In lieu of an abstract, here is a brief excerpt of the content:IntroductionAnna Mastroianni (bio) and Jeffrey Kahn (bio)In this issue of the Kennedy Institute of Ethics Journal, we subject the work of the Advisory Committee on Human Radiation Experiments to examination from many angles. Nearly one year has passed since the release of the Committee’s final report and recommendations, and it seems an appropriate time to invite discourse and reflection on the influence and impact of the Committee (...) and its efforts. Our intent is to advance understanding of the Committee and its work, its place in the evolution of bioethics and public policy, as well as the broader legacy of restoring trust in the conduct of human subjects research.In 1993, President Clinton and Secretary of Energy Hazel O’Leary initiated an investigation of America’s involvement in radiation experiments on its citizens during the Cold War. The investigation resulted in the appointment of the Committee in January 1994. Some issues raised by these radiation experiments were brought to the attention of the nation by revelations contained in a Pulitzer Prize-winning series of newspaper stories about plutonium injections carried out by the government on allegedly unsuspecting subjects during the Cold War. The Committee faced a broad mandate, which included piecing together the history of Cold War radiation experiments and human subjects research, as well as recommending remedies for past wrongs and mechanisms to ensure that such wrongs could not be repeated in the future.This issue of the Journal consists of articles and accompanying commentaries on historical, philosophical, policy, and political aspects of the Committee’s work that are important to bioethics. This collection of articles, authored by Committee members, staff, and leading scholars, is designed to paint a picture of the breadth and complexity of the Committee’s efforts and to provide context and to stimulate discussion of significant issues.In the first article, Ruth Faden provides her unique perspective as chair of the Committee. She goes beyond the necessary overview and background of the Committee to reflect on the impact and meaning of the Committee’s work to bioethics and public policy.Much of the Committee’s effort was directed at gathering and uncovering information about the history of Cold War radiation experiments, an endeavor fairly foreign to bioethics but critically important to understanding the context in which to make moral judgments about the past. Jonathan Moreno and Susan Lederer discuss how the Committee’s work changed some of the traditional views of the history of research ethics. The commentary by Allan Brandt and Lara Freidenfelds further illuminates the value of understanding this recovered history. [End Page ix]In making moral judgments about the past, the Committee confronted complex questions about how to assess wrongdoing and the culpability of the government and its agents. Allen Buchanan explains why this was such a difficult but crucial task and how the Committee worked through some of the answers to these questions. His discussion illustrates the challenges to consensus in the committee decision-making process described in Ruth Macklin’s article in this issue on committees and consensus. Tom Beauchamp analyzes the frameworks for making retrospective moral judgments developed by two committees, the Advisory Committee and the University of California at San Francisco Ad Hoc Fact Finding Committee on World War II Human Radiation Experiments, and critiques their applications of the frameworks in the case of the plutonium injection experiments.The Committee recognized that in order to prevent wrongs seen in the past from occurring in the future, it would be necessary to understand the human subjects protections now in place. Nancy Kass and Jeremy Sugarman discuss the results of the Committee’s attempts to measure the operation and effectiveness of the current system for protection of human subjects. Paul Appelbaum comments on the relevance and value of the Committee’s empirical projects to contemporary human subjects research.The Committee’s work, and the products of any commission’s work, must be viewed partly in light of the place of commissions in bioethics scholarship and policymaking. Appointed commissions can have significant impacts on scholarly and public thinking, policymaking, and future direction, and bring high visibility to issues. It is important to realize that the conclusions of the Committee... (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.

Federal policies on human subjects research have undergone a progressive transformation. In the early decades of the twentieth century, federal policies largely relied on the discretion of investigators to decide when and how to conduct research. This approach gradually gave way to policies that augmented investigator discretion with externally imposed protections. We may now be entering an era of even more stringent external protections. Whether the new policies effectively absolve investigators of personal responsibility for conducting ethical research, and whether it (...) is wise to do so, remains to be seen. (shrink)

A couple may have a child to provide stem cells for another child. They may also use preimplantation testing—even, troubling though it is, prenatal testing and selective abortion—to ensure a close tissue match.

Federal policies on human subjects research have undergone a progressive transformation. In the early decades of the twentieth century, federal policies largely relied on the discretion of investigators to decide when and how to conduct research. This approach gradually gave way to policies that augmented investigator discretion with externally imposed protections. We may now be entering an era of even more stringent external protections. Whether the new policies effectively absolve investigators of personal responsibility for conducting ethical research, and whether it (...) is wise to do so, remains to be seen. (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)

: 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)

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)

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)

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)

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)

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)

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.

I had the privilege of chairing the Institute of Medicine Committee on the Necessity of Chimpanzees in Biomedical and Behavioral Research in 2011, an effort that has lessons not only about the questions presented to it, but also about the policy and practice of the use of chimpanzees in research and about animal research policy in general. In this essay I will assess the impact and implications of the committee's work and at the same time clarify what I see as (...) its limits. All in all, I believe it is fair to say that the committee's recommendations and the process of its work represent a success for bioethics‐related consensus committees. The combination of topic, timing, and public stakeholder sentiment may have aligned in unique ways that contributed to that success. But even if it turns out to be a special case of sorts, there are lessons to be learned for the future. (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)

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)

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)

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)

Successful preimplantation genetic diagnosis (PGD) 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 (IVF) 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” (rather than to avoid a sex-linked disorder), 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)

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)