Abstract
The International Commission on Radiological Protection (ICRP) has established Task Group 94 under Committee 4 to develop a report on the ethical foundations of the system of radiological protection. The aim of this report is to consolidate the basis of ICRP recommendations, to improve understanding of the system, and to provide a basis for communication on radiation risk and its perception. Through a series of workshops organised by the Commission in cooperation with the International Radiation Protection Association and its associate societies involving radiological protection professionals and specialists of ethics around the world, Task Group 94 has identified the key ethical and social values underpinning the system of radiological protection. The purpose of eliciting the ethical principles and values of the radiological protection system is not only to clarify the rationale for recommendations made by the Commission, but also to assist in discussions related to its practical implementation. A clear understanding of the ethical principles will help resolve dilemmas caused by potential conflicts in actions that might be considered, or decisions that must be made.
1. INTRODUCTION
Despite long recognition that radiological protection is not only a matter of science but also of values, International Commission on Radiological Protection (ICRP) reports have rarely addressed the ethical foundations of its system of radiological protection explicitly. This does not mean that the Commission is unaware of the importance of such considerations. Protection recommendations inevitably represent an ethical position, irrespective of whether that position is explicit or implicit. However, the discussion of ethical considerations is not entirely absent from ICRP reports.
The lessons learned from management of the consequences from Chernobyl, and more recently from Fukushima, have certainly played a key role in the increase in recent interest in ethical aspects of radiological protection, and the awareness that the traditional emphasis on the science of radiation has shown its limits, and therefore human and ethical dimensions of the exposure situations are important and sometimes decisive in the decision-making process.
It is in this context that ICRP initiated a reflection on the ethical foundations of the radiological protection system in early 2010. After an initial phase during which Committee 4 reviewed the literature on the subject, Task Group 94 was created in October 2013 to work on the ethics of radiological protection. The first step of Task Group 94 was to review the reports of the Commission to identify the ethical values associated with the system of radiological protection for occupational, public, and medical exposures, and for protection of the environment. A draft report is now in preparation presenting the ethical and social values structuring the system of radiological protection, and its implementation for the different types of exposure situations and categories of exposure. This is the first concerted effort by the Commission to reflect upon and describe the ethical basis of the system of radiological protection in some detail.
The draft report identifies key components of the ethical theories and principles prevailing in the fields of safety, health, labour, the environment, and sustainable development relevant to the system of radiological protection. In order to involve ethicists, philosophers, social scientists, and radiological protection professionals from different regions of the world, a series of six workshops was held by the Commission in collaboration with the International Radiation Protection Association to fully examine, discuss and debate the ethical basis of the current system of radiological protection [Daejeon (Korea) and Milan (Italy) in 2013; Baltimore (USA) in 2014; Madrid (Spain), Cambridge, MA (USA), and Fukushima (Japan) in 2015].
This paper summarises the current text of the Task Group 94 draft report: Chapter 2 presents the key steps concerning the scientific, ethical and practical evolutions of the system of radiological protection since the first ICRP report in 1928; Chapter 3 describes the core ethical values underpinning the present system (ICRP, 2007a); and Chapter 4 addresses the key procedural ethical values for implementation of the system.
2. EVOLUTION OF THE SYSTEM OF RADIOLOGICAL PROTECTION: SCIENCE, ETHICAL VALUES, AND EXPERIENCE
The present system of radiological protection is based on three pillars: the science of radiation, combining scientific knowledge from different disciplines; a set of values rooted in ethics and morality; and experience accumulated from the day-to-day practice of radiological protection professionals. Due to uncertainties concerning the risk associated with radiation at low doses, this system fundamentally promotes a prudent approach for protecting people against the detrimental effects of radiation exposure. The following sections describe how the system has evolved progressively over the 20th Century in relation to historical events associated with the use of x rays and radioactivity.
2.1. The early days: do no harm
The international system of radiological protection (‘the system’) was ‘born’ in 1928, with the first recommendations of the International X-Ray and Radium Protection Committee (ICRP, 1928), although some advice had been published much earlier (Fuchs, 1896). Nearly three decades had passed since the discovery of x rays (Roentgen, 1895), natural radioactivity (Becquerel, 1896) and radium (Curie, 1898), during which time the use of radiation in medicine had skyrocketed.
The 1928 Recommendations provided advice meant to avoid harmful skin reactions: ‘the dangers of over-exposure … can be avoided by the provision of adequate protection.’ This advice was based on the best scientific knowledge at the time about the effects of radiation exposure, the experience of nearly 30 y of practice, and the desire to avoid harm. The relatively simple, implicit ethical value of non-maleficence, avoidance of doing harm, was sufficient, as it was thought that straightforward protection measures could keep exposures sufficiently low to avoid harm entirely.
The 1950 Recommendations (ICRP, 1951) saw the first hints of the evolution of the ethical basis of system beyond the avoidance of doing harm, or at least that the practicalities of achieving this aim might be less straightforward than previously thought, recommending that ‘every effort be made to reduce exposures to all types of ionising radiation to the lowest possible level’.
2.2. A more complex problem: managing risk, a matter of balance
The 1950s saw a growing concern about the effects of radiation exposure not only to workers and patients, but also to the public. This growing concern, along with the increasing use of radiation in many fields, the expected increase in the nuclear energy industry, and emerging evidence of increased leukaemia in radiologists and atomic bomb survivors, had a profound influence on the system.
In Publication 9 (ICRP, 1966), noting the absence of evidence regarding the existence of a threshold for this type of effect and in view of the uncertainty concerning the nature of the dose–effect relationship in the induction of malignancies, the Commission saw ‘…no practical alternative, for the purposes of radiological protection, to assuming a linear relationship between dose and effect, and that doses act cumulatively’.
Cancer and genetic effects, for which it is assumed that there is no absolutely safe level of exposure (no threshold), presented a much more ethically complex situation than before. It was no longer enough to avoid doing harm by keeping exposures sufficiently low; it appeared to be impossible to completely avoid any risk of doing harm. The problem shifted from avoiding harm to managing the probability of harm. This was elaborated on in Publication 26 (ICRP, 1977), where the primary aim of the system was described as ‘protection of individuals, their progeny, and mankind as a whole while still allowing necessary activities from which radiation exposure might result’.
2.3. A broader perspective: protecting the environment per se
The ICRP system also expanded its view from human to non-human species. Publication 26 (ICRP, 1977) included the first description of extending protection beyond humans, expanding the scope of the system to include protection of the environment. However, it did not go much beyond the assertion that ‘if man is adequately protected then other living things are also likely to be sufficiently protected’. This statement, although reworded, was repeated in Publication 60 (ICRP, 1991): ‘the standards of environmental control needed to protect man to the degree currently thought desirable will ensure that other species are not put at risk.’
Protection of the environment was treated more substantially in Publication 91 (ICRP, 2003). This report suggested a framework, based on scientific and ethical-philosophical principles, by which a policy for the protection of non-human species could be achieved.
The elaboration of ICRP framework for protection of the environment (ICRP, 2003) was based explicitly on a reflection on ethics. On this occasion, ICRP referred to sustainable development and human dignity. Procedural ethics was addressed clearly, and a discussion on tools and guidelines was provided for the implementation of ethical issues in the ICRP system.
2.4. More than protection from physical harm
The widespread impact of the Chernobyl accident in 1986, increasing awareness of the legacy of areas contaminated by past activities, the importance of natural sources of radiation, and concern regarding malevolent acts following the attack on the World Trade Center in New York City on 11 September 2001 challenged the ICRP system. Later, the Fukushima accident in 2011 would challenge the system again in much the same way.
No doubt, the core of the system remained the protection of people and the environment from physical harm, but these events also highlighted the need to consider some broader societal issues more carefully. Therefore, Publication 103 (ICRP, 2007a) introduced the idea of ‘existing exposure situations’ and ‘emergency exposure situations’, as distinct from ‘planned exposure situations’, and also emphasised the importance of ‘the participation of relevant stakeholders rather than radiological protection specialists alone’.
These ideas were expanded upon shortly thereafter. For example, Publication 111 (ICRP, 2009) introduced the idea of self-help protection, where individuals take informed actions to improve the radiological situation for themselves, their family, and their community. This implies a level of autonomy (flowing from the concept of dignity), relying on information, advice, and support from authorities and other experts.
3. CORE ETHICAL VALUES UNDERPINNING THE SYSTEM
3.1. The system of radiological protection today
The present radiological protection system consists of a set of interdependent elements interacting to achieve the objectives. The so-called fundamental principles of protection (justification, optimisation, and limitation) are central to the system and apply to the different types of exposure situations (planned, emergency, and existing) and categories of exposure (occupational, public, and medical exposure of patients). They are also related to the protection criteria (reference levels, dose constraints, and dose limits) applied to sources or individuals to restrict exposures, and also to what is called the basic requisites for practical implementation of the system (accountability, transparency, and stakeholder involvement) which are common to all three types of exposure situation.
The following sections present how the values of beneficence/non-maleficence and prudence are combined with the values of justice and dignity within the system.
3.2. Beneficence and non-maleficence
As far as the protection of human health is concerned, the objective of the Commission’s recommendations is ‘to manage and control exposures to ionising radiation so that deterministic effects are prevented, and the risks of stochastic effects are reduced to the extent reasonably achievable’. In the ethical context, the desire to do good is called ‘beneficence’, and the desire to do no harm is called ‘non-maleficence’.
In its most general meaning, beneficence is the action to promote the well-being of others. Thus, in a way, beneficence includes non-maleficence, which is the principle of avoiding harm. ‘Do no harm’ is one of the demands of the Hippocratic Oath. By developing recommendations seeking to protect people against the harmful effects of radiation, the Commission undoubtedly contributes to serve the best interests of individuals and, indirectly, the quality of social life. This is achieved in practice by ensuring that deterministic effects are avoided and stochastic effects are reduced as far as achievable given the prevailing circumstances. Non-maleficence is closely related to prevention, which aims to take measures in order to avoid a situation from deteriorating. Non-maleficence therefore aims to limit risk by eliminating or reducing the likelihood of hazards.
Beneficence and non-maleficence may sometimes be separate actions, but may also be two aspects of one action. The good will to provide benefit does not always result in good consequences. An action to prevent some harm may cause other harm. Meanwhile, an action to protect others from harm, even if there is no intention of providing benefit, may be able to preserve benefit, even well-being of individuals. It is important to balance actions with intentions of beneficence and non-maleficence.
3.3. Prudence
The ICRP system of radiological protection of humans is based on a wide spectrum of scientific knowledge, ranging from metrology to epidemiology, going through disciplines as diverse as anatomy, physiology, pathology and radiobiology. All this knowledge is integrated in a series of models of varying complexity. The use of models, associated with the lack of precise information on some parameters, inevitably introduces uncertainties in the estimates, and therefore requires reliance on value judgements.
Despite the ongoing effort undertaken to critically evaluate and reduce these uncertainties, the Commission is led to use a default option: a series of inferences, extrapolations and assumptions. One of the key assumptions concerning radiation risk is the absence of a threshold for stochastic effects adopted in the 1960s to respond to the uncertainty on the relationship between dose and effect, especially for low doses.
From an ethical viewpoint, a situation that requires decision making and acting without the full knowledge of the consequences should be governed by the virtue of prudence. It is worth noting that the term ‘prudence’ only appeared in the most recent formulations of the Commission’s recommendations in relation to the linear-non-threshold (LNT) model: ‘The Commission considers that the continued application of the LNT model…provides a prudent basis for practical purposes of radiological protection…’ or: ‘The LNT model is not universally accepted as biological truth, but rather, because we do not actually know what level of risk is associated with very-low-dose exposure, it is considered to be a prudent judgement for public policy aimed at avoiding unnecessary risk from exposure’ (ICRP, 2007a).
Prudence is essentially a practical virtue of making decisions about what is uncertain. It is the virtue of deliberation and judgement in order to make choices without full knowledge of the scope and consequences of our actions. It is also the ability to choose and act on what is in our power to do and not to do. Prudence therefore has a direct relationship to action and practice. As such, prudence is one of the core values structuring the radiological protection system.
3.4. Justice
The principle of optimisation of protection requires that all exposures should be kept as low as reasonably achievable, taking into account economic and societal factors, using restrictions on individual exposures to reduce inequities in the distribution of exposures among exposed groups. This is the cornerstone of the system. On one hand, it is a principle of action that allows the practical implementation of prudence. On the other hand, it allows the introduction of fairness in the distribution of exposures among people exposed. This dimension of fairness, or equity as designated by the Commission, refers directly to the ethics of justice.
The principle of limitation of individual exposures requires that all individual exposures do not exceed the protection criteria recommended by the Commission. Like the principle of optimisation, it refers directly to the ethical values of prudence, but mainly to justice by restricting the risk in an equal manner for a given exposure situation and category of exposure.
It must be emphasised that the Commission never referred to justice explicitly, neither in its latest recommendations nor in earlier recommendations. However, the idea of limiting individual exposures in order to correct possible disparities in the distribution of health damage due to radiation among exposed populations appeared as early as Publication 26 (ICRP, 1977). In addition, Publication 60 was the first to use the term ‘inequity’: ‘When the benefits and detriments do not have the same distribution through the population, there is bound to be some inequity. Serious inequity can be avoided by the attention paid to the protection of individuals’ (ICRP, 1991).
3.5. Dignity
Considering respect for human dignity as a founding value of the radiological protection system is not obvious a priori. However, on closer examination, it can be seen as running through the system early on. Dignity is an attribute of the human condition; the idea that something is due to the human being because she/he is human. This means that every individual deserves unconditional respect, whatever her/his age, sex, health, social condition, ethnic origin, and religion.
Personal autonomy is the corollary of human dignity. This is the idea that individuals have the capacity to act freely and morally. The radiological protection system respects and promotes the autonomy of people facing radioactivity in their daily lives, whether at work, as a patient, or simply as citizens confronted with situations such as radon in their homes (ICRP, 2014b) or radiation from security screening in airports (ICRP, 2014a).
In radiological protection, the desire to respect dignity was first fostered in the medical field in relation to protection in biomedical research in the early 1990s (ICRP, 1992), and later on with the protection of patients (ICRP, 2007b) in connection with the principle of ‘informed consent’. In parallel, the value of dignity can be found in relation to protection of the environment (ICRP, 2003), in which the concept of ‘human dignity’ is associated with seeking a fair process of consensus development for future generations.
More recently, respecting the dignity of individuals and preserving their autonomy have found expression in empathy for people living in post-accident areas or the legacy sites. It is interesting to note that the promotion of dignity is also closely related to a set of procedural ethical values – transparency, accountability, and inclusiveness – which are linked to practical implementation of the system of radiological protection. These aspects are developed in more detail in Chapter 4.
4. ETHICS IN IMPLEMENTATION OF THE RADIOLOGICAL PROTECTION SYSTEM
For the practical implementation of its recommendations, the Commission sets out a number of requirements relating to the procedural and organisational aspects of radiological protection. It gives some indication of the type of infrastructures and managerial arrangements to ensure efficient implementation of these requirements, but does not go into detail. It merely lays down some broad principles, leaving other international organisations the task of developing them (IAEA, 2014). Three of these requirements deserve to be highlighted because they are common to all exposure situations: accountability, transparency, and stakeholder involvement. Ethically, they refer to the ethics of responsibility, procedural justice, and human dignity, respectively.
4.1. Accountability and transparency
Accountability can be defined as the principle that people who are in charge to make decisions must answer for their actions to all those who are likely to be affected positively, as well as negatively, by these actions. This definition refers directly to the ethics of responsibility, which states that everybody has to account for the foreseeable consequences of her/his actions.
The concept of accountability appeared explicitly in Publication 60 (ICRP, 1991). It says: ‘The first stage of responsibility is the duty to establish objectives, to provide the measures needed to achieve those objectives, and to ensure that these measures are properly carried out. This is essentially a prospective concept. Those bearing responsibility should then have the authority to commit the resources needed to meet their responsibilities. There is also a retrospective component of responsibility, sometimes called accountability, that requires a continuing review of performance to be made so that failures can be identified and steps taken to prevent recurrence.’ The Commission also considered the accountability of the present generation towards the future. This was mentioned explicitly in Publications 77, 81, 91 and 122 (ICRP, 1997, 1998, 2003, 2013) related to waste management and protection of the environment.
Transparency in relation to ethics refers to procedural justice, and concerns the fairness of the process through which information is intentionally shared between individuals and/or organisations. Transparency does not simply mean communication or consultation.
Regarding the radiological protection system, transparency on exposures and protection actions for the workers has been integrated into ICRP recommendations since the 1960s: ‘Workers should be suitably informed of the radiation hazard entailed by their work and of the precautions to be taken’ (ICRP, 1966). Since then, this requisite has been taken over and expanded in the subsequent recommendations (ICRP, 1991, 2007a). It was not, however, until the 2000s that transparency became a general principle, applicable not only to information about exposures and protection actions, but also to the decision-making processes concerning the choices of protective actions made by policy makers. Moreover, it was generalised to all categories of exposure: occupational, medical, and members of the public. Publication 101b (ICRP, 2006) was the first to introduce this, dedicated to the optimisation of protection and bearing the evocative subtitle ‘Broadening the process’.
Finally, in its latest recommendations, the Commission emphasised that ‘…scientific estimations and value judgements should be made clear whenever possible, so as to increase the transparency, and thus the understanding of how decisions have been reached’ (ICRP, 2007a), which shows that recognising the requisite of transparency should apply wherever value judgements are involved in the radiological protection system.
4.2. Stakeholder involvement
In recent decades, stakeholder involvement has become an essential part of the ethical framework in private and public sector organisations. Inclusiveness is one of the essential procedural values, with transparency and accountability, to make ethical decisions in organisations. This value has recently appeared in the field of radiological protection, which has long been perceived as rather paternalistic by some people.
Concretely, engaging stakeholders in radiological protection emerged in the late 1980s and early 1990s in the context of management of exposures in areas contaminated by the Chernobyl accident, and sites contaminated by past nuclear activities in the USA (Beierle and Cayford, 2002; Lochard, 2004). Indeed, citizens found themselves involved in situations where they were confronted directly with radioactivity in everyday life, and this posed new questions to which the system in place at the time had difficulty in responding.
Stakeholder involvement was first introduced by ICRP in Publication 82: ‘Many situations of prolonged exposure are integrated into the human habitat and the Commission anticipates that the decision-making process will include the participation of relevant stakeholders rather than radiological protection specialists alone’ (ICRP, 1999). This became a requisite in Publication 103 in relation to the principle of optimisation of protection: ‘It should also be noted that the Commission mentions, for the first time, the need to account for the views and concerns of stakeholders when optimising protection’ (ICRP, 2007a).
Experience from Chernobyl and, more recently, Fukushima demonstrated that empowerment of affected people helps them to regain confidence, to understand the situation that they are confronted with, and to make informed decisions to act accordingly (Lochard, 2013). In other words, engaging stakeholders is a way to demonstrate respect, and also, in the case of post-accident situations, to help restore their dignity.
In post-accident situations, it is the responsibility of experts and authorities to ensure fair support to all different groups of affected individuals. Fairness in this respect refers to the fundamental values of equity and transparency. This requirement to be treated fairly is a key condition for those concerned to enter into a dialogue with the authorities, and have the objective to restore decent and sustainable living conditions. This dialogue with experts allows citizens to better understand their individual situations, and to empower them to make informed decisions. This empowerment process relies on the development of ‘a practical radiological protection culture’ among individuals and communities.
4.3. Reasonableness and tolerability
The problems of deciding which actions are required to ensure that exposures are kept as low as reasonably achievable given the prevailing circumstances, and which level of risk can be considered as tolerable for the exposed individuals, are central to the radiological protection system. Both are consequences of the assumption that there is no threshold for stochastic effects. Reasonableness is intimately linked to the optimisation principle and tolerableness to the limitation principle, which together aim to reflect prudence and justice in protection.
Regarding tolerability, in the 1970s, the Commission relied on the emerging discipline of risk assessment to try to find a scientific rationality to the question on a ‘non-acceptable risk level’. The Commission developed an approach based primarily on comparing radiation risk with other similar risks in society to determine the degree of tolerability of an exposure (or of the associated risk), thus allowing, depending on the exposure situation, distinction between unacceptable and tolerable levels of exposure (ICRP, 1991). This conceptual framework, although based on a rational approach, does not escape the need to use value judgements to make a decision about the tolerability of the risk. It is interesting to note that ultimately the Commission defined tolerable exposures as those that are ‘not welcome but can be reasonably tolerated’, thus making reasonableness a key component of tolerability.
The quest for reasonableness and tolerability are eminently ethical questions. Decades of efforts to define these two concepts in a variety of recognised fields have shown that scientific rationality is not sufficient. It is necessary to consider factors beyond simply the dose, the cost, and risks to balance many societal and ethical considerations, including common knowledge and the experiences accumulated over time.
In practice, searching for reasonableness and tolerability is a permanent question that depends on the prevailing circumstances to act wisely based on accumulated knowledge and experiences [i.e. with the desire to do more good than harm (beneficence/non-maleficence), to avoid unnecessary risk (prudence), to seek for fair distribution of exposures (justice), and to treat people with respect (dignity)].
5. CONCLUSIONS
The ICRP system of radiological protection is based on three pillars: science, ethics, and experience. As far as ethics is concerned, the system is rooted in the three major theories of moral philosophy: deontological ethics, utilitarian ethics, and virtue ethics; and they rely on four core ethical values: beneficence/non-maleficence, prudence, justice, and dignity. Beneficence and non-maleficence are directly related to the aim to prevent deterministic effects and to reduce the risk of stochastic effects. Prudence allows taking account of uncertainties concerning both the deterministic and stochastic effects of radiation on health. Justice is the way to ensure social equity and fairness in decisions related to protection. Lastly, dignity considers the respect that one must have for people. Over the past decade, the system has also integrated procedural values such as accountability, transparency, and stakeholder involvement, reflecting the importance of allocating responsibilities to those involved in the radiological protection process, and to properly inform and preserve the autonomy and dignity of the individuals potentially or actually exposed to radiation.
The primary goal and responsibility of the Commission should be to develop the science of radiological protection for the public benefit. Nevertheless, the Commission thinks that by eliciting and diffusing the ethical values and related principles that underpin the radiological protection system, both experts and the public will undoubtedly gain a clearer view of the societal implications of its recommendations. Just as science, ethics alone is unable to provide a definitive solution to the questions and dilemmas generated by the use or presence of radiation. However, ethics can certainly provide useful insights into the principles and philosophy of radiological protection, and thus help the dialogue between experts and citizens.