Despite recent advances in ways to prevent transmission of HIV from a mother to her child during pregnancy, infants continue to be born and become infected with HIV, particularly in southern Africa where HIV prevalence is the highest in the world. In this region, emphasis has shifted from voluntary HIV counselling and testing to routine testing of women during pregnancy. There have also been proposals for mandatory testing. Could mandatory testing ever be an option, even in (...) high-prevalence settings? Many previous examinations of mandatory testing have dealt with it in the context of low HIV prevalence and a well-resourced health care system. In this discussion, different assumptions are made. Within this context, where mandatory testing may be a strategy of last resort, the objections to it are reviewed. Special attention is paid in the discussion to the entrenched vulnerability of women in much of southern Africa and how this contributes to both HIV prevalence and ongoing challenges for preventing HIV transmission during pregnancy. While mandatory testing is ethically plausible, particularly when coupled with guaranteed access to treatment and care, the discussion argues that the moment to employ this strategy has not yet come. Many barriers remain for pregnant women in terms of access to testing, treatment and care, most acutely in the southern African setting, despite the presence of national and international human rights instruments aimed at empowering women and removing such barriers. While this situation persists, mandatory HIV testing during pregnancy cannot be justified. (shrink)

Despite recent advances in ways to prevent transmission of HIV from a mother to her child during pregnancy, infants continue to be born and become infected with HIV, particularly in southern Africa where HIV prevalence is the highest in the world. In this region, emphasis has shifted from voluntary HIV counselling and testing to routine testing of women during pregnancy. There have also been proposals for mandatory testing. Could mandatory testing ever be an option, even in (...) high‐prevalence settings? Many previous examinations of mandatory testing have dealt with it in the context of low HIV prevalence and a well‐resourced health care system. In this discussion, different assumptions are made. Within this context, where mandatory testing may be a strategy of last resort, the objections to it are reviewed. Special attention is paid in the discussion to the entrenched vulnerability of women in much of southern Africa and how this contributes to both HIV prevalence and ongoing challenges for preventing HIV transmission during pregnancy. While mandatory testing is ethically plausible, particularly when coupled with guaranteed access to treatment and care, the discussion argues that the moment to employ this strategy has not yet come. Many barriers remain for pregnant women in terms of access to testing, treatment and care, most acutely in the southern African setting, despite the presence of national and international human rights instruments aimed at empowering women and removing such barriers. While this situation persists, mandatory HIV testing during pregnancy cannot be justified. (shrink)

: The Centers for Disease Control and Prevention (CDC) has recommended that HIV testing be routinely offered to certain patients in hospitals with a high prevalence of HIV infection and on all pregnant women. The CDC does not, however, offer implementation level guidelines for obtaining informed consent. We provide a moral justification for requiring informed consent for HIV testing and propose guidelines for securing such consent. In particular we argue that genuine informed consent can be secured without elaborate (...) counseling, such as that currently used at Counseling and Testing Sites, provided that sufficient written notice is given to the patients before testing and that they are specifically asked for permission. (shrink)

In recent times, informed consent has been adopted worldwide as a cornerstone to ensure autonomy during HIV testing. However, there are still ongoing debates on whether the edifice on which informed consent requirements are grounded, that is, personal autonomy, is philosophically, morally, and practically sound, especially in countries where HIV is an epidemic and/or may have a different ontological perspective or lived reality. This study explores the views of participants from Zambia. In-depth and focus group discussions were conducted at (...) various locations in Lusaka and Chongwe, Zambia. Participants came from various demographics, including people living with HIV, healthcare professionals and workers, policymakers, pregnant women, churchgoers, teachers, rural-based persons, and police officers. Data were manually analysed by conducting inductive and deductive thematic analyses. Results show that participants were not in favour of HIV policies that promote personal autonomy at the expense of pursuit of the common good. Participants viewed interdependence, not autonomy, as an essential characteristic of being human. The participants’ views have a realistic potential to provide a contextual and appropriate ethical, respectful, and realistic foundation for HIV testing policies. (shrink)

Recent global advances in available technology to prevent mother-to-child HIV transmission necessitate a rethinking of contemporary and previous ethical debates on HIV testing as a means to preventing vertical transmission. In this paper, we will provide an ethical analysis of HIV-testing strategies of pregnant women. First, we argue that provider-initiated opt-out HIV testing seems to be the most effective HIV test strategy. The flip-side of an opt-out strategy is that it may end up as involuntary testing (...) in a clinical setting. We analyse this ethical puzzle from a novel perspective, taking into account the moral importance of certain hypothetical preferences of the child, as well as the moral importance of certain actual preferences of the mother. Finally, we balance the conflicting concerns and try to arrive at an ethically sound solution to this dilemma. Our aim is to introduce a novel perspective from which to analyse testing strategies, and to explore the implications and possible benefits of our proposal. The conclusion from our analysis is that policies that recommend provider-initiated opt-out HIV testing of pregnant mothers, with a risk of becoming involuntary testing in a clinical setting, are acceptable. The rationale behind this is that the increased availability of very effective and inexpensive life-saving drugs makes the ethical problems raised by the possible intrusiveness of HIV testing less important than the child's hypothetical preferences to be born healthy. Health care providers, therefore, have a duty to offer both opt-out HIV testing and available PMTCT (preventing mother-to-child transmission) interventions. (shrink)

People should be allowed to decide how and where they wish to be tested for HIV without there being a formal requirement for pretest counsellingIn his paper, Ethics of HIV testing in general practice without informed consent, Fraser argues that pretest counselling and informed consent are pillars of the ethical conduct of HIV testing. In my response I want to look critically at these contentions. While I will agree with Fraser that it is always necessary to get informed (...) consent from a patient for an HIV test I will argue that an emphasis on pretest counselling as a prerequisite for testing can actually undermine a patient’s autonomy, the very principle that informed consent seeks to promote.This response will start with an analysis of Case Two as this highlights the fundamental importance of informed consent. It will then go on to look at Case One and show how the special application of informed consent in the field of HIV testing can, in certain circumstances, lead to a reduction in patient autonomy.CASE TWOIn Fraser’s second case a 43 year old married clergyman presented with a recurrent infection of his little toe and the preliminary lab reports queried Kaposi’s sarcoma. The general practitioner thought that because of the patient’s lifestyle there was little risk of HIV infection, “suggesting the possibility of HIV, when it is unexpected and the risk low, can in itself cause anxiety and distress”. On these grounds the GP did not call the patient in for an HIV test.Some might argue that the GP should have tested the clergyman. This could have been done in one of two ways: by seeking his explicit consent for an HIV test, or by getting blanket consent for a range of tests, including HIV, without HIV being explicitly mentioned. …. (shrink)

The concept of “moral equivocation” may be defined in the context of an ethical framework for moral judgment. This framework comprises two universal principles of right: the Dependency Principle, found in Plato's Republic, and the Democracy Principle. Moral equivocation is evident in a violation of either of these two principles. At the cultural level, coping with moral equivocation often requires moral compromise, as is evident in applying the Dependency-Democracy Principles Ethical Framework to the issue of HIV testing for pregnant (...) women. (shrink)

Objective: To explore the accounts and perspectives of junior doctors who were offered an HIV test by their employing National Health Service (NHS) trust and discuss ethical issues posed by this new policy. Design: Qualitative in-depth interview study. Setting: 4 NHS hospital trusts. Participants: 24 junior doctors who had been offered an HIV test as part of their pre-employment occupational health checks. Results: The manner in which HIV tests were offered to junior doctors varied both between and within the NHS (...) trusts. Overall, the doctors were highly critical of the way the HIV test was offered. Recurrent themes surrounding a lack of discussion and information regarding the indications for the test and implications of a positive result influenced the the doctors’ perception of their experiences. As a consequence of the shortcomings of how the test was offered, most of the doctors held the misperception that HIV testing was mandatory and many felt unable to decline the test. The majority of doctors referred to patient protection as adequate justification for being offered an HIV test. Conclusions: Junior doctors offered an HIV test under new Department of Health occupational health guidance were disparaging about how the test was offered. The findings of this study affect thousands of junior doctors in the UK, and the impact of these results is extensive. Participants’ suggestions regarding how the process of offering an HIV test can be improved are discussed and ethical issues regarding the new Department of Health policy are highlighted. (shrink)

© 2014 Taylor Francis. The Centers for Disease Control and Prevention recommends routine human immunodeficiency virus testing of every client presenting for services in venues where HIV prevalence is high. Because older adults have particularly poor prognosis if they receive their diagnosis late in the course of HIV disease, any screening provided to younger adults in these venues should also be provided to older adults. We examined aging-related disparities in recent and ever HIV testing in a probability sample (...) of at-risk adults seeking services in needle exchange sites, sexually transmitted disease clinics, and Latino community clinics that provide HIV testing. Using multiple logistic regression with generalized estimating equations, we estimated associations between age category and each HIV testing outcome. Even after controlling for covariates such as recent injection drug use, older adults had 40% lower odds than younger adults did of having tested in the past 12 months or ever. Aging-related disparities in HIV testing exist among clients of these high HIV prevalence venues and may contribute to known aging-related disparities in late diagnosis of HIV infection and poor long-term prognosis. (shrink)

This paper considers the ethics of routine antenatal HIV testing and the role of informed consent within such a policy in order to decide how we should proceed in this area—a decision that ultimately rests on the relative importance we give to public health goals on the one hand and respect for individual autonomy on the other.A recent illuminating qualitative study by Zulueta and Boulton1 explores the practicalities of informed consent in routine antenatal HIV testing. Its results support (...) what I have argued1 is inevitable with routine testing policies of this kind: that routine antenatal testing regimes are incompatible with requirements for informed consent. It has become clear that intervention could reduce the risk of transmitting HIV from mother to child from 15–20%2 to around 8%,3 or possibly as low as 2%.4,5 The evidence of this possibility produced a general trend towards introducing routine antenatal HIV screening in developed countries worldwide.6,7,8,9,10 The aim was to dramatically reduce the rate of HIV transmission from mother to child by encouraging universal antenatal HIV testing. The UK has been no exception, and in 1999 the government instructed health authorities to implement a policy of offering and recommending an HIV test to all pregnant women.11This UK antenatal screening policy and others like it, although well-meaning, are problematic in their formulation. In order to reflect contemporary ethical and legal practice, such policies attempt to marry the public health aims of maximising uptake of testing with a commitment to respect the choices of patients by requiring informed consent before they participate in screening. Thus, in the case of UK policy, health professionals are instructed to recommend the HIV test to all pregnant women in order to achieve the target of a 90% …. (shrink)

In the context of deceased organ donation, donors are routinely tested for HIV, to check for suitability for organ donation. This article examines whether a donor’s HIV status should be disclosed to the donor’s next of kin.On the one hand, confidentiality requires that sensitive information not be disclosed, and a duty to respect confidentiality may persist after death. On the other hand, breaching confidentiality may benefit third parties at risk of having been infected by the organ donor, as it may (...) permit them to be tested for HIV and seek treatment in case of positive results.We conclude that the duty to warn third parties surpasses the duty to respect confidentiality. However, in order to minimize risks linked to the breach of confidentiality, information should be restrained to only concerned third parties, that is, those susceptible to having been infected by the donor. (shrink)

This case series presents two general practice cases where HIV testing occurred, or results suggestive of HIV were received, before informed consent was obtained. Bioethical and professional principles are used to explore these dilemmas.

This article examines the home rapid HIV test as a new practice of US biocitizenship. Via an analysis of discourse surrounding self-diagnostics, I conclude that while home HIV tests appear to expand consumer rights, they are in fact the vanguard of a new form of self-testing that carries a moral urgency to protect one’s own body and to manage societal risk. In addition, these tests extend biomedical authority into the private domain, while appearing to do the exact opposite. Furthermore, (...) access to these tests may be stratified, contradicting the intent expressed by the manufacturer to reach populations in need of it most and reinforcing stigma against them. Lastly, diagnostics such as the rapid home HIV test represent new obligations for surveillance of one’s own health and that of others. The new public health effort to test the population at large has given rise to a new ‘risky’ population: the untested bodies. (shrink)

Despite decades of prevention efforts, millions of persons worldwide continue to become infected by the human immunodeficiency virus (HIV) every year. This urgent problem of global epidemic control has recently lead to significant changes in HIV testing policies. Provider-initiated approaches to HIV testing have been embraced by the Centers for Disease Control and Prevention and the World Health Organization, such as those that routinely inform persons that they will be tested for HIV unless they explicitly refuse ('opt out'). (...) While these policies appear to increase uptake of testing, they raise a number of ethical concerns that have been debated in journals and at international AIDS conferences. However, one special form of 'provider-initiated' testing is being practiced and promoted in various parts of the world, and has advocates within international health agencies, but has received little attention in the bioethical literature: mandatory premarital HIV testing. This article analyses some of the key ethical issues related to mandatory premarital HIV testing in resource-poor settings with generalized HIV epidemics. We will first briefly mention some mandatory HIV premarital testing proposals, policies and practices worldwide, and offer a number of conceptual and factual distinctions to help distinguish different types of mandatory testing policies. Using premarital testing in Goma (Democratic Republic of Congo) as a point of departure, we will use influential public health ethics principles to evaluate different forms of mandatory testing. We conclude by making concrete recommendations concerning the place of mandatory premarital testing in the struggle against HIV/AIDS. (shrink)

This qualitative cross-sectional survey, undertaken in the antenatal booking clinics of a hospital in central London, explores pregnant women’s responses to routine HIV testing, examines their reasons for declining or accepting the test, and assesses how far their responses fulfil standard criteria for informed consent. Of the 32 women interviewed, only 10 participants were prepared for HIV testing at their booking interview. None of the women viewed themselves as being particularly at risk for HIV infection. The minority of (...) the participants who declined testing differed from those who accepted, by interpreting test acceptance as risky behaviour, privileging the negative outcomes of HIV positivity and expressing an inability to cope with these, should they occur. Troublingly, only a minority of women had a broad understanding of the rationale for the test, and none fulfilled the standard criteria for informed consent. This study suggests that, although routine screening combined with professional recommendation may be successful in increasing uptake, this may be at the cost of eroding informed consent. Protecting third parties from a preventable disease may outweigh the moral duty of respecting autonomy, enshrined in Western bioethical tradition. Nevertheless, such a policy should be made transparent, debated in the public domain and negotiated with women seeking antenatal care. (shrink)

Routine testing is a practice whereby medical professionals ask all patients whether they would like an HIV test, regardless of whether there is anything unique to a given patient that suggests the presence of HIV. In three respects I aim to offer a fresh perspective on the debate about whether a developing country with a high rate of HIV infection morally ought to adopt routine testing. First, I present a neat framework that organises the moral issues at stake, (...) bringing out the basic principles involved and exhibiting their logical relationships. Second, appealing to the Kantian principle of respect for the dignity of persons, I offer a thorough justification for routine testing when it serves as a gateway to anti-retroviral treatment (ART). Third, I present a respect-based defence of the controversial and novel thesis that routine testing is morally justified even if ART is unaffordable or otherwise unavailable. (shrink)

The aim of this study was to assess the attitudes of Turkish pregnant women and antenatal health care providers towards prenatal HIV testing. A self-administered questionnaire was used. The relationships between the different groups' knowledge and attitudes were analysed by using the chi-squared statistic. A total of 494 pregnant women and 181 care providers participated. Forty-four per cent of the pregnant women thought that prenatal HIV testing should be mandatory, and 84% of the health care providers thought it (...) should be performed routinely or be mandatory. The majority of the pregnant women (74%) and half of the care providers agreed that the test results should be disclosed first to the pregnant woman. The study results also revealed that most of the prenatal care providers would not protect pregnant women's autonomy and privacy, contrary to the pregnant women's own preferences. It is essential to establish national prenatal HIV testing policies in order to prevent unethical practices and ensure satisfaction for pregnant women and health care providers. (shrink)

As the HIV epidemic continues to grow worldwide, women are increasingly and disproportionally affected. With the introduction of anti-retroviral medications that have been found to effectively prevent perinatal transmission of HIV, the approach to HIV testing in pregnant women has grown increasingly more controversial. In recent years, the model of voluntary counseling and testing (VCT) has come into question with opt-out testing now advocated for by the Centers for Disease Control and occurring widely in pregnancy. The benefits (...) of opt-out testing are numerous and may justify its use in replacing the VCT that many have come to see as insufficient. An ethical analysis of opt-out testing suggests it may be at odds with true informed consent and involve a degree of coercion that would not be allowed outside the prenatal setting. If opt-out testing is going to remain the standard of care then the ethical issues it raises must be made transparent. Strategies need to be designed for ensuring that HIV counseling and testing in pregnancy is done in accordance with ethical and reproductive rights principles. (shrink)

Despite decades of prevention efforts, millions of persons worldwide continue to become infected by the human immunodeficiency virus (HIV) every year. This urgent problem of global epidemic control has recently lead to significant changes in HIV testing policies. Provider‐initiated approaches to HIV testing have been embraced by the Centers for Disease Control and Prevention and the World Health Organization, such as those that routinely inform persons that they will be tested for HIV unless they explicitly refuse (‘opt out’). (...) While these policies appear to increase uptake of testing, they raise a number of ethical concerns that have been debated in journals and at international AIDS conferences. However, one special form of ‘provider‐initiated’ testing is being practiced and promoted in various parts of the world, and has advocates within international health agencies, but has received little attention in the bioethical literature: mandatory premarital HIV testing. This article analyses some of the key ethical issues related to mandatory premarital HIV testing in resource‐poor settings with generalized HIV epidemics. We will first briefly mention some mandatory HIV premarital testing proposals, policies and practices worldwide, and offer a number of conceptual and factual distinctions to help distinguish different types of mandatory testing policies. Using premarital testing in Goma (Democratic Republic of Congo) as a point of departure, we will use influential public health ethics principles to evaluate different forms of mandatory testing. We conclude by making concrete recommendations concerning the place of mandatory premarital testing in the struggle against HIV/AIDS. (shrink)

Case 1 reminds us that patients have duties too, while case 2 presents an instance of justified withholding of informationHow refreshing to read these two cases! No conjoined twins, fantastical chimeras, or other incredible scenarios at the fringes of medical reality. Each case highlights the practical and theoretical difficulties that doctors face in their everyday practice.Case 1: In case 1, the patient, who had declined an HIV test, changed his mind and requested an HIV test on the request form without (...) informing the doctor. The pathologist performed the tests and returned the results to the unsuspecting doctor, who duly investigated the matter. The doctor’s anxiety at the situation, as well as the worries of the entire practice and pathology laboratory, must have been deeply unpleasant. Thus the patient, no doubt unintentionally, caused much distress by requesting the HIV test. He was, at the very least, guilty of a lack of foresight and consideration. As a minimum, he should have informed the doctor of his last minute alteration. This would have enabled the doctor to discuss the implications of the test, to organise appropriate counselling, and, most importantly, to receive the results in full knowledge of the situation.As Dr Fraser points out, the experience of case 1 reinforces the importance of taking good medical notes. Even if the patient’s refusal had been documented in the notes, however, this would not have prevented him from requesting the HIV test, and indeed other tests, on the blood form. Pharmacists may still occasionally be faced with situations when they are unsure whether the doctor prescribed 10 capsules of a drug, or 110 capsules, as the patient may have added a “1” in front of the doctor’s original prescription. Similarly, how …. (shrink)

The author reviews various conceptions of autonomy to show that humans are actually not autonomous, strictly speaking. He argues for a need to rethink the personal autonomy approaches to HIV testing in sub-Saharan Africa (SSA) countries. HIV/AIDS has remained a leading cause of disease burden in SSA. It is important to bring this disease burden under control, especially given the availability of current effective antiretroviral regimens in low- and middle-income countries. In most SSA countries the ethic or value of (...) personal autonomy or self-determination is promoted as primary in HIV testing decision-making. SSA policymakers have an ontological and moral duty to adopt HIV testing policies that reflect human and medical realities, relationships, local contexts, and respect human rights for both individuals and others who are affected by HIV in society. Without rethinking the value of autonomy in HIV testing decision-making, the article cautions that attainment of the Sustainable Development Goal (SDG) 3 and the UNAIDS fast-track strategy that explicitly call to end the epidemic by 2030 will not be feasible for SSA. (shrink)

Since the introduction of drugs to prevent vertical transmission of HIV, the purpose of and approach to HIV testing of pregnant women has increasingly become an area of major controversy. In recent years, many strategies to increase the uptake of HIV testing have focused on offering HIV tests to women in pregnancy-related services. New global guidance issued by the World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS (UNAIDS) specifically notes these services as an entry (...) point for provider-initiated HIV testing and counseling (PITC). The guidance constitutes a useful first step towards a framework within which PITC sensitive to health, human rights and ethical concerns can be provided to pregnant women in health facilities. However, a number of issues will require further attention as implementation moves forward. It is incumbent on all those involved in the scale up of PITC to ensure that it promotes long-term connection with relevant health services and does not result simply in increased testing with no concrete benefits being accrued by the women being tested. Within health services, this will require significant attention to informed consent, pre- and post-test counseling, patient confidentiality, referrals and access to appropriate services, as well as reduction of stigma and discrimination. Beyond health services, efforts will be needed to address larger societal, legal, policy and contextual issues. The health and human rights of pregnant women must be a primary consideration in how HIV testing is implemented; they can benefit greatly from PITC but only if it is carried out appropriately. (shrink)

Dr de Zulueta articulates some important and commonly held concerns about the anonymised screening programme for HIV in pregnant women, which is one of a number of such programmes that are current. However, in my view, many of these concerns reflect a failure to understand two key distinctions.In both these regards, there is a danger of putting up a “straw man” for challenge. In this commentary, I wish to pick up some of these issues to help to resolve the apparent (...) ethical tensions that Dr de Zulueta has set out.Firstly, the unlinked seroprevalence surveillance programmes, including that on pregnant women, comprise research studies that are designed to inform policy and practice, as well as individual decision making. They are not screening for the purpose of clinical care. The anonymisation is a procedural research tool, which enables the studies to be done in a way that does not undermine consent or individual autonomy. The ethical standards and duties expected of professionals are thus, in this specific regard, those that relate to the conduct of clinical research. That research is evidently designed to improve the quality of clinical care as a result of the information and insight gained. The duty of care is to apply the results of properly conducted and valid research in order to improve clinical practice on behalf of the individuals receiving care, in this case the mother and unborn child. The research conducted, in this case by a particular form of screening procedure, is not the same as a screening procedure done for clinical purposes to identify individuals who could benefit from an intervention. The ethical debate must therefore focus on the purpose in applying the procedure, not on the procedure itself, regardless of intent.Secondly, it is vital to distinguish, in debating such …. (shrink)

HIV stigmatization is one of the most notable barriers to individual testing, seriously impairing global efforts in the fight against HIV/AIDS. Because stigmatization is strongly embedded in local cultural and social habits, humanitarian healthcare workers providing HIV testing, counselling and prevention programs in low and middle income countries have become a serious alternative to local healthcare providers. This case study addresses some of the ethical dilemmas that humanitarian healthcare workers face when confronted with HIV-associated stigma.

This essay argues that informed consent remains desirable for both moral and practical reasons in regard to HIV testing by physicians. At the very least, respect for consent preserves patient control over treatment and affords the opportunity for education about the nature of HIV-related disorders. Nevertheless, there do appear to be circumstances under which involuntary testing may occur especially when health care workers may have become occupationally exposed to risk of HIV infection. To eliminate conflicts between health workers (...) and their patients, however, it is desirable to work to eliminate the stigmatizing and discriminatory effects of HIV infection that can induce persons to resist testing. (shrink)

Seroprevalence monitoring of HIV in pregnant women by anonymised unlinked testing has been widely adopted in the UK and other countries. The scientific rationale is to eliminate participation and selection bias. The ethical justification is that the public good outweighs any harm to individuals. The assumption has been that individuals have had their autonomy respected by the offer of informed consent. In the light of new scientific evidence, it is doubtful that the public good is best served by the (...) continuation of anonymously testing women receiving antenatal care. It is submitted that it is no longer ethical for health professionals to refrain from informing pregnant women of the benefits of voluntary named testing, or to request their consent to anonymised testing. The legal and moral concept of duty of care is examined, and the abrogation of this duty through anonymisation is explained. (shrink)

“Anonymised screening is a research tool to inform policy and practice and individual decision making, but is not a tool to identify those at risk that could directly benefit from intervention.”1The assumption that the information acquired will be used to prioritise health care resources may prove false. A government, after weighing up the costs and benefits, may choose not to adopt appropriate interventions. Or, even if a policy is proposed,, it may not be adhered to. Even as I write, antenatal (...) clinics that serve populations with the highest concentration of refugees from sub-Saharan Africa, and therefore of those at risk, still do not have a policy of universal screening.Anonymised screening is a form of non-therapeutic research, and should comply with the Helsinki Declaration on Non-therapeutic Research involving Human Subjects. I have already argued that physicians who undertake anonymised screening have abrogated their duty, as outlined in article one, “... to remain the protector of the life and health of that person on whom biomedical research is being carried out”.2In addition, article four states: “In research on man, the interest of science and society should never take precedence over considerations related to the wellbeing of the subject.”2The desire for an outcome—perfect epidemiological figures—should not override the ethics of the process whereby this is achieved. The …. (shrink)

Home diagnostic testing is becoming part of the modern medical landscape, but many ethical and policy questions remain unresolved. Most of them first surfaced during the long regulatory deliberations over the home HIV test, the first home test for a contagious illness sold in the United States. Between 1989 and 2012, federal regulators and their consultants debated the ideal metrics for such a test, its benefits, and its potential harms for both individuals and communities. Ultimately, two iterations of the (...) home HIV test were marketed in the United States; neither one of them changed the course of the national HIV epidemic, as hoped. This failure has powerful implications for home testing for other contagious diseases. (shrink)

This study sought to assess barriers and enhance readiness to consent to home and Planned Parenthood HIV testing among 60 out-patients from a mental health and substance abuse clinic in rural Appalachia. Testing barriers included not knowing where to get tested, lack of confidentiality, and loss of partners if one tested sero-positive. The intervention yielded lowered HIV stigma, increase in HIV knowledge, and agreement to take the HIV home test. These results are encouraging because they suggest that a (...) brief educational intervention is a critical pathway to the success of the National Institutes on Drug Abuse’s Seek, Test, Treat, and Retain initiative in poor rural counties. (shrink)

When in 2006 the Centers for Disease Control and Prevention issued revised recommendations for HIV testing in health care settings, vocal opponents charged that use of an ?opt-out? approach to presenting HIV testing to patients; the implementation of nontargeted, widespread HIV screening; the elimination of a separate signed consent; and the decoupling of required HIV prevention counseling from HIV testing are unethical. Here we undertake the first systematic ethical examination of the arguments both for and against the (...) recommendations. Our examination reveals that the ethical concerns raised by the critics predominately pertain not to ethically suspect elements of the recommendations themselves, but to suspicions that they will be implemented improperly. It has not been shown that the recommendations cannot be implemented properly. Here we show that in the United States the recommendations are morally justifiable and that safeguards or regulatory oversight may serve to ensure that the recommendations are properly implemented. (shrink)

Administraation of antiretroviral therapy to women during pregnancy, labor and delivery, and to infants postnatally can dramatidy reduce mother-to- child HIV transmission. However, pregnant women need to know that they are HIV-infected to take advantage of antiretroviral therapy, and many women do not know their HIV status. One-half of HIV-infected infants in the United States were bornto women who had not been tested for HIV or for whom the time of testing was not known. Although fewer than 400infants are (...) infected perinatally in the United States each year, that number could be reduced even further through policies aimed at HIV testing during pregnancy.The reasons toadopt such a policy are strong: the pathophysiology of perinatal transmission is clear, prophylaxis is effective and safe, and the intended beneficiaries of the intervention - babies - cannot protect themselves. (shrink)

Administraation of antiretroviral therapy to women during pregnancy, labor and delivery, and to infants postnatally can dramatidy reduce mother-to- child HIV transmission. However, pregnant women need to know that they are HIV-infected to take advantage of antiretroviral therapy, and many women do not know their HIV status. One-half of HIV-infected infants in the United States were bornto women who had not been tested for HIV or for whom the time of testing was not known. Although fewer than 400infants are (...) infected perinatally in the United States each year, that number could be reduced even further through policies aimed at HIV testing during pregnancy.The reasons toadopt such a policy are strong: the pathophysiology of perinatal transmission is clear, prophylaxis is effective and safe, and the intended beneficiaries of the intervention - babies - cannot protect themselves. (shrink)

This paper looks at some of the ethical concerns regarding a recent application to the U.S. Food and Drug Administration for approval of the sale of HIV tests over-the-counter directly to consumers. The concept of at-home HIV testing is not new, but OraSure Technologies Inc., a U.S. manufacturer of rapid HIV tests, is now seeking FDA approval to take at-home testing one step further to enable consumers to test themselves and interpret the results without the assistance of an (...) outside party. This paper reviews some of the purported benefits and potential risks of at-home HIV testing, and looks at the way one Canadian company is attempting to address the potential risks. In doing so, this paper brings to the fore concerns regarding corporate involvement in the regulatory approval of biotech products. (shrink)