Public health ethics, like the field of public health it addresses, traditionally has focused more on practice and particular cases than on theory, with the result that some concepts, methods, and boundaries remain largely undefined. This paper attempts to provide a rough conceptual map of the terrain of public health ethics. We begin by briefly defining public health and identifying general features of the field that are particularly relevant for a discussion of public health ethics.Public health is primarily concerned with (...) the health of the entire population, rather than the health of individuals. Its features include an emphasis on the promotion of health and the prevention of disease and disability; the collection and use of epidemiological data, population surveillance, and other forms of empirical quantitative assessment; a recognition of the multidimensional nature of the determinants of health; and a focus on the complex interactions of many factors—biological, behavioral, social, and environmental—in developing effective interventions. (shrink)

No consensus yet exists on how to handle incidental fnd-ings in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are fndings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers (...) have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed. (shrink)

BackgroundEthics review is the process of assessing the ethics of research involving humans. The Ethics Review Committee is the key oversight mechanism designated to ensure ethics review. Whether or not this governance mechanism is still fit for purpose in the data-driven research context remains a debated issue among research ethics experts.Main textIn this article, we seek to address this issue in a twofold manner. First, we review the strengths and weaknesses of ERCs in ensuring ethical oversight. Second, we map these (...) strengths and weaknesses onto specific challenges raised by big data research. We distinguish two categories of potential weakness. The first category concerns persistent weaknesses, i.e., those which are not specific to big data research, but may be exacerbated by it. The second category concerns novel weaknesses, i.e., those which are created by and inherent to big data projects. Within this second category, we further distinguish between purview weaknesses related to the ERC’s scope and functional weaknesses, related to the ERC’s way of operating. Based on this analysis, we propose reforms aimed at improving the oversight capacity of ERCs in the era of big data science.ConclusionsWe believe the oversight mechanism could benefit from these reforms because they will help to overcome data-intensive research challenges and consequently benefit research at large. (shrink)

While the bioethics literature demonstrates that the field has spent substantial time and thought over the last four decades on the goals, methods, and desired outcomes for service and training in bioethics, there has been less progress defining the nature and goals of bioethics research and scholarship. This gap makes it difficult both to describe the breadth and depth of these areas of bioethics and, importantly, to gauge their success. However, the gap also presents us with an opportunity to define (...) this scope of work for ourselves and to help shape the broader conversation about the impact of academic research. Because of growing constraints on academic funding, researchers and scholars in many fields are being asked to demonstrate and also forecast the value and impact of their work. To do that, and also to satisfy ourselves that our work has meaningful effect, we must understand how our work can motivate change and how that change can be meaningfully measured. In a field as diverse as bioethics, the pathways to and metrics of change will likewise be diverse. It is therefore critical that any assessment of the impact of bioethics research and scholarship be informed by an understanding of the nature of the work, its goals, and how those goals can and ought to be furthered. In this paper, we propose a conceptual model that connects individual bioethics projects to the broader goals of scholarship, describing the translation of research and scholarly output into changes in thinking, practice, and policy. One of the key implications of the model is that impact in bioethics is generally the result of a collection of projects rather than of any single piece of research or scholarship. Our goal is to lay the groundwork for a thoroughgoing conversation about bioethics research and scholarship that will advance and shape the important conversation about their impact. (shrink)

Beyond Consent examines the concept of justice, and its application to human subject research, through the different lenses of various research populations: children, the vulnerable sick, captive and convenient populations, women, people of colour, and subjects in international settings. Separate chapters address the evolution of research policies, implications of the concept of justice for the future of human subject research, and the ramifications of this concept throughout the research enterprise.

Public health raises critical ethics issues and concerns, making public heath ethics an essential topic for students and public health professionals. The 73 chapters in this volume examine public health ethics across a broad range of public health topics both in the U.S. and globally. It is the first ever comprehensive collection devoted to public health ethics.

Nanomedicine is yielding new and improved treatments and diagnostics for a range of diseases and disorders. Nanomedicine applications incorporate materials and components with nanoscale dimensions where novel physiochemical properties emerge as a result of size-dependent phenomena and high surface-to-mass ratio. Nanotherapeutics and in vivo nanodiagnostics are a subset of nanomedicine products that enter the human body. These include drugs, biological products, implantable medical devices, and combination products that are designed to function in the body in ways unachievable at larger scales. (...) Nanotherapeutics andin vivonanodiagnostics incorporate materials that are engineered at the nanoscale to express novel properties that are medicinally useful. These nanomedicine applications can also contain nanomaterials that are biologically active, producing interactions that depend on biological triggers. Examples include nanoscale formulations of insoluble drugs to improve bioavailability and pharmacokinetics, drugs encapsulated in hollow nanoparticles with the ability to target and cross cellular and tissue membranes and to release their payload at a specific time or location, imaging agents that demonstrate novel optical properties to aid in locating micrometastases, and antimicrobial and drug-eluting components or coatings of implantable medical devices such as stents. (shrink)

: Pharmacogenetics offers the prospect of an era of safer and more effective drugs, as well as more individualized use of drug therapies. Before the benefits of pharmacogenetics can be realized, the ethical issues that arise in research and clinical application of pharmacogenetic technologies must be addressed. The ethical issues raised by pharmacogenetics can be addressed under six headings: regulatory oversight, confidentiality and privacy, informed consent, availability of drugs, access, and clinicians' changing responsibilities in the era of pharmacogenetic medicine. We (...) analyze each of these categories of ethical issues and provide policy approaches for addressing them. (shrink)

The Institute of Medicine (IOM) Committee on the Necessity of the Use of Chimpanzees in Biomedical and Behavioral Research made a series of recommendations that, as of an announcement on June 26, 2013, the National Institutes of Health (NIH) is turning into implemented guidelines. Many advocates, including some researchers and scholars, have suggested that the Committee’s recommendations could be applied successfully to other animal species. This article examines, from my perspective as the IOM Committee’s chair, some of the most important (...) features of the Committee’s work, addresses whether chimpanzees represent a special or unique case for the purpose of research policy, and suggests an approach for evaluating the applicability of the Committee’s recommendations for other animal species used in research. I first present my perspective on the features of the Committee’s work that influenced its approach and conclusions. I then argue that despite the fact that chimpanzees represent a somewhat unique case for restricted research use, their case still offers important lessons for policy regarding the use of other species. Finally, I offer some observations regarding the recommendations and implications of the report from the NIH Working Group charged with crafting guidelines for implementing the IOM Committee’s recommendations. (shrink)

Successful preimplantation genetic diagnosis to avoid creating a child affected by a genetically-based disorder was reported in 1989. Since then PGD has been used to biopsy and analyze embryos created through in viuo fertilization to avoid transferring to the mother’s uterus an embryo affected by a mutation or chromosomal abnormality associated with serious illness. PGD to avoid serious and early-onset illness in the child-to-be is widely accepted. PGD prevents gestation of an affected embryo and reduces the chance that the parents (...) will be faced with a difficult decision of whether to terminate the pregnancy. More controversial have been PGD to select the sex of the child-to-be for “family balancing”, PGD for mere susceptibility to disease and for late-onset disorders such as Alzheimer diseas, and most controversially, PGD to create a donor child who is Human Leukocyte Antigen (HLA-matched with a preexisting sibling in need of stem cell transplant. (shrink)

Successful preimplantation genetic diagnosis to avoid creating a child affected by a genetically-based disorder was reported in 1989. Since then PGD has been used to biopsy and analyze embryos created through in viuo fertilization to avoid transferring to the mother’s uterus an embryo affected by a mutation or chromosomal abnormality associated with serious illness. PGD to avoid serious and early-onset illness in the child-to-be is widely accepted. PGD prevents gestation of an affected embryo and reduces the chance that the parents (...) will be faced with a difficult decision of whether to terminate the pregnancy. More controversial have been PGD to select the sex of the child-to-be for “family balancing”, PGD for mere susceptibility to disease and for late-onset disorders such as Alzheimer diseas, and most controversially, PGD to create a donor child who is Human Leukocyte Antigen (HLA-matched with a preexisting sibling in need of stem cell transplant. (shrink)

: 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 reproductive technologies. (shrink)

: The supply of organs for transplant remains inadequate to meet the needs of waiting patients, in spite of many programs and approaches to increase rates of donation. Over the years there have been numerous proposals to introduce schemes that would move toward the outright sale of organs. Three articles in this issue of the Journal propose methods for increasing organ supply—two by moving toward a market approach and the third by advocating a change in social culture. All three suffer (...) from shortcomings, including the endorsement and encouragement of the exploitation of those who may offer organs. Although the shortage of organs must be addressed, the social price of a market in organs is too high, and proposals to encourage a rethinking of social responsibility are unlikely to be effective. (shrink)

Predictive genetic testing poses fundamental questions for disability insurance, a crucial resource funding basic needs when disability prevents income from work. This article, from an NIH-funded project, presents the first indepth analysis of the challenging issues: Should disability insurers be permitted to consider genetics and exclude predicted disability? May disabilities with a recognized genetic basis be excluded from coverage as pre-existing conditions? How can we assure that private insurers writing individual and group policies, employers, and public insurers deal competently and (...) appropriately with genetic testing? (shrink)

Epidemiology is a core science of public health, focusing on research related to the distribution and determinants of both positive and adverse health states and events and on application of knowledge gained to improve public health. The American College of Epidemiology (ACE) is a professional organization devoted to the professional practice of epidemiology. As part of that commitment, and in response to concerns for more explicit attention to core values and duties of epidemiologists in light of emerging issues and increased (...) scrutiny of epidemiology, the College developed, adopted, and published a set of Ethics Guidelines. The structure of the ACE ethics guidelines is in four parts: (1) a brief statement of core values and duties of epidemiologists, coupled with the virtues important to professional practice; (2) concise statements of key duties and obligations; (3) exposition of the duties and obligations with more applications; and (4) a brief summary and conclusion. The Guidelines have been published on the ACE website and in the official College journal Annals of Epidemiology. The guidelines contain (and maintain) core elements that define the discipline of epidemiology and its fundamental duties, but they are also intended to be dynamic and evolving, responsive to a changing professional and social environment. (shrink)

Genetic testing poses fundamental questions for insurance. Testing can predict a low probability of future illness and disability, which can help promote the insurability of individuals with a family history of genetic risk, but it can also invite insurers to reject applicants, increase premiums, exclude people with certain illnesses and disabilities, and otherwise adjust the underwriting processes for individuals with certain genotypes. In the workplace, these issues may cause employers who offer or pay for insurance to alter their hiring behavior, (...) either by selecting those with desirable genetic makeup or rejecting, dismissing, or reassigning those who carry an unwanted risk, ultimately threatening employability and the safety net that insurance is intended to provide. (shrink)

Lainie Ross, in her article in this issue, criticizes on ethical grounds a number of factors in the University of Minnesota program that allows unrelated strangers to donate kidneys for transplant. I have to admit that when the transplant center at the University proposed allowing the practice of what came to be called nondirected donation, I was skeptical about a number of the same issues that trouble Dr. Ross. But as my colleagues and I examined and discussed the ethics of (...) such a plan, along with the risks to prospective donors, their possible motivations, and the logistics of performing the surgeries under conditions of anonymity between donor and recipient, among other factors, we came to believe that such donations can be ethically acceptable. As a product of frequent meetings over the course of a year in advance of the first nondirected donation, we set out to craft a process that would first and foremost meet the test of an ethical approach to organ donation and transplant, the description of which was published in the New England Journal of Medicine in August 2000. (shrink)

At its core, public health introduces tensions between individuals' autonomy and the need to account for the perspectives and needs of communities and populations. It further raises social justice issues, including fair allocation of limited resources. This article examines and elaborates on these tensions and their resolutions using specific public health examples. Experiences in the 1980s and 1990s with HIV/AIDS provide a particularly rich collection of issues that brought ethical issues in public health to the public's attention, and in so (...) doing challenged previously held assumptions about the appropriate consideration of individual rights in the context of population health objectives. Lastly, the article examines some of the ethical challenges arising in public health applications of recent science and technology advances, specifically the emerging area of public health genomics and the large scale collection and analysis of health information. (shrink)

Successful preimplantation genetic diagnosis to avoid creating a child affected by a genetically-based disorder was reported in 1989. Since then PGD has been used to biopsy and analyze embryos created through in viuo fertilization to avoid transferring to the mother’s uterus an embryo affected by a mutation or chromosomal abnormality associated with serious illness. PGD to avoid serious and early-onset illness in the child-to-be is widely accepted. PGD prevents gestation of an affected embryo and reduces the chance that the parents (...) will be faced with a difficult decision of whether to terminate the pregnancy. More controversial have been PGD to select the sex of the child-to-be for “family balancing”, PGD for mere susceptibility to disease and for late-onset disorders such as Alzheimer diseas, and most controversially, PGD to create a donor child who is Human Leukocyte Antigen (HLA-matched with a preexisting sibling in need of stem cell transplant. (shrink)

At a White House ceremony in October 1995, the Advisory Committee on Human Radiation Experiments presented its Final Report to President Bill Clinton. The 925-page report and the over 2,000 pages of supplemental volumes summarized eighteen months of investigative research, debate, and deliberation on historical and contemporary issues in human subjects research. The Advisory Committee's efforts were aided by unprecedented support from the highest levels of the executive branch, including the heads of eight cabinet-level agencies and their departments' resources. The (...) presidentially appointed committee and its staff delved into long-forgotten Cold Warera government archives, listened to hours of public testimony, interviewed key players in the development of medical therapies and nuclear weapons, and studied ethical issues arising in today's research.In this article we focus on a critical, but narrowly defined, part of the Advisory Committee's Final Report: remedying harms or wrongs to subjects of human radiation experiments conducted or sponsored by the U.S. government between 1944 and 1974. (shrink)

This book is a rich blend of analyses by leading experts from various cultures and disciplines. A compact introduction to a complex field, it illustrates biotechnology's profound impact upon the environment and society. Moreover, it underscores the vital relevance of cultural values. This book empowers readers to more critically assess biotechnology's value and effectiveness within both specific cultural and global contexts.

At a White House ceremony in October 1995, the Advisory Committee on Human Radiation Experiments presented its Final Report to President Bill Clinton. The 925-page report and the over 2,000 pages of supplemental volumes summarized eighteen months of investigative research, debate, and deliberation on historical and contemporary issues in human subjects research. The Advisory Committee's efforts were aided by unprecedented support from the highest levels of the executive branch, including the heads of eight cabinet-level agencies and their departments' resources. The (...) presidentially appointed committee and its staff delved into long-forgotten Cold Warera government archives, listened to hours of public testimony, interviewed key players in the development of medical therapies and nuclear weapons, and studied ethical issues arising in today's research.In this article we focus on a critical, but narrowly defined, part of the Advisory Committee's Final Report: remedying harms or wrongs to subjects of human radiation experiments conducted or sponsored by the U.S. government between 1944 and 1974. (shrink)

This commentary asks what we can learn from our oversight of controversial science and how can we do better in the future? After briefly examining the history of gene transfer research oversight, some observations are offered for the oversight of nanobiotechnology and other emerging areas of science.