Estimation of fetal dose during diagnostic nuclear medicine procedures especially in child bearing Greek women

Medical uses of radiation have grown rapidly over the past decade in Hellas. A part of these may concern Diagnostic Nuclear Medicine procedures implemented in pregnant patients. The potential detriment from ionizing radiation to embryo/fetus is related to the fetal dose and the stage of pregnancy at which exposure occurs. The purpose of this review is to inform about the risk from radiation to the embryo/fetus, to provide a data base of fetal doses in early pregnancy for nuclear medicine procedures in Hellas which are determined by National and European protocols and laws and to suggest actions that should be considered in order to optimize the diagnostic procedure keeping the fetal dose as low as reasonably achievable maintaining a good diagnostic result for the pregnant. Average fetal dose for most nuclear medicine procedures in Hellas varies between 0,3 and 18 mGy doses which can not justify the termination of pregnancy.     

The phenomenon of harmonisation in European medical law

As the field of medical law is regarded, since the 1950s two most significant entities recognized by international law have been present in the sphere of Europe: The Council of Europe which members signed to protect fundamental rights and freedoms and the European Union established upon the original European Communities which influence protection of fundamental rights steadily tends to grow especially in the last decades and results in a legally binding Charter of Fundamental Rights of the European Union. Despite the impressive amount of reservations and exceptions to the conventions, the European Convention for Protection of Human Rights and Fundamental Freedoms and particularly the Convention on Human Rights and Biomedicine are presented as great instruments for influencing national laws. The role of European institutions in coordinating, harmonising or even unifying national laws as far the issue of public health is concerned is much more difficult - on one hand there are the legal binding measures permitted under specific provisions of EU Treaties to define the minimum standard, on the other hand the subsidiary of the Union's action in the area of public health and the doctrine of complementary competence happen to be rather dominant.     

Access to abortion services: the impact of the European convention on human rights in Ireland

Abortion is unlawful in Ireland except where it is necessary to save the life of the mother. The right to life of the unborn child is safeguarded under Article 40.3.3 degrees of Bunreacht na hEireann (the Irish Constitution). In 2003 the European Convention on Human Rights was incorporated into Irish domestic legislation, subject to the provisions of the Irish Constitution. The aim of this paper is to consider the potential impact of the ECHR on access to abortion services within the State. This paper commences with discussion of the statutory prohibition on abortion and the Constitutional provisions concerning the protection afforded to the unborn child. It will then be necessary to examine the implications for Ireland of recent European Court of Human Rights' decisions, in particular the recent judgment in A, B & C v Ireland, regarding the right to legal abortions given the unique nature of the legal status of the ECHR and its relationship with the Irish Constitution.     

Pregnant stewardess--should she fly?

There is much pressure on the airlines to allow stewardesses to fly while pregnant. Some of them want to fly in quite advanced stages of pregnancy. This paper offers a survey of the problem, the hazards that may occur and some guidelines for the physician. The author outlines the normal changes to be expected with advancing pregnancy and those factors that could have an adverse effect on a pregnant stewardess and her fetus, such as hypoxia, trauma, abortion, the hazards of travel, and flying itself. Certain legal problems of unemployment and medical disability also are discussed. Travel alone offers no real danger to the pregnant stewardess in the first trimester of pregnancy; however, because of the changing mechanics of her size, posture, and increasing unsteadiness, it would be wisest to require a pregnant stewardess to cease flying at 13 weeks, with an absolute prohibition of flying after the 20th week.     

Equivalent dose to the fetus from occupational exposure of pregnant staff in diagnostic radiology

The protection of the unborn children of pregnant women from ionizing radiations is very important because the fetus is particularly vulnerable to the effects of ionizing radiation. From the radiation protection perspective, the International Commission on Radiological Protection regards the unborn child as a member of the public when considering the occupational exposure of pregnant workers. The determination of the equivalent dose to the unborn child in diagnostic radiology is of interest as a basis for risk estimates from occupational exposures of the pregnant worker. In this paper, coefficients for converting dosemeter readings to equivalent dose to the fetus have been calculated using Monte Carlo simulation. X-ray transport was simulated by tracing individual photons through soft tissue phantoms. Equivalent dose to the uterus was used to simulate the equivalent dose to the fetus during the first 2 months of pregnancy. The Monte Carlo model was validated experimentally by direct measurements made in an Alderson female Rando phantom for a range of irradiation conditions. The two sets of data indicated good agreement with the Monte Carlo results, being relatively greater than the experimental results to a maximum of about 15%.     

The application of the European Convention of Human Rights to the field of psychiatry

The European Convention of Human Rights enumerates a set of individual rights and fundamental freedoms and defines supra-national legal procedures whereby individuals, who believe themselves victims of human rights abuses and are unable to gain redress through domestic courts, can petition the European Commission of Human Rights.     

The history of abortion-related acts and current issues in Japan

In Japan abortion is categorized into two types by law; one is illegal feticide and the other is legal abortion. The present criminal law forbids feticide in principle and the life of a fetus is protected. However, abortion can be practiced under the "Eugenic Protection Act" established in 1948 (currently referred to as the "Maternal Protection Act"), and is readily available in Japan. In this paper, I have traced the historical origins of abortion law and attempted to clarify the problems related to the current laws relating to artificial abortion. As a result, the existence of contradictions between attitudes toward the life of the fetus and that of the mother, women's right to self determination, and women's rights under current legislation has been clarified.     

Implications of ICRP 60 and the patient directive 97/43 Euratom for nuclear medicine.

The Council of the European Union has completely renewed the framework regarding radiation protection by adopting 2 directives: Directive 97/43 Euratom lays down the general principles of the radiation protection of individuals undergoing exposure to ionizing radiations related to medical exposures, as a supplement of Directive 96/29 Euratom laying down the basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiations. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with these two directives before 13 May 2000. Since medical applications represent the largest man-made sources of radiation exposure for the European population and exposure to low levels of ionizing radiations has become a sensitive issue for the public, the nuclear medicine community is concerned by the set of European legislation which appear to be more restrictive than the previous one. It is based on the scientific knowledge concerning radiation protection as expressed in particular in Recommendation No. 60 of the International Commission on Radiological Protection. In this paper, the directives are carefully analyzed and evaluated in terms of their potential impact on nuclear medicine practice.     

Embryonic stem cell research: terminological ambiguity may lead to legal obscurity

National regulation on embryonic stem cell research in the European Union is ambiguous, due to a lack of consistent scientific terminology as exemplified by the Dutch Embryos Act. To force a breakthrough in this ethically dubious research topic, a more careful use of terminology would be in the interest of both the scientific community and the lawmakers, in order to avoid terminology becoming associated with research or applications for which it is inappropriate. Therefore I will first clarify the technological possibilities in an age of biological control. Secondly, we will critically analyse the statements of the European Convention on Human Rights and Biomedicine concerning embryo research and cloning. The Convention prohibits human reproductive cloning but does not take a clear position on so-called therapeutic cloning. Finally, we will give an overview of the most recent legislative initiatives within the European Union on this matter.     

Sonographic differentiation between blighted ovum and early viable pregnancy

Thirty-five patients referred either for confirmation of pregnancy or because of vaginal bleeding associated with early pregnancy were examined sonographically. The sonograms were evaluated prospectively to determine whether a blighted ovum or early missed abortion could be differentiated from an early viable pregnancy lacking fetal echoes. A well defined trophoblastic reaction, continuous around the gestational sac, is a very good prognostic sign for continued viability; a sac greater than 2 cm in diameter without embryonic echoes is a poor prognostic sign. However, no sonographic features were found to be reliable in differentiating viable from nonviable pregnancy (presenting as an empty gestational sac) on a single sonographic examination. The authors recommend follow-up sonographic evaluation in 10-14 days.     

欧洲儿童CT成像的诊断参考水平

欧盟委员会（EC）发布了最新《欧洲儿童成像诊断参考水平指南》（辐射防护第185号）。该指南详细介绍了建立欧洲儿童成像诊断参考水平（DRL）的背景、目的、方法和用法,涵盖X射线摄影、透视、CT及介入放射学（IR）方面。回顾性分析了现有欧洲儿童国家级DRL（NDRL）的现状、优势和局限性,在现有辐射剂量数据资源的基础上,达成了一些共识,出台了欧洲儿童的DRL（EDRL）,为欧洲儿童的辐射防护优化提供了最新的指导意见。对于国内放射从业人员了解相关知识具有积极的借鉴意义。     

Fetus radiation doses from nuclear medicine and radiology diagnostic procedures. Potential risks and radiation protection instructions

Although in pregnancy it is strongly recommended to avoid diagnostic nuclear medicine and radiology procedures, in cases of clinical necessity or when pregnancy is not known to the physician, these diagnostic procedures are to be applied. In such cases, counseling based on accurate information and comprehensive discussion about the risks of radiation exposure to the fetus should follow. In this article, estimations of the absorbed radiation doses due to nuclear medicine and radiology diagnostic procedures during the pregnancy and their possible risk effects to the fetus are examined and then discussed. Stochastic and detrimental effects are evaluated with respect to other risk factors and related to the fetus absorbed radiation dose and to the post-conception age. The possible termination of a pregnancy, due to radiation exposure is discussed. Special radiation protection instructions are given for radiation exposures in cases of possible, confirmed or unknown pregnancies. It is concluded that nuclear medicine and radiology diagnostic procedures, if not repeated during the pregnancy, are rarely an indication for the termination of pregnancy, because the dose received by the fetus is expected to be less than 100 mSv, which indicates the threshold dose for having deterministic effects. Therefore, the risk for the fetus due to these diagnostic procedures is low. However, stochastic effects are still possible but will be minimized if the radiation absorbed dose to the fetus is kept as low as possible.     

Physicians' perceptions of teratogenic risk associated with radiography and CT during early pregnancy

OBJECTIVE: The objective of our study was to determine family physicians' and obstetricians' perceptions of the risk of major fetal malformations associated with exposure to radiation from radiography and CT during early pregnancy. MATERIALS AND METHODS: Structured questionnaires were sent to 400 family physicians and 100 obstetricians selected randomly across Ontario, Canada. The physicians were informed about the 1-3% baseline risk for major malformations and were asked about their perceptions of the risk to the fetus associated with an abdominal radiograph and an abdominal CT scan during early pregnancy and whether they would recommend a therapeutic abortion after such exposure. RESULTS: Fifty-five percent (218/400) of the family physicians and 69% (69/100) of the obstetricians responded to our questionnaire. Forty-four percent of family physicians estimated the risk associated with an abdominal radiograph to be 5% or greater, and 61% estimated the risk associated with an abdominal CT scan to be 5% or greater. Eleven percent of obstetricians estimated the risk associated with radiographs to be 5% or greater (p < 0.001), and 34% estimated the risk associated with CT scans to be 5% or greater (p < 0.001). Among family physicians, 1% recommended an abortion if the fetus was exposed to radiation from radiography and 6% after exposure to radiation from CT. None of the obstetricians recommended an abortion after exposure to radiation from an abdominal radiograph, but 5% recommended an abortion after exposure to radiation from an abdominal CT scan in early pregnancy. CONCLUSION: Our survey shows that physicians who care for pregnant women perceive the teratogenic risk associated with an abdominal radiograph and an abdominal CT scan to be unrealistically high during early pregnancy. This misperception could lead to increased anxiety among pregnant women seeking counseling and to unnecessary terminations of otherwise wanted pregnancies. This perception of high teratogenic risk associated with radiation could also lead to a delay in needed care of pregnant women.     

The response of Islamic jurisprudence to ectopic pregnancies, frozen embryo implantation and euthanasia

The opinions of the Jurisconsult of Egypt on Islamic law regarding test tube fertilization, embryo transfer and abortion are explained. Test tube babies, if not derived from the husband's sperm, are by definition, "zina" or the result of illicit sexual intercourse. This type of quasi-adultery is punishable by mere disgracing, rather than lapidation, or stoning to death. Such children cannot inherit even from the mother. Possibly, a female child may marry the husband, to be legitimized in terms of inheritance. Under Islamic law, embryo transfer is illegal insofar as it involves artificial insemination of the donor by the husband; temporary maternity by the donor is a jural concept that has no place in Islamic family law. The egg of the donor, not the surrogate mother, places the issue in the thorny area of multiple suckling. There have been no pronouncements by Islamic legal experts on euthanasia or pregnancy by in vitro fertilization of orphaned embryos. Abortion law "ijhad" in Kuwait was amended in 1982 to permit abortion where either grievous bodily harm to the mother is imminent or it is proved that the baby will suffer incurable brain damage or severe mental retardation. The decision must be approved unanimously by 3 Muslim consultant physicians presided over by an obstetrician or gynecologist, parental consent is required, and the hospital must have an obstetric-gynecological wing. There is precedent in Islamic law for saving the life of the mother where there is a clear choice of allowing either the fetus or the mother to survive. Similarly in case of miscarriage or attempted miscarriage, damages for a fetus or stillborn are less than those paid for a live birth. Penalties for therapeutic abortion, for example after exposure to German measles, have been viewed as less serious before 120 days of gestation, when the Prophet indicated that the embryo is given a soul. These ethical interpretations are worth considering for Western jurists as a source of ideas.     

Ultrasound of the empty gestation sac in threatened abortion

The major concern when an empty gestation sac is encountered during threatened abortion is whether or not the pregnancy is viable. Viable pregnancies are managed expectantly, whereas non-viable pregnancies are treated by evacuation of the uterus. Early evacuation of the non-viable pregnancy spares the patient considerable anxiety and discomfort. This study shows that a single ultrasound examination is useful in differentiating viable from non-viable empty gestation sacs. The size of the empty gestation sac was found to be the most useful criterion for determining non-viability. Empty gestation sacs with sizes greater than 26 mm were non-viable, a specificity of 100%, accounting for 43% (42 out of 102) of patients in our series. Other ultrasound criteria found to be useful were shape, position, wall and decidual reaction. The positive predictive value for a successful outcome to a pregnancy was low, being only 41% (9 out of 22).     

Launching the Greek forensic DNA database. The legal framework and arising ethical issues

Since the creation of the first national DNA database in Europe in 1995, many European countries have legislated laws for initiating and regulating their own databases.The Greek government legislated a law in 2008, by which the National DNA Database of Greece was founded and regulated. According to this law, only DNA profiles from convicted criminals were recorded. Nevertheless, a year later, in 2009, the law was amended to permit the creation of an expanded database including innocent people and children.Unfortunately, the new law is very vague in many aspects and does not respect the principle of proportionality. Therefore, according to our opinion, it will soon need to be re-amended.Furthermore, prior to legislating the new law, there was no debate with the community itself in order to clarify what system would best suit Greece and what the citizens would be willing to accept.We present the current legal framework in Greece, we highlight issues that need to be clarified and we discuss possible ethical issues that may arise.     

Looking at the formulation of national biosecurity education action plans

In order for states to be assured of their compliance with the requirements of the Biological and Toxin Weapons Convention, it is necessary that all those science and policy stakeholders working within that state should be aware of their responsibilities under the Convention. This can only be achieved through a comprehensive national biosecurity education programme. We propose that each state should produce a national biosecurity action plan, with accompanying resources and materials to achieve this. A number of resources are already available online to support states in this challenge. We present a model for a national biosecurity action plan and propose a number of ways in which this may be achieved.     

Human rights, bioethics, and mental disorder

This article considers the international human rights instruments which set minimum standards for the content and use of mental health legislation, and the extent to which they represent 'hard law' (binding and enforceable in domestic or international courts) or 'soft law' which is not strictly binding in the same sense but which may provide persuasive authority or may be used in debate to embarrass a Government into compliance. The article considers the extent to which these various instruments impose both 'negative obligations' on states not to interfere with rights such as physical integrity or protection against arbitrary detention and 'positive' obligations on states to take positive steps to uphold the rights of individuals. The article on the case law under the European Convention on Human Rights showing how 'soft law' sources are increasingly used by the Strasbourg Court as aids to construing the scope of Convention rights. The article concludes by suggesting that whilst mentally disordered people may be afforded different treatment in relation to general bioethics instruments on the international plane, they are also entitled to rights under Disability Conventions which enjoin states to take positive steps to promote equal treatment, social inclusion and protection against discrimination and stigma.     

Organisation and management of the first clinical trial of BNCT in Europe (EORTC Protocol 11961)

Boron Neutron Capture Therapy is based on the ability of the isotope¹⁰B to capture thermal neutrons and to disintegrate instantaneously producing high LET particles. The only neutron beam available in Europe for such a treatment is based at the European High Flux Reactor HFR at Petten (The Netherlands). The European Commission, owners of the reactor, decided that the potential benefit of the facility should be opened to all European citizens and therfore insisted on a multinational approach to perform the first clinical trial in Europe on BNCT. This precondition had to be respected as well as the national laws and regulations. Together with the Dutch authorities actions were undertaken to overcome the obvious legal problems. Furthermore, the clinical trial at Petten takes place in a nuclear research reactor, which apart from being conducted in a non-hospital environment, is per se known to be dangerous. It was therefore of the utmost importance that special attention is given to safety, beyond normal rules, and to the training of staff. In itself, the trial is an unusual Phase I study, introducing a new drug with a new irradiation modality, with really an unknown dose-effect relationship. This trial must follow optimal procedures, which underscore the quality and qualified manner of performance.

     

Regional metrology organisations and the JCRB.

In 1999, National Metrology Institutes (NMIs) from some 39 countries signed the International Committee of Weights and Measures (CIPM) Mutual Recognition Arrangement (MRA) in Paris. The MRA, drawn up by the CIPM, under the authority given to it in the Metre Convention, was in response to requirements of Governments and Regulators to provide a sound technical foundation for trade agreements. Core objectives of the MRA are to allow for the establishment of the degree of equivalence of national measurement standards and to provide for mutual recognition of calibration certificates issued by NMIs. This presentation will detail the evolution of the MRA. Globally, NMIs are affiliated to Regional Metrology Organisations (RMOs). The key role of the RMOs in the MRA process will be discussed along with the structure and objectives of the various RMOs worldwide. The Joint Committee of the RMOs and the BIPM (JCRB) plays a central part in the effective operation of the MRA. Its tasks, membership and output will also be described.