Ethics of Radiological Protection—recent developments

Ethics of Radiological Protection—recent developments Abstract The International Commission on Radiological Protection (ICRP) has recently reviewed the ethical foundations of its recommendations. The approach taken in its report is similar to principlism, i.e. the system of Beauchamp and Childress proposed in their ‘Principles of Biomedical Ethics.’ The commission identifies a number of ‘core values’ which have helped shape the evolution of the ICRP system of radiological protection, namely ‘Beneficence and non-maleficence’, ‘Prudence’, ‘Justice’ and ‘Dignity’. In addition, ‘procedural values’ are cited that are important for the system’s applications in practice, ‘Accountability’, ‘Transparency’ and ‘Inclusiveness (Stakeholder Participation)’. It is emphasized that these values are common to or at least acceptable for people from different cultural backgrounds, which for an endeavour as global in nature as radiological protection seems to be quite important and appropriate. Thus, the ICRP document on ‘Ethics of radiological protection’ could set a standard for other areas. biomedical ethics, common morality, cross-cultural ethics, ethics of public health, radiation protection Risks of radiation exposure from natural and man-made sources Radiological protection is a discipline closely related to public health. We are all exposed to radiation from natural sources. For most inhabited regions of the world, external exposure from cosmic and terrestrial radiation and internal exposure from radioactivity in food and drink result in an effective dose of ~1 mSv per year (The effective dose is a measure of the health risk due to radiation exposure, i.e. the probability of cancer induction and genetic effects. It takes into account the effectiveness of various types of radiation and the sensitivity of various organs or tissues exposed.). Depending on the building materials used, inhalation of the radioactive noble gas radon and its decay products can cause an additional effective dose in the same order of magnitude. The world average of effective dose from natural sources is ~2.4 mSv per year.1 In many developed countries, this natural radiation exposure is now equalled or even exceeded by radiation exposure from medical applications. Here, of course, individual doses can vary quite a bit, with somebody undergoing computed tomography easily receiving 10 mSv and somebody having a dental panoramic radiograph being exposed to only 10 µSv. The average annual effective dose due to medical applications in the USA, for instance, has increased from 0.5 mSv in 1980 to 3 mSv in 2006.2 What do we know about the health risks associated with such exposures? Not much, to be honest. There is direct epidemiological evidence for the carcinogenic effects of radiation mainly at much higher doses, namely those to which people were exposed due to the atomic bomb explosions in Hiroshima and Nagasaki 1945. So far, significant increases of cancer risk have been found for those who were exposed to more than ~100 mSv. The assumption generally made in radiological protection, however, is that the risk per dose can be extrapolated from this dose range down to the range of 1–10 mSv.3 The risk factor currently considered to best reflect the findings from Japan is 5% fatal cancer cases per Sv, i.e. of 100 000 people exposed to 1 Sv, 5000 will die of a radiation induced cancer (in addition to those 25 000 in such as group who will die of cancer due to other reasons) (The average dose of the survivors of the atomic bomb explosions was of course much smaller, ~200 mSv, so that the estimated number of fatal cancer cases here is ~1000 among 100 000.).4 In the case of medical exposure, computed tomography with a dose of 10 mSv would accordingly be expected to induce 50 cases of cancer death among 100 000 people. Here, of course, an additional factor has to be taken into consideration: the latency period of most radiation induced cancers is at least 20 years, and because many patients undergoing a computed tomography are elderly or seriously ill, their chance of surviving long enough to ‘experience’ the radiation induced cancer is small. Nevertheless, it has been estimated that in the USA ~2% of all cancer deaths may be attributable to medical radiation exposure, which is more than 10 000 cases every year.5 Another situation in which radiation exposure poses a health risk is living in the radioactively contaminated zone around a wrecked nuclear power plant such as Chernobyl or Fukushima. The evacuation criterion currently applied in Fukushima is an effective dose of 20 mSv per year, i.e. people should not stay where the dose due to the nuclear accident is higher than that limit. In most cases it is actually much lower.6 But it is important to realize that with a dose limit of 20 mSv for evacuation, a risk of 1:1000 is considered tolerable in this case, in other words the causation of 100 cancer deaths (in 20 years from now or more) among 100 000 non-evacuated inhabitants, and that for every year of them staying in the contaminated area. Ethical aspects of radiological protection The risk estimates for nuclear accidents in particular, but also those cited above for medical radiation exposure, show that all this is not a matter of science alone, but clearly has ethical aspects. Why is a dose limit of 20 mSv per year, i.e. a risk of 1:1000 per year considered tolerable? Why is the higher risk associated with computer tomography as compared to magnetic resonance imaging or other types of radiography found irrelevant in many cases? Some of it comes down to economic considerations: evacuation is expensive, the computed tomography equipment has to be amortized, and so on, and so on. The question then is how to weigh risks of human health and well-being against finances. But there are other factors: some people are not prepared to change their habitual way of life and do not care about assumed radiation risks; others are extremely apprehensive and not do not want to accept a small risk even if they are assured the alternative is much riskier. There is also the question of how to act under uncertainty: how sure do we have to be about health risks before we adopt measures? And finally there is the problem of how decisions are made: by the specialists alone, or with the inclusion of stakeholders? The International Commission on Radiological Protection (ICRP) did not address this kind of questions for a long time, or at least did not address them directly. Radiological Protection was considered mainly a matter of science, and perhaps of practical experience as well, but not of ethics. Only gradually it was realized that this understanding was too narrow, and that in actuality the system of radiological protection had implicitly incorporated certain values from its very beginning. In 2013, it was finally decided to appoint a task group on ‘Ethics of Radiological Protection’ (ICRP TG94) and to ask it to review the Commission’s publications with respect to ethical aspects which might be contained therein.7 At the same time, ICRP together with the International Radiation Protection Association (IRPA) initiated a series of workshops around the world, two each in Europe, East Asia and North America, in which relevant topics were discussed with radiological protection professionals as well as ethics specialists. The task group also benefitted from discussions in a number of other symposia and congresses where special sessions were held on ethics of radiological protection. A draft report was compiled and after preliminary approval by the Commission offered for public consultation through the ICRP website. The final text was approved in 2017 and published in 2018.8 The report first provides a historical analysis of the ICRP recommendations which endeavours to show that ethical values have been at the basis of the system of radiological protection throughout its evolution, although as mentioned above they were rarely discussed explicitly. The document does not aim to present completely new ideas for the ethics of radiological protection, but rather to identify a set of values relevant to the ICRP system in the past and present, and applicable to current and foreseeable problems with sensible results. The second part of the document then presents what are called the ‘core values’ which underlie radiological protection, along with ‘procedural values’ which are supposed to drive its practical applications. The ‘core values’ are: - Beneficence/Non-maleficence: Do good, and avoid doing harm - Prudence: Recognize and follow the most reasonable course of action, even when full knowledge of its consequences is not available - Justice: Distribute benefits and risks fairly - Dignity: Treat individuals with unconditional respect, and recognize the capacity to deliberate, decide and act without constraint Under the heading ‘procedural values’, the document mentions - Accountability: Be answerable to all those who are possibly affected by your actions - Transparency: Be open about decisions and activities that may affect others and communicate them in a clear, accurate, timely, honest and complete manner - Inclusiveness: Involve all relevant parties (stakeholders) in decision-making processes Similarities and differences with the ‘Principles of Biomedical Ethics’ As readers who are familiar with the ‘Principles of Biomedical Ethics’ by Beauchamp and Childress9 will readily see, the ‘core values’ have some similarity with that system, but there are also differences. Beauchamp and Childress present ‘beneficence’ and ‘non-maleficence’ as two independent values, whereas ICRP combines them into one, emphasizing the necessity of balancing good and harm. This reflects the first principle of radiological protection—justification: ‘Any decision that alters the radiation exposure situation should do more good than harm.’ ‘Prudence’ is not mentioned as an independent value by Beauchamp and Childress. It is, however, of great importance for radiological protection, where sometimes action has to be taken without exact knowledge of the risks involved, for instance at low doses. In such cases, the second principle of radiological protection applies—optimization: ‘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.’ Here the underlying assumption is that even small doses of radiation carry a certain risk, with a similar risk per dose as observed at higher doses, and that this approach is based on ‘prudence’. Although ICRP also refers to ‘precaution’ (more details in Ref.8), this is not the only consideration guiding optimization; ‘economic and societal factor’ are not to be neglected. So ‘prudence’, at least as used by ICRP, is a broader concept than ‘precaution’, because it looks at the risks of the individual, but also at the benefits for the larger whole. We will briefly come back to this below. Beauchamp and Childress list ‘respect for autonomy’ instead of ‘dignity’. This has been attributed to their Western cultural background, which assigns decision making in a clinical situation to the patient and the patient only, whereas the approach may be different elsewhere in the world (but that is a different discussion). ‘Dignity’ is a more fundamental concept, basic not only to autonomous decision making, but also to non-discrimination, for instance, and this is what the ICRP document is referring to in particular. Together with ‘justice’, which is common to biomedical ethics and ethics of radiological protection, ‘dignity’ forms the basis of the third principle of radiological protection—dose limitation: ‘The total dose to any individual from regulated sources in planned exposure situations…should not exceed the limits specified.’ The main purpose here is a fair distribution of risks, and the avoidance of treating a person as a mere means to an end, which could happen if one individual would be exposed to a relatively high risk in order to save many from a relatively low one. Identification of additional relevant principles There has been some discussion about whether the ‘principles of biomedical ethics’, which were developed mainly as a guide for decision making in clinical situations, can also be applied to questions of public health. In order to cover specific aspects of that field, some authors have argued that the Beauchamp and Childress approach should be supplemented with a number of additional principles or core values. Two proposals will be considered here. Under the title, ‘How Many Principles for Public Health Ethics’, Coughlin10 discusses what would be needed if Beauchamp and Childress’s approach was to be applied beyond biomedicine, and comes up with two additional principles. Schröder-Bäck et al.11 reflect on a possible basis for a curriculum of public health ethics in a paper entitled ‘Teaching seven principles for public health ethics’. Similar to Coughlin, they do not doubt the usefulness of Beauchamp and Childress’ principles, but suggest adding three more. We can therefore restrict the following short review to five additional principles: - Precaution: Precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically. - Solidarity: Solidarity or social cohesion…relates to how united, connected, and cooperative a society is. - Health Maximization: The primary end sought is the health of the broader constituency of the public. - Efficiency: There is a moral duty to use scarce health resources efficiently. - Proportionality: In weighing and balancing individual freedom against wider social goods, considerations will be made in a proportionate way. I have elsewhere discussed these additional principles with regard to environmental health, which can be considered to be a subdomain of public health on the one hand, and to encompass radiological protection on the other.12 Similar to Coughlin and Schröder-Bäck et al., I have suggested that the ‘principles of biomedical ethics’ should be considered as basis, but that there are related principles, or core values which are needed to cover issues specific to the field, namely ‘dignity’ as a corollary to ‘respect for autonomy’, ‘solidarity’ as a corollary to ‘beneficence’, ‘precaution’ as a corollary of ‘non-maleficence’ and ‘sustainability’ as a corollary of ‘justice’. ‘Prudence’, which was mentioned above as one of the core values identified by the International Commission of Radiological Protection, can then be understood as ‘precaution’ coupled with ‘solidarity’, as has been briefly discussed above: the optimization principle of radiological protection recommends to keep radiation exposures as low as reasonably achievable (‘precaution’), taking into account economic and societal factors (‘solidarity’). It may also be interesting to note that several contributors to the public consultation process leading up to the creation of the ICRP document about ‘Ethics of radiological protection’ brought up the topic of ‘solidarity’ which they suggested should be mentioned as an independent principle. It has to be said, of course, that the mandate of the task group preparing the document was to identify those values which had actually been explicitly referred to in the publications of ICRP, and that this was not the case for ‘solidarity’. Another principle referred to during the public consultation process was ‘sustainability’. This concept does appear in some of ICRP documents, but not prominently enough to identify it as a core value. ‘Sustainability’ can relate to the advantages and disadvantages of certain measures within a relatively short period of time, say a few decades, but also during much longer intervals, in which case we speak of ‘intergenerational equity.’ The necessity of a cross-cultural approach Beauchamp and Childress claim that their ‘Principles of Biomedical Ethics’ are rooted in ‘common morality’, which is ‘not relative to cultures or individuals, because it transcends both’.9 They are not really interested, however, in the question of where and how the ‘common morality’ can be found. When they introduced the term, they just claimed that ‘all morally serious persons,’ (fourth edition) or later ‘all persons committed to morality’ (seventh edition), would agree with their four principles. This is not convincing, because there is no way of ascertaining what ‘all’ such persons think or feel, to say nothing of the difficulties of defining ‘morally serious’ or ‘committed to morality’. More effort is needed to show that these principles have cross-cultural validity—or to find others that are more widely acceptable. The International Commission on Radiological Protection (8: Annex C of ‘Ethics of radiological protection’) adopted an approach which assesses the cross-cultural validity of the proposed core values by comparing written and oral traditions of different cultures around the world. These have provided moral guidance over the centuries and are still considered relevant by a majority of people. That is not to say that secular ethics is wrong and useless, but just that a degree of worldwide consensus already exists and is reflected in those traditions. Important sources of morality are, for instance, the sacred scriptures of the world’s great religions, such as the Vedas and the Bhagavad-Gita for the Hindus, the Sermons of the Buddha for the Buddhists, the Torah for the Jews, the Gospels for the Christians, the Qur’an for the Muslims, the Writings of Bahá’u’lláh for the Bahá’ís, and so on. Oral traditions in the form of proverbs, stories, legends, and myths, especially those of indigenous peoples who have no written records, should not to be ignored either, nor should seminal texts of various kinds which have had a formative influence over the centuries, such as the Hippocratic Oath, or the works of certain philosophers of ancient Greece and China like Aristotle and Confucius. Whatever we may think of the individual sources, in their entirety they reflect the ‘common morality’ of mankind. There is no space here to look at the individual core and procedural values and provide evidence for the high esteem in which they are held by people adhering to a broad range of religious and philosophical traditions. Suffice it to say that the ICRP document on ‘Ethics of Radiological Protection’ does refer to different sources of the kind mentioned above and cites passages from them which indeed suggest that there is cross-cultural agreement regarding the values identified as important for radiological protection. The document also, as one example of non-Western ethics, discusses Confucian theory. It turns out that in spite of claims about special ‘Asian values’, which allegedly are different from those ‘forced upon the world’ by the West, Confucian thought in everyday life emphasizes moral values quite compatible with Western ideas (see also Ref.13). Of course, a similar more detailed analysis would be good to have for other cultural contexts as well, but that was not found to be practical in the scope of the current ICRP report. So much seems clear, at least: the common morality approach introduced by Beauchamp and Childress into biomedical ethics and applied, in a modified form, for the ethics both of public health in general and of radiological protection in particular, can be reinforced by reference to religious and philosophical traditions around the world and thus achieve truly global legitimacy. Acknowledgements Thanks are due to my fellow-members in ICRP TG94 Chieko Kurihara and Nicole E. Martinez, as well as to my daughter, Maryam Zölzer-Yazdani, for valuable comments on a draft version of this paper. References 1 UNSCEAR (Unites Nations Scientific Committee on the Effects of Atomic Radiation). Sources and Effects of Ionizing Radiation. Report to the General Assembly, With Scientific Annexes . New York: United Nations, 2000. 2 Linet MS, Slovis TL, Miller DL et al.  . Cancer risks associated with external radiation from diagnostic imaging procedures. CA Cancer J Clin  2012; 62: 75– 100. Google Scholar CrossRef Search ADS PubMed  3 McLean AR, Adlen EK, Cardis E et al.  . A restatement of the natural science evidence base concerning the health effects of low-level ionizing radiation. Proc Biol Sci  2017; 284: 20171070. Google Scholar CrossRef Search ADS PubMed  4 ICRP (International Commission on Radiological Protection). The 2007 Recommendations of the International Commission on Radiological Protection. ICRP Publication 107. Ann ICRP  2007; 37. 5 Brenner DJ, Hall EJ. Computed tomography—an increasing source of radiation exposure. N Engl J Med  2007; 357: 2277– 84. Google Scholar CrossRef Search ADS PubMed  6 Nomura S, Blangiardo M, Tsubokura M et al.  . Postnuclear disaster evacuation and chronic health in adults in Fukushima, Japan: a long-term retrospective analysis. BMJ Open  2016; 6: e010080. Google Scholar CrossRef Search ADS PubMed  7 Clement C, Lochard J. Recent reflections on the ethical basis of the system of radiological protection. In: Zölzer F, Meskens G (eds). Ethics of Environmental Health . Oxford: Routledge, 2017: 76– 85. 8 ICRP (International Commission on Radiological Protection). Ethical foundations of the system of radiological protection. ICRP Publication 138. Ann ICRP  2018; 47. 9 Beauchamp TL, Childress JF. Principles of Biomedical Ethics . Oxford: University Press, 1979, 1994, 2013.1, 19944, 20137. 10 Coughlin SS. How many principles for Public Health Ethics. Open Public Health J  2008; 1: 8– 16. Google Scholar CrossRef Search ADS PubMed  11 Schröder-Bäck P, Duncan P, Sherlaw W et al.  . Teaching seven principles for public health ethics: towards a curriculum for a short course on ethics in public health programmes. BMC Medical Ethics  2014; 15: 73– 82. Google Scholar CrossRef Search ADS PubMed  12 Zölzer F. A common morality approach to environmental health ethics. In: Zölzer F, Meskens G (eds). Ethics of Environmental Health . Oxford: Routledge, 2017: 51– 68. 13 Kurihara C, Cho K, Toohey RE. Core ethical values of radiological protection applied to Fukushima case: reflecting common morality and cultural diversities. J Radiol Prot  2016; 36: 991– 1003. Google Scholar CrossRef Search ADS PubMed  © The Author(s) 2018. Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/about_us/legal/notices) http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of Public Health Oxford University Press

Ethics of Radiological Protection—recent developments

Journal of Public Health , Volume Advance Article – Apr 24, 2018

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Abstract

Abstract The International Commission on Radiological Protection (ICRP) has recently reviewed the ethical foundations of its recommendations. The approach taken in its report is similar to principlism, i.e. the system of Beauchamp and Childress proposed in their ‘Principles of Biomedical Ethics.’ The commission identifies a number of ‘core values’ which have helped shape the evolution of the ICRP system of radiological protection, namely ‘Beneficence and non-maleficence’, ‘Prudence’, ‘Justice’ and ‘Dignity’. In addition, ‘procedural values’ are cited that are important for the system’s applications in practice, ‘Accountability’, ‘Transparency’ and ‘Inclusiveness (Stakeholder Participation)’. It is emphasized that these values are common to or at least acceptable for people from different cultural backgrounds, which for an endeavour as global in nature as radiological protection seems to be quite important and appropriate. Thus, the ICRP document on ‘Ethics of radiological protection’ could set a standard for other areas. biomedical ethics, common morality, cross-cultural ethics, ethics of public health, radiation protection Risks of radiation exposure from natural and man-made sources Radiological protection is a discipline closely related to public health. We are all exposed to radiation from natural sources. For most inhabited regions of the world, external exposure from cosmic and terrestrial radiation and internal exposure from radioactivity in food and drink result in an effective dose of ~1 mSv per year (The effective dose is a measure of the health risk due to radiation exposure, i.e. the probability of cancer induction and genetic effects. It takes into account the effectiveness of various types of radiation and the sensitivity of various organs or tissues exposed.). Depending on the building materials used, inhalation of the radioactive noble gas radon and its decay products can cause an additional effective dose in the same order of magnitude. The world average of effective dose from natural sources is ~2.4 mSv per year.1 In many developed countries, this natural radiation exposure is now equalled or even exceeded by radiation exposure from medical applications. Here, of course, individual doses can vary quite a bit, with somebody undergoing computed tomography easily receiving 10 mSv and somebody having a dental panoramic radiograph being exposed to only 10 µSv. The average annual effective dose due to medical applications in the USA, for instance, has increased from 0.5 mSv in 1980 to 3 mSv in 2006.2 What do we know about the health risks associated with such exposures? Not much, to be honest. There is direct epidemiological evidence for the carcinogenic effects of radiation mainly at much higher doses, namely those to which people were exposed due to the atomic bomb explosions in Hiroshima and Nagasaki 1945. So far, significant increases of cancer risk have been found for those who were exposed to more than ~100 mSv. The assumption generally made in radiological protection, however, is that the risk per dose can be extrapolated from this dose range down to the range of 1–10 mSv.3 The risk factor currently considered to best reflect the findings from Japan is 5% fatal cancer cases per Sv, i.e. of 100 000 people exposed to 1 Sv, 5000 will die of a radiation induced cancer (in addition to those 25 000 in such as group who will die of cancer due to other reasons) (The average dose of the survivors of the atomic bomb explosions was of course much smaller, ~200 mSv, so that the estimated number of fatal cancer cases here is ~1000 among 100 000.).4 In the case of medical exposure, computed tomography with a dose of 10 mSv would accordingly be expected to induce 50 cases of cancer death among 100 000 people. Here, of course, an additional factor has to be taken into consideration: the latency period of most radiation induced cancers is at least 20 years, and because many patients undergoing a computed tomography are elderly or seriously ill, their chance of surviving long enough to ‘experience’ the radiation induced cancer is small. Nevertheless, it has been estimated that in the USA ~2% of all cancer deaths may be attributable to medical radiation exposure, which is more than 10 000 cases every year.5 Another situation in which radiation exposure poses a health risk is living in the radioactively contaminated zone around a wrecked nuclear power plant such as Chernobyl or Fukushima. The evacuation criterion currently applied in Fukushima is an effective dose of 20 mSv per year, i.e. people should not stay where the dose due to the nuclear accident is higher than that limit. In most cases it is actually much lower.6 But it is important to realize that with a dose limit of 20 mSv for evacuation, a risk of 1:1000 is considered tolerable in this case, in other words the causation of 100 cancer deaths (in 20 years from now or more) among 100 000 non-evacuated inhabitants, and that for every year of them staying in the contaminated area. Ethical aspects of radiological protection The risk estimates for nuclear accidents in particular, but also those cited above for medical radiation exposure, show that all this is not a matter of science alone, but clearly has ethical aspects. Why is a dose limit of 20 mSv per year, i.e. a risk of 1:1000 per year considered tolerable? Why is the higher risk associated with computer tomography as compared to magnetic resonance imaging or other types of radiography found irrelevant in many cases? Some of it comes down to economic considerations: evacuation is expensive, the computed tomography equipment has to be amortized, and so on, and so on. The question then is how to weigh risks of human health and well-being against finances. But there are other factors: some people are not prepared to change their habitual way of life and do not care about assumed radiation risks; others are extremely apprehensive and not do not want to accept a small risk even if they are assured the alternative is much riskier. There is also the question of how to act under uncertainty: how sure do we have to be about health risks before we adopt measures? And finally there is the problem of how decisions are made: by the specialists alone, or with the inclusion of stakeholders? The International Commission on Radiological Protection (ICRP) did not address this kind of questions for a long time, or at least did not address them directly. Radiological Protection was considered mainly a matter of science, and perhaps of practical experience as well, but not of ethics. Only gradually it was realized that this understanding was too narrow, and that in actuality the system of radiological protection had implicitly incorporated certain values from its very beginning. In 2013, it was finally decided to appoint a task group on ‘Ethics of Radiological Protection’ (ICRP TG94) and to ask it to review the Commission’s publications with respect to ethical aspects which might be contained therein.7 At the same time, ICRP together with the International Radiation Protection Association (IRPA) initiated a series of workshops around the world, two each in Europe, East Asia and North America, in which relevant topics were discussed with radiological protection professionals as well as ethics specialists. The task group also benefitted from discussions in a number of other symposia and congresses where special sessions were held on ethics of radiological protection. A draft report was compiled and after preliminary approval by the Commission offered for public consultation through the ICRP website. The final text was approved in 2017 and published in 2018.8 The report first provides a historical analysis of the ICRP recommendations which endeavours to show that ethical values have been at the basis of the system of radiological protection throughout its evolution, although as mentioned above they were rarely discussed explicitly. The document does not aim to present completely new ideas for the ethics of radiological protection, but rather to identify a set of values relevant to the ICRP system in the past and present, and applicable to current and foreseeable problems with sensible results. The second part of the document then presents what are called the ‘core values’ which underlie radiological protection, along with ‘procedural values’ which are supposed to drive its practical applications. The ‘core values’ are: - Beneficence/Non-maleficence: Do good, and avoid doing harm - Prudence: Recognize and follow the most reasonable course of action, even when full knowledge of its consequences is not available - Justice: Distribute benefits and risks fairly - Dignity: Treat individuals with unconditional respect, and recognize the capacity to deliberate, decide and act without constraint Under the heading ‘procedural values’, the document mentions - Accountability: Be answerable to all those who are possibly affected by your actions - Transparency: Be open about decisions and activities that may affect others and communicate them in a clear, accurate, timely, honest and complete manner - Inclusiveness: Involve all relevant parties (stakeholders) in decision-making processes Similarities and differences with the ‘Principles of Biomedical Ethics’ As readers who are familiar with the ‘Principles of Biomedical Ethics’ by Beauchamp and Childress9 will readily see, the ‘core values’ have some similarity with that system, but there are also differences. Beauchamp and Childress present ‘beneficence’ and ‘non-maleficence’ as two independent values, whereas ICRP combines them into one, emphasizing the necessity of balancing good and harm. This reflects the first principle of radiological protection—justification: ‘Any decision that alters the radiation exposure situation should do more good than harm.’ ‘Prudence’ is not mentioned as an independent value by Beauchamp and Childress. It is, however, of great importance for radiological protection, where sometimes action has to be taken without exact knowledge of the risks involved, for instance at low doses. In such cases, the second principle of radiological protection applies—optimization: ‘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.’ Here the underlying assumption is that even small doses of radiation carry a certain risk, with a similar risk per dose as observed at higher doses, and that this approach is based on ‘prudence’. Although ICRP also refers to ‘precaution’ (more details in Ref.8), this is not the only consideration guiding optimization; ‘economic and societal factor’ are not to be neglected. So ‘prudence’, at least as used by ICRP, is a broader concept than ‘precaution’, because it looks at the risks of the individual, but also at the benefits for the larger whole. We will briefly come back to this below. Beauchamp and Childress list ‘respect for autonomy’ instead of ‘dignity’. This has been attributed to their Western cultural background, which assigns decision making in a clinical situation to the patient and the patient only, whereas the approach may be different elsewhere in the world (but that is a different discussion). ‘Dignity’ is a more fundamental concept, basic not only to autonomous decision making, but also to non-discrimination, for instance, and this is what the ICRP document is referring to in particular. Together with ‘justice’, which is common to biomedical ethics and ethics of radiological protection, ‘dignity’ forms the basis of the third principle of radiological protection—dose limitation: ‘The total dose to any individual from regulated sources in planned exposure situations…should not exceed the limits specified.’ The main purpose here is a fair distribution of risks, and the avoidance of treating a person as a mere means to an end, which could happen if one individual would be exposed to a relatively high risk in order to save many from a relatively low one. Identification of additional relevant principles There has been some discussion about whether the ‘principles of biomedical ethics’, which were developed mainly as a guide for decision making in clinical situations, can also be applied to questions of public health. In order to cover specific aspects of that field, some authors have argued that the Beauchamp and Childress approach should be supplemented with a number of additional principles or core values. Two proposals will be considered here. Under the title, ‘How Many Principles for Public Health Ethics’, Coughlin10 discusses what would be needed if Beauchamp and Childress’s approach was to be applied beyond biomedicine, and comes up with two additional principles. Schröder-Bäck et al.11 reflect on a possible basis for a curriculum of public health ethics in a paper entitled ‘Teaching seven principles for public health ethics’. Similar to Coughlin, they do not doubt the usefulness of Beauchamp and Childress’ principles, but suggest adding three more. We can therefore restrict the following short review to five additional principles: - Precaution: Precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically. - Solidarity: Solidarity or social cohesion…relates to how united, connected, and cooperative a society is. - Health Maximization: The primary end sought is the health of the broader constituency of the public. - Efficiency: There is a moral duty to use scarce health resources efficiently. - Proportionality: In weighing and balancing individual freedom against wider social goods, considerations will be made in a proportionate way. I have elsewhere discussed these additional principles with regard to environmental health, which can be considered to be a subdomain of public health on the one hand, and to encompass radiological protection on the other.12 Similar to Coughlin and Schröder-Bäck et al., I have suggested that the ‘principles of biomedical ethics’ should be considered as basis, but that there are related principles, or core values which are needed to cover issues specific to the field, namely ‘dignity’ as a corollary to ‘respect for autonomy’, ‘solidarity’ as a corollary to ‘beneficence’, ‘precaution’ as a corollary of ‘non-maleficence’ and ‘sustainability’ as a corollary of ‘justice’. ‘Prudence’, which was mentioned above as one of the core values identified by the International Commission of Radiological Protection, can then be understood as ‘precaution’ coupled with ‘solidarity’, as has been briefly discussed above: the optimization principle of radiological protection recommends to keep radiation exposures as low as reasonably achievable (‘precaution’), taking into account economic and societal factors (‘solidarity’). It may also be interesting to note that several contributors to the public consultation process leading up to the creation of the ICRP document about ‘Ethics of radiological protection’ brought up the topic of ‘solidarity’ which they suggested should be mentioned as an independent principle. It has to be said, of course, that the mandate of the task group preparing the document was to identify those values which had actually been explicitly referred to in the publications of ICRP, and that this was not the case for ‘solidarity’. Another principle referred to during the public consultation process was ‘sustainability’. This concept does appear in some of ICRP documents, but not prominently enough to identify it as a core value. ‘Sustainability’ can relate to the advantages and disadvantages of certain measures within a relatively short period of time, say a few decades, but also during much longer intervals, in which case we speak of ‘intergenerational equity.’ The necessity of a cross-cultural approach Beauchamp and Childress claim that their ‘Principles of Biomedical Ethics’ are rooted in ‘common morality’, which is ‘not relative to cultures or individuals, because it transcends both’.9 They are not really interested, however, in the question of where and how the ‘common morality’ can be found. When they introduced the term, they just claimed that ‘all morally serious persons,’ (fourth edition) or later ‘all persons committed to morality’ (seventh edition), would agree with their four principles. This is not convincing, because there is no way of ascertaining what ‘all’ such persons think or feel, to say nothing of the difficulties of defining ‘morally serious’ or ‘committed to morality’. More effort is needed to show that these principles have cross-cultural validity—or to find others that are more widely acceptable. The International Commission on Radiological Protection (8: Annex C of ‘Ethics of radiological protection’) adopted an approach which assesses the cross-cultural validity of the proposed core values by comparing written and oral traditions of different cultures around the world. These have provided moral guidance over the centuries and are still considered relevant by a majority of people. That is not to say that secular ethics is wrong and useless, but just that a degree of worldwide consensus already exists and is reflected in those traditions. Important sources of morality are, for instance, the sacred scriptures of the world’s great religions, such as the Vedas and the Bhagavad-Gita for the Hindus, the Sermons of the Buddha for the Buddhists, the Torah for the Jews, the Gospels for the Christians, the Qur’an for the Muslims, the Writings of Bahá’u’lláh for the Bahá’ís, and so on. Oral traditions in the form of proverbs, stories, legends, and myths, especially those of indigenous peoples who have no written records, should not to be ignored either, nor should seminal texts of various kinds which have had a formative influence over the centuries, such as the Hippocratic Oath, or the works of certain philosophers of ancient Greece and China like Aristotle and Confucius. Whatever we may think of the individual sources, in their entirety they reflect the ‘common morality’ of mankind. There is no space here to look at the individual core and procedural values and provide evidence for the high esteem in which they are held by people adhering to a broad range of religious and philosophical traditions. Suffice it to say that the ICRP document on ‘Ethics of Radiological Protection’ does refer to different sources of the kind mentioned above and cites passages from them which indeed suggest that there is cross-cultural agreement regarding the values identified as important for radiological protection. The document also, as one example of non-Western ethics, discusses Confucian theory. It turns out that in spite of claims about special ‘Asian values’, which allegedly are different from those ‘forced upon the world’ by the West, Confucian thought in everyday life emphasizes moral values quite compatible with Western ideas (see also Ref.13). Of course, a similar more detailed analysis would be good to have for other cultural contexts as well, but that was not found to be practical in the scope of the current ICRP report. So much seems clear, at least: the common morality approach introduced by Beauchamp and Childress into biomedical ethics and applied, in a modified form, for the ethics both of public health in general and of radiological protection in particular, can be reinforced by reference to religious and philosophical traditions around the world and thus achieve truly global legitimacy. Acknowledgements Thanks are due to my fellow-members in ICRP TG94 Chieko Kurihara and Nicole E. Martinez, as well as to my daughter, Maryam Zölzer-Yazdani, for valuable comments on a draft version of this paper. References 1 UNSCEAR (Unites Nations Scientific Committee on the Effects of Atomic Radiation). Sources and Effects of Ionizing Radiation. Report to the General Assembly, With Scientific Annexes . New York: United Nations, 2000. 2 Linet MS, Slovis TL, Miller DL et al.  . Cancer risks associated with external radiation from diagnostic imaging procedures. CA Cancer J Clin  2012; 62: 75– 100. Google Scholar CrossRef Search ADS PubMed  3 McLean AR, Adlen EK, Cardis E et al.  . A restatement of the natural science evidence base concerning the health effects of low-level ionizing radiation. Proc Biol Sci  2017; 284: 20171070. Google Scholar CrossRef Search ADS PubMed  4 ICRP (International Commission on Radiological Protection). The 2007 Recommendations of the International Commission on Radiological Protection. ICRP Publication 107. Ann ICRP  2007; 37. 5 Brenner DJ, Hall EJ. Computed tomography—an increasing source of radiation exposure. N Engl J Med  2007; 357: 2277– 84. Google Scholar CrossRef Search ADS PubMed  6 Nomura S, Blangiardo M, Tsubokura M et al.  . Postnuclear disaster evacuation and chronic health in adults in Fukushima, Japan: a long-term retrospective analysis. BMJ Open  2016; 6: e010080. Google Scholar CrossRef Search ADS PubMed  7 Clement C, Lochard J. Recent reflections on the ethical basis of the system of radiological protection. In: Zölzer F, Meskens G (eds). Ethics of Environmental Health . Oxford: Routledge, 2017: 76– 85. 8 ICRP (International Commission on Radiological Protection). Ethical foundations of the system of radiological protection. ICRP Publication 138. Ann ICRP  2018; 47. 9 Beauchamp TL, Childress JF. Principles of Biomedical Ethics . Oxford: University Press, 1979, 1994, 2013.1, 19944, 20137. 10 Coughlin SS. How many principles for Public Health Ethics. Open Public Health J  2008; 1: 8– 16. Google Scholar CrossRef Search ADS PubMed  11 Schröder-Bäck P, Duncan P, Sherlaw W et al.  . Teaching seven principles for public health ethics: towards a curriculum for a short course on ethics in public health programmes. BMC Medical Ethics  2014; 15: 73– 82. Google Scholar CrossRef Search ADS PubMed  12 Zölzer F. A common morality approach to environmental health ethics. In: Zölzer F, Meskens G (eds). Ethics of Environmental Health . Oxford: Routledge, 2017: 51– 68. 13 Kurihara C, Cho K, Toohey RE. Core ethical values of radiological protection applied to Fukushima case: reflecting common morality and cultural diversities. J Radiol Prot  2016; 36: 991– 1003. Google Scholar CrossRef Search ADS PubMed  © The Author(s) 2018. Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/about_us/legal/notices)

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Published: Apr 24, 2018

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