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  • Dr Bridget Haire is a research fellow at the Kirby Institute, where she conducts research in the areas of research ... moreedit
One sunny Friday afternoon in the early 90s I was on a tram going from St Kilda Road to the city. A tall gaudily dressed transgender woman on the opposite seat was on the nod, peaceful enough, occasionally opening a single eye, and... more
One sunny Friday afternoon in the early 90s I was on a tram going from St Kilda Road to the city. A tall gaudily dressed transgender woman on the opposite seat was on the nod, peaceful enough, occasionally opening a single eye, and clutching a small overstuffed handbag. She reminded me overpoweringly of my mother, also tall and thin, who was at that time ensconced in a hospital bed, frequently on the nod, with sly witty expressions passing across her face as the morphine floated through her.
The ethical conduct of HIV prevention researchers is subject to scrutiny. Many clinical trials take place in low and middle income countries where HIV incidence is high, but the benefits of research are often first enjoyed in high income... more
The ethical conduct of HIV prevention researchers is subject to scrutiny. Many clinical trials take place in low and middle income countries where HIV incidence is high, but the benefits of research are often first enjoyed in high income countries. The provision of ancillary care--medical care provided to clinical trial participants during a trial, which is not related to the research question--is one way in which trial participants can receive direct benefits from their participation in research. We argue that such care is a legitimate benefit of research participation. This care does not constitute 'undue inducement' if the research study itself involves minimal risk and is subject to ethical and regulatory oversight. We also argue that research teams working with populations who have sub-optimal healthcare access have a duty to provide ancillary care within agreed limits. These limits should be negotiated to ensure that the research remains feasible and economically viable.
In his article ‘The Ebola Clinical Trials: a precedent for research ethics in disasters’, Philippe Calain constructs a compelling case as to why and how experiences from the recent Ebola epidemic should be used to develop a framework for... more
In his article ‘The Ebola Clinical Trials: a precedent for research ethics in disasters’, Philippe Calain constructs a compelling case as to why and how experiences from the recent Ebola epidemic should be used to develop a framework for disaster research ethics. In particular, Calain proposes a useful model for assessing whether or not an unproven intervention could be suitable for human use in a disaster context, and makes a powerful argument against the separation of patient care from research goals. In this commentary, I argue that the separation of patient care goals from research goals is also unhelpful in the context of other forms of participant disadvantage even when that disadvantage is less severe than an ongoing public health emergency. I contend that recognising that research in disadvantaged populations is an intervention that could and should aim to produce positive outcomes for participants, just as it should in disaster contexts, therefore seems a well-justified lesson that can be extrapolated from the experience of the Ebola epidemic.
HIV pre-exposure prophylaxis (PrEP) can alleviate anxiety about acquiring HIV, particularly for gay men and other men who have sex with men. However, research with PrEP providers has rarely examined HIV anxiety. We conducted 25... more
HIV pre-exposure prophylaxis (PrEP) can alleviate anxiety about acquiring HIV, particularly for gay men and other men who have sex with men. However, research with PrEP providers has rarely examined HIV anxiety. We conducted 25 semistructured interviews in 2019-2020 with PrEP providers in New South Wales and Western Australia, and analyzed data thematically. Participants included general practitioners and sexual health nurses and doctors. Our analysis explores providers' views on providing PrEP to reduce HIV anxiety for gay men, serodiscordant couples where the partner with HIV has an undetectable viral load, and for “worried well” individuals who the providers speculated might have undisclosed risk. Although providers viewed PrEP as beneficial for many people's personal lives and relationships, they felt cautious about prescribing PrEP solely for HIV anxiety, while at the same time reporting that they prescribed PrEP if individuals insisted on it and had no medical contraindications.
BackgroundReliable estimates of the population proportion eligible to donate blood are needed by blood collection agencies to model the likely impact of changes in eligibility criteria and inform targeted population‐level education,... more
BackgroundReliable estimates of the population proportion eligible to donate blood are needed by blood collection agencies to model the likely impact of changes in eligibility criteria and inform targeted population‐level education, recruitment, and retention strategies. In Australia, the sole estimate was calculated 10+ years ago. With several subsequent changes to the eligibility criteria, an updated estimate is required.Study Design and MethodsWe conducted a cross‐sectional national population survey to estimate eligibility for blood donation. Respondents were aged 18+ and resident in Australia. Results were weighted to obtain a representative sample of the population.ResultsEstimated population prevalence of blood donation eligibility for those aged 18–74 was 57.3% (95% CI 55.3–59.3). The remaining 42.7% (95% CI 40.7–44.7) were either temporarily (25.3%, 95% CI 23.5–27.2) or permanently ineligible (17.4%, 95% CI 16.1–18.9). Of those eligible at the time of the survey, that is, with the UK geographic deferral for variant Creutzfeldt‐Jakob disease included, (52.9%, 95% CI 50.8–54.9), 14.2% (95% CI 12.3–16.3) reported donating blood within the previous 2 years. Eligibility was higher among men (62.6%, 95% CI 59.6–65.6) than women (52.8%, 95% CI 50.1–55.6). The most common exclusion factor was iron deficiency/anemia within the last 6 months; 3.8% (95% CI 3.2–4.6) of the sample were ineligible due to this factor alone.DiscussionWe estimate that approximately 10.5 million people (57.3% of 18–74‐year‐olds) are eligible to donate blood in Australia. Only 14.2% of those eligible at the time of survey reported donating blood within the previous 2 years, indicating a large untapped pool of potentially eligible blood donors.
In many countries around the world, people who inject drugs remain at high risk of HIV acquisition not because effective forms of prevention are unknown, nor because they find effective prevention undesirable, but because those in charge,... more
In many countries around the world, people who inject drugs remain at high risk of HIV acquisition not because effective forms of prevention are unknown, nor because they find effective prevention undesirable, but because those in charge, mainly politicians but also bureaucrats, find evidence-based practice politically unacceptable. The evidence for preventive efficacy of harm reduction strategies, most prominently needle and syringe programmes (sometimes called ‘needle exchange programmes’) but also treatment programmes such as opiate substitution, is irrefutable.1 However, political responses to drug use issues are varied and complex, so the will to implement appropriate harm reduction programmes in the interests of public health remains lacking in too many jurisdictions. As a consequence, the discussion of how best, in the context of research, to reduce HIV incidence in populations of people who inject drugs but are not offered comprehensive access to known prevention strategies is—tragically—an important one. Dawson et al 2 focus on access to sterile injecting equipment and recognise that this should remain the ‘default’ standard of prevention for HIV prevention trials involving people for whom injecting drug use is the primary risk factor for HIV acquisition. ‘Standard of prevention’ means the background or minimal HIV risk reduction interventions offered to all participants in a trial, regardless of what other investigational interventions they are assigned to receive. The standard of prevention concept is grounded in the ethical principle of beneficence—that researchers and sponsors are obliged to maximise benefits and minimise risks to participants in research studies.3 …
In clinical research there is a tension between the role of a doctor, who must serve the best interests of the patient, and the role of the researcher, who must produce knowledge that may not have any immediate benefits for the research... more
In clinical research there is a tension between the role of a doctor, who must serve the best interests of the patient, and the role of the researcher, who must produce knowledge that may not have any immediate benefits for the research participant. This tension is exacerbated in HIV research in low and middle income countries, which frequently uncovers comorbidities other than the condition under study. Some bioethicists argue that as the goals of medicine and those of research are distinct, it is a mistake for researchers to assume therapeutic responsibilities while engaging in research. Others propose that there is a duty of care, but disagree as to how this is limited and specified. In this qualitative study, principal investigators from HIV prevention trials discuss their experience of providing medical benefits to participants within the context of conducting research into HIV biomedical prevention technologies. They describe the limitations imposed at times by funders and at times by infrastructure constraints, and canvass the importance of ancillary care provision and capacity building in trial communities. The views of the principal investigators are compatible with the perspective that there is a duty of care, limited by the nature of the research, the depth of the relationship between research and participant, and the capacity of the research site. The therapeutic orientation in HIV prevention trial appears to be indivisible from competent research practise by making concrete and appropriate benefits available to trial participants and their communities that support rather than compete with local infrastructure.
Published data show that new HIV prevention strategies including treatment‐as‐prevention and pre‐exposure prophylaxis (PrEP) using oral antiretroviral drugs (ARVs) are highly, but not completely, effective if regimens are taken as... more
Published data show that new HIV prevention strategies including treatment‐as‐prevention and pre‐exposure prophylaxis (PrEP) using oral antiretroviral drugs (ARVs) are highly, but not completely, effective if regimens are taken as directed. Consequently, their implementation may challenge norms around HIV prevention. Specific concerns include the potential for ARV‐based prevention to reframe responsibility, erode beneficial sexual norms and waste resources. This paper explores what rights claims uninfected people can make for access to ARVs for prevention, and whether moral claims justify the provision of ARV therapy to those who do not yet clinically require treatment as a way of reducing HIV transmission risk. An ethical analysis was conducted of the two strategies, PrEP and treatment‐as‐prevention, using a public health stewardship model developed by the Nuffield Bioethics Council to consider and compare the application of PrEP and treatment‐as‐prevention strategies. We found that treating the person with HIV rather than the uninfected person offers advantages in settings where there are limited opportunities to access care. A treatment‐as‐prevention strategy that places all the emphasis upon the positive person's adherence however carries a disproportionate burden of responsibility. PrEP remains an important option for receptive partners who face increased biological vulnerability. We conclude that the use of ARV for prevention is ethically justified, despite imperfect global to drugs for those in clinical need. The determination of which ARV‐based HIV prevention strategy is ethically preferable is complex and must take into account both public health and interpersonal considerations.
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Holland reported being a consultant for The Medicines Co, Affinium Pharmaceuticals Inc, and... more
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Holland reported being a consultant for The Medicines Co, Affinium Pharmaceuticals Inc, and Forest/Cerexa. Dr Fowler reported receiving grants from the National Institutes of Health, MedImmune, Forest/Cerexa, Pfizer, Merck, Advanced Liquid Logics, Theravance, Novartis, and Cubist; serving as chair of the scientific advisory board for V710 Staphylococcus aureus vaccine for Merck; being a consultant for Pfizer, Novartis, Galderma, Novadigm, Durata, Debiopharm, Genentech, Achaogen, Affinium, Medicines Co, Cerexa, Tetraophase, Trius, MedImmune, Bayer, Theravance, and Cubist; having a patent from NCGR; receiving royalties from UpToDate; and receiving payment for educational presentations from Cubist, Cerexa, Durata, and Theravance.
In their recent paper' Undue inducement: a case study in CAPRISA 008', Mngadi et al conclude that a participant in an HIV prevention study who deliberately... more
In their recent paper' Undue inducement: a case study in CAPRISA 008', Mngadi et al conclude that a participant in an HIV prevention study who deliberately concealed her pregnancy was not'unduly induced' to participate by the offer of an experimental product. This paper argues that while the authors' conclusion is sound, the framing of this case study is consistent with the preoccupation in research ethics with the concept of undue inducement, coupled with a highly risk-averse attitude to pregnancy (regardless of whether those risks may be willingly assumed by pregnant women themselves). We suggest that the critical research ethics question raised by Mngadi et al's case study is not 'undue inducement', but the exclusion of pregnant women from research studies where the risks are acceptable to the potential participant, and benefits likely. We also suggest that current regulatory paradigms regarding pregnancy are both overly paternalistic and value the fetus over the mother. In order to ensure timely provision of new HIV prevention agents, we argue that there is a need for expeditious testing of proven effective agents in pregnancy, with due consideration given to situations where preliminary efficacy data exist but fall short of licensure standards. This requires a paradigm shift from researchers, funders, regulators and ethical review bodies towards practices that critically examine the legitimacy of the exclusion of pregnant women on a study-by-study basis.
Nigerian research ethics committees are charged with the responsibility to monitor ongoing research to ensure compliance with ethical standards. Recent evidence from qualitative studies on research conduct however, indicate that many... more
Nigerian research ethics committees are charged with the responsibility to monitor ongoing research to ensure compliance with ethical standards. Recent evidence from qualitative studies on research conduct however, indicate that many research studies fail to implement their protocols as written, and that this is not reported due to a failure of comprehensive monitoring. As Nigeria is in many respects a highly suitable country in which to conduct HIV biomedical prevention research, we argue there is a need to reprioritise the strengthening of the monitoring capacity of ethics committees so that such vital and ethically complex research can be conducted with confidence. We identify the need for (i) improved resourcing and training of ethics committee members, and (ii) comprehensive planning of research monitoring as part of the ethics committee protocol review process. We also highlight the significance of community collaboration and the establishment of a central pool of national monitors, as essential components for reinvigorating monitoring capacity.
The devastating toll of the Ebola epidemic in West Africa necessitates considerations of new approaches to research into new prevention technologies and treatments for Ebola Virus Disease (EVD). Research must be planned and delivered in... more
The devastating toll of the Ebola epidemic in West Africa necessitates considerations of new approaches to research into new prevention technologies and treatments for Ebola Virus Disease (EVD). Research must be planned and delivered in consultation with civil society from the epicentre to prevent mistrust and misunderstanding. Ethical considerations include development of local research and regulatory capacity; negotiating the standard of prevention packages for research participants, including healthcare workers; and strengthening health systems in developing countries to ensure effective response to future EVD outbreaks in the region. Also, strategic consultation with local communities is an ethical imperative for EVD research, particularly where there is potential for differential access to prevention and care packages between trial staff and local hospital staff.

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