DNA could play. 3 Instead, it is likely that the responsibility arises through the actions of the... more DNA could play. 3 Instead, it is likely that the responsibility arises through the actions of the father that causally contribute to the existence of a child. This is consistent with the voluntarist principle that restricts the acquisition of special responsibilities to voluntary actions. 4 However, it also leads to cases in which the assignment of parental responsibility looks unfair. Consider the following case. Accidental father Casual acquaintances Gaston and Loretta have sex. They use two forms of contraception: he uses a condom and she is taking the oral contraceptive pill. However, these methods are not 100% reliable and Loretta becomes pregnant. Upon learning this, Gaston recommends that she abort the fetus and offers to pay for an abortion. Further, he informs her, he has no intention of supporting a child if she brings the fetus to term. Nevertheless, Loretta decides that she wants the child, bears it, and sues Gaston for child support.
Waiting time is widely used in health and social policy to make resource allocation decisions, ye... more Waiting time is widely used in health and social policy to make resource allocation decisions, yet no general account of the moral significance of waiting time exists. We provide such an account. We argue that waiting time is not intrinsically morally significant, but its use is justified across a range of pretheoretically compelling scenarios. First, there is a duty of fairness prohibiting line cutting where a sufficiently just queue exists. Second, where candidates are in relevantly similar circumstances, allocating by waiting time is efficient, maximizes distribution equality relative to other Pareto efficient distributions, and approaches the fairness of an equiprobable lottery.
Research projects sponsored by rich countries or companies and carried out in developing countrie... more Research projects sponsored by rich countries or companies and carried out in developing countries are frequently described as exploitative. One important debate about the prevention of exploitation in research centers on whether and how clinical research in developing countries should be responsive to local health problems. This paper analyses the responsiveness debate and draws out more general lessons for how policy makers can prevent exploitation in various research contexts. There are two independent ways to do this in the face of entrenched power differences: to impose restrictions on the content of benefit-sharing arrangements, and to institute independent effective oversight. Which method should be chosen is highly dependent on context.
The International Bill of Rights enshrines a right to health, which includes a right to access es... more The International Bill of Rights enshrines a right to health, which includes a right to access essential medicines. This right frequently appears to conflict with the intellectual property regime that governs pharmaceutical patents. However, there is also a human right that protects creative works, including scientific productions. Does this right support intellectual property protections, even when they may negatively affect health? This article examines the recent attempt by the Committee on Economic, Social and Cultural Rights to resolve this issue and argues that it fails. This is problematic because it means defenders of the present patent regime can continue using human rights documents to support their position. I offer a new framework for resolving the problem by examining the values that underlie human rights. The relationship between intellectual property laws and the provision of new drugs to those who need them is contentious. Critics of the present patent system argue that the high prices supposed necessary to promote medical innovation prevent access to lifesaving drugs. Indeed, some maintain that this is a violation of the right to health recognised in international treaties. Others claim that intellectual property rights are similarly recognised by international treaties that protect the rights of authors. In November 2005, the Committee on Economic, Social and Cultural Rights issued a General Comment that attempted to clarify the relationship between the right to health and intellectual property (IP) rights. It strictly distinguishes human rights from IP rights, and thereby implies that the only human rights relevant to the access to medicines issue are those, like the right to health, which support universal access. This paper argues that the General Comment fails to demonstrate that there is no conflict within the human rights framework between a right to health and IP rights, thus leaving open the danger that human rights documents will be used to defend pharmaceutical patents. It proposes an alternative strategy that has the potential to resolve this problem by analysing the justifications for protecting creative products. A preliminary note on methodology is in order. This paper reaches its conclusions through ethical, not legal, analysis. Though it examines legal documents, the ultimate goal is not to draw conclusions about what the law is, but rather about what it ought (morally) to be. Consequently, I am concerned with the moral foundations of human rights claims, and my Competing interest: None declared.
Highly efficacious vaccines for covid-19 are now being distributed in high income countries. At t... more Highly efficacious vaccines for covid-19 are now being distributed in high income countries. At the same time, multinational covid-19 vaccine trials continue-and new trials are being planned-around the world. 1
Nearly 20 years ago, a series of trials evaluating shortcourse zidovudine for the prevention of m... more Nearly 20 years ago, a series of trials evaluating shortcourse zidovudine for the prevention of mother-tochild transmission of human immunodeficiency virus (HIV) provoked global controversy when the sponsors were accused of ethical double standards-conducting research on vulnerable developing country populations that would not be permitted in high-income countries. 1 Following this controversy, and responding to underrepresentation of developing countries in these debates, the Fogarty International Center at the National Institutes of Health (NIH) launched a grants program to support masters-level, socioculturally relevant training in research ethics in low-and middle-income countries (LMICs). Since the program began, the volume of research in LMICs and the funds devoted to global health have expanded substantially. 2,3 The majority of the research is still sponsored by institutions based in high-income countries, including pharmaceutical companies, governmental agencies like NIH, and private foundations. Some of the increase in LMIC-based research results from greater funding for diseases that affect people in these countries; some is a result of private companies seeking lower costs and patients naive to treatment. 2,4 New challenges have emerged, as LMICs increasingly must address the dual burden of communicable and noncommunicable diseases. New technologies, including widespread access to mobile phones and the decreasing cost of genomic analysis, have expanded the scope of research. Ethical controversies continue to arise, tarnishing the reputation of global health research and, in some countries, halting research altogether. In the face of these changes, grantees, program staff, and outside experts conducted a collaborative selfassessment of the Fogarty International Center program 12 years after its inception. Fourteen articles present this extensive evaluation. 5,6 The authors examine the state of research ethics in LMICs, summarize the lessons learned, identify future needs, and attempt to chart a way forward to address them. Despite significant progress, the mission of building research ethics capacity in LMICs is not finished. However, the landscape of research and research ethics is substantially different than in 2000. New approaches are needed to build on what has been achieved and respond to new challenges.
Estimates of the burden of disease assess the mortality and morbidity that affect a population by... more Estimates of the burden of disease assess the mortality and morbidity that affect a population by producing summary measures of health such as quality-adjusted life years (QALYs) and disability-adjusted life years (DALYs). These measures typically do not include stillbirths (fetal deaths occurring during the later stages of pregnancy or during labor) among the negative health outcomes they count. Priority setting decisions that rely on these measures are therefore likely to place little value on preventing the more than three million stillbirths that occur annually worldwide. In contrast, neonatal deaths, which occur in comparable numbers, have a substantial impact on burden of disease estimates and are commonly seen as a pressing health concern. In this paper we argue in favor of incorporating unintended fetal deaths that occur late in pregnancy into estimates of the burden of disease. Our argument is based on the similarity between late-term fetuses and newborn infants and the assumption that protecting newborns is important. We respond to four objections to counting stillbirths: (1) that fetuses are not yet part of the population and so their deaths should not be included in measures of population health; (2) that valuing the prevention of stillbirths will undermine women's reproductive rights; (3) that including stillbirths implies that miscarriages (fetal deaths early in pregnancy) should also be included; and (4) that birth itself is in fact ethically significant. We conclude that our proposal is ethically preferable to current practice and, if adopted, is likely to lead to improved decisions about health spending. Estimates of the burden of disease, such as the Global Burden of Disease Study (GBD), 1 attempt to assess the impact of mortality and morbidity as a result of disease by producing summary measures of population health that allow for comparisons between diseases and between regions. For instance, the GBD uses the disability-adjusted life year (DALY), which represents health lost to both death and disability using a common unit. Roughly speaking, one DALY represents the loss of one year of healthy life. While DALYs purport simply to represent health lost, they are also designed to be used for priority setting in the allocation of funds for research, treatment, and prevention, and have in fact been used for this purpose. 2 The fact that two diseases differ in the number of DALYs they create may be taken as a basis for prioritizing research into the disease that is associated with more; the fact that one health intervention averts more DALYs for the same cost than another may be used to justify prioritizing the first over the second within a public health care system. As DALYs were originally designed, and as they are currently implemented, they take into account the impact of disease on individuals starting at birth, but not on unborn fetuses. The
The vast majority of health research resources are used to study conditions that affect a small, ... more The vast majority of health research resources are used to study conditions that affect a small, advantaged portion of the global population. This distribution has been widely criticized as inequitable and threatens to exacerbate health disparities. However, there has been little systematic work on what individual health research funders ought to do in response. In this article, we analyze the general and special duties of research funders to the different populations that might benefit from health research. We assess how these duties apply to governmental, multilateral, nonprofit, and for-profit organizations. We thereby derive a framework for how different types of funders should take the beneficiaries of research into account when they allocate scarce research resources.
The idea that payment for research participation can be coercive appears widespread among researc... more The idea that payment for research participation can be coercive appears widespread among research ethics committee members, researchers, and regulatory bodies. Yet analysis of the concept of coercion by philosophers and bioethicists has mostly concluded that payment does not coerce, because coercion necessarily involves threats, not offers. In this article we aim to resolve this disagreement by distinguishing between two distinct but overlapping concepts of coercion. Consentundermining coercion marks out certain actions as impermissible and certain agreements as unenforceable. By contrast, coercion as subjection indicates a way in which someone's interests can be partially set back in virtue of being subject to another's foreign will. While offers of payment do not normally constitute consent-undermining coercion, they do sometimes constitute coercion as subjection. We offer an analysis of coercion as subjection and propose three possible practical responses to worries about the coerciveness of payment.
During the recent Ebola epidemic, some commentators and stakeholders argued that it would be unet... more During the recent Ebola epidemic, some commentators and stakeholders argued that it would be unethical to carry out a study that withheld a potential treatment from affected individuals with such a serious, untreatable disease. As a result, the initial trials of experimental treatments did not have control arms, despite important scientific reasons for their inclusion. In this paper, we consider whether the duty to rescue entails that it would be unethical to withhold an experimental treatment from patientparticipants with serious diseases for which there are no effective treatments, even when doing so is scientifically necessary to test the effectiveness of the treatment. We argue that the duty to rescue will rarely apply. The context of medical research also throws new light on the content of the duty to rescue, since the interests of future patients-who stand to benefit from the fruits of medical research-are relevant to whether the duty applies.
New medicines and vaccines are predominantly tested in high-income countries. However, as the COV... more New medicines and vaccines are predominantly tested in high-income countries. However, as the COVID-19 pandemic highlighted, the populations who can benefit from these interventions are not limited to these wealthier regions. One-third of novel Food and Drug Administration approved drugs, sponsored by large companies, treat infectious diseases like tuberculosis and HIV, which disproportionately affect low-income and middle-income countries (LMICs). The medicines for non-communicable diseases (NCDs) are also relevant to LMIC health needs, as over three-quarters of deaths from NCDs occur in LMICs. There are concerns clinical trial data may not extrapolate across geographical regions, as product effectiveness can vary substantially by region. The pentavalent rotavirus vaccine, for example, had markedly lower efficacy in LMICs. Efficacy variations have also been found for other vaccines and drugs. We argue there are strong ethical arguments for remedying some of this uneven distribution...
It is a commonplace that coercion by the recipient of consent renders that consent invalid. It is... more It is a commonplace that coercion by the recipient of consent renders that consent invalid. It is also commonly held that the pressure of natural misfortunes does not invalidate consent that is given as a result. But what about when the coercive force comes from a third party, not from the person to whom consent would be proffered? Consider the following cases, drawn from the experiences of physicians and health researchers while obtaining informed consent. Teenager. A 16 year old male is participating as a healthy control in an epilepsy study. He is articulate and thoughtful, and clearly understands the study well. When asked why he agreed to participate he replies: "My mom thinks I should do the study while I'm here. If I don't, she'll be mad, so it's easier just to go along with it." 1 Depressive. Mr. R is blind and suffers from severe unipolar depression that has not responded to medication. His psychiatrist recommends electroconvulsive therapy. During discussion of the pros and cons of treatment, Mr. R confides that he is terrified of ECT, but his family have told him that they will not take care of him at home any longer unless he undergoes it. 2 Wife. A research team is recruiting participants for a genetic study of hypertension from patients who attend a health clinic in rural Nigeria. The first woman the researchers ask to participate tells them: "I have to talk to my husband. He makes those decisions." A day later she returns and says that she is willing to participate. 3 In this paper I analyze how threats from a third party affect consent. I argue that, as with other cases of coercion, we should distinguish threats that render consent invalid from threats whose force is too weak to invalidate consent and threats that are legitimate. Illegitimate controlling third party threats render consent invalid just as they do in two party cases. However, knowing that the consent is invalid is not sufficient to tell the recipient of consent what she may or should do. I argue that when presented with a token of consent from someone whom she thinks is experiencing an illegitimate controlling threat, the recipient may act on that token if and only if doing so represents a reasonable joint decision for her and the victim of coercion. The appropriate action for someone faced with third party coercion therefore depends on the other options open to her and those open to the victim of coercion. I close by applying my analysis to a case of consent to medical research. Coercion and Consent Recent philosophical analysis of the nature of coercion focuses on interpersonal threats. Though disagreements about some details remain, there is consensus that the paradigm case of coercion involves one person (the coercer) threatening to make another person (the
Journal of Empirical Research on Human Research Ethics, Dec 1, 2013
in response to the increasing need for research ethics expertise in low-and middleincome countrie... more in response to the increasing need for research ethics expertise in low-and middleincome countries (LMICs), the NIH's Fogarty International Research Ethics Education and Curriculum Development Program has provided grants for the development of training programs in international research ethics for LMIC professionals since 2000. This collection of papers draws upon the combined expertise of Fogarty grantees, trainees, and other experts to assess the state of research ethics in LMICs, and the lessons learned over 12 years of international research ethics education; to assess future needs; and to chart a way forward to meet those needs. In this introductory paper we briefly sketch the evolution of research ethics as applied to LMIC research, the underpinning and evolution of the Fogarty bioethics program, and summarize key conclusions from the other papers in the collection.
Journal of the American Dental Association, Apr 1, 2017
Background-Ethics in health care and research is based on the fundamental principle of informed c... more Background-Ethics in health care and research is based on the fundamental principle of informed consent. However, informed consent in geriatric dentistry is not well documented. Poor health, cognitive decline, and the passive nature of many geriatric patients complicate this issue.
The use of placebo controls in clinical trials remains controversial. Ethical analysis and intern... more The use of placebo controls in clinical trials remains controversial. Ethical analysis and international ethical guidance permit the use of placebo controls in randomized trials when scientifically indicated in four cases: (1) when there is no proven effective treatment for the condition under study; (2) when withholding treatment poses negligible risks to participants; (3) when there are compelling methodological reasons for using placebo, and withholding treatment does not pose a risk of serious harm to participants; and, more controversially, (4) when there are compelling methodological reasons for using placebo, and the research is intended to develop interventions that can be implemented in the population from which trial participants are drawn, and the trial does not require participants to forgo treatment they would otherwise receive. The concept of methodological reasons is essential to assessing the ethics of placebo controls in these controversial last two cases. This article sets out key considerations relevant to considering whether methodological reasons for a placebo control are compelling. Keywords Ethics; placebo control; randomized controlled trial Randomized, placebo controlled trials (PCTs) are widely considered to be the most rigorous method of evaluating the efficacy of treatment or prevention interventions. To be ethical, clinical research requires balancing rigorous science with the protection of human subjects. Most people accept the use of placebo controls in trials for conditions with no effective treatment. However, PCTs raise ethical concerns when a proven effective treatment exists, since randomizing subjects to a placebo exposes them to the potential harms of nontreatment. 1 The choice of a PCT design over other designs, such as active-controlled superiority or non-inferiority trials, therefore requires ethical justification. In this paper, we review ethically acceptable uses of placebo in randomized controlled trials and analyze how and when methodological reasons are compelling enough to justify placebo use.
DNA could play. 3 Instead, it is likely that the responsibility arises through the actions of the... more DNA could play. 3 Instead, it is likely that the responsibility arises through the actions of the father that causally contribute to the existence of a child. This is consistent with the voluntarist principle that restricts the acquisition of special responsibilities to voluntary actions. 4 However, it also leads to cases in which the assignment of parental responsibility looks unfair. Consider the following case. Accidental father Casual acquaintances Gaston and Loretta have sex. They use two forms of contraception: he uses a condom and she is taking the oral contraceptive pill. However, these methods are not 100% reliable and Loretta becomes pregnant. Upon learning this, Gaston recommends that she abort the fetus and offers to pay for an abortion. Further, he informs her, he has no intention of supporting a child if she brings the fetus to term. Nevertheless, Loretta decides that she wants the child, bears it, and sues Gaston for child support.
Waiting time is widely used in health and social policy to make resource allocation decisions, ye... more Waiting time is widely used in health and social policy to make resource allocation decisions, yet no general account of the moral significance of waiting time exists. We provide such an account. We argue that waiting time is not intrinsically morally significant, but its use is justified across a range of pretheoretically compelling scenarios. First, there is a duty of fairness prohibiting line cutting where a sufficiently just queue exists. Second, where candidates are in relevantly similar circumstances, allocating by waiting time is efficient, maximizes distribution equality relative to other Pareto efficient distributions, and approaches the fairness of an equiprobable lottery.
Research projects sponsored by rich countries or companies and carried out in developing countrie... more Research projects sponsored by rich countries or companies and carried out in developing countries are frequently described as exploitative. One important debate about the prevention of exploitation in research centers on whether and how clinical research in developing countries should be responsive to local health problems. This paper analyses the responsiveness debate and draws out more general lessons for how policy makers can prevent exploitation in various research contexts. There are two independent ways to do this in the face of entrenched power differences: to impose restrictions on the content of benefit-sharing arrangements, and to institute independent effective oversight. Which method should be chosen is highly dependent on context.
The International Bill of Rights enshrines a right to health, which includes a right to access es... more The International Bill of Rights enshrines a right to health, which includes a right to access essential medicines. This right frequently appears to conflict with the intellectual property regime that governs pharmaceutical patents. However, there is also a human right that protects creative works, including scientific productions. Does this right support intellectual property protections, even when they may negatively affect health? This article examines the recent attempt by the Committee on Economic, Social and Cultural Rights to resolve this issue and argues that it fails. This is problematic because it means defenders of the present patent regime can continue using human rights documents to support their position. I offer a new framework for resolving the problem by examining the values that underlie human rights. The relationship between intellectual property laws and the provision of new drugs to those who need them is contentious. Critics of the present patent system argue that the high prices supposed necessary to promote medical innovation prevent access to lifesaving drugs. Indeed, some maintain that this is a violation of the right to health recognised in international treaties. Others claim that intellectual property rights are similarly recognised by international treaties that protect the rights of authors. In November 2005, the Committee on Economic, Social and Cultural Rights issued a General Comment that attempted to clarify the relationship between the right to health and intellectual property (IP) rights. It strictly distinguishes human rights from IP rights, and thereby implies that the only human rights relevant to the access to medicines issue are those, like the right to health, which support universal access. This paper argues that the General Comment fails to demonstrate that there is no conflict within the human rights framework between a right to health and IP rights, thus leaving open the danger that human rights documents will be used to defend pharmaceutical patents. It proposes an alternative strategy that has the potential to resolve this problem by analysing the justifications for protecting creative products. A preliminary note on methodology is in order. This paper reaches its conclusions through ethical, not legal, analysis. Though it examines legal documents, the ultimate goal is not to draw conclusions about what the law is, but rather about what it ought (morally) to be. Consequently, I am concerned with the moral foundations of human rights claims, and my Competing interest: None declared.
Highly efficacious vaccines for covid-19 are now being distributed in high income countries. At t... more Highly efficacious vaccines for covid-19 are now being distributed in high income countries. At the same time, multinational covid-19 vaccine trials continue-and new trials are being planned-around the world. 1
Nearly 20 years ago, a series of trials evaluating shortcourse zidovudine for the prevention of m... more Nearly 20 years ago, a series of trials evaluating shortcourse zidovudine for the prevention of mother-tochild transmission of human immunodeficiency virus (HIV) provoked global controversy when the sponsors were accused of ethical double standards-conducting research on vulnerable developing country populations that would not be permitted in high-income countries. 1 Following this controversy, and responding to underrepresentation of developing countries in these debates, the Fogarty International Center at the National Institutes of Health (NIH) launched a grants program to support masters-level, socioculturally relevant training in research ethics in low-and middle-income countries (LMICs). Since the program began, the volume of research in LMICs and the funds devoted to global health have expanded substantially. 2,3 The majority of the research is still sponsored by institutions based in high-income countries, including pharmaceutical companies, governmental agencies like NIH, and private foundations. Some of the increase in LMIC-based research results from greater funding for diseases that affect people in these countries; some is a result of private companies seeking lower costs and patients naive to treatment. 2,4 New challenges have emerged, as LMICs increasingly must address the dual burden of communicable and noncommunicable diseases. New technologies, including widespread access to mobile phones and the decreasing cost of genomic analysis, have expanded the scope of research. Ethical controversies continue to arise, tarnishing the reputation of global health research and, in some countries, halting research altogether. In the face of these changes, grantees, program staff, and outside experts conducted a collaborative selfassessment of the Fogarty International Center program 12 years after its inception. Fourteen articles present this extensive evaluation. 5,6 The authors examine the state of research ethics in LMICs, summarize the lessons learned, identify future needs, and attempt to chart a way forward to address them. Despite significant progress, the mission of building research ethics capacity in LMICs is not finished. However, the landscape of research and research ethics is substantially different than in 2000. New approaches are needed to build on what has been achieved and respond to new challenges.
Estimates of the burden of disease assess the mortality and morbidity that affect a population by... more Estimates of the burden of disease assess the mortality and morbidity that affect a population by producing summary measures of health such as quality-adjusted life years (QALYs) and disability-adjusted life years (DALYs). These measures typically do not include stillbirths (fetal deaths occurring during the later stages of pregnancy or during labor) among the negative health outcomes they count. Priority setting decisions that rely on these measures are therefore likely to place little value on preventing the more than three million stillbirths that occur annually worldwide. In contrast, neonatal deaths, which occur in comparable numbers, have a substantial impact on burden of disease estimates and are commonly seen as a pressing health concern. In this paper we argue in favor of incorporating unintended fetal deaths that occur late in pregnancy into estimates of the burden of disease. Our argument is based on the similarity between late-term fetuses and newborn infants and the assumption that protecting newborns is important. We respond to four objections to counting stillbirths: (1) that fetuses are not yet part of the population and so their deaths should not be included in measures of population health; (2) that valuing the prevention of stillbirths will undermine women's reproductive rights; (3) that including stillbirths implies that miscarriages (fetal deaths early in pregnancy) should also be included; and (4) that birth itself is in fact ethically significant. We conclude that our proposal is ethically preferable to current practice and, if adopted, is likely to lead to improved decisions about health spending. Estimates of the burden of disease, such as the Global Burden of Disease Study (GBD), 1 attempt to assess the impact of mortality and morbidity as a result of disease by producing summary measures of population health that allow for comparisons between diseases and between regions. For instance, the GBD uses the disability-adjusted life year (DALY), which represents health lost to both death and disability using a common unit. Roughly speaking, one DALY represents the loss of one year of healthy life. While DALYs purport simply to represent health lost, they are also designed to be used for priority setting in the allocation of funds for research, treatment, and prevention, and have in fact been used for this purpose. 2 The fact that two diseases differ in the number of DALYs they create may be taken as a basis for prioritizing research into the disease that is associated with more; the fact that one health intervention averts more DALYs for the same cost than another may be used to justify prioritizing the first over the second within a public health care system. As DALYs were originally designed, and as they are currently implemented, they take into account the impact of disease on individuals starting at birth, but not on unborn fetuses. The
The vast majority of health research resources are used to study conditions that affect a small, ... more The vast majority of health research resources are used to study conditions that affect a small, advantaged portion of the global population. This distribution has been widely criticized as inequitable and threatens to exacerbate health disparities. However, there has been little systematic work on what individual health research funders ought to do in response. In this article, we analyze the general and special duties of research funders to the different populations that might benefit from health research. We assess how these duties apply to governmental, multilateral, nonprofit, and for-profit organizations. We thereby derive a framework for how different types of funders should take the beneficiaries of research into account when they allocate scarce research resources.
The idea that payment for research participation can be coercive appears widespread among researc... more The idea that payment for research participation can be coercive appears widespread among research ethics committee members, researchers, and regulatory bodies. Yet analysis of the concept of coercion by philosophers and bioethicists has mostly concluded that payment does not coerce, because coercion necessarily involves threats, not offers. In this article we aim to resolve this disagreement by distinguishing between two distinct but overlapping concepts of coercion. Consentundermining coercion marks out certain actions as impermissible and certain agreements as unenforceable. By contrast, coercion as subjection indicates a way in which someone's interests can be partially set back in virtue of being subject to another's foreign will. While offers of payment do not normally constitute consent-undermining coercion, they do sometimes constitute coercion as subjection. We offer an analysis of coercion as subjection and propose three possible practical responses to worries about the coerciveness of payment.
During the recent Ebola epidemic, some commentators and stakeholders argued that it would be unet... more During the recent Ebola epidemic, some commentators and stakeholders argued that it would be unethical to carry out a study that withheld a potential treatment from affected individuals with such a serious, untreatable disease. As a result, the initial trials of experimental treatments did not have control arms, despite important scientific reasons for their inclusion. In this paper, we consider whether the duty to rescue entails that it would be unethical to withhold an experimental treatment from patientparticipants with serious diseases for which there are no effective treatments, even when doing so is scientifically necessary to test the effectiveness of the treatment. We argue that the duty to rescue will rarely apply. The context of medical research also throws new light on the content of the duty to rescue, since the interests of future patients-who stand to benefit from the fruits of medical research-are relevant to whether the duty applies.
New medicines and vaccines are predominantly tested in high-income countries. However, as the COV... more New medicines and vaccines are predominantly tested in high-income countries. However, as the COVID-19 pandemic highlighted, the populations who can benefit from these interventions are not limited to these wealthier regions. One-third of novel Food and Drug Administration approved drugs, sponsored by large companies, treat infectious diseases like tuberculosis and HIV, which disproportionately affect low-income and middle-income countries (LMICs). The medicines for non-communicable diseases (NCDs) are also relevant to LMIC health needs, as over three-quarters of deaths from NCDs occur in LMICs. There are concerns clinical trial data may not extrapolate across geographical regions, as product effectiveness can vary substantially by region. The pentavalent rotavirus vaccine, for example, had markedly lower efficacy in LMICs. Efficacy variations have also been found for other vaccines and drugs. We argue there are strong ethical arguments for remedying some of this uneven distribution...
It is a commonplace that coercion by the recipient of consent renders that consent invalid. It is... more It is a commonplace that coercion by the recipient of consent renders that consent invalid. It is also commonly held that the pressure of natural misfortunes does not invalidate consent that is given as a result. But what about when the coercive force comes from a third party, not from the person to whom consent would be proffered? Consider the following cases, drawn from the experiences of physicians and health researchers while obtaining informed consent. Teenager. A 16 year old male is participating as a healthy control in an epilepsy study. He is articulate and thoughtful, and clearly understands the study well. When asked why he agreed to participate he replies: "My mom thinks I should do the study while I'm here. If I don't, she'll be mad, so it's easier just to go along with it." 1 Depressive. Mr. R is blind and suffers from severe unipolar depression that has not responded to medication. His psychiatrist recommends electroconvulsive therapy. During discussion of the pros and cons of treatment, Mr. R confides that he is terrified of ECT, but his family have told him that they will not take care of him at home any longer unless he undergoes it. 2 Wife. A research team is recruiting participants for a genetic study of hypertension from patients who attend a health clinic in rural Nigeria. The first woman the researchers ask to participate tells them: "I have to talk to my husband. He makes those decisions." A day later she returns and says that she is willing to participate. 3 In this paper I analyze how threats from a third party affect consent. I argue that, as with other cases of coercion, we should distinguish threats that render consent invalid from threats whose force is too weak to invalidate consent and threats that are legitimate. Illegitimate controlling third party threats render consent invalid just as they do in two party cases. However, knowing that the consent is invalid is not sufficient to tell the recipient of consent what she may or should do. I argue that when presented with a token of consent from someone whom she thinks is experiencing an illegitimate controlling threat, the recipient may act on that token if and only if doing so represents a reasonable joint decision for her and the victim of coercion. The appropriate action for someone faced with third party coercion therefore depends on the other options open to her and those open to the victim of coercion. I close by applying my analysis to a case of consent to medical research. Coercion and Consent Recent philosophical analysis of the nature of coercion focuses on interpersonal threats. Though disagreements about some details remain, there is consensus that the paradigm case of coercion involves one person (the coercer) threatening to make another person (the
Journal of Empirical Research on Human Research Ethics, Dec 1, 2013
in response to the increasing need for research ethics expertise in low-and middleincome countrie... more in response to the increasing need for research ethics expertise in low-and middleincome countries (LMICs), the NIH's Fogarty International Research Ethics Education and Curriculum Development Program has provided grants for the development of training programs in international research ethics for LMIC professionals since 2000. This collection of papers draws upon the combined expertise of Fogarty grantees, trainees, and other experts to assess the state of research ethics in LMICs, and the lessons learned over 12 years of international research ethics education; to assess future needs; and to chart a way forward to meet those needs. In this introductory paper we briefly sketch the evolution of research ethics as applied to LMIC research, the underpinning and evolution of the Fogarty bioethics program, and summarize key conclusions from the other papers in the collection.
Journal of the American Dental Association, Apr 1, 2017
Background-Ethics in health care and research is based on the fundamental principle of informed c... more Background-Ethics in health care and research is based on the fundamental principle of informed consent. However, informed consent in geriatric dentistry is not well documented. Poor health, cognitive decline, and the passive nature of many geriatric patients complicate this issue.
The use of placebo controls in clinical trials remains controversial. Ethical analysis and intern... more The use of placebo controls in clinical trials remains controversial. Ethical analysis and international ethical guidance permit the use of placebo controls in randomized trials when scientifically indicated in four cases: (1) when there is no proven effective treatment for the condition under study; (2) when withholding treatment poses negligible risks to participants; (3) when there are compelling methodological reasons for using placebo, and withholding treatment does not pose a risk of serious harm to participants; and, more controversially, (4) when there are compelling methodological reasons for using placebo, and the research is intended to develop interventions that can be implemented in the population from which trial participants are drawn, and the trial does not require participants to forgo treatment they would otherwise receive. The concept of methodological reasons is essential to assessing the ethics of placebo controls in these controversial last two cases. This article sets out key considerations relevant to considering whether methodological reasons for a placebo control are compelling. Keywords Ethics; placebo control; randomized controlled trial Randomized, placebo controlled trials (PCTs) are widely considered to be the most rigorous method of evaluating the efficacy of treatment or prevention interventions. To be ethical, clinical research requires balancing rigorous science with the protection of human subjects. Most people accept the use of placebo controls in trials for conditions with no effective treatment. However, PCTs raise ethical concerns when a proven effective treatment exists, since randomizing subjects to a placebo exposes them to the potential harms of nontreatment. 1 The choice of a PCT design over other designs, such as active-controlled superiority or non-inferiority trials, therefore requires ethical justification. In this paper, we review ethically acceptable uses of placebo in randomized controlled trials and analyze how and when methodological reasons are compelling enough to justify placebo use.
Uploads
Papers by Joseph Millum