Competence and consent to research: A critique of the recommendations of the national bioethics advisory commission*

Concern about the participation of incompetent subjects in psychiatric research has grown in the last several years. In response, the National Bioethics Advisory Commission (NBAC) recommended in its recent report that all investigations involving persons with mental disorders that may be associated with cognitive impairment that may pose greater than minimal risk to subjects utilize independent assessors to verify the capacities of subjects prior to entry into the study. This recommendation poses several problems for the conduct of research and the protection of research subjects. First, it fails to target that group of subjects most likely to be at risk for incapacity. Second, it focuses on too broad a range of research projects, many of which pose little risk to participants. The substantial costs of this approach are therefore not likely to be outweighed by concomitant benefits. In place of the NBAC recommendation, the author proposes a more flexible system of capacity assessment, designed to balance the costs with a greater likelihood of achieving meaningful protection for research subjects with mental disorders.     

The therapeutic misconception: a threat to valid parental consent for pediatric neuroimaging research

Neuroimaging research has brought major advances to child health and wellbeing. However, because of the vulnerabilities associated with neurological and developmental conditions, the parental need for hope, and the expectation of parents that new medical advances can benefit their child, pediatric neuroimaging research presents significant challenges to the general problem of consent in the context of research involving children. A particular challenge in this domain is created by the presence of therapeutic misconception on the part of parents and other key research stakeholders. This article revierws the concept of therapeutic misconception and its role in pediatric neuroimaging research. It argues that this misconception can compromise consent given by parents for the involvement of their children in research as healthy controls or as persons with neurological and developmental conditions. The article further contends that therapeutic misconception can undermine the research ethics review process for proposed and ongoing neuroimaging studies. Against this backdrop, the article concludes with recommendations for mitigating the effects of therapeutic misconception in pediatric neuroimaging research.     

Disciplining Bioethics: Towards a Standard of Methodological Rigor in Bioethics Research

Contemporary bioethics research is often described as multi- or interdisciplinary. Disciplines are characterized, in part, by their methods. Thus, when bioethics research draws on a variety of methods, it crosses disciplinary boundaries. Yet each discipline has its own standard of rigor-–so when multiple disciplinary perspectives are considered, what constitutes rigor? This question has received inadequate attention, as there is considerable disagreement regarding the disciplinary status of bioethics. This disagreement has presented five challenges to bioethics research. Addressing them requires consideration of the main types of cross-disciplinary research, and consideration of proposals aiming to ensure rigor in bioethics research.     

Bad news about bad news: the disclosure of risks to insurability in research consent processes

One of the phenomena associated with research is "incidental findings," that is, unexpected findings made during the research, and outside the scope of the research, which have potential health importance. One underappreciated risk of incidental findings is the potential loss of the research subject's insurability; or if a research subject fails to disclose incidental findings when applying for insurance, the insurance contract may be voidable by the insurer. In this article, we seek to explain the insurability risks associated with incidental findings and to make recommendations for how researchers and research ethics committees should address the issue of disclosure of these risks.     

Informed consent for research on stored blood and tissue samples: a survey of institutional review board practices

Numerous position papers have outlined informed consent recommendations for the collection, storage, and future use of biological samples; however, there currently is no consensus regarding what kinds of information should be included in consent forms. This study aimed to determine whether institutional review boards (IRBs) vary in their informed consent requirements for research on stored biological samples, and whether any variation observed could be correlated to factors such as volume of work, IRB members' familiarity with ethical issues in genetic research, and IRBs' use of either of two policy guidelines as resources. A brief survey was mailed to all IRB chairpersons on a mailing list obtained from the Office for Human Research Protections. Survey questions included whether consent forms for the collection of biological samples for future use address each of six provisions recommended in current guidelines and position statements, and whether IRBs used the Office for Protection from Research Risks' 1993 Protecting Human Research Subjects: Institutional Review Board Guidebook, chapter 5 (hereinafter IRB Guidebook) or the National Bioethics Advisory Commission's 1999 Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, Volume I (hereinafter Report) in their deliberations. Despite a low response rate (22%, 427 respondents), results indicate that IRB practices vary substantially. The degree to which the provisions were included in consent forms was found to correlate positively with IRBs that review a greater volume of protocols annually, those that use the National Bioethics Advisory Commission Report in their deliberations, and those that draw on both the Report and the IRB Guidebook.     

The issue of consent in research that administers drugs of addiction to addicted persons

In addiction, impaired control over drug use raises questions about the capacity of addicted persons to consent to participate in research studies in which they are given their drug of addiction. We review the case for doing such research, and the arguments that addiction does, and does not, prevent addicted persons from consenting to such research. We argue for a more nuanced view that acknowledges that while in some situations addiction impairs decision-making capacity, it does not eliminate such capacity. We conclude with some suggestions for recruiting addicted subjects and designing experiments in ways to obtain free and informed consent.     

State socialism and the welfare state: a critique of two conventional paradigms

The post–war development of industrialised nations has been led by the idea of a welfare state. On the other hand, research on current and former communist states is still dominated by an age–old notion of 'state socialism'. This article provides a critical assessment of the two conventional paradigms by reviewing their implications within the historical and international contexts. By tracing its ideological roots and contrasting with the changing reality, it is argued that state socialism was misused in representing Marxist guidelines and is outdated in characterising the reforming socialist societies. By emphasising the experience of developing nations the article further challenges the welfare state as the paradigm for studying the general direction of a modern society. Attention is drawn to the study of a general public policy, and the economic state model is revisited for conceptualising the experience of a non–welfare state nation such as China.     

Childcare policies and services in Hong Kong after the handover: Beyond a feminist critique

This article reviews the development of childcare policies and services in Hong Kong after the handover, gauging it with two standards: promoting the equal development of children and gender equality in our society. Statistics derived from data taken from multiple sources show that the government has been sticking to a “positive non‐intervention approach” to welfare development and that the male breadwinner/female carer model prevalent in this region was shaped and strengthened by current childcare policies and services. The current provision of childcare services is insufficient to guarantee the equal use of childcare among children of different socioeconomic backgrounds, or to ease the tension between the needs of childcare and job requirements in a family, or to emancipate married women from the domestic sphere. A “generative welfare approach” that collects fiscal resources and redistributes them strategically with a systemic mind‐set has been suggested for social policy and service planning, including spending the money in the right place, launching smart and practical policies that can achieve both pragmatic effects and ideological improvement in the area of gender equality, providing financial support or subsidies to a company for the provision of parental leave, and increasing the provision of quality childcare services.     

The Royal Commission,ATSIC and Self-Determination: A Review of the Royal Commission into Aboriginal Deaths in Custody

The National Report of the Royal Commission into Aboriginal Deaths in Custody, in recommending fundamental reforms of government policy, proposed a primarily political and administrative notion of Aboriginal empowerment or ‘self-determination’. That is, the Commissioner argued the fundamental importance of publicly-funded Aboriginal organisations and urged governments to relax financial accountability requirements imposed on them. The paper quotes extensively from the National Report to argue that this, rather than ‘land rights’ or ‘economic independence’ is what the Commissioner meant by ‘self-determination’. But what is the place of the Aboriginal and Torres Strait Islander Commission (ATSIC) in such a view of Aboriginal and Islander political development? The paper demonstrates the Commissioner's ambivalence about ATSIC, and his failure consistently to project ATSIC's role when making his recommendations about health, alcohol and housing policies. It concludes by citing Commonwealth responses which indicate that ATSIC is likely to emerge as an obstacle in the Commissioner's scenario of Aboriginal and Islander political development.     

The ethical review of medical research: a social movement to protect the interests of research subjects

This paper is based upon observations made in the United States regarding the operation of the Institutional Review Boards. Institutional Review Boards are an essential part of the American system for the ethical review of human subjects research and it is argued that their importance is due in part to the American approach to the protection of minority groups. It is important to evaluate the effectiveness of the Institutional Review Boards since a similar model is being proposed by the National Health & Medical Research Council as part of the ethical review of medical research projects conducted in Australia.     

National,independent oversight: Reinforcing the safety net for human subjects research*

National, independent oversight is vital to resolve the problems and inconsistencies in oversight of human subjects research. Three key functions that must be considered in any proposal for such a mechanism are (1) issue spotting, (2) guidance on identified issues, and (3) sampling and follow‐up. The 1998 report and recommendations of the National Bioethics Advisory Commission concerning research involving persons with mental disorders that may affect decisionmaking capacity address these functions in part, but application is limited to a small segment of the research population. Incorporation of these three key functions in a formal, national, independent oversight process is necessary in order to ensure accountability and maintain public trust in research.