Opt-out Policy Research Articles

Improving the Supply of Donor Organs

DONOR ORGANS ARE A VALUABLE BUT SCARCE REsource that provide a lifesaving procedure to thousands of patients per year. However, the demand for organs of all types far exceeds supply. In 2009, 50 463 patients were added to the United Network for Organ Sharing’s wait list, 28 463 patients received an organ transplant, and 6683 patients died while waiting for a suitable organ. Despite substantial effort and research devoted to improving donation rates in the United States, these rates remain substantially lower than those in many other developed countries. Many techniques such as implied consent, opt-out policies, breakthrough collaborative and quality improvement methods, and financial incentives have been proposed to expand the pool of organ donors. Two articles in this issue of JAMA present important information about this problem and provide simultaneously sobering and encouraging insights into strategies to improve the supply of organs. The randomized controlled trial by Mascia and colleagues compared the conventional ventilatory method used for potential lung donors with a lung preservation (protective) strategy from the time of brain death. The protective strategy included lower tidal volumes, higher positive endexpiratory pressure, alveolar recruitment maneuvers after any ventilator disconnection, and the use of continuous positive airway pressure during apnea tests. This study breaks important new ground in providing a solid evidence base for the care of potential organ donors and testing techniques of organ preservation. The surgeons evaluating the organs for transplant suitability were blinded to the ventilation strategy (conventional vs protective) and all outcomes (including organ donations other than the lung) were followed up. The results of the study are profound. The protective strategy nearly doubled the number of eligible lungs at 6 hours (32 patients [54%] in the conventional strategy vs 56 patients [95%] in the protective strategy) and doubled the number of patients from whom lungs for transplant were harvested (lungs from 16 patients [27%] in the conventional strategy vs 32 patients [54%] in the protective strategy). Furthermore, although the numbers are small, there appears to be no detrimental effect of the protective strategy on transplant outcomes, either with the lungs or with other organs that were harvested at the same time. The secondary analyses provide evidence of a mechanistic reason as well. Levels of several inflammatory cytokines were significantly elevated among patients in the conventional strategy group. These results are encouraging for several reasons. First, they demonstrate that in a cohort of patients who have already consented to be organ donors, the rate of viable organ procurement was doubled. In the context of lung transplantation, this has the potential to help eliminate the disparity between demand and supply. In 2009, 2234 candidates were added to the lung transplant waiting list and there were 1568 lung donors. Doubling that donation rate could potentially meet steady-state demand as well as reduce waiting-list backlog, especially because each donor provides organs for more than 1 transplant. Second, although the sample size of the study by Mascia et al is small, there appears to be no detrimental effect on transplantation outcomes of either the transplanted lung or the other organs obtained from the donor. Third, this study has set the methodological bar regarding how such organ donor preservation studies should be conducted and demonstrated that such high-quality, controlled, and mechanistically informative studies are possible in the transplantation setting. However, the protective ventilation strategy is specific to lungs for transplantation, and further studies are needed to determine whether tailored preservation strategies will increase the viability of other organs. The report by Halpern and colleagues evaluates the potential effect of a more complete use of organ donation af-

Should Students Be Able to Opt Out of Evolution? Some Philosophical Considerations

One new development in the ongoing creationism/evolution controversy has been the proposal to institute opt-out policies that would allow creationist parents to exempt their children from any instruction involving evolution. By way of an explanation of some of the philosophical issues at play in the debate over evolution and the nature of science, this article shows the educational folly of such policies. If evolution is taught properly, it should not be possible to opt out of it without opting out of biology. Moreover, if Intelligent Design creationist criticisms of evolution and scientific naturalism were taken as the basis for opting out, then the effect would be even more radical and would require opting out of science entirely.

Smoking prevalence and smoking cessation services for pregnant women in Scotland

BackgroundOver 20% of women smoke throughout pregnancy despite the known risks to mother and child. Engagement in face-to-face support is a good measure of service reach. The Scottish Government has set a target that by 2010 8% of smokers will have quit via NHS cessation services. At present less than 4% stop during pregnancy. We aimed to establish a denominator for pregnant smokers in Scotland and describe the proportion who are referred to specialist services, engage in one-to-one counselling, set a quit date and quit 4 weeks later.MethodsThis was a descriptive epidemiological study using routinely collected data supplemented by questionnaire information from specialist pregnancy cessation services.Results13266 of 52370 (25%) pregnant women reported being current smokers at maternity booking and 3133/13266 (24%) were referred to specialist cessation services in 2005/6. Two main types of specialist smoking cessation support for pregnant women were in place in Scotland. The first involved identification using self-report and carbon monoxide breath test for all pregnant women with routine referral (1936/3352, 58% referred) to clinic based support (386, 11.5% engaged). 370 (11%) women set a quit date and 116 (3.5%) had quit 4 weeks later. The second involved identification by self report and referral of women who wanted help (1195/2776, 43% referred) for home based support (377/1954, 19% engaged). 409(15%) smokers set a quit date and 119 (4.3%) had quit 4 weeks later. Cost of home-based support was greater. In Scotland only 265/8062 (3.2%) pregnant smokers identified at maternity booking, living in areas with recognised specialist or good generic services, quit smoking during 2006.ConclusionsIn Scotland, a small proportion of pregnant smokers are supported to stop. Poor outcomes are a product of current limitations to each step of service provision - identification, referral, engagement and treatment. Many smokers are not asked about smoking at maternity booking or provide false information. Carbon monoxide breath testing can bypass this difficulty. Identified smokers may not be referred but an opt-out referral policy can remove this barrier. Engagement at home allowed a greater proportion to set a quit date and quit, but costs were higher.

Low uptake of HIV testing during antenatal care: a population-based study from eastern Uganda

This article discusses a population-based study from rural eastern Uganda that examines the uptake and determinants for HIV testing among pregnant women in Iganga/Mayuge Demographic Surveillance Site (DSS) where field assistants regularly collect data from households on vital events and other variables in a population of 67200 inhabitants. It finds that intensified counseling at health facilities and referral follow-up are needed as well as HIV testing services at ANC facilities to increase the coverage of HIV testing among pregnant women.

The harm principle and the ethics of routine antenatal HIV testing in South Africa

Under South Africa’s ‘opt-in’ policy of HIV testing, only about half of the 80% of pregnant women having access to prevention of mother-to-child transmission (PMTCT) of HIV programmes accept HIV testing – a test that is necessary for entry into the PMTCT programme.1 To alleviate the general problem of low uptake of HIV testing, some parties (including Justice Edwin Cameron of the Supreme Court of Appeal of South Africa) have advocated a policy of routine ‘opt-out’ HIV testing which, in an antenatal care setting, would mean that pregnant women are tested unless they indicate otherwise. 2 Such an opt-out policy would, however, be unacceptable in South Africa (SA) as it is deemed not to satisfy the counselling and informed consent requirements stipulated by law. The Health Professions Council of South Africa and the South African Medical Association hold similar sentiments. 3 Insofar as the opt-out approach is not deemed sufficiently vol untary, it can be regarded as coercive or limiting of liberty. Questions may then be raised about individual liberty (or right to autonomy) and when it may be justified to restrict this. In the case under discussion, it specifically raises the issue of whether the putative tension between the pregnant woman’s autonomy and the widely presumed parental responsibility of acting for the child’s benefit should ultimately lean in favour of the unborn child or the mother. Posed differently: under what circumstances is it justified for a woman to choose to opt out of a programme which could reduce the chances of passing HIV to her child from about 35% to about 2%? 4

Role and justification of web archiving by national libraries

This paper reports on a questionnaire survey of 16 national libraries designed to clarify how national libraries attempt to justify their web archiving activities. Results indicate they envisage that a) the benefits brought about by their initiatives are greater than the overall costs, b) the costs imposed on libraries are greater than the costs imposed on stakeholders, and c) all of them are making efforts to respond to legal risks in various ways (e.g. legislation, contracting and opt-out policies) although there are trade-off relations in terms of costs for negotiation, scope of access and size and scope of the web archive. The paper discusses whether a basic logic for justification of their web archiving is valid from the perspective of balancing cost—benefit. Further, it highlights the potential, underlying premises of the logic that motivates the intervention of national libraries as public sector organizations.

Opt-out testing for stigmatized diseases: A social psychological approach to understanding the potential effect of recommendations for routine HIV testing.

Little research has studied experimentally whether an opt-out policy will increase testing rates or whether this strategy is especially effective in the case of stigmatized diseases such as HIV. In Study 1, a 2 x 2 factorial design asked participants to make moral judgments about a person's decision to test for stigmatized diseases under an opt-in versus an opt-out policy. In Study 2, a 2 x 2 factorial design measuring testing rates explored whether opt-out methods reduce stigma and increase testing for stigmatized diseases. Study 1 results suggest that getting tested draws suspicion regarding moral conduct in an opt-in system, whereas not getting tested draws suspicion in an opt-out system. Study 2 results suggest that an opt-out policy may increase testing rates for stigmatized diseases and lessen the effects of stigma in people's reluctance to test. A social psychological approach to health services can be used to show how testing policies can influence both the stigmatization associated with testing and participation rates. An understanding of how testing policies may affect patient decision making and behavior is imperative for creating effective testing policies.

Protecting HIV-positive women's human rights: recommendations for the United States National HIV/AIDS Strategy

To bring the United States in line with prevailing human rights standards, its National HIV/AIDS Strategy will need to explicitly commit to a human rights framework when developing programmes and policies that serve the unaddressed needs of women. This paper focuses on two aspects of the institutionalized mistreatment of people with HIV: 1) the criminalization of their consensual sexual conduct; and 2) the elimination of informed and documented consensual participation in their diagnosis through reliance on mandatory and opt-out testing policies. More than half of US states have HIV-specific laws criminalizing the consensual sexual activity of people with HIV, regardless of whether transmission occurs. Many of these laws hinge prosecution on the failure of HIV-positive people to disclose their HIV status to a sexual partner. The Obama Administration should explore administrative and legislative incentives to eliminate these laws and prosecutions, and target a portion of prevention funding for anti-stigma training. Testing policies should be reconsidered to remove opt-out and/or mandatory HIV testing as a condition for receipt of federal funding; incentives should encourage states to adopt local policies mandating counseling; and voluntary HIV testing should be offered regardless of the provider's undocumented perception of an individual's risk.

Top ten in Journal of Biology in 2009: stem cells, influenza, pit bulls, Darwin, and more

This is a more or less frivolous look at the top ten most accessed articles - of any kind - published in Journal of Biology this year. Frivolous, because the validity of any conclusions drawn from this statistic is undermined by many considerations. The number of times an article is accessed does not measure how many people actually read it, nor, for most articles, is it any indication of how much it will be cited (itself an imperfect measure of importance): it is most likely to reflect what people think they want to read about. Even then, there is the problem that more recently published articles have had less time to accrue accesses; although by far the highest access rates occur in the first three or four weeks after publication, most in the first two, so that in practice, given the actual numbers, even correcting for these discrepancies would make no difference to the top five, though it might affect the last two or three on the list. Indeed, the two most accessed articles, an Opinion from Arthur Lander on the stem cell concept [1] and a Q&A from Stephen Turner, Lorena Brown, Peter Doherty and Anne Kelso on what we have learned about the influenza A (H1N1) pandemic virus [2], were both published relatively recently, in September. Clearly a major factor is topicality: the earlier influenza A (H1N1) Q&A from Doherty and Turner [3] is also on the list, at seventh. Another factor, probably, is the whiff of controversy - Lander's article asks whether the stem cell concept is holding us back - and an Opinion from Alexey Khodjakov and Conly Rieder, provocatively entitled 'The nature of cell cycle checkpoints: facts and fallacies' [4], published more recently still, is ninth. The third most accessed of the top ten combines a topic of perennial interest - in all senses of that word - with probably the most arresting title we have published this year: 'Are we training pit bulls to review our manuscripts?' [5], under which Virginia Walbot not only answers the question (yes), but proposes a taming protocol. The pit-bull reviewer is the problem that we for our part have proposed to address with our experimental re-review opt-out policy - see 'What are journals for?' [6], at eighth - an experiment whose results I should have liked to report had the n so far been large enough to raise any discussion above the anecdotal. I do however feel able with reasonable confidence to reject one of the most important objections to the policy, which is that if authors are allowed to opt out of re-review of their revised manuscripts reviewers may refuse to referee them. We have had no refusals - although it is impossible to say whether this means reviewers are content with the policy, or simply don't read beyond the first paragraph of the request to where the policy is explained. Probably both. What else? Fifth most accessed, and again both topical and provocative, is Jonathan Howard's Opinion on why Darwin didn't discover Mendel's laws [7]; and the two research papers in the top ten, Chan et al. on conservation of gene expression in vertebrate tissues [8] and Puigbo et al. on the tree of life [9] both reflect the current preoccupation with the potential of genomic analysis for resolving profound evolutionary issues - in one case, the longstanding issue of the path to our remote ancestry; in the other, the more recent question of how exactly the evolution of form and function reflects the evolution of gene regulation. The tenth most accessed article is a Minireview by Lucy Dalton-Griffin and Paul Kellam on infectious causes of cancer [10]. There seems little question that the articles that most reliably interest the broadest spectrum of readers without any special topical, controversial, political or provocative appeal, are those on biology with direct medical relevance. In 2010, we shall be recognizing this interest with a series of articles on biology addressed to clinical issues. Ring in the new.

Increased Uptake of HIV Testing With the Integration of Nurse-Initiated HIV Testing Into Routine Prenatal Care

Increased Uptake of HIV Testing With the Integration of Nurse-Initiated HIV Testing Into Routine Prenatal Care

Overcoming Obstacles to Evolution Education: The OOPSIE Compromise—A Big Mistake

Opt-out policies are typically invoked to excuse students from activities to which they or their parents may have religious objections, such as reciting the Pledge of Allegiance, dissecting animals in a laboratory, or attending sex education classes. Occasionally, however, a school or school district allows students to opt out of academic topics, including, sometimes, evolution. Opt-out policies specifically including evolution are a big mistake—for the students who opt out, for their classmates whose studies are disrupted, and especially for their teachers, who cannot fulfill their duty to instruct their charges about biology without emphasizing evolution.

Opt-Out Testing: Who Can Afford to Take Care of Patients with Newly Diagnosed HIV Infection?

The appropriate adoption of a policy of opt-out universal testing for human immunodeficiency virus (HIV) will likely increase the number of new HIV-infected patients seeking care by at least 25% over the next several years. On the basis of recent analyses, this policy will save lives and reduce medical care costs. However, the majority of clinics are currently operating at maximum capacity and cannot absorb the influx of newly identified patients. Therefore, the implementation of the policy of opt-out testing will expose deficiencies in clinic capacity and will likely precipitate a crisis in health care access and delivery for patients seeking care at these clinics. A comprehensive assessment of the funding requirements of existing HIV clinics is urgently needed, and sufficient resources must be appropriated to ensure that existing clinics can expand their capacity to absorb the onslaught of HIV-infected patients newly identified via the opt-out testing policy.

HIV-1 seroconversion during pregnancy resulting in vertical transmission

The uptake of antenatal HIV testing in England and Scotland improved from 33% in 1998 to 92% in 2004 after implementing an opt-out policy. However, there is the potential for missing HIV seroconversion during pregnancy unless a further test is carried out between antenatal booking, which mostly occurs between 12-14 weeks, and delivery. We report a 32-year old Caucasian woman who developed a primary symptomatic HIV infection late in pregnancy. Unfortunately, despite antiretroviral treatment, caesarean section and formula feeding to reduce the risk of mother to child transmission (MCT), the baby was found to be infected by 12 weeks of age. Despite a 95% uptake rate at King's College Hospital, another HIV seroconversion during late pregnancy was detected after the partner was admitted with AIDS defining diagnoses. In the absence of national data on HIV seroconversion rates in pregnancy, further maternal HIV testing later in pregnancy, especially for women at-risk in an ethnically diverse area such as London, should be considered.

HIV testing pregnant women in Washington State

The CDC recommends that HIV testing be a routine part of prenatal care. Washington State utilizes an ���Opt-out��� policy where HIV testing is to be routine unless the woman specifically declines to be tested. Questions were added to the Washington State Pregnancy Risk Assessment Monitoring System (PRAMS) survey in order to investigate HIV testing in pregnant women.

Influence of an “Opt-Out” Test Strategy and Patient Factors on Human Immunodeficiency Virus Screening in Pregnancy

To estimate both human immunodeficiency virus (HIV) testing acceptance rates in pregnancy using an opt-out policy and patient characteristics influencing acceptance. At the first prenatal visit, HIV testing was offered using an opt-out approach. Reasons for refusing testing were explored. Demographic information was collected on all study subjects. In the prospective portion of the study, 1,140 of 1,233 women (92.5%) accepted testing. Race was predictive of accepting HIV testing, with Asian women significantly less likely (odds ratio [OR] 0.4; 95% confidence interval [CI] 0.3-0.6; P<.001) and Hispanic women significantly more likely (OR 6.9; 95% CI 2.2-22.0; P=.001) to be tested. Although English as a first language, country of birth, and insurance status were not significantly associated with acceptance, women who were fluent in English were more likely to be tested (OR 2.0; 95% CI 1.2-3.3; P=.01). Our testing rates were significantly higher than the provincial average. Using an opt-out strategy, HIV testing rates in our clinic were significantly higher than the provincial average. Rates were influenced by race and fluency in English.

Authors v. Archivers: The Copyright Infringement Battle Over Web Pages

Archiving Internet content by storing old versions of Web pages is currently a growing trend because of the educational, cultural, and evidentiary value it provides. Google and the Internet Archive are two examples of Internet archives that provide this service. However, by storing old versions of Web pages without first obtaining the permission of authors, Internet archives infringe on the copyrights of authors. Under the fair use exception to copyright infringement, Internet archives may be legally authorized to archive old versions of Web pages without first obtaining the permission of authors in certain situations. However, this paper argues that, in all cases, the burden should be placed on authors to notify Internet archives that they wish for their Web pages to be excluded from the archive, rather than placing the burden on Internet archives to contact authors before they archive Web pages. By not overburdening Internet archives, the current opt-out policy is more advantageous than an opt-in policy because it allows Internet archives to continue to provide the benefits of archiving old Web pages to the public.

Desperately seeking targets: the ethics of routine HIV testing in low-income countries

The human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) pandemic, and responses to it, have exposed clear political, social and economic inequities between and within nations. The most striking manifestations of this inequity is access to AIDS treatment. In affluent nations, antiretroviral treatment is becoming the standard of care for those with AIDS, while the same treatment is currently only available for a privileged few in most resource-poor countries. Patients without sufficient financial and social capital -- i.e., most people with AIDS -- die each day by the thousands. Recent AIDS treatment initiatives such as the UNAIDS and WHO "3 by 5" programme aim to rectify this symptom of global injustice. However, the success of these initiatives depends on the identification of people in need of treatment through a rapid and massive scale-up of HIV testing. In this paper, we briefly explore key ethical challenges raised by the acceleration of HIV testing in resource-poor countries, focusing on the 2004 policy of routine ("opt-out") HIV testing recommended by UNAIDS and WHO. We suggest that in settings marked by poverty, weak health-care and civil society infrastructures, gender inequalities, and persistent stigmatization of people with HIV/AIDS, opt-out HIV-testing policies may become disconnected from the human rights ideals that first motivated calls for universal access to AIDS treatment. We leave open the ethical question of whether opt-out policies should be implemented, but we recommend that whenever routine HIV-testing policies are introduced in resource-poor countries, that their effect on individuals and communities should be the subject of empirical research, human-rights monitoring and ethical scrutiny.

Évaluation de politiques de retrait des terres pour la régulation d'un marché agricole

The paper is devoted to the welfare analysis of voluntary and opt-out mandatory set-aside policies relying on the incentive theory under adverse selection. Differently from Bourgeon et al. [1995], farms are composed of homogeneous yield plots. Optimal regulation by price and set-aside leads to theoretical and numerical results for soft wheat and low quality wine markets. Price adjustment limits the social cost due to the producers' information rent involving redistributional transfers between producers, consumers and taxpayers.

An expedient and ethical alternative to xenotransplantation.

The current voluntary posthumous organ donation policy fails to provide sufficient organs to meet the demand. In these circumstances xenografts have been regarded as an expedient solution. The public perception seems to be that the only impediments to this technology are technical and biological. There are, however, important ethical issues raised by xenotransplantation that need to be considered as a matter of urgency. When the ethical issues raised by using non-human animals to provide replacement organs for human beings are considered in a wider context and the possible alternatives to xenotransplantation are taken into account, a new dimension is added to the debate. In this broader context it is argued that a less ethically problematic solution is to adopt a presumed consent or opt-out organ procurement policy to regulate posthumous organ harvesting from humans. If there are still too few organs available, then the whole question of transplantation must be reassessed.

Brain stem death and organ donation

The need for a reliable means to diagnose brain stem death (BSD) was met in the UK by a Code of Practice drawn up in 1976. The diagnostic criteria are classified as essential preconditions, exclusions and clinical tests. Practical advice on performance of the tests is given. When BSD has been diagnosed the patient's suitability for organ donation should be considered. Patient eligibility plus practical, ethical and legal issues concerning consent for donation are discussed. After consent has been obtained, the goal of intensive care is to ensure the organs are maintained in an optimum condition before and during the donor operation. There is an increasing shortfall in organs available for transplantation owing to improvements in health care, road safety and imaging. Suggested means of increasing the supply of organs include opt-out policies, elective ventilation, asystolic donation and live-related kidney donation.