Radiation Protection Dosimetry Advance Access published April 17, 2008 Radiation Protection Dosimetry (2008), pp. 1–4
doi:10.1093/rpd/ncn087
ETHICAL ISSUES IN MEDICO-LEGAL EXPOSURES Geraldine O’Reilly* and J. F. Malone Department of Medical Physics and Bioengineering, St James’s Hospital, Dublin 8, Ireland, UK
The Medical Exposure Directive (MED) 97/43/Euratom defines medico-legal procedures as ‘procedures performed for insurance or legal purposes without a medical indication’. The term ‘medico-legal exposures’ covers a wide range of possible types of exposures, very different in nature, for which the only feature in common is the fact that the main reason for performing them does not relate directly to the health of the individual being exposed to ionising radiation. The key issue in medicolegal exposures is justification. Balancing the advantages and disadvantages of such exposures is complex because not only can these be difficult to quantify and hence compare, but often the advantage may be to society whereas the disadvantage is usually to an individual. This adds an additional layer of ethical complexity to the problem and one, which requires input from a number of sources beyond the established radiation protection community. Because medico-legal exposures are considered to be medical exposures, they are not subject to dose limits. In medico-legal exposures where the benefit is not necessarily to the individual undergoing the exposure, the question must be asked as to whether or not this is an appropriate framework within which to conduct such exposures. This paper looks at the current situation in Europe, highlighting some of the particular problems that have arisen, and tries to identify the areas, which require further clarification and guidance.
INTRODUCTION The Council Directive 97/43/EURATOM, on the health protection of individuals against the dangers of ionising radiation in relation to medical exposures(1), the so-called Medical Exposure Directive (MED), defines medico-legal procedures as ‘procedures performed for insurance or legal purposes without a medical indication’. Article 5.4 of the Directive requires Member States to ensure that procedures are put in place that should be observed in the case of these types of examinations. The Directive also requires that special attention be given to the justification and optimisation of such exposures (Art 3.1 (d)). This is the first time that radiation protection legislation has tried to deal explicitly with the issue of medico-legal exposures in a European Directive. However in doing so, it has given rise to a number of issues that remain unresolved. This is clear from the differing approaches adopted by Member States in implementing the relevant provisions of the MED. This paper looks at the current situation in Europe, highlighting some of the issues that have arisen and tries to identify some of the areas, which require further clarification and guidance.
MEDICO-LEGAL PROCEDURES Medico-legal procedures are defined, within the MED, as those procedures which are performed for insurance or legal purposes without a medical indication. Although the term ‘insurance purposes’ might be considered to be reasonably self-explanatory and somewhat contained, ‘legal purposes’ can have a *Corresponding author:
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very broad interpretation. The consequence of this is that the definition in its current format covers a wide range of exposure types, the only common feature of which is that there is no strict medical indication for the exposure. Some examples may help to further illustrate the ambiguities that can arise. An X-ray of the wrist where there is a suspected fracture is clearly medically indicated whereas X-raying the wrist of an asylum seeker to assess age is not and is almost certainly a medico-legal exposure. However, if the individual undergoing the exposure is a suspected victim of child abuse and the X-ray of the wrist is part of a skeletal survey to look for older injuries, then the classification is unclear. Another example is the requirement in some countries for chest X-rays of immigrants to establish tuberculosis status. This could be argued to be medically indicated if the individuals are either symptomatic or come from a country where incidence is high and a positive diagnosis would result in treatment. If neither of these are the case and a positive diagnosis would result in refused entry, then the exposure is probably medico-legal(2). A list of exposures that might be considered to be medico-legal is given in Table 1(3). From this table, it can be seen that medico-legal exposures cover a wide range of possible scenarios and exposures of very different nature and extend beyond those performed for insurance or as a result of legal proceedings. One common feature that they share is that the main reason for performing them does not relate directly to the health of the individual being exposed. Because of the diversity apparent above, medicolegal exposures are in fact difficult to define precisely and it is not always easy to decide how best to categorise certain exposures. Often exposures that
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G.O’REILLY AND J. F. MALONE Table 1. List of medico-legal exposures that were included in the European survey. Drugs search in the body Weapon or drug search on the body Truck content Age assessment Suspicion of child abuse Sportsmen
Insurance Civil Litigation
Immigration or Emigration Prisoners Pre-employment procedures
Search in the body for drugs Search on the body for weapons, drugs, contrabands, etc. X-ray search of a truck or container Assessment of age by wrist or dental X-ray Diagnostics for occult injury Regular preventive diagnostic of sportsmen, health status in connection with transfers, diagnosis of bone cartilage to predict growth (and length) for dancers, basket ball players, etc. Diagnostics to find undiagnosed, latent as pre-condition of insurance Diagnostics to find presence or absence of injuries or diseases to be used as evidence in court proceedings Diagnostics for undiagnosed diseases in immigrants or emigrants, e.g. of tuberculosis Diagnostics to detect objects swallowed by prisoners Diagnostics to identify previously undiagnosed illness in prospective employee
unusual and infrequent occurrence, but also in cases where X-rays are required for insurance purposes or as a pre-employment requirement. Again the exposed individual usually consents to the procedure but where alternatives are not available, and this may be particularly relevant in the case of the person seeking insurance, there is, in effect, an inhibition of freedom of choice(6). There is also a considerable inequity in the bargaining power of the two parties in both situations. This raises ethical questions about the justification of such exposures.
SURVEY OF PRACTICE IN MEMBER STATES In 2001, a working party of the Article 31 Group of Experts, who advise the European Commission, carried out a survey in relation to medico-legal exposures. A questionnaire was circulated to all Member States and the responses analysed. The results of this survey were published in Radiation Protection 130(3). In 2006, as part of the SENTINEL project, a modified version of this questionnaire was circulated to all project partners. The SENTINEL questionnaire on Medico-legal exposures requested information on the following: (i) (ii) (iii)
established practice, frequency; consent issues; category: medical, medico-legal, occupational, etc.; legal provisions; procedure: justification, responsibilities, location and training.
(iv) (v) might on initial consideration appear to be medicolegal could in fact be occupational or medically indicated. The definition contained within the Directive is not sufficient to solve this problem. An example of this is the routine random X-raying of workers in diamond mines as a crime prevention measure(4). Although this could be considered to be a medicolegal exposure, if the process is known to be a condition of work prior to employment, then the exposure might be argued to be occupational. However, a further level of complexity is added if the mine is an area of high poverty and little alternative employment, then it could be argued that employees have little freedom of action. The question then arises as to whether the exposure is justified and informed consent freely given. In their safety guide, the BSS(5), the IAEA state that “Radiological examinations for theft detection purposes are deemed to be not justified. . .”. The example of the diamond mines is interesting in that it highlights the justification issues that arise when an exposure which although voluntary, takes place in circumstances where the exposed individual has little freedom of choice. This situation arises not only in the diamond industry, which is a rather
These topics had all been investigated in the earlier survey. That survey had concluded that most member states carried out some or all of the exposures listed in Table 1. There was a 40% response rate to the SENTINEL questionnaire. For the most part, the results indicated a similar situation to that which pertained when the original questionnaire was circulated in 2001. From those that responded, the following could be deduced. † † † † †
Medico-legal exposures are carried out in all Member states. There is a lack of knowledge within Member States on established practices in their own countries. There is a lack of agreement between Member States on classification of some types of exposures. Where medico-legal exposures take place, they are mainly on a voluntary basis with consent being obtained. There is little information on frequencies available.
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ETHICAL ISSUES IN Non MEDICO-LEGAL EXPOSURES
† †
Most countries had established legal provisions for these exposures. For most exposures, a radiologist and/or medical practitioner was involved; exceptions to this were weapons detection and examination (scanning) of trucks.
On most topics, similar conclusions could be drawn from both surveys. The earlier work had also concluded that there was considerable variation between legal provisions in Member States and that there is a need for increased communication and co-operation between various authorities involved/responsible. It was clear from both surveys that it was difficult to access accurate information through the normal channels of contact of professionals working in the area of radiation protection. This was evidenced both by some minor inconsistencies in data between the two surveys and the absence of data in some areas. There was a clear need for further work in this area, but it was also clear that it required a different approach to ensure a more comprehensive and accurate response. Survey Design Survey research has a long tradition in the social sciences and medicine(7). The survey method used to gather information on medico-legal exposures was typical of a research methodology that was essentially quantitative in nature. However, although surveys are versatile and are useful in obtaining a structured overview of practice, they lack the richness of in-depth qualitative research. Given that the objective was to identify the range of practices in place and to gain an insight into the nature of these practices, it is likely that a more qualitative approach or a combination of the two might have proved more effective. Qualitative methods on the one hand represent the phenomenological or ethnographic approach that seeks to examine phenomena in context to generate theory(8), whereas quantitative or positivistic research aims to test hypotheses using objective measures to predict and control phenomena(9). Quantitative data consist of information that is numerical in form. However, the model of measurement does not always easily fit the variables one would like to measure. This is certainly the case in relation to the survey in question. The situation in various member states is intrinsically more complex than one that would lend itself to a simplistic quantitative approach. One of the features of quantitative research is that it can miss contextual detail and in this particular situation, that detail is vital to comprehension. However, the quantitative approach could have been more effective if it had been preceded by qualitative research that could have provided a general understanding of existing practice.
This would have enabled a more focused and informed approach when designing the methodology for data gathering. The literature emphasises the need to choose a research methodology to suit the research question. A multi-method or triangulation approach can assist in ensuring data accuracy and can facilitate the integration of quantitative and qualitative approaches. Begly(10) states that triangulation has two main goals, “confirmation and completeness of data”. By using triangulation, data are enriched while allowing for divergent results and additional confidence in the findings. There are various types of triangulation but all share a common feature, which is that there is more than one approach to the collection and analysis of data. A review of both the 2001 and 2006 surveys reveals inconsistencies and possible inaccuracies. The distribution of questionnaires, initially to a single point of contact meant that there was no systematic process of ensuring either completeness or accuracy of the data returned. This was evident from some of the responses and led to uncertainties in relation to the reliability of some elements of the data. Although it would have added considerably to the task of data collection, a second method of acquiring data would have introduced an additional level of confidence in the data gathered. CLASSIFICATION OF EXPOSURES As currently framed, medico-legal exposures are a sub-set of medical exposures. Therefore, the provisions of the MED are directly applicable. In addition, there are some specific provisions in the MED for medicolegal procedures but, as with all medical exposures, there are no dose limits. Although it is generally accepted that dose limits are not appropriate for medical exposures where the risk/benefit ratio is very different to that which pertains for public or occupational exposures(11), this is not necessarily the case for medico-legal exposures. For these types of exposures, the benefit is often not to the individual exposed but to the wider society such as in the case of immigration chest X-rays. Although these X-rays are generally low dose and must be considered in that context, the same is not the case for all medico-legal exposures. For instance, some European countries are reported to use CT as the preferred method of investigation for those suspected of having swallowed drugs for the purposes of cross-border smuggling(12). This practice has the potential to result in significant doses to the individual scanned and yet is not subject to any dose limit or constraint, even though there is no medical indication for the exposure. Obviously, justification is an essential element of this practice but it is important that these and other similar practices are carried out within an appropriate framework of radiation protection. This may be challenging if they
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continue to be classified as medico-legal exposures and as such are effectively medical exposures and hence without dose limits. A further complication is that of the categories of exposures listed in Table 1, there were differences in their classification between member states. For example, the search of containers using X-rays is considered to be a medico-legal exposure by some member states but not by others. This has obvious implications as containers move from one jurisdiction to another. So for instance a container arriving at a UK border could be scanned using X-rays and would only be subject to the provisions of the BSS (96/29/ Euratom(13)) and not the MED (97/43/Euratom). The same container arriving at a French border would not be X-rayed, to detect clandestines, as this is considered to be illegal. The practice in the UK is justified on the grounds of societal benefits (effective border control), indirect benefits for the people hiding in the trucks and for economic reasons(14). It is also the case that the motivation for carrying out the exposure can affect how it is categorised. For example, a pre-employment exposure might be considered to be occupational if the purpose is to protect the worker and/or his colleagues. However, if the motivation is to protect the employer from financial liability, the exposure might be classified as medico-legal. In considering this issue, further it will be seen that justification is of paramount importance in medico-legal exposures. JUSTIFICATION ISSUES Previous work(15) identified a range of exposures that might be termed medico-legal and initiated a debate on whether or not they were in fact medico-legal. It was concluded that although it was possible in many instances to classify or categorise the exposure, the justification remained difficult. It was recognised that the justification process had to take account of a broad range of considerations with a wide array of social and economic issues that are inherent in this matter. In fact, it can be seen that the key issue in medico-legal exposures is justification. Balancing the advantages and disadvantages of such exposures is complex, because not only can these be difficult to quantify and hence compare, but often the advantage may be to society whereas the disadvantage is usually to an individual. This adds an additional layer of complexity to the problem and one, which requires input from a number of sources beyond the established radiation protection community CONCLUSIONS The difficulties in the implementation of the provisions on medico-legal exposures in Directive 97/43
are evident. In trying to implement the MED, there has been a varied approach adopted by Member States on this issue. It is clear that considerable diversity exists, in Europe, as to what is regarded as a medico-legal as opposed to a medical or even an occupational exposure. Even within Member States, differences of opinion exist. There is a need for Member States to give a clear definition as to what constitutes a medico-legal exposure and having done so, there is then a need to identify those exposures that can in principle be justified and those that can never be justified. Only after this identification, is it possible to give special rules and guidance on justification and optimisation of every single exposure, and to define specific procedures for all possible scenarios.
REFERENCES 1. Council Directive 97/43/EURATOM, on the health protection of individuals against the dangers of ionising radiation in relation to medical exposures. OJ L 180 of 09.07.1997. 2. Zuur, C. Introduction. Radiat. Prot. 130, 5–7 (2002). 3. Leitz, W. and Marshall-Depommier, E. Current situation concerning medico-legal exposures in Member States. Radiat. Prot. 130, 15–20 (2002). 4. Sharp, C. Theft detection (or new light on a girl’s best friend) In: Faulkner, K and Teunen, D, Eds. Justification in Radiation Protection. (London: The British Institute of Radiology) 1998. pp. 26– 28. ISBN 0 905749 40 5. 5. International Atomic Energy Agency. Occupational radiation protection. Safety Standards Series No. RS-G-1.1. (Vienna: IAEA) (1999). 6. Binchy, W. The implications of medico-legal exposures in different contexts. Radiat. Prot. 130, 63–66 (2002). 7. Hardy, M. and Mulhall, A.). Nursing Research: Theory & Practice (London: Chapman & Hall) (1994). 8. Behi, R. and Nolan, M. What is research? Some definitions and dilemmas. Br. J. Nurs. 4(2) 111 –114 (1995). 9. Parahoo, K. Questionnaires: use, value and limitations. Nurse Res. 1(2): 40– 45 (1993). 10. Begley, C. Using triangulation in nursing research. J. Adv. Nurs. 24, 122–128 (1996). 11. International Commission on Radiological Protection. Radiological Protection and Safety in Medicine. ICRP Publication 73. Ann. ICRP 26(2) (1997). 12. Magnusson, T. The role of X-rays in drug detection. Radiat. Prot. 130, 56–58 (2002). 13. Council Directive 96/29/EURATOM laying down basic safety standards for the protection of the health of workers and the general public against the dangers of ionising radiation. OJ L 159 of 29.06.1996. 14. Rogers, K. The use of transmission based technology in the detection of clandestine entrants. Radiat. Prot. 130, 39– 40 (2002). 15. Radiation Protection 130. Medico-legal exposures, exposures with ionising radiation without medical indication. Proceedings of International Symposium, Dublin, 4-6 September 2002.
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