60 research outputs found

    The challenges and opportunities of conducting a clinical trial in a low resource setting: The case of the Cameroon mobile phone SMS (CAMPS) trial, an investigator initiated trial

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    Conducting clinical trials in developing countries often presents significant ethical, organisational, cultural and infrastructural challenges to researchers, pharmaceutical companies, sponsors and regulatory bodies. Globally, these regions are under-represented in research, yet this population stands to gain more from research in these settings as the burdens on health are greater than those in developed resourceful countries. However, developing countries also offer an attractive setting for clinical trials because they often have larger treatment naive populations with higher incidence rates of disease and more advanced stages. These factors can present a reduction in costs and time required to recruit patients. So, balance needs to be found where research can be encouraged and supported in order to bring maximum public health benefits to these communities. The difficulties with such trials arise from problems with obtaining valid informed consent, ethical compensation mechanisms for extremely poor populations, poor health infrastructure and considerable socio-economic and cultural divides. Ethical concerns with trials in developing countries have received attention, even though many other non-ethical issues may arise. Local investigator initiated trials also face a variety of difficulties that have not been adequately reported in literature. This paper uses the example of the Cameroon Mobile Phone SMS trial to describe in detail, the specific difficulties encountered in an investigator-initiated trial in a developing country. It highlights administrative, ethical, financial and staff related issues, proposes solutions and gives a list of additional documentation to ease the organisational process

    Media reporting of tenofovir trials in Cambodia and Cameroon

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    BACKGROUND: Two planned trials of pre-exposure prophylaxis tenofovir in Cambodia and Cameroon to prevent HIV infection in high-risk populations were closed due to activist pressure on host country governments. The international news media contributed substantially as the primary source of knowledge transfer regarding the trials. We aimed to characterize the nature of reporting, specifically focusing on the issues identified by media reports regarding each trial. METHODS: With the aid of an information specialist, we searched 3 electronic media databases, 5 electronic medical databases and extensively searched the Internet. In addition we contacted stakeholder groups. We included media reports addressing the trial closures, the reasons for the trial closures, and who was interviewed. We extracted data using content analysis independently, in duplicate. RESULTS: We included 24 reports on the Cambodian trial closure and 13 reports on the Cameroon trial closure. One academic news account incorrectly reported that it was an HIV vaccine trial that closed early. The primary reasons cited for the Cambodian trial closure were: a lack of medical insurance for trial related injuries (71%); human rights considerations (71%); study protocol concerns (46%); general suspicions regarding trial location (37%) and inadequate prevention counseling (29%). The primary reasons cited for the Cameroon trial closure were: inadequate access to care for seroconverters (69%); participants not sufficiently informed of risks (69%); inadequate number of staff (46%); participants being exploited (46%) and an unethical study design (38%). Only 3/23 (13%) reports acknowledged interviewing research personnel regarding the Cambodian trial, while 4/13 (30.8%) reports interviewed researchers involved in the Cameroon trial. CONCLUSION: Our review indicates that the issues addressed and validity of the media reports of these trials is highly variable. Given the potential impact of the media in formulation of health policy related to HIV, efforts are needed to effectively engage the media during periods of controversy in the HIV/AIDS epidemic

    Professional responsibilities of biomedical scientists in public discourse

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    This article describes how a small but vocal group of biomedical scientists propagates the views that either HIV is not the cause of AIDS, or that it does not exist at all. When these views were rejected by mainstream science, this group took its views and arguments into the public domain, actively campaigning via newspapers, radio, and television to make its views known to the lay public. I describe some of the harmful consequences of the group's activities, and ask two distinct ethical questions: what moral obligations do scientists who hold such minority views have with regard to a scientifically untrained lay audience, and what moral obligations do mainstream newspapers and government politicians have when it comes to such views. The latter question will be asked because the "dissidents" succeeded for a number of years in convincing the South African government of the soundness of their views. The consequences of their stance affected millions of HIV infected South Africans severely

    The standard of care debate: against the myth of an "international consensus opinion"

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    It is argued by Lie et al in the current issue of the Journal of Medical Ethics that an international consensus opinion has formed on the issue of standards of care in clinical trials undertaken in developing countries. This opinion, so they argue, rejects the Declaration of Helsinki's traditional view on this matter. They propose furthermore that the Declaration of Helsinki has lost its moral authority in the controversy in research ethics. Although the latter conclusion is supported by this author, it will be demonstrated in this paper that there is not such a thing as an international consensus opinion, and that the authorities used by Lie et al as evidence in support of their claim should not be relied upon as authorities or final arbiters in this debate. Furthermore, it will be shown that arguments advanced substantively to show that lower standards of care are ethically acceptable in the developing world, conflate scientific with economic reasons, and ultimately fail to bolster the case they are designed to support

    Conscientious objection and compromising the patient: Response to Hughes

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    Hughes offers a consequentialist response to our rejection of accommodation of conscientious objection in medicine. We argue here that his compromise proposition has been tried in many jurisdictions and has failed to deliver unimpeded access to care for eligible patients. The compromise position, entailing an accommodation of conscientious objection provided there is unimpeded access, fails to grasp that the objectors are both determined not to provide services they object to as well as to subvert patient access to the objected to services. Unpredictable future developments in drug RandD and resulting treatment and prevention options in medicine make the compromise position unrealistic

    ETHICS IN BIOETHICS

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    Doctors have no right to refuse medical assistance in dying, abortion or contraception

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    In an article in this journal, Christopher Cowley argues that we have 'misunderstood the special nature of medicine, and have misunderstood the motivations of the conscientious objectors'. We have not. It is Cowley who has misunderstood the role of personal values in the profession of medicine. We argue that there should be better protections for patients from doctors' personal values and there should be more severe restrictions on the right to conscientious objection, particularly in relation to assisted dying. We argue that eligible patients could be guaranteed access to medical services that are subject to conscientious objections by: (1) removing a right to conscientious objection; (2) selecting candidates into relevant medical specialities or general practice who do not have objections; (3) demonopolizing the provision of these services away from the medical profession
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