Colin J. H. Thomson

No need to go! Workplace studies and the resources of the revised National Statement

AbstractIn 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.

Research Ethics Committees

Research ethics committees have become standard international practice during the past several decades. They emerged in the 1960s and 1970s in response to unethical research practices. Committees are typically established and their members appointed by research institutions but also by governments. Their broad aims are to protect the welfare of research participants, ensure research is conducted as approved, and promote confidence in human research. Their broad functions are reviewing, requesting changes to, and approving human research proposals; monitoring their conduct; dealing with complaints; suspending research proposals; and reporting on their performance. Membership typically includes those who know research disciplines, those aware of community attitudes and values, and those who know applicable legal and institutional constraints. Recent initiatives seek to reduce duplication of committee review and ensure the quality of review by accreditation.

Human Research Ethics Guidelines in Australia

This chapter describes the human research ethics guidelines that have been issued by national government agencies in Australia between 1966 and the present time. The identity, statutory or formal authority to issue such guidelines of each of these agencies is described as is the composition of the committees and approval bodies of each of the issuing agencies. The processes that these agencies were required to follow in the development and issues of guidelines are examined, as well as the more informal processes that they adopted in guideline development. These include requirements for public consultation and promulgation. Finally, the chapter concludes with some reflections on the strengths and weaknesses of those processes and on the effects of recent statutory changes to the key agencies.

The value of respect in human research ethics: a conceptual analysis and a practical guide

Abstract In order to continue to maintain public trust and confidence in human research, participants must be treated with respect. Researchers and Human Research Ethics Committee members need to be aware that modern considerations of this value include: the need for a valid consenting process, the protection of participants who have their capacity for consent compromised; the promotion of dignity for participants; and the effects that human research may have on cultures and communities. This paper explains the prominence of respect as a value when considering the ethics of human research and provides practical advice for both researchers and Human Research Ethics Committee members in developing respectful research practices.

Contextualising Merit and Integrity within Human Research

The first consideration of any Australian Human Research Ethics Committee should be to satisfy itself that the project before them is worth undertaking. If the project does not add to the body of knowledge, if it does not improve social welfare or individual wellbeing then the use of human participants, their tissue or their data must be questioned. Sometimes, however, committees are criticised for appearing to adopt the role of scientific review committees. The intent of this paper is to provide researchers with an understanding of the ethical importance of demonstrating the merit of their research project and to help them develop protocols that show ethics committees that adequate attention has been paid to this central tenet in dealing ethically with human research participants. Any person proposing human research must be prepared to show that it is worthwhile. This paper will clarify the relationship between research merit and integrity, research ethics and the responsibilities of human research ethics committees.

Monitoring medical research conduct: why, how and by whom?

Research by Karunaratne and colleagues discloses that, in some research projects, communication with participants about the research was either not achieved or used methods different from those that the ethics committee had approved. Participants often preferred to trust the researchers to explain the research and many had not heard of the research ethics committee. Researchers did not always follow the approved consent process and preferred monitoring by self-reporting to a research ethics committee to a process involving feedback from participants such as that proposed by the authors. The study identifies examples of gaps between the design of research approved by an ethics committee and the implementation of that design. The authors appear to accept conventional assumptions about monitoring of research, namely, that discovering whether such a gap exists and, if so, deciding what the consequences of its occurrence should be the responsibility of a research ethics committee. These assumptions merit reassessment in the context of any monitoring of medical research involving humans. Why should that research be monitored? How should monitoring be conducted? Who should conduct it? In the following paragraphs, some approaches to those questions are sketched.

Beneficence as a principle in human research.

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.

Justice in human research ethics. A conceptual and practical guide.

AbstractOne of the core values to be applied by a body reviewing the ethics of human research is justice. The inclusion of justice as a requirement in the ethical review of human research is relatively recent and its utility had been largely unexamined until debates arose about the conduct of international biomedical research in the late 1990s. The subsequent amendment of authoritative documents in ways that appeared to shift the meaning of conceptions of justice generated a great deal of controversy. Another difficulty has been that both the theory and the substance of justice that are applied by researchers or reviewers can be frequently seen to be subjective. Both the concept of justice — whether distributive or commutative — and what counts as a just distribution or exchange — are given different weight and meanings by different people.In this paper, the origins and more recent debates about the requirement to consider justice as a criterion in the ethical review of human research are traced, relevant conceptions of justice are distinguished, and the manner in which they can be applied meaningfully in the ethical review of all human research is identified.We also explain the way that these concepts are articulated in, and the intent and function of, specific paragraphs of the National Statementon Ethical Conduct in Human Research (2007). The National Statement identifies a number of issues that should be considered when a human research ethics committee is reviewing the justice aspects of an application. We provide guidance to researchers as to how they can show that there is a fair distribution of burdens and benefits in the participant experience and the research outcomes. We also provide practical guidance to researchers on how to think through issues of justice so that they can demonstrate that the design of their research projects meets this ethical requirement.

'… (D)eath, a necessary end, will come when it will come', (William Shakespeare, Julius Caesar, Act 2, Scene 2.).

The treatment of medical patients nearing the end of their lives has long been a cause of concern to health practitioners and their legal advisers. In the past, when all of the effects of treatment relied on to relieve pain or suffering were unknown, there was tension among the goals of that treatment. These were to ensure that a doctor’s decisions and treatments were: • Within the law • Within the bounds of acceptable medical practice • Met the patient’s needs and – often – the family members’ expectations On the one hand, doctors were advised that so long as they did not intend to cause the death of their patient, but rather to relieve the patient’s pain or suffering, the administration of treatment that that would possibly (or even probably) hasten the time of death would be lawful. On the other hand, lawyers (and some doctors) were also aware that, in legal contexts other than medicine, mere knowledge of probable consequences was sufficient to meet the mental element for a successful murder prosecution. Eloquent testimony to the uncertainty that troubled the medical profession was the popularity of the poet Arthur Clough’s cynical rendering of the sixth Commandment:

Good Medical Practice: Maintenance of professional competence

No doctor will deny an ethical obligation to provide competent clinical care to patients, but many have been reluctant to embrace compulsory continuing medical education (CME) or compulsory recertification of their professional competence. Such reluctance in regard to making this obligation compulsory relates to factors including scepticism that recertification will necessarily improve standards of patient care or prevent the problems created by incompetent members of the profession; awareness that the medical profession is generally very committed to CME, and to evaluation of care through clinical research and its dissemination and publication; and, lastly, sensitivity by many doctors to the accountability already required of them by the courts, health complaints mechanisms and medical boards. There has, however, emerged a more positive approach to the need to document maintenance of professional competence in the profession with formal initiatives taken by all the medical colleges. These initiatives, while eschewing examinations, are designed to reflect the realities of everyday professional life and are consistent with education and learning theory, itself still evolving. A small proportion of doctors still resent this perceived bureaucratic intrusion, but the benefits for the medical profession and the community outweigh any additional effort involved in documenting what most doctors already do. Apart from the ethical dimension there are other influences at work in the move to document the maintenance of professional learning and competence of doctors.