There is an alleged tension between undue inducement and exploitation in research trials. This paper considers claims that increasing the benefits to research subjects enrolled in international, externally-sponsored clinical trials should be avoided on the grounds that it may result in the undue inducement of research subjects. This article contributes to the debate about exploitation versus undue inducement by introducing an analysis of the available empirical research into research participants' motivations and the influence of payments on research subjects' behaviour and (...) risk assessment. Admittedly, the available research in this field is limited, but the research that has been conducted suggests that financial rewards do not distort research subjects' behaviour or blind them to the risks involved with research. Therefore, I conclude that research sponsors should prioritise the prevention of exploitation in international research by providing greater benefits to research participants. (edited). (shrink)
In 2004 Emanuel et al. published an influential account of exploitation in international research, which has become known as the 'fair benefits account'. In this paper I argue that the thin definition of fairness presented by Emanuel et al, and subsequently endorsed by Gbadegesin and Wendler, does not provide a notion of fairness that is adequately robust to support a fair benefits account of exploitation. The authors present a procedural notion of fairness – the fair distribution of the benefits of (...) research is to be determined on a case-by-case basis by the parties involved in each study. The fairness of the distribution of benefits is not assessed against an independent normative standard. Emanuel et al.'s account of fairness provides a framework for objecting only to transactions that occur without the fully informed consent of the weaker party. As a result, a debate about exploitation collapses into a debate about consent. This is problematic because, as the proponents of the fair benefits framework acknowledge, neither the trial participants' consent nor the host community's consent preclude exploitation. Attempts to stipulate normative standards of fairness to protect research subjects in developing countries have been controversial and divisive, and it is therefore understandable that bioethicists would be tempted to develop accounts of exploitation that are independent of such prescriptive principles. I conclude, however, that the utility of the fair benefits model of exploitation as a policy tool will ultimately depend on whether a substantive principle of fairness can be developed to underpin it. (shrink)
As the demand for human eggs for stem cell research increases, debate about appropriate standards for recruitment and compensation of women intensifies. In the majority of cases, the source of eggs for research is women undergoing fertility treatment requiring ovarian stimulation and egg retrieval. The principle of "just participant selection" requires that research subjects be selected from the population that stands to benefit from the research. Based on this principle, infertile women should be actively recruited to donate eggs for fertility-related (...) research only. It is unethical to exclusively or predominantly recruit infertile women to donate eggs for stem cell research that concerns general medical conditions. It is preferable to recruit women from the general population to donate eggs for such research, and these women should be viewed as healthy volunteers. To avoid exploitation, these donors should receive compensation for both the direct and indirect costs associated with their donation. (shrink)
Trust is taken to be one of the foundational values in the doctor-patient relationship, facilitating access to the benefits of health care and providing a guarantee against possible harms. Despite this foundational role, some doctors betray the trust of their patients. Trusting involves granting discretionary powers and makes the truster vulnerable to the trustee. Patients trust medical practitioners to act with goodwill and to act competently. Some patients carry pre-existing vulnerabilities, for reasons such as gender, poverty, age, ethnicity, or disability, (...) and these vulnerabilities can be exacerbated when such patients extend their trust to a doctor. Gender stereotypes reduce women's ability to challenge and thereby assess their doctor's competency. In addition, women are more likely to be distrusted by their doctors and have their experiences of medical symptoms discounted. In this paper, we analyze two extreme examples of breaches of medical trust that exploited the vulnerability of women in the health care system: the "unfortunate experiment" at the National Women's Hospital in New Zealand and the Harold Shipman murders of elderly patients in the United Kingdom, examining the potential role of gender in the outcomes with regard to trust. Major breaches of medical trust such as these typically lead to government inquiries, revisions of ethical guidelines, and substantive policy change in an effort to re-establish public and patient trust. We argue that the medical profession has an ethical obligation to put mechanisms in place to protect vulnerable patients from abuses of trust, to monitor colleagues' competence, and to be prepared to blow the whistle to protect patients who are not in a position to recognize misplaced trust. Such mechanisms will act disprosportionately to reduce harm to women as patients. (shrink)
Inclusion in research is a question of both scientific validity of research results and just distribution of the benefits of medical research within a community. Therefore, inappropriate exclusions from research can be regulated as a matter of science or a matter of ethics. In this paper we examine the definitions of appropriate/fair inclusion in the Australian and U.S. regulatory systems and discuss the processes for interpreting and implementing these normative standards. In the second part of the paper, we present original (...) results from the first study of sex-specific research in Australia. One hundred and thirteen published papers were examined: 35 percent were classified as inappropriate sex-specific research, where exclusion was not biologically necessary, and/or there was no justification for the exclusion of one sex. Our results indicate that a scientific approach to inclusion, rather than one grounded in ethical review, is likely to be more effective in achieving appropriate sex-specific research. In the absence of effective regulation, we will continue to see research that discriminates unfairly and perpetuates gender stereotyping. (shrink)
