Ethics at Phase 0: Clarifying the Issues

The Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA) recently issued documents encouraging sponsors to consider microdose testing before launching Phase I trials, and many commentators predict that such methodologies will be applied more routinely in drug development. However, exploratory testing has provoked several ethical criticisms. Skeptics question the value and validity of microdose trials, and whether they present a reasonable balance of risks and benefits for subjects. Another major criticism is that such studies serve mainly commercial ends. The present article explores these and other ethical concerns for studies conducted in the oncology setting. It concludes that microdosing is not inconsistent with prevailing practices in Phase I research, and that in principle, such studies could strengthen the ethical basis for Phase I trials by providing them better evidentiary justification.     

Children at Risk: Legal and Societal Perceptions of the Potential Threat that the Possession of Child Pornography Poses to Society

This article examines legal and social discourses surrounding the phenomenon of child pornography, considering the legal responses to child pornography (particularly when an individual is found to be in possession of such material), and the way in which such material, the child, and the possessor of child pornography are socially constructed.
The article raises the question of whether there has been a moral panic regarding child pornography and the possession of such material, but also considers whether there are real reasons to consider that the possession of child pornography should remain illegal. Research studies which aim to establish the existence of a causal link between possessing child pornography and the act of committing child sexual abuse are examined, as is the argument that criminalizing the possession of child pornography reduces the market for such material. Finally, there is an analysis of the possible impact of social constructions of the child as innocent.     

Private and public voices: Does family group conferencing privilege the voice of children and families in child welfare?

This article examines the use of family group conferencing in child protection and considers its ability to privilege the voice of children and families who reach the attention of statutory child protection services. The family group conference (FGC) is a process of family decision-making in child protection, originally developed in Aotearoa New Zealand, and now practised in many countries including the UK. Examining the literature and research relating to the FGC it considers whether the approach provides a genuine context of participation and partnership, or whether it has become an instrumental professionally led practice as families are charged with greater responsibilities for children at risk.     

(Why) should we require consent to participation in research?

It is widely accepted that informed consent is a requirement of ethical biomedical research. It is less clear why this is so. As an argumentative strategy the article asks whether it would be legitimate for the state to require people to participate in research. This article argues that the consent requirement cannot be defended by appeal to any simple principle, such as not treating people merely as a means, bodily integrity, and autonomy. As an argumentative strategy the article asks whether it would be legitimate for the state to require people to participate in research. I argue that while it would be legitimate and potentially justifiable to coerce people to participate in research as a matter of first-order moral principles, there are good reasons to adopt a general prohibition on coercive participation as a matter of second-order morality.     

The insanity defense: effects of abolition unsupported by a moral consensus

The insanity defense reflects the moral judgment that some criminal defendants do not deserve criminal sanctions because of mental incapacity. This Note examines the alternative formulations, such as guilty but mentally ill and diminished responsibility, that some states have enacted in the face of growing controversy over the insanity defense. It observes that the alternatives, if used in lieu of the insanity defense, distort the criminal law and do not comport with the legal doctrine of responsibility, which eschews punishing mentally ill defendants. The Note concludes that the insanity defense should not be abolished unless the moral consensus changes regarding the criminal responsibility of mentally ill defendants.     

Research with minors in Germany

The European GCP Directive has been implemented into German law in sect. 40 ff. AMG (German pharmaceutical law). Unlike the Directive, German pharmaceutical law basically differentiates between three constellations of clinical trials on minors: clinical trials on healthy minors, clinical trials on ill minors with an individual benefit for the individual participant, and clinical trials on ill minors without direct benefit for the individual participant, but with a so-called "group benefit". Particularly the latter possibility of conducting clinical trials on minors even if no individual benefit can be expected is not a matter of course in Germany since due to historical experiences a sceptical attitude towards clinical research on humans prevailed for a long time. German legislature has availed itself of the option granted by Article 3 of the GCP Directive to establish a higher level of protection of clinical trial subjects than the European level.     

Why Listening to Children and Young People is Important in Family Justice

During the last 30 years, there has been a growing body of evidence indicating that children and young people often feel marginalized when their parents are making critical decisions that will shape their young lives, and they are calling for family justice professionals to hear their voices. This article explores the research evidence, examines the relevant theories about child development, and demonstrates how a focus on age‐related competency fails to take account of children's subjective meanings about their lives. The authors consider a model of participation first designed to understand adult participation in government and show how this can be usefully applied to understanding children's participation in family justice.     

The legal basis for ethical withholding and withdrawing of life-sustaining medical treatment in children

Withholding and withdrawing life-sustaining medical treatment are common in paediatric practice, especially in intensive care units. However, not all clinicians apparently adhere to principles in ethical guidelines or to the principles which are to be found in judgments from common law cases arising when doctors and parents dispute treatment. This article examines selected ethical guidelines and compares them to judgments in leading cases. The rationale to forgo treatment is usually the child's "best interests" in both clinical practice guidelines and legal cases but in the former "best interests" may remain ill defined. Although "best interests" must essentially pertain to the individual child, the interests of others are not irrelevant. In legal cases "best interests" of the child are defined in terms such as "burden versus benefit", "futility", "indignity", "intolerability", "prolonging death rather than saving life" and "quality of life". These or like terms should form the basis of ethical decisions in discussions with parents when contemplating withholding or withdrawing life-sustaining treatment.     

Physician-assisted suicide in Oregon: a medical perspective

This Article examines the Oregon Death with Dignity Act from a medical perspective. Drawing on case studies and information provided by doctors, families, and other care givers, it finds that seemingly reasonable safeguards for the care and protection of terminally ill patients written into the Oregon law are being circumvented. The problem lies primarily with the Oregon Public Health Division ("OPHD"), which is charged with monitoring the law. OPHD does not collect the information it would need to effectively monitor the law and in its actions and publications acts as the defender of the law rather than as the protector of the welfare of terminally ill patients. We make explicit suggestions for what OPHD would need to do to change that.     

FUTURE CHILD'S RIGHTS IN NEW REPRODUCTIVE TECHNOLOGY:THINKING OUTSIDE THE TUBE AND MAINTAINING THE CONNECTIONS

This article considers whether children born through assisted human reproduction are entitled to information about their biological origins. It examines the issue both from a clinical perspective, citing social science research and the personal narratives of donor‐conceived children, and from a legal perspective, outlining the extent of a child's “right to know” in different jurisdictions. The article suggests that a uniform legal approach is needed that will recognize the right of all children to access details about their identity and conception, for the sake of their psychological well‐being. The article includes a fact scenario that considers the situation of a donor‐conceived child who has become the subject of a custody dispute, and who has not been told the circumstances of his conception.     

TRICARE; coverage of National Cancer Institute (NCI) sponsored Phase I studies. Final rule

This final rule adds coverage of National Cancer Institute (NCI) sponsored Phase I studies for certain beneficiaries. The NCI sponsored clinical treatment trials are conducted in a series of steps called phases. Phase I trials are the first studies conducted in people. They evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe.     

The rights of donor inseminated children to know their genetic origins in Australia

Twenty years after it was recognised that adopted children have rights to understand their origins, the dawn has finally broken with respect to children conceived as a result of the Assisted Reproductive Technologies (ART), specifically donor insemination (DI). Recipients and practitioners of conception technologies focus their energies and ethical deliberation on the achievement of pregnancy and the successful birth of the child. Law, in contrast, must focus beyond birth to enshrine respect for the rights of the child, who is 'not legally capable of defending [his or her] own future interests.' This article undertakes an assessment of what is in the best interests of a child using empirical studies to ground a position that should be adopted by law in Australia. This article also critically evaluates the current legal position of the various States and Territories with regards to a DI conceived child's rights to know of their form of conception; access to identifying information of their donor; at what age they may access information; the position of DI children born before existing legislation; record-keeping; and finally whether international law grants such children rights. Australian children must enjoy the right in theory and practice to know they were donor conceived and the identity of their donor. It is disappointing that New South Wales, as the most recent State to propose legislation on ART, has not utilised international empirical research on the best interests of DI children or even followed the Infertility Treatment Act 1995 (Vic) which seems to be far more progressive in recognising how best to protect the rights of DI children. The current legal position is chaotic. States and Territories should confer power on the Federal Government to legislate uniform and explicit regulation of ART for the benefit of DI children.     

Subjects with agency? Children’s participation in family law proceedings

Galvanised by the UN Convention on the Rights of the Child, many jurisdictions now recognise children’s rights to participate in decisions that affect them. While such legal rights have increased, research on family law proceedings shows how children’s views can still be undermined, ignored or not even sought in decisions about them. This article uses the academic resources of childhood studies, to consider dominant and alternative narratives of children’s participation within Scottish family law. Drawing upon reported case law and empirical research, the article concludes that children’s participation gains protection by being institutionalised but children’s participation is attenuated because it is not recognised as relational and contextual. As rationality, consistency and autonomy are privileged, the weight given to children’s views is lessened by concerns about children being manipulated or distressed. Courts and their decisions may be child-focused, centring on children’s welfare, but they are not child-inclusive, involving children in decision-making.     

Right to Experimental Treatment: FDA New Drug Approval, Constitutional Rights, and the Public's Health

On May 2, 2006, a divided panel of the U.S. Court of Appeals for the District of Columbia, in a startling opinion, Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach, held that terminally ill patients who have exhausted all other available options have a constitutional right to experimental treatment that FDA has not yet approved. Although ultimately overturned by the full court, Abigail Alliance generated considerable interest from various constituencies. Meanwhile, FDA proposed similar regulatory amendments, as have lawmakers on both sides of the aisle in Congress. But proponents of expanded access fail to consider public health and consumer safety concerns. In particular, allowing patients to try unproven treatments, outside of controlled clinical trials risks both the study's outcome and the health of patients who might benefit from the deliberate, careful process of new drug approval as it currently operates under FDA's auspices.     

INTERPARENTAL CONFLICT AS A RISK FACTOR FOR CHILD MALADJUSTMENT: Implications for the Development of Prevention Programs

This article reviews research on the effects of interparental conflict on children and examines its implications for divorce education programs designed to reduce conflict after divorce. Basic research indicates that prevention programs for parents will be most effective in fostering children's adaptation to divorce if they can reduce the level of destructive conflict that children are exposed to, foster good parent–child relationships, and keep children from being caught in the middle of parental tensions and disagreements. Programs for children are likely to be most helpful if they help children learn ways to cope with situations in which they feel pressured to side with one parent against the other and avoid feeling responsible for parental problems. Although psycho-educational programs are widely available and often court-mandated, evaluation studies are rare and support for their efficacy is mixed.     

A Leap of Faith? Sanctioning Xenotransplant Clinical Trials

Introducing a new medical technique, procedure or drug to the public via clinical trials is risky at the best of times. When the trial involves a biotechnology which holds out the promise of prolonging, if not saving, life the push to move from the laboratory to clinical trials may be hard to resist. In this article I explore whether the regulatory scheme for clinical trials in the UK is able to accommodate developing technologies by considering how the current legal and ethical frameworks determine when a procedure such as xenotransplantation should proceed to trials. In particular, I discuss whether basing our regulatory schemes on the principles espoused in the Declaration of Helsinki offer sufficient protection to those who may be affected by xenotransplant trials – the recipient, their health-care workers, close contacts and, unusually, the wider public. I question whether it is possible for a technology to be approved for clinical trials when allowing such trials may benefit the individual but ultimately negatively impact on society as a whole.     

Virtue and the Law: The Good Moral Character Requirement in Occupational Licensing,Bar Regulation,and Immigration Proceedings

Character plays a crucial role in US law. This article explores flaws in how moral character requirements determine who can work in licensed occupations, who can practice law, and who can immigrate to the United States or become a citizen. Section I summarizes psychological research on character, which raises questions about a central legal premise that individuals have a settled disposition capable of accurately predicting their behavior independent of situational influences. Section II examines the role of moral character as an employment credential. Almost a third of the workforce is covered by licensing laws that typically require proof of good character and often unjustly penalize the seventy million Americans with criminal records. Section III examines the idiosyncratic and inconsistent application of moral character requirements for lawyers. Section IV focuses on similar flaws in immigration contexts. Section V identifies reform strategies to improve the fairness of character‐related decisions in the law.     

Medical Evidence and Expert Testimony in Child Sexual Abuse

Expert medical testimony in child sexual abuse cases can be critical to the outcome of a legal case. This article will review the development of the medical knowledge and clinical expertise in child sexual abuse. Since the passage of mandatory child abuse reporting laws, the forensic medical examination of a child for evidence of sexual abuse has become standard. Until recently, many myths regarding female genital anatomy existed but were based primarily on dogma and lack of empirical research. Over the past 25 years, many research studies and accumulating clinical evidence have expanded medical knowledge and debunked old myths. Physical evidence, even in cases of alleged genital or anal penetration is rare. Sexually transmitted infections are also uncommon and often require medical interpretation as to their significance in a prepubertal child. Specialized medical knowledge, training, and clinical expertise have developed in order to evaluate children presenting with allegations of sexual abuse. Such medical expertise provides invaluable service to courts. We review criteria for evaluating such expertise in light of current medical practice.     

Parenting in Families of Low Socioeconomic Status: A Review with Implications for Child Welfare Practice

Families involved in the child welfare system overwhelmingly draw from low socioeconomic (SES) populations. Impoverished children are placed in foster care at disproportionate rates. Addressing this dynamic requires understanding the adaptations low‐income families make when parenting under adversity so that accurate assessments of their needs occur. This article focuses on two aspects of child welfare practice: the evaluation of parenting capacity and service delivery. It examines, in particular, how well current practices and guidelines, as outlined in the literature, fit with more general research on families and parenting in low‐SES environments and offers suggestions for improving practice.     

Parenthood in Murder‐Suicide News. Idealized Fathers and Murderous Mums

In this article I analyse how parents' lethal violence is presented in Finnish murder‐suicide news reports. I explore how gendered ideas of parenthood and violence affect these constructions. The cases that I am interested in are those with child victims where the perpetrator is either the father or the mother. The theoretical frame of analysis is feminist ethnomethodology, and Membership Categorization Analysis is used as the method. One of the starting‐points is that parenthood is gendered in a way that mothers and fathers have different rights, responsibilities and competences in our culture. In other words, moral orders of fathering and mothering exist. Because of this, women's and men's violent actions towards their own children are understood differently. When a man kills his children and himself he can be portrayed as a caring parent. Instead, in a certain context a woman can be ‘a killer mum’, her act ‘a murder’ and her personality described in the light of the deed. The focus of this article is on gender and family categorization used in murder‐suicide news in Finnish newspapers and the moral orders created in them. I explore the differences by mainly using two case examples: 1) a man who killed his three children and himself, and 2) a woman who killed her husband, two children and herself. The consequences of these newspaper constructions are also considered.