While the general tenants of the Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects, first adopted in 1964 and amended nine times until today, more sophisticated ethical frameworks focused on radiological protection in research settings are emerging. In addition, the scientific understanding of radiation dosimetry and radiation epidemiology advances, the radiation imaging and therapy technologies are more numerous and complex, and medical practice has evolved with the implementation of the electronic health record and societal expectations, as examples. All of these areas impact the radiological protection guidance needed for human subjects’ research when using radiation technologies (diagnostic imaging procedures, nuclear medicine, and radiotherapies).
There have also been significant advances in the field of biomedical research ethics since ICRP Publication 62 on Radiological Protection in Biomedical Research (1992) which include but are not limited to: what is informed consent and what is shared decision-making; the right to know and not to know; the right to drop out of a research study with removal of private health information. There are new disciplines of research that include use of ‘big data’, artificial intelligence/machine learning; radiation genetics, imaging sciences and radiomics, and the blurring of the line between clinical practice improvement and clinical research that require guidance. There is also a societal expectation that wider stakeholder input into the research design, implementation, analysis, and reporting be used and would include an oversight board external to the research group or institution.
ICRP’s system of radiological protection has ethics, along with science and experience, as one of the three pillars of the system. Publication 138 explicitly discusses and clarifies these ethical foundations. These advances build on the classical framework published by Beauchamp and Childress (i.e., respect for autonomy, non-maleficence, beneficence, and justice), which is interpreted in research settings in the Belmont Report. TG 109 (Ethics of Radiological Protection in Medical Diagnosis and Treatment) builds on both ICRP Publication 138 and Beauchamp and Childress to address RP ethics specifically in medical settings focusing on patients, but it does not address RP for research participants including healthy volunteers. The objective of the present work builds on these two ICRP publications and will be developed to update ethical principles in health research in humans, in the field of radiological science for promoting radiological protection.
There is a need to provide updated guidance since the 1991 Publication 62 as there have been significant advances in social norms, ethical frameworks, scientific RP evidence, and medical practice leading to new complexity in human biomedical research involving ionising radiation. The scope is limited to human subjects deliberately or accidentally exposed to ionising radiation. The report is intended to be of use to individuals, regulatory bodies and ethical committees concerned with the design, assessment (justification), evaluation and oversight of human biomedical research.
To implement activities, a face to face meeting will be organised in Q4 of 2022 (or Q1 of 2023) to be followed by a topical on-line workshop to gather ideas and contribution from the larger community. These two meetings will launch the drafting procedure and clear assignment of tasks for revision of P62 will be organised among TG members.
On-line regular meetings will be preferred throughout the writing phase with the possibility to organise sub-group meetings. Report for review will be prepared for Q3 of 2024 followed by MC approval and consultation in Q2 2025.
Publication of the revised report is expected by Q2 2026, which will be followed by an on-line webinar to reach a large audience.
The Task Group will develop a report for publication in Annals of the ICRP, on-line webinar about the publication contents and/or a podcast, slide set summary of each chapter key points for local facility teaching. In addition, the Task Group will develop materials suitable for ICRPædia in collaboration with the Scientific Secretariat.
|Isabelle Thierry-Chef (Chair), Bacelona Institute for Global Health (ISGlobal), Spain|
|Kimberly Applegate (Member), University of Kentucky COM (retired), USA|
|Catrin Baureus Koch (Member), OKG NPP, Sweden|
|Chieko Kurihara-Saio (Member), Japan|