Loane Skene

Competence to give informed consent in acute psychosis is associated with symptoms rather than diagnosis

To investigate the association between competence to give informed consent to treatment, specific symptomology and diagnostic category, 110 inpatients diagnosed with DSM-IV acute schizophrenia (n = 64), schizoaffective disorder (n = 25) and bipolar affective disorder (n = 21) were interviewed using the MacArthur Competence Assessment Tool for Treatment (MacCAT-T) and the Positive and Negative Syndrome Scale (PANSS). Results indicated no significant difference in competence between the three disorders. Elevated positive, cognitive and excitement PANSS factor scores had lower MacCAT-T scores. Further analyses indicated symptoms that impair cognition; particularly, conceptual disorganisation and poor attention were most consistently related to poor performance on competence tests.

Ownership of human tissue and the law

Genetic researchers and medical practitioners often need to obtain access to stored human tissue without consent from the people concerned. But the laws that relate to the ownership of, and control over, stored human tissue are at present unclear, especially in the light of recent cases and inquiries. Here, I discuss how the law might be clarified, and argue that the law should allow stored human tissue to be used without consent, providing that this occurs with ethical approval and that the confidentiality of the donor is protected.

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.

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.

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.Genet Med 2012:14(1):122–128

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

BackgroundGenetic 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.MethodsThis 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.DiscussionThis 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 registrationAustralia and New Zealand Clinical Trials Register (ANZCTR): ANZCTRN12608000642381.

NEUROIMAGING AND THE WITHDRAWAL OF LIFE-SUSTAINING TREATMENT FROM PATIENTS IN VEGETATIVE STATE

In a recent English case before the Family Division of the English High Court, the Official Solicitor objected to the withdrawal of treatment from a patient diagnosed as being in vegetative state (VS) despite agreement between the NHS Trust and the patient’s family that treatment should be withdrawn: An NHS Trust v. J. One objection arose from the possibility, based on a recent medical article, that a functional magnetic resonance imaging test (fMRI, commonly called a brain scan) might indicate that the patient retained a degree of consciousness. This seems to be the first objection of this kind and in this case, after a short time, the Official Solicitor agreed with the family and the Trust that treatment should be withdrawn without performing fMRI. However, all cases involving the withdrawal of life-sustaining treatment from patients in VS must come before a court (now the Court of Protection) and the issue is likely to be raised again. Indeed, given the significant advances in neuroimaging studies of VS since 2006, and probable further scientific progress in the near future, questions about the legal significance of fMRI are likely to become increasingly important. This paper assesses the possible effects on decision making about the withdrawal of life-sustaining treatment if fMRI suggests that a patient in VS has some level of consciousness. It focuses on the principles set out in the Mental Capacity Act 2005 (UK) (which has come into force since the case mentioned above), the Mental Capacity Act Code of Practice (CoP) and the common law. Relevant legal factors include the patient’s wishes expressed in an ‘advance decision to refuse medical treatment’ under the Act, decisions by a donee of a lasting power of attorney appointed under the Act, both of which are binding under the Act if they apply in the circumstances; and, if there is no such provision, the patient’s best interests, taking account of the patient’s wishes inferred from general evidence and the futility of continuing treatment. Current research suggests that neuroimaging will at most establish that some patients diagnosed as being in VS are in fact in a condition that clinicians describe as a ‘minimally conscious state’ (MCS). The patients reported to date have not recovered beyond that state and, indeed, may revert to VS. However, applications for fMRI when judicial approval is sought from the Court of Protection to withdraw treatment from patients in VS may delay the process and raise issues for the Court in assessing the relevance of fMRI to the patient’s interests. This paper outlines legal principles relevant to judicial review and discusses underlying philosophical issues, including the limited availability of resources for health care.

Who owns your body? Legal issues on the ownership of bodily material

Who owns your body and parts removed from it? Can you legally sell your bodily material--or information derived from it? Can you legally prevent other people gaining access to your excised bodily material, including your blood relatives who might need your tissue or genetic information for their own genetic tests? What legal remedies are there if people take or use your bodily material without your consent? And why are the answers to these questions vitally important for scientists?

The role of the church in developing the law

The church and other community organisations have a legitimate role to play in influencing public policy. However, intervention by the church and other religious bodies in recent litigation in Australia and the United Kingdom raises questions about the appropriateness of such bodies being permitted to intervene directly in the court process as amici curiae. We argue that there are dangers in such bodies insinuating their doctrine under the guise of legal argument in civil proceedings, but find it difficult to enunciate a principled distinction between doctrine and legal argument. We advise that judges should exercise caution in dealing with amicus submissions.

Ethics Report on Interspecies Somatic Cell Nuclear Transfer Research

This report considers whether research involving the creation of human-animal interspecies somatic cell nuclear transfer (iSCNT) embryos raises new ethical issues, and if so, whether it requires additional or special criteria and oversight distinct from research on human-animal chimeras.