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Pragmatic ethical basis for radiation protection in diagnostic radiology

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Objective: Medical ethics has a tried and tested literature and a global active research community. Even among health professionals, literate and fluent in medical ethics, there is low recognition of radiation protection principles such as justification and optimization. On the other hand, many in healthcare environments misunderstand dose limitation obligations and incorrectly believe patients are protected by norms including a dose limit. Implementation problems for radiation protection in medicine possibly flow from apparent inadequacies of the International Commission on Radiological Protection (ICRP) principles taken on their own, coupled with their failure to transfer successfully to the medical world. Medical ethics, on the other hand, is essentially global, is acceptable in most cultures, is intuitively understood in hospitals, and its expectations are monitored, even by managements. This article presents an approach to ethics in diagnostic imaging rooted in the medical tradition, and alert to contemporary social expectations. ICRP and the International Radiation Protection Association (IRPA), both alert to growing ethical concerns, organized a series of consultations on ethics for general radiation protection in the last few years. Methods: The literature on medical ethics and implicit ICRP ethical values were reviewed qualitatively, with a view to identifying a system that will help guide contemporary behaviour in radiation protection of patients. Application of the system is illustrated in six clinical scenarios. The proposed system is designed, as far as is possible, so as not to be in conflict with the conclusions emerging from the ICRP/IRPA consultations. Results and conclusion: A widely recognized and well-respected system of medical ethics was identified that has global reach and claims acceptance in all cultures. Three values based on this system are grouped with two additional values to provide an ethical framework for application in diagnostic imaging. This system has the potential to be robust and to reach conclusions that are in accord with contemporary medical, social and ethical thinking. The system is not intended to replace the ICRP principles. Rather, it is intended as a well-informed interim approach that will help judge and analyse situations that arouse ethical concerns in radiology. Six scenarios illustrate the practicality of the value system in alerting one to possible deficits in practice. Advances in knowledge: Five widely recognized values and the basis for them are identified to support the contemporary practice of diagnostic radiology. These are essential to complement the widely used ICRP principles pending further development in the area.
Content may be subject to copyright.
BJR doi: 10.1259/bjr.20150713
Received:
28 August 2015
Revised:
14 December 2015
Accepted:
17 December 2015
© 2015 The Authors. Published by the British Institute of Radiology under the terms
of the Creative Commons Attribution-NonCommercial 4.0 Unported License http://
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commercial reuse, provided the original author and source are credited.
Cite this article as:
Malone J, Z¨
olzer 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
1
JIM MALONE PhD, FIPEM and
2
FRIEDO Z ¨
OLZER, PhD
1
School of Medicine, Trinity Centre for Health Sciences, St Jamess Hospital Dublin, Dublin, Ireland
2
Department of Radiology, Toxicology and Civil Protection, Faculty of Health and Social Studies, University of South Bohemia in
ˇ
Cesk´
e
Budˇ
ejovice,
ˇ
Cesk´
e Budˇ
ejovice, Czech Republic
Address correspondence to: Prof. Jim Malone
E-mail: jfmalone@tcd.ie
Objective: Medical ethics has a tried and tested literature
and a global active research community. Even among
health professionals, literate and fluent in medical ethics,
there is low recognition of radiation protection principles
such as justification and optimization. On the other hand,
many in healthcare environments misunderstand dose
limitation obligations and incorrectly believe patients are
protected by norms including a dose limit. Implementa-
tion problems for radiation protection in medicine
possibly flow from apparent inadequacies of the In-
ternational Commission on Radiological Protection
(ICRP) principles taken on their own, coupled with their
failure to transfer successfully to the medical world.
Medical ethics, on the other hand, is essentially global, is
acceptable in most cultures, is intuitively understood in
hospitals, and its expectations are monitored, even by
managements. This article presents an approach to ethics
in diagnostic imaging rooted in the medical tradition, and
alert to contemporary social expectations. ICRP and the
International Radiation Protection Association (IRPA),
both alert to growing ethical concerns, organized a series
of consultations on ethics for general radiation protection
in the last few years.
Methods: The literature on medical ethics and implicit
ICRP ethical values were reviewed qualitatively, with
a view to identifying a system that will help guide
contemporary behaviour in radiation protection of
patients. Application of the system is illustrated in
six clinical scenarios. The proposed system is designed,
as far as is possible, so as not to be in conflict with
the conclusions emerging from the ICRP/IRPA
consultations.
Results and conclusion: A widely recognized and well-
respected system of medical ethics was identified that
has global reach and claims acceptance in all cultures.
Three values based on this system are grouped with
two additional values to provide an ethical framework
for application in diagnostic imaging. This system has
the potential to be robust and to reach conclusions that
are in accord with contemporary medical, social and
ethical thinking. The system is not intended to replace
the ICRP principles. Rather, it is intended as a well-
informed interim approach that will help judge and
analyse situations that arouse ethical concerns in
radiology. Six scenarios illustrate the practicality of
the value system in alerting one to possible deficits in
practice.
Advances in knowledge: Five widely recognized values
and the basis for them are identified to support the
contemporary practice of diagnostic radiology. These are
essential to complement the widely used ICRP principles
pending further development in the area.
INTRODUCTION
The system of radiation protection in the great majority of
countries in the world is based on the recommendations of
the International Commission on Radiological Protection
(ICRP).
1
The publications of ICRP are specically designed
for radiation protection, and are based on a solid scientic
evidential base, combined with value judgments that allow
it be applied to practical problems in industry, medicine,
education, research and in everyday life. Some of the values
on which ICRP relies are articulated, but many are implied
and not explicitly present. The source documents in which
ICRP values are most clearly articulated are the recom-
mendations of the main commission in publications 26, 60
and 103.
13
With respect to medical uses, publication 105 is
also important, although it adds little, if anything, to the
principles.
4
In medicine, there is a longstanding system of values
stretching back to the Hippocratic Oath, which recog-
nizes the need for care and ethical sensitivity in the
way patients are treated and treatments are delivered.
Theresultantcorpusofknowledgeandexperienceis
impressive. Medical ethics has a tried and tested teaching lit-
erature for undergraduates and postgraduates, as well as an
active research community throughout the world. Approaches
have evolved that are essentially global and are acceptable in
most cultures.
57
For the most part, scholarship in medical ethics does not at-
tend to the problems in radiation protection. In practice, it
appears there is an unwritten assumption that matters relating
to radiation are dealt with in a separate system and medical/
general ethicists have not engaged with it. In consequence,
radiation protection in medicine has enjoyed exceptional in-
dependence, which allowed it unique access to management
and resources. The counterpoint is that the ethical issues in
radiation protection have low recognition in the medical world,
with the exception of a handful of radiation protection spe-
cialists who advise in the area. For example, patients are
afforded some protection by advisory diagnostic reference
levels. This, in our experience, leads to the mistaken belief
among many healthcare professionals that patients are pro-
tected by good practices which include limits on total radiation
dose. This illustrates the somewhat isolated position that ra-
diation protection has, until recently, occupied vis- `
a-vis con-
temporary social and ethical thinking and leaves it exposed on
some important matters.
The systems of medical ethics and the ICRP system for radiation
protection overlap signicantly. However, there is no simple way
of mapping one onto the other.
79
Analysis of the ICRP system
identies different strands of Western utilitarian and de-
ontological ethics, although the impact of some of these has
been attenuated with time (Appendix 1). Notwithstanding, it is
likely that a widely recognized approach to medical ethics may
prove helpful.
Recently, the global nature of radiation protection has been
explicitly recognized in ICRP Task Group 94 on Ethics of
Radiological Protection.
10
This is mandated to identify the
basic values behind the system and their mutual relation-
ships. It is not expected to rewrite the principles of radiation
protection but rather show how they are compatible with
and rooted in a broadly accepted common morality.
The work of this task group has been informed by a series
of workshops/consultations held in Asia, Europe and the
Americas which have looked at the ethical basis of radio-
logical protection. These have been organized jointly by
IRPA (International Radiation Protection Association) and
ICRP.
10,11
In addition, the European Commission has sup-
ported enquiries into the ethical basis for radiation pro-
tection in its wide-ranging Open Project for the European
Radiation Research Area (OPERRA), as well as in its earlier
project on Safety and Efcacy for New Techniques and
Imaging Using New Equipment to Support European Leg-
islation (SENTINEL).
9,12
Pending the outcome of these developments, which may take
some time, an interim approach is proposed here for the
medical area. It is consistent with the ICRP/IRPA con-
sultations. The proposed approach is global in its reach and
will help issues arising in radiology be judged and reected on,
not just against the ICRP principles, but also taking on board
contemporary thinking on social, medical and ethical
concerns.
10
The proposed approach in this article is based on a set of
principles/values that can be applied to problems in medical
radiation protection and that potentially have high recognition
in medicine. In our view, the approach to ethical decision-
making in medicine proposed by Beauchamp and Childress
provides a good basis to this aim.
57,13
Their Principles of
Biomedical Ethics, rst published in 1979, is highly regarded
and reached its seventh edition in 2012.
7,13,14
In it, the authors
suggest that ethical questions in medicine can be addressed by
referring to four basic principles:
Respect for autonomy (of the individual)
Non-malecence (do not harm)
Benecence (do good)
Justice (be fair).
These principles are rooted in common morality. They are of
sufcient generality and exibility to be widely deployed in
medicine and, by extension, in radiology.
A closer look at ethics traditions as well as social expectations
identies additional values which are also relevant for ethical
decision-making in the radiological context. While these are
implied by Beauchamp and Childresss basic principles, it is
valuable to give them the additional emphasis of being spe-
cically mentioned. The most important of these, in our
view, are:
prudence: (keep in mind possible long-term risks of
actions) and
honesty: (share knowledge with those concerned truthfully).
The notion of prudence is respected across cultures and reli-
gions. It is generally understood to be at the heart of the Pre-
cautionary Principle, which is highly valued in dealing with
scientic problems where action is required in the absence of
denitive data. Honesty, in the sense used here is often thought
as working in an open and transparent manner.
All of the principles are described and explored more fully in
the Building Blocks section of the Methods and Materials, in
the Pragmatic Value Set section of the Results and in the
Discussion and Conclusion section. The Methods and
Materials section is followed by the Results section, which
notjustdetailsthepragmaticsetofve values, but also
provides a set of scenarios illustrating their deployment. The
article ends with an extended Discussion and Conclusion
section.
METHODS AND MATERIALS
The literature on medical ethics and the implicit ICRP ethical
values were reviewed qualitatively, with a view to identifying
a system, or set of principles/values that will help guide con-
temporary behaviour particularly, but not exclusively, in radia-
tion protection of patients. The proposed system is designed, as
far as is possible, to:
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olzer
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be presented using accessible language for the values and/or
principles
be based on a small number (ve) of core values which would
be easy to remember
have the possibility of achieving more widespread recognition
in medicine and
not be in conict with the ICRP/IRPA consultations in
the area.
Terminology
When referring to justication, optimization and dose limi-
tation, the three principlesof radiation protection, we
continue to use the term principleexclusively for those from
ICRP, whereas Beauchamp and Childress also use the term
principle, and we use their term in introducing their prin-
ciples. However, once that is done, we substitute the term
valuewhen dealing with concepts or clusters of concepts
from medical ethics. This is to assist readability and avoid
confusion.
Building blocks for the pragmatic value set
Beauchamp and Childress developed four principles for bio-
medical ethics.
5,6
These are the proposed building blocks for an
ethics of radiological protection in medicine.
68
Four principles
Respect for autonomy In the medical context, this value is to
ensure that the patient is the main decision-maker in his or her
own case. Consideration for the individuals point of view in
some form is probably part of medical professional ethics all
over the world. With regard to radiological protection, it sug-
gests that wherever possible, the imposition of a risk has to take
account of the individuals volition, and this is a prerequisite for
justication.
Non-malecence and benecence To abstain from doing
harmis one of the central features of the Hippocratic Oath, and
so is working for the good of the patient. Of course, it has
always been understood that there may be situations where pain,
or even damage, has to be inicted to achieve healing, and thus
non-malecence and benecence need to be balanced. Both
principles, and the awareness of the fact that they sometimes
work against each other, can be found in European, Arabian,
Indian and Chinese traditions.
Justice The Golden Rule”—“Treat others as you would like to
be treated yourself”—is one of the most common ethical guide-
lines around the world. Even its wording is strikingly similar in
different traditions. It can serve as a support for the principles of
non-malecence and benecence, but its greatest importance is in
support of the value of justice, as it asks everyone to consider the
interests of the other as if they were his or her own.
Three related values
Several authors have raised the question if, perhaps, addi-
tional principles/values might be needed.
7,8,11
We reviewed
their suggestions, keeping in mind the current needs of ra-
diological protection in medicine. Three are identied as
being of immediate importance to the pragmatic value set. All
are of well-established importance in the public and/or en-
vironmental health literature and, we believe, extending their
applicability to radiation protection in radiology will be
of value.
Human dignity It could be argued that respect for autonomy
is actually based on (a certain understanding of) human
dignity and thus the latter does not need to be invoked as an
additional value. We nevertheless prefer to explicitly mention
it. Human dignity is more easily demonstrable as a cross-
cultural concept than autonomy. All great religious and phil-
osophical traditions recognize it. It appears in a contemporary
form at the beginning of the United Nations Universal Dec-
laration of Human Rights.
15
Prudence One of the most discussed additions to the four
principles when it comes to public and/or environmental health
is prudence or precaution. It is found in various written and oral
traditions around the globe and was embraced by several sci-
entic and public meetings over the last few decades. It may be
paraphrased by stating that where an action potentially causes
a serious irreversible harm, measures to protect against it must
be taken even if the causal relationships involved are not fully
established scientically.
1618
This is further discussed in the
Results and Discussion sections.
Honesty Honesty extends well beyond nancial matters and
includes openness and transparency with regard to the benets
and risks of procedures. Justice, intergenerational equity and
inclusivity require that people are not deceived. Honesty, ve-
racity and truthfulness have therefore been suggested as guiding
values for the interaction between specialists and lay people
exposed to radiation. Accountability also arises as a matter of
honesty that is relevant in the context of radiation protection.
The two sets of building blocks presented here are regrouped
and integrated together in the proposed Pragmatic Set of ve
Values presented in the Results section: we refer to respect for
autonomy and human dignity as one joint value, as we do to
non-malecence and benecence.
Scenarios
Application of the system is illustrated in six clinical scenarios.
Each scenario is described and then scored as complying or not
complying with each of the values in the Pragmatic Set. The
evaluation of compliance, or otherwise, is the personal judgment
of the authors. Compliance with a value is indicated as being
strong (Y), weak (y) or neutral (2). Likewise, non-compliance is
indicated as strong (N), weak (n) or neutral (2). Some aspects
of the scenarios demonstrate compliance with a value, when
considered from one perspective, and non-compliance, when
considered from another from another. Thus, it is possible to
score both (Y/y) and (N/n) for the same value.
RESULTS
Pragmatic working set of values and ICRP principles
We suggest that the approach of Beauchamp and Childress,
proceeding from middle-level principles acceptable to different
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schools of ethics and demonstrably part of a worldwide com-
mon morality, can be applied in radiation protection. It may be
helpful and advantageous to frame ethical dilemmas in radiology
in terms of these values, rather than relying solely on the
established principles of justication, optimization and dose
limitation.
Beauchamp and Childresss principles are used to provide the
rst three values in the Pragmatic Set. For the rst, we added
Dignity, to respect for autonomy for the reasons already men-
tioned in the methods section (Table 1). A corollary of dignity
and respect for autonomy is the requirement of informed
consent. This idea is widespread in Western societies, although
it may encounter with some reservations in cultural contexts which
are more paternalistic.
Beauchamp and Childresss second and third principles, non-
malecence and benecence, are presented as a single value in
the pragmatic set (Ta ble 1 ). This has been done elsewhere, for
instance, in the source ethics document, the Belmont Report
on guidelines for protection of human subjects in research.
17
In the context of radiological protection, non-malecence
and benecence together support the concept of justication
as well as that of optimization. In the latter case, application
may be somewhat more complicated, as the interests of the
wider community become a consideration. Weighing eco-
nomic and societal factors on the one hand, and individual
health on the other, is by no means an easy task, but common
morality requires it should not be neglected.
For radiological protection, Beauchamp and Childresssfourth
principle of justice is the main foundation of the concept of
dose limitation, as it prevents inequities of harms and benets.
It also implies due concern for fairness, particularly in our
treatment of the most vulnerable, such as children, or
radiation-sensitive individuals. This provides the third value in
the Pragmatic Set.
To these, we added the two additional values Prudence and
Honesty. Prudence is taken as a code for precaution and the
precautionary principle, although it is generally taken to be
a broader concept than precaution. Prudence can be seen as an
extension of non-malecence, with an emphasis on our lack of
knowledgeabouttheexactrisks;forinstance,therisksof
small doses of radiation. There is much confusion about its
place in radiation protection. Hence, it is included explicitly as
the fourth value in the Pragmatic Set (Tabl e 1 ). For the pur-
pose of radiation protection, which must work out of an
incomplete scientic evidence base, a clear and high-level
conclusion on the application of prudence is available from
the 1998 statement of the Wingspread Conference on the
Precautionary Principle. It states that When an activity raises
threats of harm to human health or the environment, pre-
cautionary measures should be taken even if some cause and
effect relationships are not fully established scientically.
16
This has a valid resonance in radiation protection of patients
and workers and has been reiterated in many and varied forms
since.
1820
Honesty and truthfulness are considered virtues around the
world, even though the exact degree of openness which should
be shown to, say, a seriously ill patient may be debatable. With
radiation risks, radiation protection has tended to favour
a somewhat closed and paternalistic approach, particularly in
dealings with the press, patients and public. However, there is
increasing agreement that it is important to communicate
openly, even our uncertainties, with honesty. Autonomous
individuals have a right to expect this (Table 1). Honesty also
carries an implied willingness to be accountable, and it is the
fth value in the Pragmatic Set.
When conict between the values arises, they need balancing,
i.e. their relative importance has to be weighed in each case, and
their application must be carefully nuanced to take account of all
the contributing issues.
6
The values also need specication,
i.e. concrete rules or guidelines have to be derived for different
areas of application. Beauchamp and Childress discuss the
practical application of the values and how they may be bal-
ancedand speciedat length. Their work in these matters is
frequently cited and highly regarded.
14,21,22
Scenarios
Six scenarios are presented involving examinations conducted
on individuals exposed in a medical setting. The intention is to
illustrate the application of the proposed values in a plausible
and diverse set of situations, indicate how the approach might
initially be deployed and stimulate work that will be necessary
to identify the approach that will best serve radiation pro-
tection in diagnostic imaging in the future. This inevitably
involves providing examples of situations that might prove
problematic when judged against the pragmatic value set.
However, it is not our intention to be unduly critical or to offer
prescriptive remedies to these situations here. Effective solutions
will inevitably have to be subject to evaluation and assessment in
the real world of departments delivering a day-to-day service.
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-malecence; benecence 5,17 Do no harm and do good
3 Justice 5,7,8In 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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olzer
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Figure 1, Scenario 1
This presents a scenario involving Mr Black, a professor of or-
thopaedic surgery. He holds a weekly outpatient clinic in
a public hospital. He sees both new patients and follow-up cases.
His clinic is well resourced and is a model of efciency, running
to time with little waiting around for patients. Prof. Black insists
all patients attending have an up-to-date radiology examination
of the relevant part before he sees them. This obviously is
contrary to the principal of justication. The director of radi-
ology and the medical physics expert advised him against this
practice. His response is dismissive, pointing out that radiology
in their hospital is home to queues and waiting lists, whereas he
runs an efcient patient-friendly service.
He requires that patients bring their lm folder or DVD to the
clinic. He states it takes too long to get a radiology report which,
when received, may not address the issue he wants addressed. So
he reads the images himself. Pre-signed forms or authorized
referrals on the information system are provided for patients,
and they are sent to radiology for the required examination. The
Radiology Department are concerned that Prof. Black may by-
pass the department entirely if they refuse to participate, so
reluctantly do so. Prof. Black does not share any of these con-
cerns with his patients. Likewise, he does not discuss benet/risk
information with them, which he dismisses as largely specula-
tive. He feels that as a doctor he is an advocate for his patients
interests and, in his view, acts accordingly.
Mr Black is obviously of the paternalist school. The two-row
table at the bottom of the Scenario 1 panel (Figure 1)indicates
how well his practice complies with the ve-value pragmatic
set. Clearly, the practice fails all ve on signicant grounds, and
he scores a No (N) for each. With respect to Dignity/autonomy,
this is not respected in the way the decision to conduct
examinations is taken, so this scores N (No). He also scores
a small y (a limited yes) in recognition of his efforts to provide
atimelyefcient service respecting his patients. His practice
exposes many patients to unnecessary radiation risk with no
benet, so he scores an N under Non-malecence. He reads the
images himself which, some will argue, adds to the potential
for harm. He scores N under Justice as either the patient, in-
surance or society will have to pay for all unnecessary and
possibly useless examinations. His timely efcient service also scores
a small y under this heading. He does not reckon on the possibility
of risk and offers practically no information to the patient, so scores
a clear N for the last two headings, Prudence and Honesty.
Figure 1, Scenario 2
This presents a scenario in which a female patient (mid-30s) is
referred to the radiology department of a moderate-sized
district hospital for an elective non-urgent CT pelvic scan. Her
family physicians history justies the scan in the opinion of the
radiologist. An appointment is arranged some months ahead, as
she will be on holiday in the meantime. She attends the hospital at
the appointed time and is asked if she is pregnant, or might be
pregnant, to which she responds noas she is careful.
The patient has the examination, which reveals no pathology,
but also discloses that she is pregnant. She is unexpectedly
delighted to nd herself pregnant, but worried by the pros-
pectthatthechildsheiscarryingmaybedamagedbythe
scan. She reviews the information available on the Internet
and nds the Food and Drug Administration attributes
a potential risk of future cancer to irradiation. She nds the
attributed level of risk unacceptable. 1 week later, the radi-
ologist dealing with the case meets with her, assures her there
is no signicant risk, and advises she should not be con-
cerned. She (the radiologist) further explains that even if the
embryo had been damaged, it would not have implanted and
would have been lost. After further researching the issue on
the Internet, the patient nds what the radiologist put to her
unconvincing, as she was 4 months pregnant at the time of
the scan. She fails to attend a further appointment and
decides to seek a termination.
The table at the bottom of Scenario 2 scores compliance with the
pragmatic value set. On the positive side is the fact that the
hospital asks the pregnancy question, and thereby tries not to do
harm. In doing this, it aligns with much of conventional prac-
tice. On the negative side, any member of the public could point
out that asking someone if they are pregnant in a relatively
public place is an unreliable method of establishing their status.
Nevertheless, the hospital feels it is following available advice for
good practice in the area.
23
However, while this advice claims it
is based on current scientic evidence, it does not clearly ac-
knowledge its dependence on value judgments. Hence, some
patients who are pregnant or members of the public could nd
the positions taken to be, for example, lacking in prudence. The
hospitals reasons for not undertaking a more rigorous assessment
are that it is time consuming and inconvenient. The hospital has
been challenged on the practice by previous patients, and after
review, felt it would be too disruptive to alter it.
This approach can be faulted on the grounds of failing to re-
spect the autonomy of both the mother and possibly the
embryo/foetus (N); exposing both to potential harm (N);
failing to act prudently and follow the precautionary principle
when there is possible but unproven risk (N); and not behaving
in a transparent way both before and after the examination
(N). Under the Justice heading, the behaviour of the hospital
might be taken as relatively neutral. A (y) is scored under
Dignity/autonomy, Non-malecence and Honesty, for asking
the pregnancy question, being willing to act on it and being
open/transparent within the limits of the professional advice
available to it.
The hospitals approach is consistent with much of the prac-
tice throughout the world.
24,25
However, many of the areas in
which medicine has found itself involved in public scandals
are those where individual dignity and autonomy has been
sacriced to long-established and professionally sanctioned
practices.
8,26
Issues around exposure of patients who are
pregnant (and pregnant staff) provide many examples of
scenarios that might be better resolved in the context of
a wider deliberation using the pragmatic value set than on the
basis of the legal or ICRP systems alone. Both afford in-
teresting problems for reection/analysis, but the broader
perspective of Beauchamp and Childressand the additional
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values provide valuable perspectives that help view the prob-
lem more holistically.
Figure 1, Scenario 3
This scenario deals with the practice of Dr Amber, an inter-
ventional cardiologist in private practice. She undertakes
individual health assessments for symptom-free patients referred
by other practitioners, self-referred or who self-present. Dr
Amber explains all the risks of interventional cardiac procedures
including the potential radiation risks. She explains the radiation
risk is unproven. She conducts the procedures on request
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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olzer
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consultation and for the procedure. The procedures are un-
dertaken in the associated imaging centre, in which she is
a shareholder. The nancial interest is not disclosed to the
patient.
In terms of compliance with the pragmatic value set, the scores
are presented in the bottom of the panel of Scenario 3
(Figure 1). Dr Amber scores highly on respecting the auton-
omy of the individual (Y) and on Honesty (Y) as she takes a lot
of trouble to inform the patient and get consent. She also
scores an (n) for Dignity/autonomy as she does not share the
uncertainty about risk with the patient and an (n) for Honesty
arising from non-disclosure of her shareholder interest in
the imaging facility. On the other areas, including Non-
malecence, Justice, and Prudence, she scores (N) owing to the
probability that harm may ow from the unjustied and un-
necessary examinations.
Figure 1, Scenario 4
This scenario deals with a case in which Mr Grey is referred for
an examination as part of his follow-up for previous cancer,
from which he appears to be in remission. A full abdominal CT
including a contrast phase is undertaken; no change is reported
since the last scan. The risk of a CT scan is explained to Mr Grey
and consent is obtained. The dose noted for Mr Grey is the same
as that in the original diagnostic investigation. This is not war-
ranted, as a simpler procedure could have elicited the in-
formation required in the follow-up study. The problem here is
a failure of both justication and optimization. It might arise
from inadequate information provided in the referral, or in-
adequate radiology protocols that fail to distinguish between the
follow-up and the initial more demanding and exploratory di-
agnostic investigations. Unacceptably high dosage for examina-
tions can arise from many sources including inadequately
differentiated protocols that do not distinguish between initial
referrals and follow-up investigations.
In Scenario 4, the Dignity/autonomy of the individual is recog-
nized through explaining the risk and obtaining consent (Y).
However, there is also a failure in this area as the same protocol is
applied to all patients where important differences exist (n). The
consequences of this are inadequately recognized and give rise to
additional problems. These include failures under the headings of
Justice (n) and Non-malecence (N) owing to unnecessary
exposures. An (N) is also scored under Prudence and Honesty.
Figure 1, Scenario 5
This scenario concerns Dr Browne, an experienced well-
trained paediatric radiologist. A 2-year-old boy is referred for
a whole-body CT examination. Dr Browne believes the exam-
ination is justied. She advises the childs parents, his legal
proxies, that the examination should proceed. The parents
enquire about the risks, if any, from the examination. She (Dr
Browne) reassures them that there are none they need consider.
She deects further questioning by explaining that the hospital
is the leading one in the country for this type of examination in
young children (which is true) and it will not be better per-
formed elsewhere. Her reasons for deecting the question,
which she does as a matter of policy, are two-fold. First, it takes
too much time to respond to detailed requests for further in-
formation. Second, and more important in her mind, that
informed parents may withdraw their children from the ex-
amination. The examination is clearly justied from the history
provided by the referrer and is technically well performed and
reported on efciently and promptly.
This scenario raises interesting problems. Clearly the dignity/
autonomy of the child is respected in ensuring the examination
is justied (Y). However, the radiologists behaviour towards the
parents does not respect their dignity/autonomy and their role as
legal proxies for the patient (N). Behaviour with respect to the
Honesty category was also unsatisfactory. Patients or their legal
proxies are entitled to, and should receive, honest transparent
information, when they request it (N). The other categories,
Non-malecence, Prudence, and Justice were all exemplary and
hence each scores a yes (Y).
Figure 1, Scenario 6
Many issues arise in a subset of human exposures that appear
like medical examinations, but are not conducted for the benet
of the person involved, i.e. they are not medical procedures in
the normal sense of the term (e.g. drug searches, weapon
searches, screening of migrants etc.).
27,28
Scenario 6 deals with Ms Whyte, age 28 years, who arrives at the
airport after a long-haul ight. She is behaving nervously, and
sniffer dogs alert the authorities to check her baggage. They nd
a small amount of cannabis in one of her bags, and she continues
to behave suspiciously. After some deliberation, the authorities
decide that she may be a drug mule and request an abdominal/
pelvic CT scan. She is healthy with no symptoms and referred to
a local hospital with which the customs service has a contract to
provide scans in such circumstances. She is not apprised of the
radiation or any other risks and permission is not sought. She
strenuously objects to the procedure, but eventually allows it to be
performed so that she can go home, as she knows she is innocent.
The scan is performed promptly, competently and with opti-
mized dose. The report is made available to the customs service.
It shows no sign of concealed drugs in body cavities, but also
shows Ms Whyte to be pregnant. She is promptly advised ac-
cordingly by the customs ofcer, who also advises her of her
pregnancy. Ms Whyte had thought she might be pregnant but
was not sure. She is distressed by the situation, but the customs
ofcer is unable to offer her any advice on the pregnancy or
possible radiation damage to her foetus.
The hospital assumes this scan is justied by the customs service
which, in turn, assumes the hospital deals with this issue. In the
ICRP system, it has no value to Ms Whyte as a medical pro-
cedure, and hence is not medically justied. The requirements
for consent and possibly for condentiality are also dispensed
within the process described here.
8,28
In the circumstances, the
hospital should have robust authorization processes to mandate
such departures from normal practices and ensure public con-
dence cannot be undermined. Likewise, the customs service
must have an open and transparent protocol detailing how such
scan requests are justied and who the authorizing ofcer is.
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7of11 birpublications.org/bjr Br J Radiol;89:20150713
In some countries, a judge must underwrite the request for
a non-medical radiological examination, as the risks and benets
involved are essentially social rather than medical.
8,27,28
This scenario appears as negative under all the headings in the
table at the bottom of Scenario 5 (N). Ms Whytes dignity/
autonomy are put to one side in the performance of the ex-
amination and perhaps even more clearly in disclosing the scan
results to third parties, particularly in connection with her
pregnancy. All of these are compounded by a justication pro-
cess that falls between stools, and fails to establish the subject is
pregnant before the examination is performed. There are also
problems under the headings of non-malecence, justice, pru-
dence, and honesty. On the positive side, there is a social benet,
which is shown as a (Y) under justice accompanying the (N)
already scored there on Ms Whytes behalf. The customs ofcers
treat her as well as the situation allows, allowing a small (y)
under dignity/autonomy. This scenario illustrates the problems
encountered in reaching a balanced judgment in these sit-
uations, but the pragmatic value set helps ag the issues involved
more clearly.
DISCUSSION AND CONCLUSION
A pragmatic set of ve values is proposed to help guide evalu-
ation of day-to-day activities in diagnostic imaging. The need for
such a practical set of values arises from the high levels of social
expectation with respect to behaviour of health professionals in
the area, particularly in the event of accidents or other events
that become the subject of public scrutiny. Three of the values
are derived from the well-regarded Beauchamp and Childress
approach, which are independent of ethical theories and cul-
tures. The other two, prudence and honesty, are derivable from
the Beauchamp and Childressapproach, but are explicitly in-
cluded to help address practical concerns in areas where the
day-to-day culture of radiation protection may be somewhat
distanced from contemporary public values. This is particularly
so in the case of prudence and precaution, when dealing with the
uncertainties around radiation risks; likewise with honesty and
transparency, and when dealing with matters of consent and
communication with patients. All of these will require nuanced
application that also addresses balancing the competing demands
of the values in an intelligent, sensitive and skilled manner.
As to the origin of the Beauchamp and Childress system, the authors
believe it is rooted in common morality,i.e. not relative to cul-
tures or individuals, because it transcends both.
7
This is one of the
strengths of their approach.
5,7
Initially, Beauchamp and Childress
were not speaking about different cultures. They were trying to nd
middle-level principles that both could agree on. Beauchamp was
a utilitarian, i.e. for him the consequences of onesactionswerethe
only thing that counted, while Childress based himself on de-
ontological arguments and was thus mainly concerned with an
individualsdutiestowardsotherindividuals(AppendixA).These
two approaches are usually considered incompatible, as their fun-
damental criteria for moral good are different. Nevertheless, the
authors saw that they could nd common ground. It was not that
the utilitarian and the deontologist each contributed one or more
principles which the other had to match. Rather, both could fully
agree with all four principles, albeit for different reasons.
As the world shrinks to a global village,thereisaneedto
develop approaches to decision-making that are acceptable for
people from different cultural backgrounds. The enterprise of
radiology is, more than most medical activities, truly global in its
clinical application, research base, industrial infrastructure and
regulatory framework. Thus, it is now important to have
a matching global framework for ethics to guide its practice in
medicine, into the future.
7,8
Patients travel and will nd them-
selves in the presence of doctors brought up in a different cultural
context. Doctors travel and will encounter patients and peers
from radically different cultures in different cultural contexts.
International organizations such as the World Health Organisa-
tion, International Atomic Energy Agency, European Commission
and ICRP and numerous professional bodies have to present their
ndings in language that is not alien to large groups of health
professionals and lay populations throughout the world.
The point can be made, however, that it is not enough to refer to
acommon moralityand merely claim that all persons com-
mitted to moralitywould agree with Beauchamps and Child-
resss principles. Rather, we have to base our reasoning on
principles that can be shown to exist and demand respect in
different cultural contexts and indeed be backed by, or consis-
tent with, the time-honoured written and oral traditions that
people around the world refer to for moral guidance. There is
not space here to go into detail on this approach. Sufce to say
that we are of the opinion that the principles proposed by
Beauchamp and Childress can indeed be demonstrated in a wide
range of cultural, religious and philosophical contexts.
5,7,8
The importance of the two additional values (prudence and
honesty) is often overlooked in discussions of radiation pro-
tection in the radiology. At this stage, they may be viewed as
buttresses for the core Beauchamp and Childress values.
8
When
a fully developed and widely agreed system is well embedded in
radiology, the need to state these explicitly may decline.
With regard to prudence, ICRP appears to support the Pre-
cautionary Principle, particularly in adopting the linear no-
threshold (LNT) model for extrapolation to low doses. Yet, it also
states calculation of the number of cancer deaths based on
collective effective doses from trivial individual doses should be
avoided.This is justied by saying that such calculations would be
biologically and statistically very uncertain.
1,29
As the Pre-
cautionary Principle applies precisely to those cases involving
uncertainty, the ICRP position here seems to be somewhat self-
contradictory. The United Nations Scientic Committee on the
Effects of Atomic Radiation position, discouraging population risk
calculations for small doses, also requires more robust justica-
tion with respect to prudence and the Precautionary Principle.
30
An equivocal approach to prudence has been adopted at a sur-
prisingly high level in some professional bodies and is also fav-
oured by some well-regarded experts in medical physics and
radiation protection.
3133
For example, an American Association
of Physicists in Medicine statement appears to favour, on the
surface at least, emphasizing the benets of diagnostic inves-
tigations without reckoning the risks.
33
A more extreme version of
this is encountered among some practitioners who are linear no
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olzer
8of11 birpublications.org/bjr Br J Radiol;89:20150713
threshold sceptics, do not advise patients about risk and disregard
it in their approach to diagnosis or treatment.
8,31,32,34
Behaving as
though there is no risk is inconsistent with the precautionary
principle, even though doing so may have professional advocates
and may, as noted above, appear to be endorsed in some pub-
lications. Thus, the value of prudence needs to be re-emphasized
in medical radiation protection and to be applied with conviction.
The culture of radiation protection in medicine has come to rely
heavily on professionals avoiding talking to patients about the
uncertainties involved, and assuring them that everything is ne.
This is no longer acceptable, both as a purely practical matter
and, more important, as a consequence of the emphasis placed
on the autonomy of the individual in contemporary thinking.
The value of autonomy of the individual implies that patients
have the right to know of possible risk, so that they can make
good informed decisions about their own healthcare. This, in
turn, implies that radiologists, other healthcare providers and
radiation protection professionals have a duty to inform patients
on benets and risks, on the basis of the best available estimates
and the associated uncertainties.
7,8,3538
This is even further
emphasized by the related value of human dignity. The message
should be that there may, or may not, be a signicant risk; we do
not know the exact size, but the best estimates of the scientic
and medical community are conservative and are discounted in
the decision to recommend an examination. Excessive re-
assurance is not appropriate in the face of real uncertainty and
ultimately damages credibility. Furthermore, patients constantly
encounter and cope with larger uncertainties in other aspects of
the medical interventions they experience.
Because of their basis in medical ethics and social expectation,
the pragmatic value set could reasonably be expected to achieve
a higher level of recognition in medicine than the ICRP prin-
ciples. They might, thereby, help facilitate the transfer of core
messages of radiation protection more effectively to its largest
area of application. They should help movement towards a style
of behaviour in radiation protection that is consistent with
contemporary social and ethical thought. Health professionals
should more easily and uently relate to them, and apply them,
with greater ease. They are less likely to allow issues be missed,
be overlooked or be opportunistically neglected. This applies
even where the professionals involved are not experts in ethics,
as the language involved is mainly intuitive and familiar to those
in medicine. On the other hand, the language of radiation
protection often seems arcane and mysterious to those not
deeply involved.
26
Radiology is essentially a medical activity and
is likely to benet from sharing in the safety/ethics culture and
language with the rest of medicine.
The pragmatic value set proved to be an effective roadmap in
the evaluation of six scenarios. It helps reaching decisions that
are likely to be socially acceptable and respected. The set is not
intended to replace the well-established and legally mandated
principles of justication and optimization championed by
ICRP and by governments in legislation. Rather, they will
supplement these and add considerably to them in aiding
decision-making in socially sensitive areas. Pending the out-
come of the current ICRP/IRPA initiatives, the values give an
intuitively clear and credible basis for assessing events, pro-
tocols and behaviour of health professionals in radiological
imaging. In addition, the value set may nd application in
areas such as nuclear medicine and radiotherapy which are not
explored here.
ACKNOWLEDGMENTS
J Malone is grateful to the trustees of the Robert Boyle Foundation
and to the European Commissions SENTINEL (Safety and Ef-
cacy for New Techniques and Imaging Using New Equipment to
Support European Legislation) project for their support of this
work. F Z¨
olzer thankfully acknowledges support by the OPERRA
(Open Project for the European Radiation Research Area).
FUNDING
This project received no direct funding, but drew on experience
in various employments and projects in which the authors were
involved.
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APPENDIX A BRIEF EXPOSITION OF WESTERN
ETHICAL THEORIES
The recommendations of the ICRP obviously presuppose certain
elements of moral philosophy, but these are not always made
explicit. Individual authors,
A1,2
among them members of the
commission itself,
A3,4
have identied inuences mainly of util-
itarian and deontological ethics.
Utilitarianism has arguably had the stronger impact at least
during the rst few decades of the ICRP. It is a concept de-
veloped by the British philosophers Jeremy Bentham
(17481832)
A5
and John Stuart Mill (18061873).
A6
Both con-
sidered the outcome, or utility, of our actions as the only valid
criterion for their moral goodness or badness: if what we do
causes more benet than harm, it is good; if it causes more harm
than benet, it is bad. This is nicely captured in the phrase. It is
the greatest happiness of the greatest number of people that is
the measure of right and wrong. The clearest reection in the
ICRP system of this kind of thinking is certainly the principle of
justication: Any decision that alters the radiation exposure
situation should do more good than harm. When it rst
appeared in 1977 (Publication 26), it was worded differently, but
equally utilitarian: No practice shall be adopted unless its in-
troduction produces a positive net benet.
A7
The second prin-
ciple of radiological protection, optimization, is also based on
a consideration of outcomes: The likelihood of exposure, the
number of people exposed and the magnitude of their individual
doses shall be kept as low as reasonably achievable, taking into
account economic and societal factors. It was introduced by
ICRP in as early as 1958, although it was worded a little dif-
ferently at the time: as low as readily achievable(ALARA).
A8
Either way, it became known as the ALARA principle. It is
generally understood as urging not only a net benet, but
a maximum of good over harm. In 1973, ICRP explicitly recom-
mended costbenet analysis as a tool for optimization, strength-
ening the notion that the underlying concept was utilitarian.
A9
The second inuence, deontological ethics, considers as morally
valid nothing else than our duty(Greek: deon), and thus
insists that we should never, even if we expected our action to
cause more good than harm, neglect the respect for the individual
person. And thus, according to the German philosopher Im-
manuel Kant (17241804), we should act in accordance with the
Categorical Imperative, which, in one of its formulations, says,
Act in such a way that you treat humanity, whether in your own
person or in the person of any other, never merely as a means to
an end.
A10
It seems that during the 1970s, the ICRP recognized
that focusing only on the principle of as low as reasonably
achievabledid not offer enough protection for the individual. If
the reasonableis judged on the basis of a costbenet analysis
only, we cannot rule out that somebody would be treated as
a means for somebody elses ends. For instance, we might nd it
reasonable, or even imperative, to expose one individual to a rel-
atively high risk in order to save many others from a relatively low
one, so that the collective risk can be kept at a minimum. But,
that would be unfair to the one highly exposed person. ICRP
therefore introduced dose limitation as a third principle of radi-
ation protection in 1977: The total dose to any individual from
regulated sources in planned exposure situationsshould not
exceed the limits specied.
A7
The recommended dose limits were
supposed to keep the risk for professionally exposed radiation
workers in line with the occupational risk in other industrial
sectors, namely those that have been classied as relatively safe.
Apart from dose limitation, the inuence of deontological ethics
on radiation protection has been slow to gain ground, but is now
the subject of much discussion.
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Full paper: Ethics for radiation protection in radiology BJR
11 of 11 birpublications.org/bjr Br J Radiol;89:20150713
... The four biomedical ethical principles are autonomy, beneficence, non-maleficence, and justice [62,63]. Autonomy refers to the wishes of a patient according to their self-rule to protect themselves from harm. ...
... Healthcare providers must bring benefits to their patients by following their patients' interests and not causing harm. Healthcare providers must also treat their patients equally to ensure justice [62][63][64][65][66]. ...
... ICRP Task Group 94 on the ethics of radiological protection and many researches review the medical ethics and ethical values in radiation protections of patients [63,67]. The ICRP is specialized in radiation protection based on the scientific evidence background to support the medicine, research, and education [9,25,32,63,67]. ...
Article
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Healthcare providers have acknowledged the dangers of radiation exposure to embryonic and fetal health, yet diagnostic imaging of pregnant women is increasing. Literature that pertains to the topic of interest was reviewed to collect tertiary data. The purpose of this literature review was to present the various radiation risks for pregnant women and the fetus depending on the gestational age of the pregnancy. The specific effects of radiation on pregnant women and the fetus, X-ray risks depending on the gestational age of the pregnancy, and other potential health effects when performing diagnostic imaging procedures on pregnant women were discussed in this review. In addition, ethical issues have been considered by improving overall communication to minimize unnecessary radiation exposure to pregnant women and fetuses.
... 14 It is particularly well suited to medical and public health applications and like that adopted by ICRP for general purposes. It has also been used by WHO [11,[13][14][15]. ...
... But she was unconvinced and tended to attribute her illnesses to X-ray exposure during the war [7]. She did not acknowledge, with her laboratory colleagues, the possibility that her deteriorating condition, including [10,14]. ...
... Honesty and consent were coming to the fore and not only de rigeur, but also legally binding in many jurisdictions. These and other values, including dignity and autonomy, were addressed in European, IAEA, RICOMET and the DIMOND projects among others [71,14,10]. This period also saw serious challenges from other disciplines including the social sciences and the history of science. ...
Article
Full-text available
Starting from Röntgen's discovery and the first radiograph of his wife’s hand, the curtain was raised on a new technique with remarkable possibilities for contributing to human health. While growth in applications proceeded rapidly, it was accompanied by significant harms to those involved and by inappropriate opportunistic application. This paper places the attempts to deal with the harms and inappropriate activities side by side with the positive developments. It attempts a narrative on the development of medical radiation protection over the125-year period and places it in the context of a commentary on governance and ethics. The substance of the narrative is based on the recommendations of ICRP as they developed and altered over time. The governance commentary is based on assessing the independence of ICRP and its attention to medical exposures. In terms of ethics, the recommendations at each stage are reviewed in the light of values that are deemed appropriate to both medical ethics and radiation protection. The paper, while celebrating Röntgen-125, also hopefully provides a perspective for discussion as ICRP’s centenary in 2028 approaches. This is an important part of ensuring continued acceptance and confident use of X-Rays, and helps underwrite the possibility of further developments in the area.
... 14 It is particularly well suited to medical and public health applications and like that adopted by ICRP for general purposes. It has also been used by WHO [11,[13][14][15]. ...
... But she was unconvinced and tended to attribute her illnesses to X-ray exposure during the war [7]. She did not acknowledge, with her laboratory colleagues, the possibility that her deteriorating condition, including [10,14]. ...
... Honesty and consent were coming to the fore and not only de rigeur, but also legally binding in many jurisdictions. These and other values, including dignity and autonomy, were addressed in European, IAEA, RICOMET and the DIMOND projects among others [71,14,10]. This period also saw serious challenges from other disciplines including the social sciences and the history of science. ...
Article
Full-text available
Starting from Röntgen's discovery and the first radiograph of his wife’s hand, the curtain was raised on a new technique with remarkable possibilities for contributing to human health. While growth in applications proceeded rapidly, it was accompanied by significant harms to those involved and by inappropriate opportunistic application. This paper places the attempts to deal with the harms and inappropriate activities side by side with the positive developments. It attempts a narrative on the development of medical radiation protection over the 125-year period and places it in the context of a commentary on governance and ethics. The substance of the narrative is based on the recommendations of ICRP as they developed and altered over time. The governance commentary is based on assessing the independence of ICRP and its attention to medical exposures. In terms of ethics, the recommendations at each stage are reviewed in the light of values that are deemed appropriate to both medical ethics and radiation protection. The paper, while celebrating Röntgen-125, also hopefully provides a perspective for discussion as ICRP’s centenary in 2028 approaches. This is an important part of ensuring continued acceptance and confident use of X-Rays, and helps underwrite the possibility of further developments in the area.
... These countermeasures focused on agricultural production and urban environments rather than health surveillance, although they did include a set of "societal countermeasures" directed at actions other than those related to dose reduction, such as provision of monitoring equipment and stakeholder engagement (Oughton and Forsberg, 2009). Ethical dilemmas also arise in other areas of radiation protection, such as medical applications, facility siting and radioactive waste disposal (Hannis and Rawles, 2013;Taebi and Roeser, 2015;ICRP, 2018;Malone and Zölzer, 2016;Malone et al., 2018;), as well as other disasters and crises (Geale, 2012;WHO, 2016;Galliard and Peek, 2019). Examples include challenges in tradeoffs of risks and benefits across different sectors of society (workers and public; patients and medics; schoolchildren and adults), the particular susceptibility of vulnerable populations, and problems in obtaining consent for participation of affected individuals in disaster research (Galliard and Peek, 2019). ...
... They need to consider the balance between the reassurance and empowerment that these measures can provide, and the possibility that they might enhance stress and concerns by reminding people about the problem (SHAMISEN Consortium, 2017). As stated previously, stakeholder engagement would be a necessary part of this process, including dialogue on values highlighted in this paper, as well as other ethical values (Malone and Zölzer, 2016). ...
Article
Full-text available
Many radiation protection actions carry a multitude of direct and indirect consequences that can impact on the welfare of affected populations. Health surveillance raises ethical challenges linked to privacy and data protection , as well as questions about the net benefit of screening. The SHAMISEN project recognized these issues and developed specific recommendations to highlight ethical challenges. Following a brief overview of ethical issues related to accident management, this paper presents the SHAMISEN recommendations: R1 The fundamental ethical principle of doing more good than harm should be central to accident management; and R4 Ensure that health surveillance respects the autonomy and dignity of affected populations, and is sensitive to any inequity in the distribution of risks and impacts. While a holistic approach to accident management means that decisions will be complicated by different values, perceptions and uncertainties about outcomes, addressing ethical issues could help ensure that the assumptions and potential conflicts behind eventual decisions are as transparent as possible.
Article
Introdução: o uso da radiação ionizante na prática médica pode ocasionar eventos nocivos à saúde do indivíduo exposto. Diante disso, o emprego ético da radiação ionizante deve contemplar o que preconiza a legislação nacional e internacional, assim como os princípios de proteção radiológica e da bioética. O sofrimento moral relaciona-se à dimensão ética na prática da saúde, podendo afetar os profissionais das técnicas radiológicas. Objetivo: identificar as situações desencadeadoras de sofrimento moral nos profissionais das técnicas radiológicas em um serviço de radiologia convencional. Metodologia: trata-se de uma pesquisa qualitativa, descritiva e exploratória. Usou-se como técnicas de coleta de dados a observação participante, a entrevista semiestruturada e a validação consensual. Os dados foram analisados por meio da análise temática. Resultados e discussão: observou-se situações de sofrimento moral quando o profissional da técnica radiológica se deparava com pacientes em condições clínicas de se dirigir a unidade de diagnóstico e imagem, diante da não indicação clínica do exame radiológico, ante ao desrespeito dos princípios de proteção radiológica e perante a falta de autonomia para fazer cumprir os preceitos éticos do emprego da radiação ionizante. Conclusão: o desrespeito dos princípios legais, assim como dos princípios de proteção radiológica e bioéticos levam o profissional das técnicas radiológicas ao sofrimento moral.
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The referral is the key source of information that enables radiologists and radiographers to provide quality services. However, the frequency of suboptimal referrals is widely reported. This research reviews the literature to illuminate the challenges suboptimal referrals present to the delivery of care in radiology departments. The concept of suboptimal referral includes information, that is; missing, insufficient, inconsistent, misleading, hard to interpret or wrong. The research uses the four ethical principles of non-maleficence, beneficence, Autonomy and Justice as an analytic framework. Suboptimal referrals can cause harm by hindering safe contrast-media administration, proper radiation protection by justification of procedures, and compassionate patient care. Suboptimal referrals also hinder promoting patient benefits from the correct choice of imaging modality and protocol, an optimal performed examination, and an accurate radiology report. Additionally, patient autonomy is compromised from the lack of information needed to facilitate benefit–risk communication. Finally, suboptimal referrals challenge justice based on lack of reasonable patient prioritising and the unfairness caused by unnecessary examinations. These findings illuminate how suboptimal referrals can inhibit good health and well-being for patients in relation to safety, missed opportunities, patient anxiety and dissatisfaction. The ethical challenges identified calls for solutions. Referral-decision support tools and artificial intelligence may improve referral quality, when implemented. Strategies addressing efforts of radiology professionals are inevitable, including gatekeeping, shared decision-making and inter-professional communication; thereby raising awareness of the importance of good referral quality and promoting commitment to ethical professional conduct.
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Recent trends in medical decision-making have moved from paternalistic doctor-patient relations to shared decision-making. Informed consent is fundamental to this process and to ensuring patients' ongoing trust in the health-care profession. It cannot be assumed that patients consent to the risk associated with medical exposures, unless they have been provided with the information to make that decision. This position is supported by both the legal and ethical framework around Radiation Protection detailed in this commentary.
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Contact shielding has been in widespread use for the last 60–70 years aiming to protect against genetic effects, cancer, and other detriment. Since 2012, studies have begun to appear in the literature that question the continued use of such shielding, especially when radiographic technology has changed so much over the intervening period This literature has culminated in several professional bodies such as the American Association of Physicists in Medicine (AAPM) and the British Institute of Radiology (BIR) issuing guidance and statements recommending against the continued routine use of patient contact shielding. Many professional societies have also endorsed these statements. National statements on the matter continue to be produced. It is notable however that the major European bodies involved in diagnostic radiology and radiation safety have not to date issued a statement on patient shielding. This commentary looks at reasons for that and argues that it is now time for a European consensus statement on patient shielding. It is the authors belief that there are advantages to building on the work done by the AAPM and BIR, using the opportunity to amplify the statements, propagate the intent of the original statements, refine the message to deal with questions that have arisen since their publication. Α working group, Gonad and Patient Shielding (GAPS) has been formed by members from a) the European Federation of Organisations for Medical Physics (EFOMP), b) the Eurosafe Imaging initiative of the European Society of Radiology (ESR), c) the European Federation of Radiographers Societies (EFRS), d) EURADOS and e) the BIR to produce a joint statement on the proper application of patient shielding in diagnostic and interventional radiology.
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Whereas scientific evidence is the basis for recommendations and guidance on radiological protection, professional ethics is critically important and should always guide professional behaviour. The International Commission on Radiological Protection (ICRP) established a task group (TG-109) to advise medical professionals, patients, families, carers, the public and authorities about the ethical aspects of radiological protection of patients in the diagnostic and therapeutic use of radiation in medicine. Occupational exposures and research-related exposures are not within the scope of this task group. The TG will produce a report that will be available for consultation to the different interested parties to receive comments before publication. Presently, the report is at the stage of a working document that has benefitted from an international workshop organized on the topic by the World Health Organization (WHO). It presents the history of ethics in medicine in ICRP, explains why this subject is important and the benefits it can bring to the standard biomedical ethics. Then, because risk is an essential part in decision-making and communication, a summary is included on what is known about the dose-effect relationship, with an emphasis on the associated uncertainties. Once this theoretical framework has been presented, the report becomes resolutely more practical. First, it proposes an evaluation method to analyse specific situations from an ethical point of view. This method allows the stakeholders to review a set of six ethical values and provides hints on how they could be balanced. Then a wide range of situations (e.g. pregnancy, elderly, paediatric, end of life) is considered in two steps: first within a realistic, ethically challenging scenario on which the evaluation method is applied; and second within a more general context. Scenarios are presented and discussed, with attention to specific patient circumstances, and on how and which reflections on ethical values can be of help in the decision-making process. Finally, two important related aspects are considered: how should we communicate with patients, family, and other stakeholders, and how to incorporate ethics into the education and training of medical professionals.
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Full-text available
The ethical bases of Argentina's radiation safety approach are reviewed. The applied principles are those recommended and established internationally, namely: the principle of justification of decisions that alters the radiation exposure situation; the principle of optimization of protection and safety; the principle of individual protection for restricting possible inequitable outcomes of optimized safety; and the implicit principle of intergenerational prudence for protection future generations and the habitat. The principles are compared vis-à-vis the prevalent ethical doctrines: justification vis-à-vis teleology; optimization vis-à-vis utilitarianism; individual protection vis-à-vis deontology; and, intergenerational prudence vis-à-vis aretaicism (or virtuosity). The application of the principles and their ethics in Argentina is analysed. These principles are applied to ALL exposure to radiation harm; namely, to exposures to actual doses and to exposures to actual risk and potential doses, including those related to the safety of nuclear installations, and they are harmonized and applied in conjunction. It is concluded that building a bridge among all available ethical doctrines and applying it to radiation safety against actual doses and actual risk and potential doses is at the roots of the successful nuclear regulatory experience in Argentina.
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Medical Law and Ethics covers not only the core legal principles, key cases, and statutes that govern medical law, but also explores the key ethical debates and dilemmas that exist in the field to ensure that the law is firmly embedded within its context. The title highlights these debates, drawing out the European angles, religious beliefs, and feminist perspectives which influence legal regulations. Other features such as ‘a shock to the system’, ‘public opinion’, and ‘reality check’ introduce further sociological aspects, contributing to the way in which the subject is approached. This new edition also includes coverage of new Guidance issued by the GMC and the new Protection of Liberty Safeguards. It also outlines important case law developments on the law on mental capacity and euthanasia, including the Alfie Evans and Tafida Raqeeb litigation, case law interpreting the Mental Capacity Act, and the Court of Appeal in Conway .
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On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, thereby creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles. In carrying out the above, the Commission was directed to consider: (a) the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine, (b) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects, (c) appropriate guidelines for the selection of human subjects for participation in such research and (d) the nature and definition of informed consent in various research settings. The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its deliberations. It is the outgrowth of an intensive four-day period of discussions that were held in February 1976 at the Smithsonian Institution's Belmont Conference Center supplemented by the monthly deliberations of the Commission that were held over a period of nearly four years. It is a statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects. By publishing the Report in the Federal Register, and providing reprints upon request, the Secretary intends that it may be made readily available to scientists, members of Institutional Review Boards, and Federal employees. The two-volume Appendix, containing the lengthy reports of experts and specialists who assisted the Commission in fulfilling this part of its charge, is available as DHEW Publication No. (OS) 78-0013 and No. (OS) 78-0014, for sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402. Unlike most other reports of the Commission, the Belmont Report does not make specific recommendations for administrative action by the Secretary of Health, Education, and Welfare. Rather, the Commission recommended that the Belmont Report be adopted in its entirety, as a statement of the Department's policy. The Department requests public comment on this recommendation.
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There is an inherent conflict within clinician educators as we balance the roles of healthcare provider to patients in need of care with that of educator of learners in need of teaching. In this essay we use Beauchamp and Childress' principles of biomedical ethics as a framework to compare the relationship that clinician educators have with their patients and their learners, and suggest that while we typically apply ethical principles when addressing the needs of our patients, these principles are frequently lacking in our interactions with learners. This dichotomy reflects a person-by-situation interaction that may be partly explained by the expectations of the regulatory bodies that define how clinicians should interact with patients and how educators should interact with learners. The result is that we may fall short in applying respect for autonomy, beneficence/nonmaleficence, and justice when addressing the needs of our learners. Fortunately there are ways in which we can incorporate these ethical principles into our interactions with learners while still adhering to accreditation standards and institutional policy. These include flipped classrooms and simulated learning experiences, incorporating aspects of instructional design that have been shown to improve learning outcomes, providing additional resources to learners with greater needs, and organizing training curricula around entrustable professional activities. Although the consistent application of ethical principles with all learners during all learning experiences is likely unachievable, we can, and should, move towards more ethical treatment of our learners.
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There has been a 100‐year history of the uses of radiation in medicine and industry. Throughout that time, there has also been advice on the need to protect people from the hazards associated with exposure. This paper traces the evolution of protection standards through the differing phases that are identified. These phases reflect changes both in scientific understanding of the biological effects of exposure and of the social and ethical standards to be applied. As a result, the principles used for protection have continuously evolved and are likely to continue to do so in the future. In 1999, suggestions were published for the general form of a new set of recommendations from ICRP, which would be intended to be simpler than previous recommendations and to emphasise the protection of individuals. Subsequently, there have been widespread discussions on the way in which these suggestions might be extended to deal with the practical interpretations that will be needed. The Commission has taken note of the points made and has now agreed on the policy issues involved in the next stage of development of the next recommendations.