This paper raises questions about the epistemological foundations of evidence-based medicine . We argue that EBM is based upon reliabilist epistemological assumptions, and that this is appropriate - we should focus on identifying the most reliable processes for generating and collecting medical knowledge. However, we note that this should not be reduced to narrow questions about which research methodologies are the best for gathering evidence. Reliable processes for generating medical evidence might lie outside of formal research methods. We also question (...) the notion of the knower that is assumed by EBM. We argue that EBM assumes an enlightenment conception of knowers as autonomous, substitutable individuals. This conception is troubled by the way that clinicians learn the role of anecdote in health care and the role of patient choice, all of which bring into play features of clinicians and patients as situated individuals with particular backgrounds and experiences. EBM's enlightenment conception of the knower is also troubled by aspects of the way evidence is produced. Given these limitations, we argue that EBM should retain its reliabilist bent, but should look beyond formal research methodologies in identifying processes that yield reliable evidence for clinical practice. We suggest looking to feminist epistemology, with its focus on the standpoints of individual situated knowers, and the role of social context in determining what counts as knowledge. (shrink)

This paper sketches an account of public health ethics drawing upon established scholarship in feminist ethics. Health inequities are one of the central problems in public health ethics; a feminist approach leads us to examine not only the connections between gender, disadvantage, and health, but also the distribution of power in the processes of public health, from policy making through to programme delivery. The complexity of public health demands investigation using multiple perspectives and an attention to detail that is capable (...) of identifying the health issues that are important to women, and investigating ways to address these issues. Finally, a feminist account of public health ethics embraces rather than avoids the inescapable political dimensions of public health. (shrink)

Increasingly, policymakers within biomedicine argue that “non-financial” interests should be given equal scrutiny to individuals’ financial relationships with industry. Problematized as “non-financial conflicts of interest,” interests, ranging from intellectual commitments to personal beliefs, are managed through disclosure, restrictions on participation, and recusal where necessary. “Non-financial” interests, though vaguely and variably defined, are characterized as important influences on judgment and thus, are considered risks to scientific objectivity. This article explores the ways that “non-financial interests” have been constructed as an ethical problem (...) and the implications for research integrity. I conducted an interpretive, qualitative study, which triangulated two data sources: documents (including published accounts of identifying and managing “non-financial” interests and conflict of interest policies) and in-depth interviews with 16 leaders within evidence-based medicine, responsible for contributing to, directing, or overseeing conflict of interest policy development and implementation. This article outlines how evolutions in the definition of conflict of interest have opened the door to include myriad “non-financial” interests, resulting in the generalisation of a statistical concept—risk of bias—to social contexts. Consequently, biases appear equally pervasive among participants while in reality, a politics of objectivity is at play, with allegations of conflict of interest used as a means to undermine others’ credibility, or even participation. Iterations of the concept of conflict of interest within biomedicine have thus consistently failed to articulate or address questions of accountability including whose interests are able to dominate or distort evidence-led processes and why. Consequently, current policy solutions meant to mitigate bias may instead serve exclusionary purposes under the guise of impartiality while remaining vulnerable to interference from powerful stakeholders. (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)

It is clear that where a disease affects men and women differently, research on potential therapies or cures should include both men and women and should examine whether the therapy is effective and safe for both sexes. In this paper we consider whether there is an appropriate role for law in regulating to ensure an examination of these sex- and gender-specific aspects in health research. We consider the relative advantages and disadvantages of pursuing a regulatory approach to achieving gender equity (...) in the field of women’s health by exploring first, the meaning of gender equity, and second, the regulatory mechanisms that might be best suited to promoting the goal of gender equity. Within our examination of different regulatory forms and mechanisms, we also interrogate the shift from gender-neutral provisions relating to sex in favor of generalized notions of fairness that remove any specific consideration of sex. (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)