Protecting Future Children from In-Utero Harm.

The actions of pregnant women can cause harm to their future children. However, even if the possible harm is serious and likely to occur, the law will generally not intervene. A pregnant woman is an autonomous person who is entitled to make her own decisions. A fetus in-utero has no legal right to protection. In striking contrast, the child, if born alive, may sue for injury in-utero; and the child is entitled to be protected by being removed from her parents if necessary for her protection. Indeed, there is a legal obligation for health professionals to report suspected harm, and for authorities to protect the child's wellbeing. We ask whether such contradictory responses are justified. Should the law intervene where a pregnant woman's actions risk serious and preventable fetal injury? The argument for legal intervention to protect a fetus is sometimes linked to the concept of 'fetal personhood' and the moral status of the fetus. In this article we will suggest that even if the fetus is not regarded as a separate person, and does not have the legal or moral status of a child, indeed, even if the fetus is regarded as having no legal or moral status, there is an ethical and legal case for intervening to prevent serious harm to a future child. We examine the arguments for and against intervention on behalf of the future child, drawing on the example of excessive maternal alcohol intake.

Genetic testing of stored tissue from a deceased person to define a relative's disease risk: Legal and ethical viewpoints.

It is now possible to undertake gene sequencing on DNA obtained from stored tissue removed from a person now deceased or from stored tissue from a living person. The sequencing may assist close blood relatives who are at risk of having a mutation that predisposes them to cancer to find out their own genetic risk. If the test had been done previously Australian law would permit the test results to be provided to close blood relatives of the "originator" without consent, even if other relatives object, although good practice is to inform all family members about proposed genetic tests. However, it is less clear whether a pathology laboratory can lawfully, and should ethically provide stored tissue for genetic testing, without the originator's consent. This article argues that the law and ethics need to be clarified so pathology laboratories can confidently make stored tissue available for testing to assist blood relatives.

Improving family communication after a new genetic diagnosis: a randomised controlled trial of a genetic counselling intervention.

BACKGROUND: Genetic information given to an individual newly diagnosed with a genetic condition is likely to have important health implications for other family members. The task of communicating with these relatives commonly falls to the newly diagnosed person. Talking to relatives about genetic information can be challenging and is influenced by many factors including family dynamics. Research shows that many relatives remain unaware of relevant genetic information and the possible impact on their own health. This study aims to evaluate whether a specific genetic counselling intervention for people newly diagnosed with a genetic condition, implemented over the telephone on a number of occasions, could increase the number of at-risk relatives who make contact with genetics services after a new genetic diagnosis within a family. METHODS: This is a prospective, multi-centre randomised controlled trial being conducted at genetics clinics at five public hospitals in Victoria, Australia. A complex genetic counselling intervention has been developed specifically for this trial. Probands (the first person in a family to present with a diagnosis of a genetic condition) are being recruited and randomised into one of two arms - the telephone genetic counselling intervention arm and the control arm receiving usual care. The number of at-risk relatives for each proband will be estimated from a family pedigree collected at the time of diagnosis. The primary outcome will be measured by comparing the proportion of at-risk relatives in each arm of the trial who make subsequent contact with genetics services. DISCUSSION: This study, the first randomised controlled trial of a complex genetic counselling intervention to enhance family communication, will provide evidence about how best to assist probands to communicate important new genetic information to their at-risk relatives. This will inform genetic counselling practice in the context of future genomic testing. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Register (ANZCTR): ANZCTRN12608000642381.

Legal issues when a doctor's relationship with a "difficult" patient breaks down.

The legal duties of a doctor attending a "difficult" patient with a serious condition do not end at the last consultation, especially in a small rural community. Doctors have a continuing obligation to ensure that the patient's health is not impaired because the clinical relationship has ended. This article suggests some steps that a doctor could take to fulfil the legal obligation in such a case.

The current approach of the courts.

The approach of the courts when considering proprietary ('ownership') interests in human bodily material has been pragmatic and piecemeal. The general principle was initially that such material is not legally 'property' that can be 'owned', but courts have recognised many exceptions. In determining disputes between individuals in particular cases, they have stated principles that are often inconsistent with those stated in other cases with different facts. Later judges have been constrained by these decisions, especially when made at appellate level. They can distinguish the facts of one case from another to achieve a different outcome, but they cannot state new principles to be applied more widely to promote consistency. This requires the will of Parliament and legislation to introduce new principles. Experience to date suggests that such legislation will need to be wide-ranging and complex, with different principles for different circumstances. There will not be one area of law that answers all the issues that arise.

Position statement on ethics, equipoise and research on charged particle radiation therapy.

The use of charged-particle radiation therapy (CPRT) is an increasingly important development in the treatment of cancer. One of the most pressing controversies about the use of this technology is whether randomised controlled trials are required before this form of treatment can be considered to be the treatment of choice for a wide range of indications. Equipoise is the key ethical concept in determining which research studies are justified. However, there is a good deal of disagreement about how this concept is best understood and applied in the specific case of CPRT. This report is a position statement on these controversies that arises out of a workshop held at Wolfson College, Oxford in August 2011. The workshop brought together international leaders in the relevant fields (radiation oncology, medical physics, radiobiology, research ethics and methodology), including proponents on both sides of the debate, in order to make significant progress on the ethical issues associated with CPRT research. This position statement provides an ethical platform for future research and should enable further work to be done in developing international coordinated programmes of research.

Regulating the use of human bodily material.

The articles in this special issue consider recent developments in the law regulating the use of human bodily material and the wider implications of those developments. For some time, the law has accepted that a person who has undertaken "work and skill" on excised bodily material may obtain at least a possessory right; but the person from whom the material came did not have such a right. Now, however, the law has recognised that people may have some legal rights regarding their own bodily material. What is the nature and source of those rights? Should they be expanded? If so, what legal principles are best to do that? The most frequent suggestion is the law of property but many other areas of law are also relevant: the law of contract; tort (bailment and consent); criminal law (e.g., forensic testing); gifts; custodianship and others. These regulatory options are outlined in this editorial and discussed by lawyers and other contributors in their articles in this special issue. There are also stimulating philosophical reflections on the nature of human bodily material.

An audit of clinical service examining the uptake of genetic testing by at-risk family members.

PURPOSE: The aim of this study was to investigate the uptake of genetic testing by at-risk family members for four genetic conditions: chromosomal translocations, fragile X syndrome, Huntington disease, and spinal muscular atrophy. METHODS: A clinical audit was undertaken using genetics files from Genetic Health Services Victoria. Data were extracted from the files regarding the number of at-risk family members and the proportion tested. Information was also collected about whether discussion of at-risk family members and family communication during the genetic consultation was recorded. RESULTS: The proportion of at-risk family members who had genetic testing ranged from 11% to 18%. First-degree family members were most frequently tested and the proportion of testing decreased by degree of relatedness to the proband. Smaller families were significantly more likely to have genetic testing for all conditions except Huntington disease. Female at-risk family members were significantly more likely to have testing for fragile X syndrome. CONCLUSION: The majority of at-risk family members do not have genetic testing. Family communication is likely to influence the uptake of genetic testing by at-risk family members and therefore it is important that families are supported while communicating to ensure that at-risk family members are able to make informed decisions about genetic testing.

Development of stem cells from umbilical cord blood and blood banking: "non-controversial" and "free of political and ethical debate"?

Opponents of human embryo research have understandably welcomed pluripotent stem cells being derived from body cells including cells from umbilical cords after childbirth. The cord would otherwise be discarded and embryos are not destroyed. However, there are other ethical, legal and political issues in cord blood collection, whether for the child's future use, or a public blood bank. Information and consent procedures may be misleading. Some parents have false hopes about potential outcomes. The right of access to stored blood and other benefits is sometimes uncertain for children and their families. Private stem cell repositories may compete with public ones. People may want to impose conditions on donation. Quality control may be an issue.

Genetic health professionals and the communication of genetic information in families: Practice during and after a genetic consultation.

The communication of genetic information in families is an important process which can inform family members that they are at risk. However, evidence suggests that at-risk family members are often uninformed. Genetic health professionals have a role to assist consultands to communicate genetic information to their family members. Therefore, the aim of this study was to investigate genetic health professionals' practice with regard to the familial implications of a genetic diagnosis and subsequent family communication. An online survey resulted in 626 responses from genetic health professionals internationally. The results indicated that over 90% of genetic health professionals consistently counsel consultands about the familial implications of a genetic diagnosis during a consultation. Also there were no major differences in practice between clinical geneticists and genetic counselors. An average of 79% of genetic health professionals always send a summary letter to the consultand after a consultation. In contrast, 41% of genetic health professionals never write letters for at-risk family members. Other support is available to consultands after a consultation, but the availability of support relies on consultands and family members acting proactively and seeking out assistance from genetic health professionals for family communication. This may result in family members who are unaware that they are at risk of carrying and/or developing a genetic condition. This study is limited by the self-selection and self-reporting of the respondents' practice.

Health first, genetics second: exploring families' experiences of communicating genetic information.

Genetic information may have health and reproductive implications for the proband and their family members. The responsibility for communicating this information within families generally lies with the proband or consultand. Previous research has explored the barriers and facilitators to communication, particularly in families affected with familial cancer syndromes. This study is an exploration of families' experiences, which aims to elucidate the process of communicating genetic information in families affected with non-cancer genetic conditions. The methodology involved 12 semi-structured interviews with probands, consultands and their family members. There were six different genetic conditions present in the families: adrenoleukodystrophy (n=3), cystic fibrosis (n=3), fragile X syndrome (n=1), haemochromatosis (n=1), balanced reciprocal chromosomal translocation (n=3) and Robertsonian chromosomal translocation (n=1). The results presented arise from two key themes, (1) the diagnosis and (2) post diagnosis. The interview data illustrate that the time of the diagnosis is a traumatic experience for families and that communication stimulated by this event revolves around informing family members about the diagnosis, but not warning them of their genetic risk. Post diagnosis, the collection of information about the genetic condition and continued communication to more distant family members, often using pre-existing family communication patterns, enables the continuation of communication about the genetic condition.

The Lockhart Committee: developing policy through commitment to moral values, community and democratic processes.

The Lockhart Committee was appointed by the federal government in 2005 to review the Prohibition of Human Cloning Act 2002 (Cth) and the Research Involving Human Embryos Act 2002 (Cth). The issues in the review are ones on which community views differ widely and many people hold strong and diverging opinions. Yet all members of the committee were able to agree on their recommendations when the committee reported to Parliament in December 2005 and since that time, most of its recommendations have been implemented in amendments to federal and State legislation. This article describes the committee's process in considering the issues in the review, in consulting stakeholders and the broader community and in formulating its recommendations.

Human cloning and stem cell research: engaging in the political process. (Legislation review: prohibition of Human Cloning Act 2002 and the research involving Human Embryos Act).

Committees appointed by governments to inquire into specific policy issues often have no further role when the Committee's report is delivered to government, but that is not always so. This paper describes the activities of members of the Australian Committee on human cloning and embryo research (the Lockhart Committee) to inform Parliament and the community about the Committee's recommendations after its report was tabled in Parliament. It explains their participation in the political process as their recommendations were debated and amending legislation was passed by Parliament. It illustrates a method of communication about scientific and policy issues that explores people's concerns and what they 'need to know' to make a judgment; and then responds to questions they raise, with the aim of facilitating discussion, not arguing for one view. The paper considers whether this type of engagement and communication is appropriate and could be used in other policy discussions.

Communicating genetic information in families--a review of guidelines and position papers.

This article aims to review ethical and clinical guidelines and policies addressing the communication of genetic information in families. Websites of national and regional bioethics committees, national human genetics societies, international health organisations, genetic interest groups and legal recommendations committees were searched for guidelines and policies. The databases Medline, Web of Science and Google Scholar were also utilised to search for additional guidelines relating to the communication of genetic information in families. The guidelines and policies included in this review are limited to those available in English. The search resulted in guidelines from 18 international, regional and national organisations from six countries pertaining to family communication of genetic information. The following ideals were common in their guidelines: (1) individuals have a moral obligation to communicate genetic information to their family members; (2) genetic health professionals should encourage individuals to communicate this information to their family members; and (3) genetic health professionals should support individuals throughout the communication process. The difference between the organisations' guidelines was the inclusion of information about the role of the health professional in supporting clients during the process of communicating genetic information to their family members. Only two recommendations suggested that the health professional should support their clients by identifying at-risk family members, but more guidelines recommended that directive counselling should be undertaken to encourage clients to communicate genetic information to their family members. In conclusion, the guidelines provide an overview of the role that genetic health professionals may undertake; however, there are gaps that need to be addressed.

Undertaking research in other countries: national ethico-legal barometers and international ethical consensus statements.

Is it ethical for scientists to conduct or to benefit from research in another country if that research would be unlawful, or not generally accepted, in their own country?

Deciding about life-support: a perspective on the ethical and legal framework in the United Kingdom and Australia.

This article is concerned with the legal right of health service providers to decide whether to provide life-prolonging treatment to patients. In particular, an examination of recent decisions by the English Court of Appeal in R (Burke) v General Medical Council (Official Solicitor and Others Intervening) [2005] EWCA Civ 1003 and the European Court of Human Rights in Burke v United Kingdom (unreported, ECHR, No 19807/06, 11 July 2006) is provided. An analysis of Australian case law is undertaken together with a consideration of the limits of a patient's legal right of autonomy in relation to choosing life-prolonging medical treatment; the basis upon which such treatment can be legally withdrawn or withheld from an incompetent patient against the patient's earlier expressed wishes that it should be continued or initiated; the concept in ethics and law of a patient's best interests; and the role of courts in adjudicating disputes about the continuation of treatment in light of the recent decisions.

Outcomes of a randomised controlled trial of a complex genetic counselling intervention to improve family communication.

When an inherited genetic condition is diagnosed in an individual it has implications for other family members. Privacy legislation and ethical considerations can restrict health professionals from communicating directly with other family members, and so it is frequently the responsibility of the first person in a family to receive the diagnosis (the proband) to share this news. Communication of genetic information is challenging and many at-risk family members remain unaware of important information that may be relevant to their or their children's health. We conducted a randomised controlled trial in six public hospitals to assess whether a specifically designed telephone counselling intervention improved family communication about a new genetic diagnosis. Ninety-five probands/parents of probands were recruited from genetics clinics and randomised to the intervention or control group. The primary outcome measure was the difference between the proportion of at-risk relatives who contacted genetics services for information and/or genetic testing. Audit of the family genetic file after 18 months revealed that 25.6% of intervention group relatives compared with 20.9% of control group relatives made contact with genetic services (adjusted odds ratio (OR) 1.30, 95% confidence interval 0.70-2.42, P=0.40). Although no major difference was detected overall between the intervention and control groups, there was more contact in the intervention group where the genetic condition conferred a high risk to offspring (adjusted OR 24.0, 95% confidence interval 3.4-168.5, P=0.001). The increasing sophistication and scope of genetic testing makes it imperative for health professionals to consider additional ways of supporting families in communicating genetic information.