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This chapter focuses on informed consent, which is a central concept and practice in the protection of the rights and interests of both patients receiving clinical care and individuals participating in research. It addresses the commitment to the ethical principles underlying informed consent that dates back to the early twentieth century, as reflected in many countries' laws governing the physician–patient relationship. It also recounts how informed consent was codified into national policies and international guidelines and standards for research on human subjects. The chapter explores the parallel origins of informed consent and its applications, which are based on distinctions between clinical practice and research and do not naturally apply to or readily translate to epidemiology. It outlines the requirements for consent that have been and are treated differently in epidemiology depending on the type of activity and sometimes the practicability of seeking consent from participants.

In the early days of a pandemic, repurposing biospecimens from established research projects could prove to be extraordinarily useful in achieving substantial and timely public health benefits. Nonetheless, there are potential ethical and regulatory uncertainties that may impede access to those valuable biospecimens. In this article, we argue that there should be a presumption in favor of using previously collected identifiable research biospecimens without reconsent to directly address an infectious disease pandemic, assuming certain conditions are met. This argument fills a unique yet critical gap in decision‐making where the specific consent accompanying the identifiable biospecimens would not otherwise permit repurposing. Further, it suggests that even if gaining reconsent is feasible, doing so in a fast‐moving crisis is not necessary. This analysis also attempts to address the ethical concerns of public health authorities who already may have the power to use such specimens but are reluctant to do so.

Congenital bilateral renal agenesis has been considered a uniformly fatal condition. However, the report of using serial amnioinfusions followed by the live birth in 2012 and ongoing survival of a child with bilateral renal agenesis has generated hope, but also considerable controversy over an array of complex clinical and ethical concerns. To assess the ethical concerns associated with using serial amnioinfusions for bilateral renal agenesis, we assembled a multidisciplinary group to map the ethical issues relevant to this novel intervention. The key ethical issues identified were related to 1) potential risks and benefits, 2) clinical care compared with innovation compared with research, 3) counseling of expectant parents, 4) consent, 5) outcome measures, 6) access and justice, 7) conflicts of interest, 8) effects on clinicians, 9) effects on institutions, and 10) long-term societal implications. These ethical issues should be addressed in conjunction with systematic efforts to examine whether this intervention is safe and effective. Future work should capture the experiences of expectant parents, women who undergo serial amnioinfusions, those born with bilateral renal agenesis and their families as well as clinicians confronted with making difficult choices related to it.

We evaluate Peter Adler’s challenge to the Centers for Disease Control and Prevention (cdc) draft recommendations on male circumcision (this issue, see pp. 237–262). Thecdcadvocates elective male circumcision (mc) to improve public health in theusabased on strong scientific evidence. In marked contrast to thecdc, Adler’s criticisms depend on speculative claims and obfuscation of the scientific data. Adler’s central argument that circumcision in infancy should be delayed to allow a boy to make up his own mind as an adult fails to appreciate that circumcision later in life is a more complex operation, entails higher risk, is more likely to involve general anaesthesia and presents financial, psychological and organisational barriers. These limitations are avoided by circumcision early in infancy, when it is convenient, safe, quick, low risk, usually involves local anaesthesia and provides benefits immediately. Benefits of male circumcision include: protection against: urinary tract infections that are ten times higher in uncircumcised infants; inflammatory skin conditions; other foreskin problems; sexually transmitted infections and genital cancers in the male and his female sexual partners. Circumcision during infancy is also associated with faster healing and improved cosmetic outcomes. Circumcision does not impair sexual function or pleasure. Some authorities regard the failure to offer circumcision as unethical, just as it would be unethical to fail to encourage paediatric vaccination. Since the benefits vastly outweigh the risks, each intervention is in the best interests of the child. In conclusion, Adler’s criticisms of thecdc’s evidence-based male circumcision policy are flawed scientifically, ethically and legally, and should be dismissed as endangering public health and individual well-being.

Objective Concerns about including pregnant women in research have led to a dearth of evidence to guide safe and effective treatment and prevention of HIV in pregnancy. To better understand why these evidence gaps persist and inform guidance for responsible inclusion of pregnant women in the HIV research agenda, we aimed to learn what HIV experts perceive as barriers and constraints to conducting this research. Methods We conducted a series of group and one-on-one consultations with 62 HIV investigators and clinicians to elicit their views and experiences conducting HIV research involving pregnant women. Thematic analysis was used to identify priorities and perceived barriers to HIV research with pregnant women. Results Experts discussed a breadth of needed research, including safety, efficacy, and appropriate dosing of: newer antiretrovirals for pregnant women, emerging preventive strategies, and treatment for coinfections. Challenges to conducting research on pregnancy and HIV included ethical concerns, such as how to weigh risks and benefits in pregnancy; legal concerns, such as restrictive interpretations of current regulations and liability issues; financial and professional disincentives, including misaligned funder priorities and fear of reputational damage; and analytical and logistical complexities, such as challenges recruiting and retaining pregnant women to sufficiently power analyses. Conclusion Investigators face numerous challenges to conducting needed HIV research with pregnant women. Advancing such research will require clearer guidance regarding ethical and legal uncertainties; incentives that encourage rather than discourage investigators to undertake such research; and a commitment to earlier development of safety and efficacy data through creative trial designs.

HIV/AIDS is among the most serious diseases confronting women who are pregnant. It is also one of the few areas of research involving humans where there is a long track record of research involving pregnant women. Yet the HIV/AIDS research community has struggled to expand the research agenda from research to prevent mother-to-child transmission of HIV to research encompassing issues pertaining to the pregnant woman’s own health. Research questions of interest include: which antiretrovirals are safest and most effective for pregnant women; how best to pursue preventive regimes for pregnant women who are not infected; or, how to treat HIV’s deadly co-infections, such as tuberculosis (TB), during pregnancy. In this chapter, we describe two key lessons about research in pregnancy from the context of HIV/AIDS: first, why addressing the health needs of pregnant women, not just the needs of their offspring, is so critical; and second, why doing so is immediately possible, even as we work to resolve certain ethical and regulatory debates, particularly about when it is appropriate to impose foetal risk without the prospect of foetal benefit. In particular, the HIV/AIDS context shows how treatment or prevention of maternal disease often entails not just risk – but the prospect of benefit – to the foetus; and creative trial designs can advance no-benefit studies without imposing foetal risk in the first place. For all the challenges that research with pregnant women entails, the HIV/AIDS context reveals that it is possible to conduct a wide range of important research during pregnancy that is both ethically responsible and consonant with US regulations.

The legal case of Grimes v. Kennedy Krieger Institute, Inc, has raised concerns in the public health research community regarding the acceptable level of risk in research involving children, parental authority for informed consent, and exploitation of research subjects for the benefit of public health. We provide an overview of the case and discuss the impact of the court's decision and its possible effect on future research protection policies and practices. (Am J Public Health. 2002;92:1073–1076)

30 (2002): 170 –178.© 2002 by the American Society of Law, Medicine & Ethics.ublic health ethics, like the field of public health itaddresses, traditionally has focused more on practiceand particular cases than on theory, with the resultthat some concepts, methods, and boundaries remain largelyundefined. This paper attempts to provide a rough concep-tual map of the terrain of public health ethics. We begin bybriefly defining public health and identifying general fea-tures of the field that are particularly relevant for a discussionof public health ethics.Public health is primarily concerned with the health ofthe entire population, rather than the health of individuals.Its features include an emphasis on the promotion of healthand the prevention of disease and disability; the collectionand use of epidemiological data, population surveillance,and other forms of empirical quantitative assessment; a rec-ognition of the multidimensional nature of the determinantsof health; and a focus on the complex interactions of manyfactors — biological, behavioral, social, and environmental— in developing effective interventions.How can we distinguish public health from medicine?While medicine focuses on the treatment and cure of indi-vidual patients, public health aims to understand andameliorate the causes of disease and disability in a popula-tion. In addition, whereas the physician-patient relationshipis at the center of medicine, public health involves interac-tions and relationships among many professionals andmembers of the community as well as agencies of govern-ment in the development, implementation, and assessmentof interventions. From this starting point, we can suggestthat public health systems consist of all the people and ac-tions, including laws, policies, practices, and activities, thathave the primary purpose of protecting and improving thehealth of the public.

Personal health data supplied by users of mobile devices, health apps, and the social Web and data from tracking of consumers’ online behavior — coupled with advanced bioinformatics tools — offer opportunities for use in health research. A central ethical question is whether individuals who have provided personal information online in nonresearch contexts have consented to research uses. Here, we explore this issue of informed consent, discuss some limitations of current practices, and offer recommendations for improving consent practices through a more tailored, context-sensitive approach that makes use of the dynamism of the Web-based context. Our proposals are rooted in the ethical imperative of protecting individual rights and respecting autonomy while enabling a dynamic research environment for the advancement of clinical medicine and public health.

To force potential parents to tell their child of his/her genetic origin as a requirement for admission into an infertility programme is both wrong and discriminatory. In addition, comparing the practice of using donor gametes to conceive a child with adoption is incorrect for a number of reasons. In this article we make the argument that mandatory disclosure is both inappropriate and intrusive, and the presently available data do not justify a rigid position. Furthermore, no reasonable, practical system can be envisaged to guarantee compliance with mandatory disclosure. Although it is entirely reasonable at the time of consultation to encourage couples to consider their positions and obtain a mutual agreement on their future intent prior to treatment, the final decision on this should be a matter of free choice within the context of the couple's own value system.

Purpose State laws concerning decision-making authority for voluntary inpatient substance abuse (SA) treatment of minors may be a potential barrier to appropriate treatment. We sought to identify and classify relevant laws related to the provision of voluntary inpatient SA treatment to adolescents 12 to 17 years (minors) as an exploratory assessment to improve understanding of how these laws might affect treatment decisions. Methods In summer 2006, we conducted a survey of statutes, regulations, and legal cases in the 50 states and the District of Columbia regarding the authority of parents (or guardians) and minors to make treatment decisions for voluntary inpatient SA treatment. Results All 50 states have laws applicable to voluntary inpatient SA treatment for adolescents, and the laws vary significantly throughout the nation. If a minor and parent disagree about SA treatment, some states defer to the decision-making authority of the minor, whereas other states defer to the parent. Most significantly, the majority of states fail to specify whether the minor's or the parent's decision will control in the event of a conflict. Conclusions The lack of clarity in state laws regarding decision-making authority for voluntary inpatient SA treatment of minors may create a potential barrier to treatment for adolescents, especially those with more serious SA problems. This lack of clarity could lead to confusion among parents, adolescents, healthcare professionals, and treatment facilities, and ultimately could result in a failure to treat adolescents in need of medical attention. Policymakers should ensure that state laws clearly specify procedures to enable treatment if a conflict arises between adolescents and parents, including procedures to ensure that the due process rights of adolescents are protected.

During the nearly 10 years since its introduction, preimplantation genetic diagnosis (PGD) has been used predominantly to avoid giving birth to a child with identified genetic disease. Recently, PGD was used by a couple not only to test IVF-created embryos for genetic disease, but also to test for a nondisease trait related to immune compatibility with a child in the family in need of an hematopoetic stem cell transplant. This article describes the case, raises some ethical and policy issues, highlights gaps in U.S. policy, and finally makes some recommendations for addressing advancing genetic and reproduc- tive technologies.

In the spring of 2009, a number of U.S. schools closed in response to government health directives designed to prevent the transmission of the contagious respiratory influenza virus known as H1N1. Thousands of children were asked to stay home and avoid congregating in groups. Public health authorities asked ill workers to stay home. As spring stretched into summer, camps sent symptomatic children home. The traditional public health containment strategy known as "social distancing" has rippled throughout affected communities. Parents have been forced to risk their jobs, take unpaid leave, or use limited sick leave to care for housebound children. Children who typically rely on school or camp meal programs have gone without. Local businesses have suffered when workers and shoppers stayed home. These experiences are now being repeated in the southern hemisphere as H1N1 moves south, but with the added burdens and complications that come with the more limited infrastructures and fewer resources of the developing world. The public health efforts to stem a flu outbreak have potentially serious social ramifications. More importantly--and seemingly overlooked in pandemic planning for a virus such as H1N1--social context has major implications for the potential effectiveness of public health strategies to minimize morbidity and mortality and prevent the further spread of disease. For example, an undocumented restaurant worker receiving low wages and lacking job security and health benefits may have no real choice but to continue working through an illness, and may avoid seeking medical attention that he cannot afford and fears might lead to deportation. The worker's life situation makes it both impractical and inadvisable to respond to well-intentioned but unrealistic public health directives, putting both restaurant workers and diners at risk of infection. Policies that fail to take into account the realities of individuals' lives and the social contexts in which they live cannot hope to succeed. The accomplishment of the public health goal of minimizing the effects of outbreaks may depend in significant part on social vulnerabilities that affect an individual's or community's capacity to respond to public health directives. Vulnerabilities and Social Contexts Little attention has been given to the impact of social vulnerabilities on the effectiveness of public health preparedness strategies, a shortcoming in both policy-making and in how we think about the ethics of public health. How should we incorporate thinking about social vulnerability into pandemic planning? How should we account for social capacity to respond to directives designed to prevent the spread of disease? Whose responsibility is it to address those social barriers? Failure to account for social vulnerability may doom a prevention effort and may lead to long-lasting distrust of the public health system and of government generally in the affected population. As in other areas of health policy, pandemic flu planning may acknowledge vulnerability, but by using a categorical approach based on membership in an identifiable population subgroup. For instance, policy guidelines and scholarly work have referenced readily identifiable subgroups as more vulnerable in determining priorities for distribution of scarce vaccines and antivirals. In shortages of seasonal flu vaccine, those over sixty-five years of age typically receive priority in vaccine distribution because of their vulnerability to severe medical consequences. More recently, antivirals were recommended for treatment of H1N1-infected pregnant women as a priority group. While this categorical approach may be well meaning, the broad grouping of populations may mask social vulnerabilities that require special attention, such as improved access to health care and appropriately targeted directives. Broadly defined categories of vulnerability tend both to exclude people who belong in them and include people who do not. …