logical protection. These have been organized jointly by Discussion and Conclusion section. The Methods and
IRPA (International Radiation Protection Association) and Materials section is followed by the Results section, which
ICRP. 10,11 In addition, the European Commission has sup- not just details the pragmatic set of five values, but also
ported enquiries into the ethical basis for radiation pro- provides a set of scenarios illustrating their deployment. The
tection in its wide-ranging Open Project for the European article ends with an extended Discussion and Conclusion
Radiation Research Area (OPERRA), as well as in its earlier section.
project on Safety and Efficacy for New Techniques and
Imaging Using New Equipment to Support European Leg- METHODS AND MATERIALS
islation (SENTINEL).9,12 The literature on medical ethics and the implicit ICRP ethical
values were reviewed qualitatively, with a view to identifying
Pending the outcome of these developments, which may take a system, or set of principles/values that will help guide con-
some time, an interim approach is proposed here for the temporary behaviour particularly, but not exclusively, in radia-
medical area. It is consistent with the ICRP/IRPA con- tion protection of patients. The proposed system is designed, as
sultations. The proposed approach is global in its reach and far as is possible, to:

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• be presented using accessible language for the values and/or being of immediate importance to the pragmatic value set. All
are of well-established importance in the public and/or en-
principles
• be based on a small number (five) of core values which would vironmental health literature and, we believe, extending their
applicability to radiation protection in radiology will be
be easy to remember
• have the possibility of achieving more widespread recognition of value.
in medicine and
• not be in conflict with the ICRP/IRPA consultations in Human dignity It could be argued that respect for autonomy
is actually based on (a certain understanding of) human
the area.
dignity and thus the latter does not need to be invoked as an
additional value. We nevertheless prefer to explicitly mention
Terminology
it. Human dignity is more easily demonstrable as a cross-
When referring to justification, optimization and dose limi-
cultural concept than autonomy. All great religious and phil-
tation, the three “principles” of radiation protection, we

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osophical traditions recognize it. It appears in a contemporary
continue to use the term “principle” exclusively for those from
form at the beginning of the United Nations Universal Dec-
ICRP, whereas Beauchamp and Childress also use the term
laration of Human Rights.15
“principle”, and we use their term in introducing their prin-
ciples. However, once that is done, we substitute the term
Prudence One of the most discussed additions to the four
“value” when dealing with concepts or clusters of concepts
principles when it comes to public and/or environmental health
from medical ethics. This is to assist readability and avoid
is prudence or precaution. It is found in various written and oral
confusion.
traditions around the globe and was embraced by several sci-
entific and public meetings over the last few decades. It may be
Building blocks for the pragmatic value set paraphrased by stating that where an action potentially causes
Beauchamp and Childress developed four principles for bio- a serious irreversible harm, measures to protect against it must
medical ethics.5,6 These are the proposed building blocks for an be taken even if the causal relationships involved are not fully
ethics of radiological protection in medicine.6–8 established scientifically.16–18 This is further discussed in the
Results and Discussion sections.
Four principles
Respect for autonomy In the medical context, this value is to Honesty Honesty extends well beyond financial matters and
ensure that the patient is the main decision-maker in his or her includes openness and transparency with regard to the benefits
own case. Consideration for the individual’s point of view in and risks of procedures. Justice, intergenerational equity and
some form is probably part of medical professional ethics all inclusivity require that people are not deceived. Honesty, ve-
over the world. With regard to radiological protection, it sug- racity and truthfulness have therefore been suggested as guiding
gests that wherever possible, the imposition of a risk has to take values for the interaction between specialists and lay people
account of the individual’s volition, and this is a prerequisite for exposed to radiation. Accountability also arises as a matter of
justification. honesty that is relevant in the context of radiation protection.

Non-maleficence and beneficence “To abstain from doing The two sets of building blocks presented here are regrouped
harm” is one of the central features of the Hippocratic Oath, and and integrated together in the proposed Pragmatic Set of five
so is “working for the good of the patient”. Of course, it has Values presented in the Results section: we refer to respect for
always been understood that there may be situations where pain, autonomy and human dignity as one joint value, as we do to
or even damage, has to be inflicted to achieve healing, and thus non-maleficence and beneficence.
non-maleficence and beneficence need to be balanced. Both
principles, and the awareness of the fact that they sometimes Scenarios
work against each other, can be found in European, Arabian, Application of the system is illustrated in six clinical scenarios.
Indian and Chinese traditions. Each scenario is described and then scored as complying or not
complying with each of the values in the Pragmatic Set. The
Justice The “Golden Rule”—“Treat others as you would like to evaluation of compliance, or otherwise, is the personal judgment
be treated yourself”—is one of the most common ethical guide- of the authors. Compliance with a value is indicated as being
lines around the world. Even its wording is strikingly similar in strong (Y), weak (y) or neutral (2). Likewise, non-compliance is
different traditions. It can serve as a support for the principles of indicated as strong (N), weak (n) or neutral (2). Some aspects
non-maleficence and beneficence, but its greatest importance is in of the scenarios demonstrate compliance with a value, when
support of the value of justice, as it asks everyone to consider the considered from one perspective, and non-compliance, when
interests of the other as if they were his or her own. considered from another from another. Thus, it is possible to
score both (Y/y) and (N/n) for the same value.
Three related values
Several authors have raised the question if, perhaps, addi- RESULTS
tional principles/values might be needed.7,8,11 We reviewed Pragmatic working set of values and ICRP principles
their suggestions, keeping in mind the current needs of ra- We suggest that the approach of Beauchamp and Childress,
diological protection in medicine. Three are identified as proceeding from middle-level principles acceptable to different

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schools of ethics and demonstrably part of a worldwide “com- incomplete scientific evidence base, a clear and high-level
mon morality”, can be applied in radiation protection. It may be conclusion on the application of prudence is available from
helpful and advantageous to frame ethical dilemmas in radiology the 1998 statement of the Wingspread Conference on the
in terms of these values, rather than relying solely on the Precautionary Principle. It states that “When an activity raises
established principles of justification, optimization and dose threats of harm to human health or the environment, pre-
limitation. cautionary measures should be taken even if some cause and
effect relationships are not fully established scientifically”.16
Beauchamp and Childress’s principles are used to provide the This has a valid resonance in radiation protection of patients
first three values in the Pragmatic Set. For the first, we added and workers and has been reiterated in many and varied forms
Dignity, to respect for autonomy for the reasons already men- since.18–20
tioned in the methods section (Table 1). A corollary of dignity
and respect for autonomy is the requirement of “informed Honesty and truthfulness are considered virtues around the

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consent”. This idea is widespread in Western societies, although world, even though the exact degree of openness which should
it may encounter with some reservations in cultural contexts which be shown to, say, a seriously ill patient may be debatable. With
are more paternalistic. radiation risks, radiation protection has tended to favour
a somewhat closed and paternalistic approach, particularly in
Beauchamp and Childress’s second and third principles, non- dealings with the press, patients and public. However, there is
maleficence and beneficence, are presented as a single value in increasing agreement that it is important to communicate
the pragmatic set (Table 1). This has been done elsewhere, for openly, even our uncertainties, with honesty. Autonomous
instance, in the source ethics document, the Belmont Report individuals have a right to expect this (Table 1). Honesty also
on guidelines for protection of human subjects in research.17 carries an implied willingness to be accountable, and it is the
In the context of radiological protection, non-maleficence fifth value in the Pragmatic Set.
and beneficence together support the concept of justification
as well as that of optimization. In the latter case, application When conflict between the values arises, they need “balancing”,
may be somewhat more complicated, as the interests of the i.e. their relative importance has to be weighed in each case, and
wider community become a consideration. Weighing eco- their application must be carefully nuanced to take account of all
nomic and societal factors on the one hand, and individual the contributing issues.6 The values also need “specification”,
health on the other, is by no means an easy task, but common i.e. concrete rules or guidelines have to be derived for different
morality requires it should not be neglected. areas of application. Beauchamp and Childress discuss the
practical application of the values and how they may be “bal-
For radiological protection, Beauchamp and Childress’s fourth anced” and “specified” at length. Their work in these matters is
principle of justice is the main foundation of the concept of frequently cited and highly regarded.14,21,22
dose limitation, as it prevents inequities of harms and benefits.
It also implies due concern for fairness, particularly in our Scenarios
treatment of the most vulnerable, such as children, or Six scenarios are presented involving examinations conducted
radiation-sensitive individuals. This provides the third value in on individuals exposed in a medical setting. The intention is to
the Pragmatic Set. illustrate the application of the proposed values in a plausible
and diverse set of situations, indicate how the approach might
To these, we added the two additional values Prudence and initially be deployed and stimulate work that will be necessary
Honesty. Prudence is taken as a code for precaution and the to identify the approach that will best serve radiation pro-
precautionary principle, although it is generally taken to be tection in diagnostic imaging in the future. This inevitably
a broader concept than precaution. Prudence can be seen as an involves providing examples of situations that might prove
extension of non-maleficence, with an emphasis on our lack of problematic when judged against the pragmatic value set.
knowledge about the exact risks; for instance, the risks of However, it is not our intention to be unduly critical or to offer
small doses of radiation. There is much confusion about its prescriptive remedies to these situations here. Effective solutions
place in radiation protection. Hence, it is included explicitly as will inevitably have to be subject to evaluation and assessment in
the fourth value in the Pragmatic Set (Table 1). For the pur- the real world of departments delivering a day-to-day service.
pose of radiation protection, which must work out of an Instant solutions proposed here might well prove facile.

Table 1. Five pragmatic values/value sets to supplement the principles of the International Commission on Radiological Protection

Number Value set Source Comments

1 Dignity and autonomy 5, 7, 8, 15 Of the individual
2 Non-maleficence; beneficence 5, 17 Do no harm and do good
3 Justice 5, 7, 8 In the sense of fairness
4 Prudence/precaution 16, 18, 19, 20 Appears in precautionary principle
5 Honesty 8, this article Particularly in openness and transparency

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Figure 1, Scenario 1 delighted to find herself pregnant, but worried by the pros-
This presents a scenario involving Mr Black, a professor of or- pect that the child she is carrying may be damaged by the
thopaedic surgery. He holds a weekly outpatient clinic in scan. She reviews the information available on the Internet
a public hospital. He sees both new patients and follow-up cases. and finds the Food and Drug Administration attributes
His clinic is well resourced and is a model of efficiency, running a potential risk of future cancer to irradiation. She finds the
to time with little waiting around for patients. Prof. Black insists attributed level of risk unacceptable. 1 week later, the radi-
all patients attending have an up-to-date radiology examination ologist dealing with the case meets with her, assures her there
of the relevant part before he sees them. This obviously is is no significant risk, and advises she should not be con-
contrary to the principal of justification. The director of radi- cerned. She (the radiologist) further explains that even if the
ology and the medical physics expert advised him against this embryo had been damaged, it would not have implanted and
practice. His response is dismissive, pointing out that radiology would have been lost. After further researching the issue on
in their hospital is home to queues and waiting lists, whereas he the Internet, the patient finds what the radiologist put to her

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runs an efficient patient-friendly service. unconvincing, as she was 4 months pregnant at the time of
the scan. She fails to attend a further appointment and
He requires that patients bring their film folder or DVD to the decides to seek a termination.
clinic. He states it takes too long to get a radiology report which,
when received, may not address the issue he wants addressed. So The table at the bottom of Scenario 2 scores compliance with the
he reads the images himself. Pre-signed forms or authorized pragmatic value set. On the positive side is the fact that the
referrals on the information system are provided for patients, hospital asks the pregnancy question, and thereby tries not to do
and they are sent to radiology for the required examination. The harm. In doing this, it aligns with much of conventional prac-
Radiology Department are concerned that Prof. Black may by- tice. On the negative side, any member of the public could point
pass the department entirely if they refuse to participate, so out that asking someone if they are pregnant in a relatively
reluctantly do so. Prof. Black does not share any of these con- public place is an unreliable method of establishing their status.
cerns with his patients. Likewise, he does not discuss benefit/risk Nevertheless, the hospital feels it is following available advice for
information with them, which he dismisses as largely specula- good practice in the area.23 However, while this advice claims it
tive. He feels that as a doctor he is an advocate for his patients’ is based on current scientific evidence, it does not clearly ac-
interests and, in his view, acts accordingly. knowledge its dependence on value judgments. Hence, some
patients who are pregnant or members of the public could find
Mr Black is obviously of the paternalist school. The two-row the positions taken to be, for example, lacking in prudence. The
table at the bottom of the Scenario 1 panel (Figure 1) indicates hospital’s reasons for not undertaking a more rigorous assessment
how well his practice complies with the five-value pragmatic are that it is time consuming and inconvenient. The hospital has
set. Clearly, the practice fails all five on significant grounds, and been challenged on the practice by previous patients, and after
he scores a No (N) for each. With respect to Dignity/autonomy, review, felt it would be too disruptive to alter it.
this is not respected in the way the decision to conduct
examinations is taken, so this scores N (No). He also scores This approach can be faulted on the grounds of failing to re-
a small y (a limited yes) in recognition of his efforts to provide spect the autonomy of both the mother and possibly the
a timely efficient service respecting his patients. His practice embryo/foetus (N); exposing both to potential harm (N);
exposes many patients to unnecessary radiation risk with no failing to act prudently and follow the precautionary principle
benefit, so he scores an N under Non-maleficence. He reads the when there is possible but unproven risk (N); and not behaving
images himself which, some will argue, adds to the potential in a transparent way both before and after the examination
for harm. He scores N under Justice as either the patient, in- (N). Under the Justice heading, the behaviour of the hospital
surance or society will have to pay for all unnecessary and might be taken as relatively neutral. A (y) is scored under
possibly useless examinations. His timely efficient service also scores Dignity/autonomy, Non-maleficence and Honesty, for asking
a small y under this heading. He does not reckon on the possibility the pregnancy question, being willing to act on it and being
of risk and offers practically no information to the patient, so scores open/transparent within the limits of the professional advice
a clear N for the last two headings, Prudence and Honesty. available to it.

Figure 1, Scenario 2 The hospital’s approach is consistent with much of the prac-
This presents a scenario in which a female patient (mid-30s) is tice throughout the world.24,25 However, many of the areas in
referred to the radiology department of a moderate-sized which medicine has found itself involved in public scandals
district hospital for an elective non-urgent CT pelvic scan. Her are those where individual dignity and autonomy has been
family physician’s history justifies the scan in the opinion of the sacrificed to long-established and professionally sanctioned
radiologist. An appointment is arranged some months ahead, as practices.8,26 Issues around exposure of patients who are
she will be on holiday in the meantime. She attends the hospital at pregnant (and pregnant staff) provide many examples of
the appointed time and is asked if she is pregnant, or might be scenarios that might be better resolved in the context of
pregnant, to which she responds “no” as she “is careful”. a wider deliberation using the pragmatic value set than on the
basis of the legal or ICRP systems alone. Both afford in-
The patient has the examination, which reveals no pathology, teresting problems for reflection/analysis, but the broader
but also discloses that she is pregnant. She is unexpectedly perspective of Beauchamp and Childress’ and the additional

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values provide valuable perspectives that help view the prob- individual health assessments for symptom-free patients referred
lem more holistically. by other practitioners, self-referred or who self-present. Dr
Amber explains all the risks of interventional cardiac procedures
Figure 1, Scenario 3 including the potential radiation risks. She explains the radiation
This scenario deals with the practice of Dr Amber, an inter- risk is unproven. She conducts the procedures on request
ventional cardiologist in private practice. She undertakes and with formal consent. Separate fees are charged for the

Figure 1. Scenarios and compliance with the pragmatic value set. The main features of each scenario are described in the panels.
Compliance with value is indicated as being strong (Y), weak (y) or non-existent (2) in the small table at the bottom of each panel.
Likewise, Non-compliance is indicated as strong (N), weak (n) or non-existent (2). Some aspects of scenarios demonstrate
compliance with a value from one perspective and non-compliance from another. Thus, it is possible to score both (Y/y) and (N/n)
under the same heading.

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consultation and for the procedure. The procedures are un- too much time to respond to detailed requests for further in-
dertaken in the associated imaging centre, in which she is formation. Second, and more important in her mind, that
a shareholder. The financial interest is not disclosed to the informed parents may withdraw their children from the ex-
patient. amination. The examination is clearly justified from the history
provided by the referrer and is technically well performed and
In terms of compliance with the pragmatic value set, the scores reported on efficiently and promptly.
are presented in the bottom of the panel of Scenario 3
(Figure 1). Dr Amber scores highly on respecting the auton- This scenario raises interesting problems. Clearly the dignity/
omy of the individual (Y) and on Honesty (Y) as she takes a lot autonomy of the child is respected in ensuring the examination
of trouble to inform the patient and get consent. She also is justified (Y). However, the radiologist’s behaviour towards the
scores an (n) for Dignity/autonomy as she does not share the parents does not respect their dignity/autonomy and their role as
uncertainty about risk with the patient and an (n) for Honesty legal proxies for the patient (N). Behaviour with respect to the

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—arising from non-disclosure of her shareholder interest in Honesty category was also unsatisfactory. Patients or their legal
the imaging facility. On the other areas, including Non- proxies are entitled to, and should receive, honest transparent
maleficence, Justice, and Prudence, she scores (N) owing to the information, when they request it (N). The other categories,
probability that harm may flow from the unjustified and un- Non-maleficence, Prudence, and Justice were all exemplary and
necessary examinations. hence each scores a yes (Y).

Figure 1, Scenario 4 Figure 1, Scenario 6

This scenario deals with a case in which Mr Grey is referred for Many issues arise in a subset of human exposures that appear
an examination as part of his follow-up for previous cancer, like medical examinations, but are not conducted for the benefit
from which he appears to be in remission. A full abdominal CT of the person involved, i.e. they are not medical procedures in
including a contrast phase is undertaken; no change is reported the normal sense of the term (e.g. drug searches, weapon
since the last scan. The risk of a CT scan is explained to Mr Grey searches, screening of migrants etc.).27,28
and consent is obtained. The dose noted for Mr Grey is the same
as that in the original diagnostic investigation. This is not war- Scenario 6 deals with Ms Whyte, age 28 years, who arrives at the
ranted, as a simpler procedure could have elicited the in- airport after a long-haul flight. She is behaving nervously, and
formation required in the follow-up study. The problem here is sniffer dogs alert the authorities to check her baggage. They find
a failure of both justification and optimization. It might arise a small amount of cannabis in one of her bags, and she continues
from inadequate information provided in the referral, or in- to behave suspiciously. After some deliberation, the authorities
adequate radiology protocols that fail to distinguish between the decide that she may be a drug mule and request an abdominal/
follow-up and the initial more demanding and exploratory di- pelvic CT scan. She is healthy with no symptoms and referred to
agnostic investigations. Unacceptably high dosage for examina- a local hospital with which the customs service has a contract to
tions can arise from many sources including inadequately provide scans in such circumstances. She is not apprised of the
differentiated protocols that do not distinguish between initial radiation or any other risks and permission is not sought. She
referrals and follow-up investigations. strenuously objects to the procedure, but eventually allows it to be
performed so that she can go home, as she knows she is innocent.
In Scenario 4, the Dignity/autonomy of the individual is recog-
nized through explaining the risk and obtaining consent (Y). The scan is performed promptly, competently and with opti-
However, there is also a failure in this area as the same protocol is mized dose. The report is made available to the customs service.
applied to all patients where important differences exist (n). The It shows no sign of concealed drugs in body cavities, but also
consequences of this are inadequately recognized and give rise to shows Ms Whyte to be pregnant. She is promptly advised ac-
additional problems. These include failures under the headings of cordingly by the customs officer, who also advises her of her
Justice (n) and Non-maleficence (N) owing to unnecessary pregnancy. Ms Whyte had thought she might be pregnant but
exposures. An (N) is also scored under Prudence and Honesty. was not sure. She is distressed by the situation, but the customs
officer is unable to offer her any advice on the pregnancy or
Figure 1, Scenario 5 possible radiation damage to her foetus.
This scenario concerns Dr Browne, an experienced well-
trained paediatric radiologist. A 2-year-old boy is referred for The hospital assumes this scan is justified by the customs service
a whole-body CT examination. Dr Browne believes the exam- which, in turn, assumes the hospital deals with this issue. In the
ination is justified. She advises the child’s parents, his legal ICRP system, it has no value to Ms Whyte as a medical pro-
proxies, that the examination should proceed. The parents cedure, and hence is not medically justified. The requirements
enquire about the risks, if any, from the examination. She (Dr for consent and possibly for confidentiality are also dispensed
Browne) reassures them that there are none they need consider. within the process described here.8,28 In the circumstances, the
She deflects further questioning by explaining that the hospital hospital should have robust authorization processes to mandate
is the leading one in the country for this type of examination in such departures from normal practices and ensure public con-
young children (which is true) and it will not be better per- fidence cannot be undermined. Likewise, the customs service
formed elsewhere. Her reasons for deflecting the question, must have an open and transparent protocol detailing how such
which she does as a matter of policy, are two-fold. First, it takes scan requests are justified and who the authorizing officer is.

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In some countries, a judge must underwrite the request for As the world shrinks to a “global village”, there is a need to
a non-medical radiological examination, as the risks and benefits develop approaches to decision-making that are acceptable for
involved are essentially social rather than medical.8,27,28 people from different cultural backgrounds. The enterprise of
radiology is, more than most medical activities, truly global in its
This scenario appears as negative under all the headings in the clinical application, research base, industrial infrastructure and
table at the bottom of Scenario 5 (N). Ms Whyte’s dignity/ regulatory framework. Thus, it is now important to have
autonomy are put to one side in the performance of the ex- a matching global framework for ethics to guide its practice in
amination and perhaps even more clearly in disclosing the scan medicine, into the future.7,8 Patients travel and will find them-
results to third parties, particularly in connection with her selves in the presence of doctors brought up in a different cultural
pregnancy. All of these are compounded by a justification pro- context. Doctors travel and will encounter patients and peers
cess that falls between stools, and fails to establish the subject is from radically different cultures in different cultural contexts.
pregnant before the examination is performed. There are also International organizations such as the World Health Organisa-

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problems under the headings of non-maleficence, justice, pru- tion, International Atomic Energy Agency, European Commission
dence, and honesty. On the positive side, there is a social benefit, and ICRP and numerous professional bodies have to present their
which is shown as a (Y) under justice accompanying the (N) findings in language that is not alien to large groups of health
already scored there on Ms Whyte’s behalf. The customs officers professionals and lay populations throughout the world.
treat her as well as the situation allows, allowing a small (y)
under dignity/autonomy. This scenario illustrates the problems The point can be made, however, that it is not enough to refer to
encountered in reaching a balanced judgment in these sit- a “common morality” and merely claim that “all persons com-
uations, but the pragmatic value set helps flag the issues involved mitted to morality” would agree with Beauchamps and Child-
more clearly. ress’s principles. Rather, we have to base our reasoning on
principles that can be shown to exist and demand respect in
DISCUSSION AND CONCLUSION different cultural contexts and indeed be backed by, or consis-
A pragmatic set of five values is proposed to help guide evalu- tent with, the time-honoured written and oral traditions that
ation of day-to-day activities in diagnostic imaging. The need for people around the world refer to for moral guidance. There is
such a practical set of values arises from the high levels of social not space here to go into detail on this approach. Suffice to say
expectation with respect to behaviour of health professionals in that we are of the opinion that the principles proposed by
the area, particularly in the event of accidents or other events Beauchamp and Childress can indeed be demonstrated in a wide
that become the subject of public scrutiny. Three of the values range of cultural, religious and philosophical contexts.5,7,8
are derived from the well-regarded Beauchamp and Childress’
approach, which are independent of ethical theories and cul- The importance of the two additional values (prudence and
tures. The other two, prudence and honesty, are derivable from honesty) is often overlooked in discussions of radiation pro-
the Beauchamp and Childress’ approach, but are explicitly in- tection in the radiology. At this stage, they may be viewed as
cluded to help address practical concerns in areas where the buttresses for the core Beauchamp and Childress values.8 When
day-to-day culture of radiation protection may be somewhat a fully developed and widely agreed system is well embedded in
distanced from contemporary public values. This is particularly radiology, the need to state these explicitly may decline.
so in the case of prudence and precaution, when dealing with the
uncertainties around radiation risks; likewise with honesty and With regard to prudence, ICRP appears to support the Pre-
transparency, and when dealing with matters of consent and cautionary Principle, particularly in adopting the linear no-
communication with patients. All of these will require nuanced threshold (LNT) model for extrapolation to low doses. Yet, it also
application that also addresses balancing the competing demands states “… calculation of the number of cancer deaths based on
of the values in an intelligent, sensitive and skilled manner. collective effective doses from trivial individual doses should be
avoided”. This is justified by saying that such calculations would be
As to the origin of the Beauchamp and Childress system, the authors “biologically and statistically very uncertain”.1,29 As the Pre-
believe it is rooted in “common morality”, i.e. “not relative to cul- cautionary Principle applies precisely to those cases involving
tures or individuals, because it transcends both”.7 This is one of the uncertainty, the ICRP position here seems to be somewhat self-
strengths of their approach.5,7 Initially, Beauchamp and Childress contradictory. The United Nations Scientific Committee on the
were not speaking about different cultures. They were trying to find Effects of Atomic Radiation position, discouraging population risk
middle-level principles that both could agree on. Beauchamp was calculations for small doses, also requires more robust justifica-
a utilitarian, i.e. for him the consequences of one’s actions were the tion with respect to prudence and the Precautionary Principle.30
only thing that counted, while Childress based himself on de-
ontological arguments and was thus mainly concerned with an An equivocal approach to prudence has been adopted at a sur-
individual’s duties towards other individuals (Appendix A). These prisingly high level in some professional bodies and is also fav-
two approaches are usually considered incompatible, as their fun- oured by some well-regarded experts in medical physics and
damental criteria for moral good are different. Nevertheless, the radiation protection.31–33 For example, an American Association
authors saw that they could find common ground. It was not that of Physicists in Medicine statement appears to favour, on the
the utilitarian and the deontologist each contributed one or more surface at least, emphasizing the benefits of diagnostic inves-
principles which the other had to match. Rather, both could fully tigations without reckoning the risks.33 A more extreme version of
agree with all four principles, albeit for different reasons. this is encountered among some practitioners who are linear no

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threshold sceptics, do not advise patients about risk and disregard contemporary social and ethical thought. Health professionals
it in their approach to diagnosis or treatment.8,31,32,34 Behaving as should more easily and fluently relate to them, and apply them,
though there is no risk is inconsistent with the precautionary with greater ease. They are less likely to allow issues be missed,
principle, even though doing so may have professional advocates be overlooked or be opportunistically neglected. This applies
and may, as noted above, appear to be endorsed in some pub- even where the professionals involved are not experts in ethics,
lications. Thus, the value of prudence needs to be re-emphasized as the language involved is mainly intuitive and familiar to those
in medical radiation protection and to be applied with conviction. in medicine. On the other hand, the language of radiation
protection often seems arcane and mysterious to those not
The culture of radiation protection in medicine has come to rely deeply involved.26 Radiology is essentially a medical activity and
heavily on professionals avoiding talking to patients about the is likely to benefit from sharing in the safety/ethics culture and
uncertainties involved, and assuring them that everything is fine. language with the rest of medicine.
This is no longer acceptable, both as a purely practical matter

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and, more important, as a consequence of the emphasis placed The pragmatic value set proved to be an effective roadmap in
on the autonomy of the individual in contemporary thinking. the evaluation of six scenarios. It helps reaching decisions that
are likely to be socially acceptable and respected. The set is not
The value of autonomy of the individual implies that patients intended to replace the well-established and legally mandated
have the right to know of possible risk, so that they can make principles of justification and optimization championed by
good informed decisions about their own healthcare. This, in ICRP and by governments in legislation. Rather, they will
turn, implies that radiologists, other healthcare providers and supplement these and add considerably to them in aiding
radiation protection professionals have a duty to inform patients decision-making in socially sensitive areas. Pending the out-
on benefits and risks, on the basis of the best available estimates come of the current ICRP/IRPA initiatives, the values give an
and the associated uncertainties.7,8,35–38 This is even further intuitively clear and credible basis for assessing events, pro-
emphasized by the related value of human dignity. The message tocols and behaviour of health professionals in radiological
should be that there may, or may not, be a significant risk; we do imaging. In addition, the value set may find application in
not know the exact size, but the best estimates of the scientific areas such as nuclear medicine and radiotherapy which are not
and medical community are conservative and are discounted in explored here.
the decision to recommend an examination. Excessive re-
assurance is not appropriate in the face of real uncertainty and ACKNOWLEDGMENTS
ultimately damages credibility. Furthermore, patients constantly J Malone is grateful to the trustees of the Robert Boyle Foundation
encounter and cope with larger uncertainties in other aspects of and to the European Commission’s SENTINEL (Safety and Effi-
the medical interventions they experience. cacy for New Techniques and Imaging Using New Equipment to
Support European Legislation) project for their support of this
Because of their basis in medical ethics and social expectation, work. F Zölzer thankfully acknowledges support by the OPERRA
the pragmatic value set could reasonably be expected to achieve (Open Project for the European Radiation Research Area).
a higher level of recognition in medicine than the ICRP prin-
ciples. They might, thereby, help facilitate the transfer of core FUNDING
messages of radiation protection more effectively to its largest This project received no direct funding, but drew on experience
area of application. They should help movement towards a style in various employments and projects in which the authors were
of behaviour in radiation protection that is consistent with involved.

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APPENDIX A BRIEF EXPOSITION OF “WESTERN” a maximum of good over harm. In 1973, ICRP explicitly recom-
ETHICAL THEORIES mended cost–benefit analysis as a tool for optimization, strength-
The recommendations of the ICRP obviously presuppose certain ening the notion that the underlying concept was utilitarian.A9
elements of moral philosophy, but these are not always made
explicit. Individual authors,A1,2 among them members of the The second influence, deontological ethics, considers as morally
commission itself,A3,4 have identified influences mainly of util- valid nothing else than our “duty” (Greek: “deon”), and thus
itarian and deontological ethics. insists that we should never, even if we expected our action to
cause more good than harm, neglect the respect for the individual
Utilitarianism has arguably had the stronger impact at least person. And thus, according to the German philosopher Im-
during the first few decades of the ICRP. It is a concept de- manuel Kant (1724–1804), we should act in accordance with the
veloped by the British philosophers Jeremy Bentham Categorical Imperative, which, in one of its formulations, says,
(1748–1832)A5 and John Stuart Mill (1806–1873).A6 Both con- “Act in such a way that you treat humanity, whether in your own

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sidered the outcome, or “utility”, of our actions as the only valid person or in the person of any other, never merely as a means to
criterion for their moral goodness or badness: if what we do an end”.A10 It seems that during the 1970s, the ICRP recognized
causes more benefit than harm, it is good; if it causes more harm that focusing only on the principle of “as low as reasonably
than benefit, it is bad. This is nicely captured in the phrase. “It is achievable” did not offer enough protection for the individual. If
the greatest happiness of the greatest number of people that is the “reasonable” is judged on the basis of a cost–benefit analysis
the measure of right and wrong”. The clearest reflection in the only, we cannot rule out that somebody would be treated as
ICRP system of this kind of thinking is certainly the principle of a means for somebody else’s ends. For instance, we might find it
justification: “Any decision that alters the radiation exposure reasonable, or even imperative, to expose one individual to a rel-
situation should do more good than harm”. When it first atively high risk in order to save many others from a relatively low
appeared in 1977 (Publication 26), it was worded differently, but one, so that the collective risk can be kept at a minimum. But,
equally utilitarian: “No practice shall be adopted unless its in- that would be unfair to the one highly exposed person. ICRP
troduction produces a positive net benefit”.A7 The second prin- therefore introduced dose limitation as a third principle of radi-
ciple of radiological protection, optimization, is also based on ation protection in 1977: “The total dose to any individual from
a consideration of outcomes: “The likelihood of exposure, the regulated sources in planned exposure situations… should not
number of people exposed and the magnitude of their individual exceed the limits specified”.A7 The recommended dose limits were
doses shall be kept as low as reasonably achievable, taking into supposed to keep the risk for professionally exposed radiation
account economic and societal factors”. It was introduced by workers in line with the occupational risk in other industrial
ICRP in as early as 1958, although it was worded a little dif- sectors, namely those that have been classified as relatively safe.
ferently at the time: “as low as readily achievable” (ALARA).A8 Apart from dose limitation, the influence of deontological ethics
Either way, it became known as the ALARA principle. It is on radiation protection has been slow to gain ground, but is now
generally understood as urging not only a net benefit, but the subject of much discussion.

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