Ethical considerations related to radiosensitivity and radiosusceptibility

Abstract

Purpose: The potential for individual radiosensitivity and radiosusceptibility testing, both in clinical practice and in systems of radiological protection, raises complex ethical considerations which must be addressed both in relation to the scientific research looking at the issues themselves, and in relation to any systems of safety and protection which are then proposed for introduction.

Methods: This paper uses ethical principles for radiological protection derived by the ICRP together with other biomedical principles, to identify and evaluate some of the ethical issues associated with radiosensitivity testing.

Results and conclusions: Although the evaluation is not exhaustive, it illustrates a range of different ethical aspects that would need to be considered, prior to making recommendations for how the field might better address these challenges in its future development.

Keywords:

• Ethics
• radiosensitivity
• justice
• engagement
• ICRP

Introduction

The fields of individual radiosensitivity relating to radiotherapy patients, and radiosusceptibility from both medical and occupational ionizing radiation exposures to patients and workers require detailed ethical evaluation, and evidence of compliance with ethical principles, both at the basic research level, and also in relation to the development and eventual implementation of systems of protection and regulatory controls. While testing for radiosensitivity and radiosusceptibility has the potential to improve patient treatment and diagnosis, or protect workers, application of the assays raises a number of ethical and legal challenges. These go beyond the simple question of whether the assay will ‘do more good than harm’ to include, for example, questions about how the costs and benefits might be distributed in society, concerns about privacy and data protection and considerations of the potential for discrimination. Some of these challenges are specific to the type of assay, for example, whether the assays were applied for radiosensitivity (i.e. radiotherapy induced reactions) or radiosusceptibility (i.e. enhanced cancer risk in connection with radiodiagnosis such as CT scans or mammography) (Seibold et al. this issue). Other challenges, such as worker radiosusceptibility, are similar to those for other types of occupational exposures (e.g. sensitivity to chemical or physical stress), though to date these have not featured in international systems of Occupational Health and Safety regulation. It must also be remembered that all individuals irrespective of their health or occupation are continuously subject to variable amounts of natural background environmental ionizing radiations.

The International Commission on Radiological Protection (ICRP) recently published a document on ‘The Ethical Foundations of the ICRP System of Radiological Protection’ (ICRP 2018). In addition to providing a historical evaluation of the system of protection and the implicit ethical values addressed during its evolution, the publication also highlights the ethical dimension of radiation protection. It proposes four core ethical values underpinning the ICRP system: Beneficence/Non-maleficence, Dignity, Justice and Prudence. These values are, in turn, reflected in other biomedical and public health ethical frameworks (Kass 2001), including Beauchamp and Childress’ Principles of Biomedical Ethics, first published in 1979 (Beauchamp and Childress 2009). Likewise, the importance of societal and ethical issues was stressed in the Shamisen Recommendations on health surveillance of populations affected by a radiation accident (Shamisen 2017). While the focus in Shamisen was on the accidental situation rather than medical or occupational exposures, the recommendations also recognized the need to address well-being, dignity, justice and inequity. Recognizing that the challenges from radiosensitivity and radiosusceptibility have both a specific radiological dimension, as well as generic biomedical ethical aspects, this paper uses the ICRP 138 publication as a starting framework to evaluate the ethical considerations with these types of assays. This evaluation is not intended to be exhaustive, but rather to illustrate some of the ethical issues prior to making recommendations for how the field might better address these challenges in its future development.

Ethical considerations

Well-being

ICRP 138 combines the two norms of beneficence – providing benefits and balancing benefits against risks and costs, and non-maleficence – avoiding the causation of harm. These are well-established biomedical norms, and often combined in public health ethics to address general aspects of welfare and well-being (Kass 2001). For this paper, we group these norms under the term ‘well-being’, in order to reflect the broader societal consequences of assays. Well-being is also widely recognized from the WHO definition that ‘Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity’ (WHO 1948), and more recently in OECD work on well-being as a measure of the quality of life of populations (OECD 2013). The term was used in the Shamisen recommendations to stress the importance of social and psychological aspects of health surveillance (Shamisen 2017).

Radiosensitivity and radiosusceptibility assays have a clear potential to provide physical health benefits by improving cancer treatment, avoiding negative side-effects and enhancing worker protection. There are also economic aspects, such as balancing the cost of the assays against to opportunity to save money through tailored treatment. Psychosocial consequences could include reassurance, but might also cause worry about sensitivity to other stressors. Information on the magnitude of the effect, its relation to other potential risk factors and indeed any dose response relationship, as well rates of false positives and false negatives would be needed to be able to balance the physical harms and benefits. But this would also have knock-on effects for economic, psychological as well as legal assessment. Could doctors be sued for the negative effects of not carrying out a test?

Dignity and autonomy

Respect for dignity and autonomy recognizes the free-will and decision-making capacities of self-governing persons. In biomedical ethics, it is often associated with the norm of ensuring the free-informed consent of patients undergoing treatment, as well as securing privacy for personal data and information. Respect for autonomy also recognizes the importance of personal control over ones’ situation. Information on individual radiosensitivity and radiosusceptibility could clearly enhance patient or worker empowerment and personal control, but this would depend strongly on the context in which this information was used. The issues are similar to other challenges with personal health information, such as conforming to data protection laws and the increasing commercialization of genetic testing (Burgess et al. 2018). For example, the degree to which data from patients undergoing an assay as part of radiotherapy would be stored, anonymized and made available for further research would need to be addressed. A debate on the implications of these issues would need to include engagement with the various stakeholders, but could also play an important role in risk communication, by putting the risks of ionizing radiation in context with other environmental and genetic risk factors.

Justice and fairness

Justice refers to a group of norms concerning the distribution of risks, costs and benefits. It includes consideration of fairness in the ways advantages and disadvantages are distributed among populations, and also fairness in the rules and procedures for decision-making. Increased understanding of the differences in radiosensitivity within populations is relevant to an assessment of justice. Other questions would include whether the assays would provide equal access to health care and support, or have any impact on health insurance (would sensitive populations have to pay higher premiums?) or compensation claims (will it change the balance of probabilities that cancers were caused by radiation exposure?). Even in countries with national health insurance, there is the question of whether people should be obliged to disclose the results of genetic testing before taking out private health or life insurance schemes. If sensitivity or susceptibility was linked to a genetic trait, there would be additional issues associated with implications for children or other family members. While identification of increased radiosusceptibility in workers could be used for protective purposes, it might also lead to discrimination, or raise questions about ‘responsibility’ for any diseases or negative side-effects (lifestyle, predisposition, occupational exposure, etc.). These issues could be linked to broader debates on the implications for radiological protection of populations with different risk factors; such as whether children or women should be treated differently on the basis of increased radiation cancer risks.

Prudence

According to ICRP 138 ‘Prudence is the ability to make informed and carefully considered choices without full knowledge of the scope and consequences of actions’. Clearly, the state-of-the-art regarding radiosensitivity and radiosusceptibility is still at the stage where full knowledge is lacking, but not a situation where there is no knowledge at all, as the other papers in this issue demonstrate (Averbeck et al. this issue; Gomolka et al. 2019). Hence, prudence in this context is perhaps best met by a full and open assessment of both the scientific as well as the social and ethical uncertainties associated with the field.

To conclude, many of the ethical challenges associated with the field of radiosensitivity and radiosusceptibility have parallels with existing challenges in medical, occupational and public health. They also raise important questions about the implications for radiological protection. For example, will population level differences in radiation susceptibility impact on the assessment of health risk? Will they lead to a change in dose constraints? As the following recommendations underline, these questions can only be addressed with the participation of a wide variety of stakeholders. Assessing the implications for well-being requires knowledge from experts in radiation biology, medicine, occupational health, health economics, social scientists, etc., as well as transparency about uncertainties and assumptions. Respecting both the principles of dignity and fairness in procedure, requires the participation of affected persons (workers, patients, public, etc.) in decision-making.

Recommendations

The continuing development of work and policy relating to radiosensitivity and radiosusceptibility requires a major prospective process of imbedding ethical principles into the work at every level if the requirement to protect patients and workers is to be achieved, while maintaining the duty of care owed to these groups by those involved in the work.

Recommendation 1

All radiosensitivity and radiosusceptibility research projects should be required at the protocol stage, to document a review of the proposed work against the ICRP ethical guidance, and to state clearly in the protocol an action plan of how ethical issues are to be addressed during the work, and in relation to dissemination and publication of the results.

In relation to the development of practice or regulatory control, the ethical issues are complex. In addition to stakeholders from patients and workers, there are major national and international bodies whose roles involve the publication of guidance or even legislative requirements impacting on activities such as genetic testing, use of biomarkers, and the balance between duties to protect individuals while not causing discrimination.

Recommendation 2

Led by the European Union (EU) and ICRP, action is taken at this early stage to establish relevant stakeholder forums to identify the need for further ethical research, and deliver the necessary stakeholder consensus to allow appropriate systems of control to be developed and implemented to protect patients and workers.

It is clear that the requirement to address the issues of radiation susceptibility is well recognized both by the radiation research and the protection communities, with an increasing momentum to progress. It must be identified however, that the issue of individual sensitivity to occupational illness or disease, is by no means confined to considerations of occupational cancer from ionizing radiation exposure. Acute, chronic and cancer outcomes are well recognized with individual sensitivity demonstrated in relation to physical, chemical, biological, and even psychological exposures at work. These considerations have, however, had little impact on systems of protection from occupational disease to date.

It is considered that the aim should be to establish an ethical consensus on principles and practice to protect workers in relation to individual susceptibility to occupational illness as a whole. In this regard, it is suggested that the process is NOT best supported by the restriction of consideration to cancer from ionizing radiations, and there is a need to expand the proposed process, discussion and stakeholder involvement into the other known areas of susceptibility.

Recommendation 3

The action and forums identified in recommendation 2 should be expanded to encompass stakeholders and expertise to deal with the issue of individual susceptibility to occupational exposures as a whole, to ensure an ethical and consistent approach to the protection of workers from occupational disease.

The continuing development of work and policy relating to radio-sensitivity and radio-susceptibility requires a major prospective process of imbedding ethical principles into the work at every level if the requirement to protect patients and workers is to be achieved, while maintaining the duty of care owed to these groups by those involved in the work.

Disclosure statement

The authors report no conflict of interest regarding the work carried out in this paper.

Additional information

Funding

We thank the MELODI Association and the CONCERT European Joint Programme (H2020 Euratom grant number 662287) for the financial support of the 2018 workshop. This work was also partly funded by the Research Council of Norway (RCN) through its Centres of Excellence Funding Scheme, project number 223268. Additional funding was provided through the RCN project number 291797.

Notes on contributors

Chris Kalman

Chris Kalman is a Consultant Occupational Physician who has worked in the regulation of the UK Naval nuclear propulsion programme, as Chief Medical Officer of a Nuclear Power utility, and as Director of Occupational Health and Safety in the National Health Service in Scotland. He is a honorary lecturer in Public Health medicine at the University of Glasgow.

Deborah Oughton

Deborah Oughton is a professor in Nuclear Chemistry/Environmental Chemistry and Research Director of the NFR Centre of Excellence for Environmental Radioactivity (CERAD) at the Norwegian University of Life Sciences. She is adjunct Professor at the University of Oslo, where she teaches philosophy of science and research ethics to PhD students.