General comment: This is a very valuable document and most of it is well-written and worth reading. I am grateful for the many opportunities offered for contributing to this work, and much of my comments are the fruit of thorough discussions within the Belgian Radiation Protection Society as part of this process. I appreciate ICRP’s efforts to unravel the ethical foundations of the Radiation Protection System. This is not equivalent however to the ethics of radiation protection as a discipline. I am concerned about people misusing this document to claim the wisdom of their own decisions, merely on grounds of the fact that they are in line with ICRP recommendations. The draft document helps to understand the development of the ICRP system of protection. ICRP has evolved from utilitarian ethics to deontological ethics, and this shift has prompted emphasis on the protection of the individual rather than the collective detriment and benefit. The earlier focus on the detriment and benefit to the whole of society or mankind had suffered from the naïve application of utilitarian cost-benefit approaches. Collective dose was dismissed on grounds of its misinterpretation in terms of an associated death toll. Still, it should not be ignored that the new focus on the rights and selfish interests of the individual may be contrary to making reasonable and fair decisions for the benefit of other individuals or groups in society. One should bear in mind that in modern western society many people perceive that any risk liable to affect their health should be eradicated, with the underlying idea that any illness has a cause and that it is necessary and sufficient to eliminate all such causes in our environment and living conditions to live a long and happy life. While giving priority to the protection of the individual we should not ignore that we are a socialising species. We do have sympathy for others, we are respectful of the needs of society and despite today’s prevailing liberal economic philosophy, people often still act out of solidarity with other people. Solidarity is an important value in our societal behaviour, which is nowhere mentioned however in ICRP’s ethical scrutiny. It may not be fair to blame ICRP for this omission. The ICRP system of protection and the present analysis of its underlying ethical principles relate to guiding the decision maker in taking the right decision. It is not for the decision maker to impose solidarity; this attitude must grow from within the affected community. Fortunately, there have been many demonstrations of solidarity in post-accidental situations, both after Chernobyl and after Fukushima. There are also negative examples however, most recently about the import and consumption of food from Japan. The dissemination of a practical radiation protection culture should allow citizens to contribute to informed decisions for the well-being of the whole of society, including themselves. ICRP should strongly underline that the ethics underlying the radiation protection system are not the sole ones. The empowerment of people, stakeholder involvement and the dissemination of radiation protection culture should allow for a broader range of values, for instance solidarity, as essential parts of practical radiation protection culture.
Dose limitation: I was hoping that ICRP would take this opportunity for shedding light on the third principle of the system, dose limitation, which is at the same time the simpler one, and the most misunderstood. It suffers from not applying to all exposure situations, and even for planned situations, not to medical exposures. ICRP Publication 103 has not been followed in the international basic safety standards, that concluded that dose limitations should apply to industries processing naturally occurring radionuclides and even to some situations of radon exposure in workplaces. In (34) of the present draft the third bullet is worded very poorly so that it hardly sounds like a basic principle. It is merely a bland statement that one should do what ICRP recommends. Despite this, (55-56) as well as (61-63) introduce the right kind of reflections on the tolerability of individual risks, which in a few broad categories of exposure may require the introduction of dose limits. These are a matter of regulatory enforcement however, not a basic principle. Proposing dose limitation as a first principle causes a semantic confusion in the sense that a limit, in common language, should never be exceeded, yet, in radiation protection, it may be exceeded where this is justified. This is the case for:
i) workers, for specially authorised practices (space crew) or exposures, if the worker agrees,
ii) emergency workers, in view of the societal necessity of intervention, by workers who are duly informed of radiation risks and of the exposures they may incur,
iii) medical exposures, to the benefit of the patient or asymptomatic individual (bearing in mind the broad definition of Health by WHO), but also to the benefit of comforters and carers,
iv) medical exposures, for people participating in biomedical research programmes, in view of the societal need for such research, under specific ethical constraints,
v) emergency and existing exposure situations.
The third principle needs to be reworded to allow for the following observations:
i) A dose limit is meaningless without being enforced through regulatory control.
ii) A dose limit is not applicable if, despite the dose limit being exceeded, the practice is judged to be justified.
iii) The application of the dose limit should never be contrary to the individuals’ own benefit or interests.
While doing so, one should distinguish between:
i) The principle, in the light of tolerability of individual exposures,
ii) The application of the principle through dose limits that can be enforced in a few specific situations,
iii) International consensus on dose limits for occupational exposure (irrespective whether the exposure situation is planned or existing) and on limits for public exposure, irrespective of the prevailing circumstances in a planned exposure situation.
This leads me to propose a long-winded but more precise definition of the “third principle”:
Individual exposures should not exceed a tolerable level. In situations where dose constraints or reference levels do not offer firm guarantees for this purpose, a dose limitation system should be imposed as a means of regulatory enforcement, but applied only for the benefit of the exposed individual.
3. Beneficence/non-maleficence: Paragraphs (37-41) of section 3.1 illustrate the concept of beneficence/non-maleficence only for planned exposure situations. It should be underlined that it may be even more important in the other exposure situations, in particular non-maleficence of actions in an emergency exposure situation (allowing for the death toll of evacuation and the distress of long term relocation), beneficence of actions in an existing exposure situation (e.g. radon remediation). This omission may be a relic of Publication 103, which based the definition of a planned exposure situation essentially on it introducing a new source, which introduction should be beneficent (justified).
4. Research: The last part of paragraph (50) is rather self-defensive (we know the right answer but we need to narrow the uncertainty) and is not really needed in this publication. On the other hand, in terms of the principle of prudence, ICRP could underline that research should be open to unexpected findings, and where such findings indicate possible health consequences beyond those currently understood, that it may be prudent to protect against these consequences even if they are not yet clearly demonstrated.
5.Transparency and inclusiveness: Sections 4.2 and 4.3 are very nice, but the first one focusses on practices and does not discuss the need for transparency and for specific information to be provided with regard to emergency exposure situations, and both do not address the importance of providing stakeholders with access to independent and reliable expertise.
6. Miscellaneous: A few sentences seem grammatically incorrect, incomplete or using in my opinion the wrong terms (lines 429, 636 (patients), 683 (biota or environment), 690 (delete biota), 748 (delete non-humans), 834, 868, or seem unconvincing (1169: equity versus quality); some terms seem sloppy (biomedical ethics rather than medical, copied from biomedical research?).