ABSTRACT In establishing National Bioethics Organisations (NBOs), liberal democracies seek to acknowledge the diversity of strongly held ethical positions and the imperative to engage in public debate about important bioethical decisions. NBOs are typically given a range of responsibilities, including contributing to and stimulating public debate; providing expert opinion on relevant issues for policy deliberations; and developing public policy. The state is now found to have an interest in areas previously thought to be a matter of individual choice. NBOs can (...) provide one way of opening up public debate to allow the diversity of views to be heard in a manner that is well‐informed, articulate and responsive to both expert and ‘lay’ public views. We draw on debates in political theory about democratic decision‐making and on the policy making roles of some key NBOs. We are particularly interested in examining the capacity of NBOs to meet the democratic ideal of effective participation by the public, or citizenry, especially by those who are directly affected by the policies, in the development of effective public policy. We provide a basic framework for policy development involving NBOs that can begin to meet this ideal, a process of ‘contested deliberation’. (shrink)

ABSTRACT In establishing National Bioethics Organisations (NBOs), liberal democracies seek to acknowledge the diversity of strongly held ethical positions and the imperative to engage in public debate about important bioethical decisions. NBOs are typically given a range of responsibilities, including contributing to and stimulating public debate; providing expert opinion on relevant issues for policy deliberations; and developing public policy. The state is now found to have an interest in areas previously thought to be a matter of individual choice. NBOs can (...) provide one way of opening up public debate to allow the diversity of views to be heard in a manner that is well‐informed, articulate and responsive to both expert and ‘lay’ public views. We draw on debates in political theory about democratic decision‐making and on the policy making roles of some key NBOs. We are particularly interested in examining the capacity of NBOs to meet the democratic ideal of effective participation by the public, or citizenry, especially by those who are directly affected by the policies, in the development of effective public policy. We provide a basic framework for policy development involving NBOs that can begin to meet this ideal, a process of ‘contested deliberation’. (shrink)

Beneficence is one of the four principles that form the basis of the Australian National Statement. The aim of this paper is to explore the philosophical development of this principle and to clarify the role that beneficence plays in contemporary discussions about human research ethics. By examining the way that guidance documents, particularly the National Statement, treats beneficence we offer guidance to researchers and human research ethics committee members on the practical application of what can be a conceptually difficult principle.

In their article ‘Unintended consequences of human research ethics committees: au revoir workplace studies?’, Greg Bamber and Jennifer Sappey set out some real obstacles in the practices and attitudes of some Human Research Ethics Committees (HRECs), to research in the social sciences and particularly in industrial sociology. They sheet home these attitudes and practices to the way in which various statements in the NHMRC’s National Statement [1999] are implemented, which they say is often ‘in conflict with an important stream of (...) industrial sociological research’ in Australia. They do not discuss the recently completed revision of the NS. We undertake to show that the revised National Statement meets their concerns about research in industrial sociology, and to draw attention to the resources of the revised National Statement that engage with those concerns. A more general aim is to display the greater scope, in the revised National Statement, for researchers to show to HRECs that their research is justified by virtue of its reflecting the established methodology and traditions of their discipline. The revised National Statement, we suggest, provides for a more flexible and responsive approach than its predecessor to the ethical review of many areas of research. (shrink)

The conduct of prior ethics review of human research projects helps to protect vulnerable groups or populations from potential negative impacts of research. Contemporary considerations in human research considers the concept of vulnerability in terms of access to research opportunities, impacts on the consenting process, selection bias, and the generalisability of results. Recent work questions the validity of using enumerated lists as a check box approach to protect research participants from exploitation. Through the use of broad categories to treat cohorts (...) of human research participants as homogenous classes and label some participants as vulnerable merely because they are members of a particular class, some ethics reviewers have used the National Statement on Ethical Conduct in Human Research to strip individuals of their “ethical equality”. Labelling people as vulnerable does not help researchers or human research ethics committee members develop an understanding of the complexities of applying the principles of respect and of justice in ethical decision-making. Conversely, defining specific cohorts of research participants as needing nuanced ethical consideration, due to their vulnerable nature, may imply that other population groups need not be considered vulnerable. We contend that this assumption is erroneous. This paper explores the way that human research ethics guidance documents treat vulnerability within the Australian context and draws on contemporary discussion to focus an alternative perspective based on the principles in the National Statement on Ethical Conduct in Human Research for researchers and human research ethics committee members to consider. (shrink)

Research is increasingly recognised as a key component of medical curricula, offering a range of benefits including development of skills in evidence-based medicine. The literature indicates that experienced academic supervision or mentoring is important in any research activity and positively influences research output. The aim of this project was to investigate the human research ethics experiences and knowledge of three groups: medical students, and university academic staff and clinicians eligible to supervise medical student research projects; at two Australian universities. Training (...) in research ethics was low amongst academic staff and clinicians eligible to supervise medical student research. Only two-thirds of academic staff and students and less than half of clinicians surveyed indicated that specific patient consent was required for a doctor to include patient medical records within a research publication. There was limited awareness of requirements for participant information and consent forms amongst all groups. In the case of clinical trials, fewer clinicians and students than academics indicated there was a requirement to obtain consent. Awareness of the ethics committee focus on respect was low across all groups. This project has identified significant gaps in human research ethics understanding among medical students, and university academic staff and clinicians. The incorporation of research within medical curricula provides the impetus for medical schools and their institutions to ensure that academic staff and clinicians who are eligible and qualified to supervise students’ research projects are appropriately trained in human research ethics. (shrink)