International co-operation in biological research to address low dose radiation risk: Osaka Call-for-Action

Diagnostic medical exposures are intentional and they are applied to result in a direct benefit of the patient. In radiation therapy, the biological effects of high-dose radiation are used for the benefit of the patient to treat cancer and other diseases. Key attributes of medical uses of ionizing radiation are the justification and the optimization commensurate with the medical purposes. Avoiding unnecessary exposures diagnostic and interventional procedures is considered the key objective; in radiation therapy this requires the delivery of the required dose to the volume to be treated, avoiding unnecessary exposure of healthy tissues.

While the medical use of ionizing radiation for diagnostic and therapeutic purpose is beneficial for many patients world-wide there are scientific and operational questions remaining and focused efforts are required to bridge the gap with radiobiological research programs. The ultimate aim of the required initiatives is to improve the available scientific evidence about the risks from low radiation exposures and for better quantification of the necessary precautionary measures, which are key elements of a strong system of protection for patients, workers, and the general public.

Medical exposures remain by far the largest man-made source of exposure to ionizing radiation (UNSCEAR 2008). Over the past decades, the numbers and techniques of applications of medical exposures have increased at a substantial rate. New medical X-ray technologies and techniques (particularly with respect to CT scanning) are proving increasingly useful for clinical use, resulting in rapid growth in the number of procedures in many countries. In at least one country, this has given rise to a situation where medical exposures have resulted in population and per caput doses equal to or greater than the exposures from the previously largest source, the natural background radiation.

The Japan Society for the Promotion of Science (JSPS) plays a key role in the administration of a wide spectrum of Japan’s scientific and academic programs. JSPS has four key functions, e.g. to support research initiatives and international collaboration, to foster next generation competencies, and to strengthen the linkage with society. The committee ‘Multidisciplinary Research on the Biological Effects of Radiation’ is organized as industry–university collaboration. To enhance the research activities on biological effects of low dose radiation, JSPS aims at the improvement of international scientific cooperation and the collection and distribution of information on available scientific research activities. Within its mandate, the committee organized an international workshop in March 2018, which addressed key questions about the optimal use of ionizing radiation in medicine.

During the ‘Presidential Session’ of the workshop different approaches of low dose research using ‘international co-operation in biological effects of radiation’ were presented by experts from Japan, Europe, US, and Canada. J. Repussard the former president of the European Low Dose Initiative (MELODI) presented MELODI’s approaches and initiatives to develop international co-operation as described in the report of the High Level Expert Group (HLEG): there is an urgent need for focused research to comfort the scientific basis of the protection system for low doses (below 100 mSv)/low dose rate exposures. This can best be achieved by a multi-disciplinary approach to drawing up Strategic Research Agendas, in order to effectively address the understanding of radiation effects mechanisms. He proposed a tripartite initiative to set up a joint strategy group under the umbrella of the Nuclear Energy Agency (NEA). D. Cool from the US Electric Power Research Institute (EPRI) presented the approach of the International Dose Effect Alliance (IDEA), which is operating as an international platform for information exchange, discussion, cooperation, and collaboration in low dose radiation research. IDEA has organized several workshops to facilitate information exchange and collaboration on low dose radiation research programs, identify issues and opportunities for additional research, and fosters integrated, outcome-oriented approaches to resolve key questions of low dose risk. D. Klokov presented an overview of the low-dose radiobiology program, low dose research activities at Canadian Nuclear Laboratories (CNL), and initiatives to integrate the national research activities into or lead international consortia. Y. Shimada and Y. Yamada from the National Institute of Radiological Sciences (NIRS), National Institutes for Quantum and Radiological Science and Technology (QST) presented the Acting Network for Low Dose Radiation Research (PLANET) in Japan and the Research Plan for 2016–2022. PLANET aims at establishing an all-Japan network among regulators, academia. and research institutes, and other stakeholders (including industries) with the objective to propose strategies to improve current understanding of low dose/low dose-rate risk. T. Wada described the high-level aims of the JSPS committee: to initiate discussions among researchers in different fields and promote multi-disciplinary research with strong emphasis on medical uses of radiation.

During the discussion of the presentations additional research programs were identified which are specifically addressing key issues related to the justification, optimization, and use of low dose radiation techniques in medicine. There was strong belief among the participants of the workshop that these programs should be considered on the way forward. In addition the participants recommended to consider with priority additional aspects of the Bonn Call for Action with the aim to strengthen manufacturers’ role in contributing to the overall safety regime, to strengthen radiation protection education and training of health professionals, to increase the availability of improved global information on medical exposures and occupational exposures in medicine, to improve measures for the prevention of medical radiation incidents and accidents, to strengthen the radiation safety culture in health care, and to foster an improved radiation benefit-risk-dialog.

The Osaka Call-for-Action summarizes the consensus of the participants of the workshop. It describes available opportunities and challenges to foster coordinated work with the aim to address a broad spectrum of research issues arising in radiation protection in medicine.

The Osaka Call-for-Action

Bringing together healthcare and radiation sciences for an optimal use of ionizing radiation in medicine, and strengthened radiation protection of patients and the public.

March 2018, Osaka

The Committee on Multidisciplinary Research on the Biological Effects of Radiation (JSPS) organized the ‘International Workshop on the Biological Effects of Radiation – Bridging the Gap between Radiobiology and Medical Use of Ionizing Radiation’ (BER2018) at Osaka University on 19–21 March 2018 with the specific purpose to discuss updated concepts of biological effects of radiation. The workshop was attended by 91 participants from 7 countries and 51 organizations.

One important focus was on medical exposures, which have become a major source of human exposure to ionizing radiation worldwide. The workshop illustrated that while excellent work is being done by various research platforms and programs individually, there are additional opportunities to broaden the scientific understanding of radiation risk at low doses if we work together.

The data from A-Bomb survivors in Japan have provided the most important information on which the current international protection guidelines and recommendations have been framed. There is large number of patients available in many parts of the world who are undergoing radiological examinations and procedures such as multiple investigations with CT or interventional procedures resulting in a wide range of radiation doses, some of which are much larger than those incurred by many members of the A-Bomb survivors’ cohort. To tap this population collectively in the context of future scientific investigations would be a good opportunity to increase the evidence basis about low dose radiation risk.

The workshop illustrated the recent progression in the scientific disciplines such as radiobiology, medical physics, radiomics or even radiogenomics, genetics, and epidemiology, which are key to better understanding low dose radiation effects mechanisms. Such advances have the potential to enhance patient protection, as well as inform the scientific challenges which still lie ahead in this field. It became obvious during the discussions that there is an urgent need for a holistic multidisciplinary approach to radiation and radiation protection research which includes key partners representing the existing national and supra-national programs and researchers, international agencies, institutions, and professional associations. The aim of such an approach is to better quantify and communicate radiological risks and to reduce such risks, especially for patients.

The workshop concluded that a new approach has a high potential for quantum leap improvement in:

• Understanding the effects of radiation on humans who are exposed to radiation doses of a few tens of mSv or organ dose of a few tens of mGy;

• The further optimization of the use of ionizing radiation for medical purposes (diagnostic and/or interventional imaging, therapeutic applications), taking into account individual responsiveness of a patient to radiation, which would result in higher therapeutic efficacy, as well as enhanced patient safety;

• Risk communication concerning the risks of ionizing radiation exposures.

The workshop agreed that the objectives of the Osaka Call-for-Action represent an exciting but complex challenge, which would require:

• Tapping the potential of patient groups receiving diagnosis and therapy as a source of information;

• Bridging the gap between epidemiological and radiation biology scientists to work with medical professionals;

• The convergence of scientific disciplines, e.g. radiobiology, epidemiology, medical physics, radiomics, and relevant medical sciences, for a joint elaboration of research strategies and projects;

• The development of a holistic and multidisciplinary vision of research goals to be pursued;

• The establishment of a closely coordinated action plan agreed at international level, not only within the signees of this document – major platforms and programs of radiological sciences in EU, US, and Japan – but also with other national bodies, e.g. from China, Korea, Russia, and other countries or regions with comprehensive radiological programs, willing to contribute in order to effectively organize the required research efforts. In Europe, we already have partners, like the European radiation protection research platforms. The action plan should also consider new partners such as radiation societies including but not limited to the American Society for Radiation Oncology, Radiological Society of North America, International Organization for Medical Physics, and the various radiation research societies that are part of the International Association of Radiation Research, Health Physics Society, American Nuclear Society, and in Japan, Science Council of Japan and Nuclear Regulation Authority.

The action plan should in particular address the following issues:

• Organize collaborative multidisciplinary forums for establishing strategic research agenda with common focus;

• Exchange of research priorities, strategies, programs, and results;

• Develop operational connections between existing programs conducting low dose radiation research;

• Improve standardized methods for collecting of patient dosimetry and related biological data including molecular, animal and human, and ecological data, and regulated modalities for using such data for public research purposes, whilst preserving patients’ rights to the protection of their privacy;

• Improve radiation protection research for patients (and staff) including the harmonization of practices, optimizing technologies, and procedures and adjusting procedures for individual patients based on individual susceptibility;

• Set up an open and sustainable multicentric database and modeling infrastructure;

• Link up to social sciences with the goal of improving risk communication capabilities, for healthcare and radiation protection professionals, as well as toward the public in general;

• Enhance education about radiation and its effects among the public, students, and the radiation community as a whole.

The workshop participants call on:

• Their respective governments and responsible national agencies;

• Research platforms and committees;

• Regional and international agencies and organizations;

to support such initiatives and to facilitate their implementation.

Progress on the follow up to this Call will be reviewed at forthcoming conferences addressing low dose radiation research, as well as any special focused group meetings organized and/or involving the authors of this document.

Wolfgang Weiss

Federal Office for Radiation Protection, Neuherberg, Germany

Yoshiharu Yonekura

Institute for Radiation Sciences, Osaka University, Osaka, Japan

[email protected]

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

The publication of this special issue is supported by The Tokyo Club.