Angela Ballantyne

How to Do Research Fairly in an Unjust World

International research, sponsored by for-profit companies, is regularly criticised as unethical on the grounds that it exploits research subjects in developing countries. Many commentators agree that exploitation occurs when the benefits of cooperative activity are unfairly distributed between the parties. To determine whether international research is exploitative we therefore need an account of fair distribution. Procedural accounts of fair bargaining have been popular solutions to this problem, but I argue that they are insufficient to protect against exploitation. I argue instead that a maximin principle of fair distribution provides a more compelling normative account of fairness in relationships characterised by extreme vulnerability and inequality of bargaining potential between the parties. A global tax on international research would provide a mechanism for implementing the maximin account of fair benefits. This model has the capacity to ensure fair benefits and thereby prevent exploitation in international research.

Prenatal Diagnosis and Abortion for Congenital Abnormalities: Is It Ethical to Provide One Without the Other?

This target article considers the ethical implications of providing prenatal diagnosis (PND) and antenatal screening services to detect fetal abnormalities in jurisdictions that prohibit abortion for these conditions. This unusual health policy context is common in the Latin American region. Congenital conditions are often untreated or under-treated in developing countries due to limited health resources, leading many women/couples to prefer termination of affected pregnancies. Three potential harms derive from the provision of PND in the absence of legal and safe abortion for these conditions: psychological distress, unjust distribution of burdens between socio-economic classes, and financial burdens for families and society. We present Iran as a comparative case study where recognition of these ethical issues has led to the liberalization of abortion laws for fetuses with thalassemia. We argue that physicians, geneticists and policymakers have an ethical and professional duty of care to advocate for change in order to ameliorate these harms.

Towards a practical definition of professional behaviour

Context Professionalism remains a challenging part of the medical curriculum to define, teach and evaluate. We suggest that one way to meet these challenges is to clarify the definition of professionalism and distinguish this from medical ethics. Methods Our analysis is two staged. First, we reviewed influential definitions of professionalism and separated elements relating to (a) ethico-legal competencies, (b) clinical competence and (c) professionalism. In reference to professionalism, we then distinguished between aspirational virtues/values and specific behaviours. From these, we develop a working definition of medical professional behaviour consisting of six domains of behaviour: responsibility; relationships with and respect for patients; probity and honesty; self awareness and capacity for reflection; collaboration and team work; and care of colleagues. Second, we tested this working definition against empirical data concerning disciplinary action against practising doctors using (a) sources in the literature and (b) an original analysis of complaints received by the Medical Board of South Australia. Conclusion Our empirical analysis supports the relevance of four of the six potential domains: responsibility; relationships with and respect for patients; probity and honesty; self awareness and capacity for reflection. There are additional reasons for retaining ‘collaboration and team work’ in the medical professional behaviour curriculum but ‘care of colleagues’ may be better addressed in the ethico-legal curriculum. Our definition of professional behaviour is consistent with the theoretical literature, captures behaviours that predict future complaints against practitioners and is consistent with current complaints about professionalism in South Australian practitioners. This definition can further the teaching and assessing of professional behaviour in medical schools.

Exclusion of Women From Clinical Research: Myth or Reality?

OBJECTIVE To determine the proportion of male and female research participants and rates of sex-based analysis and sex-specific reporting in published Australian clinical research. PARTICIPANTS AND METHODS We assessed 400 clinical studies involving Australian-only participants, published in journals between January 1, 2003, and May 31, 2006 (100 per year). Numbers of male and female participants in each study and presence or absence of analysis by sex (covariate adjustment, subgroup analysis, or sex-specific reporting) were recorded. Sex-specific studies were evaluated to determine whether the exclusion of one sex was biologically necessary. RESULTS The total sample comprised 546,824 participants, of whom 73% were female; 36 studies were male-only, 78 were female-only. Of the participants in 286 studies that were not sex-specific, 56% were female. Of 114 sex-specific studies, the segregation by sex was deemed to be biologically necessary in 62%, ie, the research related directly to male or female biological function. More than one-quarter (28%) of studies with 30 participants or more published covariate adjustment or subgroup analysis by sex; 7% included sex-specific reporting of results. CONCLUSION We found no routine exclusion of women; however, few publications analyzed results by sex. Some studies excluded women or men for apparently arbitrary reasons. Research performed with male-only participants differed in nature and size from that performed with female-only participants. These data indicate the need to track the sex of research participants. In addition, they provide the basis for assessing appropriate inclusion of men and women in research and for comparing any relationship between different international regulatory models and the rates of female participation in research.

JUSTICE IN HEALTH RESEARCH: what is the role of evidence-based medicine?

Evidence-based medicine (EBM) aims to facilitate access to up-to-date, accurate information about the effectiveness of medical interventions, in order to improve human health. The quality of the research results available for EBM processes of synthesis and meta-analysis is critical to this process. If there are distortions or corruptions in the research process, EBM becomes a false prophet, collecting and propagating unreliable results. This article examines flaws in the current processes of research production and the implications of these for justice and for vulnerable patients, and explores possible solutions.

Pregnancy, Vulnerability, and the Risk of Exploitation in Clinical Research

Pregnant women and their foetuses have long been regarded as vulnerable, where being vulnerable indicates a likelihood of suffering harm. This perception has led to the widespread exclusion of pregnant women from clinical research, in order to protect foetuses and the women who carry them from any dangers associated with exposure to experimental therapeutic products or interventions. This chapter explores the ways in which pregnant women are vulnerable, and the potential risk of exploitation if pregnant women are enrolled in clinical research. There are three overlapping sources of vulnerability: inherent, situational, and pathogenic, and each of these may be dispositional (i.e. potential) or occurrent (i.e. requiring immediate action to limit harm). We argue that while pregnant women may experience one or more forms of vulnerability, in general they are not at risk of exploitation during research because they do not provide researchers with the opportunity to conduct more efficient research. We conclude with policy suggestions for conducting research with pregnant women that responds to vulnerability, promotes autonomy, and supports fair access to research participation. We focus on pregnancy registries, parental consent, and minimal risk research limits.

Patient awareness and concern regarding pharmaceutical manufacturer interactions with doctors.

Background:  The objective of the study was to determine the general public’s level of awareness of and degree of concern about the interactions between pharmaceutical manufacturers and doctors in Melbourne. This Internet was survey administered using Survey Monkey.

Gender and trust in medicine: Vulnerabilities, abuses, and remedies

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 hea...

Is sex-selective abortion morally justified and should it be prohibited?

In this paper we argue that sex-selective abortion (SSA) cannot be morally justified and that it should be prohibited. We present two main arguments against SSA. First, we present reasons why the decision for a woman to seek SSA in cultures with strong son-preference cannot be regarded as autonomous on either a narrow or a broad account of autonomy. Second, we identify serious harms associated with SSA including perpetuation of discrimination against women, disruption to social and familial networks, and increased violence against women. For these reasons, SSA should be prohibited by law, and such laws should be enforced. Finally, we describe additional strategies for decreasing son-preference. Some of these strategies rely upon highlighting the disadvantages of women becoming scarce, such as lack of brides and daughters-in-law to care for elderly parents. We should, however, be cautious not to perpetuate the view that the purpose of women is to be the consorts for, and carers of, men, and the providers of children. Arguments against SSA should be located within a concerted effort to ensure greater, deeper social and cultural equality between the sexes.

Sex bias in studies selected for clinical guidelines.

OBJECTIVE To determine the proportions of female participants in research studies selected to inform the development of national clinical guidelines and to assess these against the proportions of women affected by the conditions. METHODS We assessed 392 published articles, involving a total of 5.2 million participants, cited as references in five influential clinical guidelines addressing the use of antiarrhythmics, chronic fatigue, depression, diabetes, and colorectal cancer. For each article, we extracted the number of female participants to determine any discrepancies in the sex of participants and if the proportion of female participants as research subjects reflected the sex distribution of patients affected by the condition. RESULTS The overall and median percentages (per study) of females per guideline were: use of antiarrhythmics (35%, median 38%), chronic fatigue (70%, median 73%), colorectal cancer (67%, median 46%), depression (66%, median 66%), and diabetes (63%, median 50%). The baseline prevalence rates used for comparison purposes were (percentage female): antiarrhythmics (60% of patients 75(+) years); chronic fatigue (66%), colorectal cancer (46%), depression (66%), and diabetes (46%). CONCLUSIONS The colorectal cancer, depression, and chronic fatigue guidelines were based on research populations that accurately reflected the sex distribution of the condition in the general population. Women were slightly overrepresented in the research studies supporting the diabetes guidelines and were significantly underrepresented in the research studies supporting the guidelines on the use of antiarrhythmics. Guideline developers should be aware of and comment on the potential impact of sex. Where the evidence base is lacking, guideline developers should highlight this and, where necessary, limit their specific conclusions to populations on whom the research was performed.