WORKPACKAGE 6.
Justification, Ethics and Efficacy

Objectives

  1. To identify the ethical issues involved in the ownership of images and the use of images for research purposes and surveys
  2. To increase the penetration of professional ethical knowledge and analysis into radiological practice
  3. To identify ethical issues in radiation protection research

Description of work

  1. Meetings with ethicists from major religious and secular traditions
  2. Review of ethical considerations in medico-legal procedures3. Consensus meetings and workshops

Deliverables

  1. Ethical issues with new screening and special techniques in digital medical imaging.
  2. Safety dimensions, referral criteria and justification with new screening and special techniques in digital medical imaging.

Workpackage description

From the background material it is evident that there are a number of ethical issues arsing with regards to digital imaging. These arise, in some cases from very specific circumstances or techniques. For example issues associated with pregnancy, human fertility and healthcare screening programmes all give rise to relatively focused ethical issues. In other cases the ethical issues arise from either a broad social movement, such as globalisation or applications of information technology. Finally some of the issues arise from specific legislative developments, examples being the problems identified with medico-legal exposures, or the problems of justification particularly where resources are scarce or must be rationed. We propose to treat all of the above in a number of interlocking studies.

In many European countries new legislation with respect to Consent have created major new issues for researchers. In medical imaging these extend to the extent to which the permission of the patient is received for the use of an already acquired image for the purposes of subsequent research. The ethical issues involved in this question will be studied through a consolidation of existing views and practices, and through examining their underlying anthropology. Where possible consensus views will be identified on ethical handling of images in radiation protection research, and guidelines for ethics committees will be proposed.

At a different level, a number of ethical dilemmas arise from the fact that the Medical Radiological Equipment industry functions for practical purposes on a global scale. This means the design criteria for equipment, its AEC/dosage settings may derive from global considerations. For example, there will be differences in AEC settings for mammography on women in different counties, due to variations in breast size/composition related to usage of hormone replacement therapy. However, the European Health Service is essentially fragmented and differentiated by country and region, which gives rise to varying legal and ethical requirements. The ethical dilemmas arising from this interaction of a global industry with a national/regional service will be identified and projects in respect of the radiation protection components will be made to both.

The fact that ethical issues exist within various radiological practices including high dose procedures, medico-legal exposures, screening programmes, pregnancy and fertility is well recognised. The present solutions to these dilemmas are well documented (some in well prepared advice from the commission in documents issued by the Article 31 Medical Exposures Group). These documents represent the consensus of the professions directly involved and seldom have a significant input from jurists, theologians, ethicists or focus groups of patients. In the main professions tend to have a poor understanding of the ethical consensus of the general public. This project aims to bring scholarship from ethics, theology and information about public reaction directly into these areas to improve ethical guidelines in radiation protection, and protect against the perceived lack of sensitivity of the professions to some issues seen by the public as having a significant ethical component.

There is an inevitable ethical dilemma involved in the justification and the rationing of procedures which are highly resource intensive and involve use of expensive equipment/resources. This will frequently be reflected in referral criteria for procedures. The complimentary roles of safety and rationing, in working with or against each other, in determining referral criteria will be identified in each country and the information will be collated. Meetings will be convened to identify the ethical principles underlying these choices (where possible), and examine how consistent these principles are with the principle of Justification.

Finally, the manner in which information contained in images, and in digital image headers, is used, accessed and passed onto other systems for further use is a matter of both legal and ethical concern and debate. The existing situation in various member states, and in various components of the globalised industry will be determined and scrutinised from an ethical perspective, with a view to proposing improved practices where required.

From all of the above a clearer picture of the ethical issues and perspectives underlying the practice of modern digital imaging will emerge.