I agree with the general structure of the document and in particular support the following key messages:
page 10: (357) (23) Key Message 3: Individual patient radiation dose and risk – as we understand them – have not been disclosed to patients as a routine practice; this must change so that these data become no different from all other patient health information.
page 18: (538) (45) Key Message 6: Health care professionals respect dignity and autonomy through enabling the patient to participate in informed consent for procedures.
page 19: (602) (54) Key Message 7: Beneficence and non-maleficence (i.e. benefits and risks) cannot be disaggregated for use of radiation technologies in medicine. In justification, sparing the patient radiation exposure but failing to answer the clinical question does not benefit the patient.
page 22: (764) (75) Key Message 10: Accountability is fundamental for clinical quality and safety. It involves continuing review of performance for improvement.
page 23: (816) (83) Key Message 11: Honesty and transparency are shared responsibilities of professionals and institutions in all stages of the management and disclosure of adverse events.
page 44: (1733) (194) Key Message 24: Health-care professionals need to inform patients not only about the benefit and risk but also about the uncertainty in benefit/risk and its precise magnitude. This is based on the ethical values of transparency and honesty. The value of empathy must also be considered, since some patients may not want to know, or are afraid to learn about the level of uncertainty.
page 80: (2913) (308) Key Message 27: Although it may be of value to integrate the ethics teaching into everyday practical education, it is necessary to provide specific, practical teaching on ethics.
Comment:
Autonomy (which, according to Beauchamp and Childress, is expressed through informed consent) and informed consent itself should not be underestimated. Nor should it be summarised and implicitly addressed only by the principle of dignity. It should be made clear that justification does not include, and cannot replace, informed consent.
If more than 30 patient confusion cases per year are regularly reported to the supervisory authority, informed consent can only have been given in very few of these cases. As in other medical fields, the number of unreported cases is probably a factor of 20 or more. https://www.bag.admin.ch/dam/bag/fr/dokumente/str/strahlung-und-gesundheit/jahresberichte-strahlenschutz/jahresbericht-strahlenschutz-2022.pdf.download.pdf/Rapport_radioprotection_2022_FR.pdf, p.29/30
In the case of patient confusion, ethically relevant situations may arise. For example, when decisions have to be made about how to deal with incidental findings - even if no informed consent was granted for the examination. To avoid such situations, radiologists should see their patients before an examination (especially in the high-dose range) and obtain the patient's consent. Unfortunately, this is not common practice everywhere.
What situations are assessed by the evaluation method? Patient complaints? Situations perceived as unsatisfactory? Critical situations? Random checks?
What’s the aim of the evaluation method? Decision-making (page 50, 1929) – for use of ionizing radiation or to judge ethical practice? Learning to improve the practical application of ethics? Documentation?
When is the evaluation method performed? Before or after informed consent? Before or after the use of ionising radiation?
Is the assessment made only by radiological protection staff? Is the patient involved in the assessment of compliance or non-compliance with ethical values? He should be to avoid paternalism, shouldn’t he? (page 50, 1952-1960)
"[…] outside of routine practice or in the event of disagreement" should be described more in detail. (page 50, 1940)