Abstract:Human and animal research both operate within established standards. In the United States, criticism of the human research environment and recorded abuses of human research subjects served as the impetus for the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, and the resulting Belmont Report. The Belmont Report established key ethical principles to which human research should adhere: respect for autonomy, obligations to beneficence and justice, and special protections (...) for vulnerable individuals and populations. While current guidelines appropriately aim to protect the individual interests of human participants in research, no similar, comprehensive, and principled effort has addressed the use of (nonhuman) animals in research. Although published policies regarding animal research provide relevant regulatory guidance, the lack of a fundamental effort to explore the ethical issues and principles that should guide decisions about the potential use of animals in research has led to unclear and disparate policies. Here, we explore how the ethical principles outlined in the Belmont Report could be applied consistently to animals. We describe how concepts such as respect for autonomy and obligations to beneficence and justice could be applied to animals, as well as how animals are entitled to special protections as a result of their vulnerability. (shrink)

In 1974, the United States Congress asked a question prompting a national conversation about ethics: which ethical principles should govern research involving human participants? To embark on an answer, Congress passed the National Research Act, and charged this task to the newly established National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Commission’s mandate was modest however, the results were anything but. The outcome was The Belmont Report: a trio of principles - respect (...) for persons, beneficence, and justice - serving as an ethical compass for scientists, researchers, and institutional review boards (IRBs). Almost 50 years later, the utility, legacy, and ingenuity of The Belmont Report continues to be both admired and challenged. Critics argue that Belmont is not fit for the 21st century, while supporters praise Belmont for its enduring wisdom. The goal of this paper is to equip IRB practitioners with the tools necessary to maximally interpret The Belmont Report and meaningfully engage in ethical analysis that reconsiders outmoded legacy thinking and fixed decision-making. Through historical and contextual reflection, this paper describes how IRB practitioners can contemporize review of ethical human research using their moral imagination – a skill found at the intersection of creativity, deliberation, and empathy. (shrink)

Achieving a good clinical trial design increases the likelihood that a trial will take place as planned, including that data will be obtained from a sufficient number of participants, and the total number of participants will be the minimal required to gain the knowledge sought. A good trial design also increases the likelihood that the knowledge sought by the experiment will be forthcoming. Achieving such a design is more than good sense—it is ethically required in experiments when participants are at (...) risk of harm. This paper argues that doing a power analysis effectively contributes to ensuring that a trial design is good. The ethical importance of good trial design has long been recognized for trials in which there is risk of serious harm to participants. However, whether the quality of a trial design, when the risk to participants is only minimal, is an ethical issue is rarely discussed. This paper argues that even in cases when the risk is minimal, the quality of the trial design is an ethical issue, and that this is reflected in the emphasis the Belmont Report places on the importance of the benefit of knowledge gained by society. The paper also argues that good trial design is required for true informed consent. (shrink)

One of the Belmont Report’s most important contributions was the clear and serviceable distinction it drew between standard medical practice and biomedical research. A less well-known achievement of the Report was its conceptualization of innovative practice, a type of medical practice that is often mistaken for research because it is new, untested, or experimental. Although the discussion of innovative practice in Belmont is brief and somewhat cryptic, this does not reflect the significant progress its authors made (...) in understanding innovative practice and the distinctive ethical issues it raises. This article explores the history and broader context of Belmont’s conception of innovative practice, its strengths and weaknesses, and its contemporary relevance for scholars working in bioethics and health policy. While this conception of innovative practice deserves our attention, it is inherently limited in some important ways. (shrink)

AbstractThe Belmont Report continues to be held in high regard, and most bioethical analyses conducted in recent years have presumed that it affects United States federal regulations. However, the assessments of the report’s creators are sharply divided. Understanding the historic reputation of this monumental report is thus crucial. We first recount the historical context surrounding the creation of this report. Subsequently, we review the process involved in developing ethical guidelines and describe the report’s features. (...) Additionally, we analyze the effect of unfolding events on the subsequent creation of federal regulations, especially on gene therapy clinical trials. Moreover, throughout this paper we evaluate the ethical principles outlined in this report and describe how they overlap with the issue of protecting socially vulnerable groups. Based on the analysis, we conclude that the features of the Belmont Report cannot be considered as having affected the basic sections of the federal regulations for ethical reviews that were made uniform in 1981. Nevertheless, regarding the regulations on gene therapy clinical trials—which were at first expected to be applicable to research involving children—in addition to implementing policies regarding the public review of protocols that passed ethical review, this report’s principles are clearly reflected in the key notes that should have been referred to when the report was created. (shrink)

The ethical principles articulated in the Belmont Report and the regulatory oversight of research based on those principles seem to have served society well. Before Belmont, there were numerous egregious violations of research ethics. Since Belmont, there seem to be fewer—though good data are lacking.A central pillar of the Belmont framework is that a bright line must be drawn between medical practice and biomedical research. The Report stated that to qualify as practice, the following (...) conditions must be satisfied: the purpose of an intervention is to provide diagnosis, preventive treatment, or therapy; the intervention is designed solely to enhance the well-being of an individual... (shrink)

This article reflects on the relevance and applicability of the Belmont Report nearly four decades after its original publication. In an exploration of criticisms that have been raised in response to the report and of significant changes that have occurred within the context of biomedical research, five primary themes arise. These themes include the increasingly vague boundary between research and practice, unique harms to communities that are not addressed by the principle of respect for persons, and how (...) growing complexity and commodification in research have shed light on the importance of transparency. The repercussions of Belmont's emphasis on the protection of vulnerable populations is also explored, as is the relationship between the report's ethical principles and their applications. It is concluded that while the Belmont Report was an impressive response to the ethical issues of its day, the field of research ethics involving human subjects may have outgrown it. (shrink)

The purpose of this article is to illuminate the conceptualisations and applications of the Belmont Report’s key ethical principles of respect for persons, beneficence, and justice based on a document analysis of five of the most relevant disciplinary guidelines on internet research in the social sciences. These seminal documents are meant to provide discipline-specific guidance for research design and implementation and are regarded as key references when conducting research online. Our analysis revealed that the principles of respect and (...) beneficence were explicitly conveyed in the documents analysed, offering nuanced interpretations on issues of informed consent, privacy, and benefits and risks as well as providing recommendations for modifying traditional practices to fit the online setting. However, the invocations of the principle of justice were rather implicit and reflect an important shift from the Belmont Report’s protectionist ethical position towards more situational and dialogic approaches. With the rapidly evolving nature of internet technologies, this analysis is projected to contribute to the ongoing developments in research ethics in the social sciences by outlining the tensions and implications of the use of the internet as a methodological tool. We also seek to provide recommendations on how disciplinary associations can proceed to facilitate ethically sensitive internet research. (shrink)

For decades, the Belmont Report—and the associated regulatory framework it inspired—has been a cornerstone in the ethical conduct of research involving human subjects. Despite its canonic status, t...

With technical sophistication and innovation in the field of medical science, a considerable proportion of medical diagnosis now rely on laboratory analyses, which emphasises the crucial role of laboratory physicians in patient care. Sustaining high ethical standards remains crucial in both clinical biochemistry and laboratory medicine, and several ethical dilemmas are faced by laboratory physicians in day-to-day practice. In a low-resource country like Bangladesh, formal ethics education or ethical framework in laboratory practice is still absent; ethics has not received that (...) much attention it this field. This paper has considered ethical issues encountered during the daily routine work of laboratory physicians and specially focused on the ethical issues encountered during the pre-analytical, analytical and post-analytical phases of laboratory medicine practice and discuss those issues in light of ‘The Belmont Report’ (1978) perspective. It is not intended to be a comprehensive one, rather it aims to complement existing guidelines and documents that are available in some institutions and to offer a framework for addressing ethical issues encountered in the practice of clinical biochemistry and laboratory medicine in Bangladesh. (shrink)

Prejudice in the selection of the subjects of scientific research is morally unacceptable. Indeed, the occurrence of prejudice in the Tuskegee Syphilis Study prompted the production of the Belmont Report, setting out the basic ethical principles for the protection of human subjects of biomedical and behavioral research. The relevance of the Belmont Report to the protection of all animal subjects of scientific research is discussed.

Although written primarily for medical research, the Belmont principles have permeated clinical medicine as well. In fact, they are part of a broad cultural shift that has dramatically reworked the relationship between doctor and patient. In the early 1950s, medicine was about making the patient better and maintaining optimism when the patient could not get better. By the 1990s, medicine was about the treatment of specific physiological systems, as directed by the patient, but as limited by the society's concern (...) for justice. (shrink)

The Belmont Report is a totem of human research ethics. Its principles have provided a sustained and organizing vision for human protections and have been endorsed by various subsequent human protections policies. Besides its influence, the Belmont Report rewards multiple reads and abounds in insights, many of which have been under-attended in research ethics. Above all, the principles articulated in Belmont have proven adaptable to the many novel research strategies, approaches, settings, and challenges that have (...) emerged in the 40 years since... (shrink)

The Belmont Report was written by a US Commission charged by the US Congress to advise on research supported by the US government. Its focus was understandably domestic. In the 40 years since its publication, clinical research has become increasingly international. Many clinical trials have sites in multiple countries, and many of the host countries are relatively impoverished. Such research raises some distinctive ethical issues. This paper outlines some of the key ethical challenges that have been raised by (...) clinical research conducted in low- and middle-income countries (LMICs) and sponsored by high-income country (HIC) institutions. It then considers whether the Belmont Report has the resources to address these problems and argues that it does not. The article closes by noting some parallels between this international research and domestic US research, which suggest that the US might benefit from the discussions abroad. (shrink)

We agree with Saunkeah and colleagues that research ethics principles outlined by the Belmont Report—which guide the procedural basis for “human subjects” research in the United States throu...

The Belmont Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was essentially mandated in a public law on July 12, 1974. The publications of this Commission have turned out to be the most influential of all US ethics and bioethics commissions on US public policy and federal regulation. The reason for its influence is that this Commission was allowed—indeed required—to draft federal regulations governing research with vulnerable subjects and to produce (...) a general framework of moral principles that quickly became established as the only framework of general principles of research ethics for the government of the United States.The public law mandated that the... (shrink)

The Belmont Report, issued in 1979 by the US National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, is a landmark document providing guidance on the ethics of research involving human subjects. It is divided into three sections: “Boundaries between practice and research; “Basic ethical principles” ; and “Applications of these principles with respect to informed consent, assessment of risks and benefits, and selection of subjects.”While the Belmont Report has enduring significance, the (...) landscape of biomedical research has changed in important ways over the past 40 years. Additionally, a large and growing body of... (shrink)

Responsible research and good science are concepts with various meanings depending on one’s perspective and assumptions. Fellow researchers, research participants, policy makers and the general public also have differing expectations of the benefits of research ranging from accurate and reliable data that extend the body of knowledge, to solutions to societal concerns. Unless these differing constituencies articulate their differing views they may fail to communicate and undermine the value of research to society.

“Responsible research” and “good science” are concepts with various meanings depending on one’s perspective and assumptions. Fellow researchers, research participants, policy makers and the general public also have differing expectations of the benefits of research ranging from accurate and reliable data that extend the body of knowledge, to solutions to societal concerns. Unless these differing constituencies articulate their differing views they may fail to communicate and undermine the value of research to society.

All cells have electric potentials across their membranes, but is there really compelling evidence to think that such potentials are used as instructional cues in developmental biology? Numerous reports indicate that, in fact, steady, weak bioelectric fields are observed throughout biology and function during diverse biological processes, including development. Bioelectric fields, generated upon amputation, are also likely to play a key role during vertebrate regeneration by providing the instructive cues needed to direct migrating cells to form a wound epithelium, a (...) structure unique to regenerating animals. However, mechanistic insight is still sorely lacking in the field. What are the genes required for bioelectric‐dependent cell migration during regeneration? The power of genetics combined with the use of zebrafish offers the best opportunity for unbiased identification of the molecular players in bioelectricity. BioEssays 29:1133–1137, 2007. © 2007 Wiley Periodicals, Inc. (shrink)

This study examines the discourse representation of migrant voices in two Spanish broadsheets and two freesheets through the analysis of quoted utterances. Data analyzed were gathered within the framework of a year-long EU research pilot project aimed at developing a cost-effective methodology to comparatively analyze print media content from six EU member states. Within the paradigm of CDA and drawing on Appraisal Theory, we analyzed the writer’s use of different types of reported speech, the corresponding reporting verbs, the endorsement of (...) the reported voices, and the attitudes and emotions that these denote. Results show some significant differences in the way immigrants’ voices are reported in Spanish broadsheets and freesheets. While the stories from the broadsheets depict voices of human suffering, freesheets articles show a different immigrant voice: one which is confident, successful, and well-adapted to the host environment. (shrink)

The Belmont Report has had an enormous influence on the ethics of biomedical research over the last several decades. It has served as a philosophical foundation for federal regulations governing human subjects research, and its principles are well known to individuals across the research enterprise. Given the outsized influence Belmont has enjoyed as a core document in bioethics, it is worth reminding ourselves of the historical context in which it came to be. In this article, we examine (...) the societal forces that helped bring about the Belmont Report and that shaped its conception of ethical research. In turn, we set the stage for discussions on whether Belmont remains applicable as the research enterprise... (shrink)

The Belmont Report’s three foundational ethical principles—respect for persons, beneficence, and justice—have shaped regulation, practice, and our collective thinking about research with human beings in the United States for over 40 years. While it has proven remarkably adaptable, Belmont’s framework is a product of a specific time and historical context. Both the research enterprise and society at large have changed in significant ways since its creation. For example, the last four decades have seen a general democratization of (...) knowledge production, increasing skepticism of authority and expertise, and growing demands that institutions of power be more transparent about their activities so they can be better held to account. Within the research enterprise, the emergence of community engaged- and patient-centered research reflects these changes. This chapter examines the application of Belmont’s framework to stakeholder-engaged research, both illuminating its flexibilities and identifying its limitations, in terms of the values, norms, and expectations that are central to stakeholder-engaged research but unaccounted for by Belmont. (shrink)

When the Belmont Report was published in 1979, the European research ethics community was very small, even if we take this community to include everyone who was working in research ethics academically or professionally, and the report itself made very little impact in European medical journals.1 If we try to trace Belmont’s later reception history in Europe and in much of the bioethics literature worldwide, we find that it is most often quoted either as a landmark (...) in the history of research ethics, without any further explication of its actual content; as a forerunner of the principle-based approach to biomedical ethics developed by Tom Beauchamp and James Childress in The Principles of Biomedical Ethics ; or... (shrink)

Consumer-based datasets are the products of data brokerage firms that agglomerate millions of personal records on the adult US population. This big data commodity is purchased by both companies and individual clients for purposes such as marketing, risk prevention, and identity searches. The sheer magnitude and population coverage of available consumer-based datasets and the opacity of the business practices that create these datasets pose emergent ethical challenges within the computational social sciences that have begun to incorporate consumer-based datasets into empirical (...) research. To directly engage with the core ethical debates around the use of consumer-based datasets within social science research, I first consider two case study applications of consumer-based dataset-based scholarship. I then focus on three primary ethical dilemmas within consumer-based datasets regarding human subject research, participant privacy, and informed consent in conversation with the principles of the seminal Belmont Report. (shrink)

In one study funded by the United States Department of Agriculture, people from North Dakota were interviewed to discover which moral principles they use in evaluating the morality of transgenic organisms and their introduction into markets. It was found that although the moral codes the human subjects employed were very similar, their views on transgenics were vastly different. In this paper, the codes that were used by the respondents are developed, compared to that of the academically composed Belmont (...) class='Hi'>Report, and then modified to create the more practical Common Moral Code. At the end, it is shown that the Common Moral Code has inherent inconsistency flaws that might be resolvable, but would require extensive work on the definition of terms and principles. However, the effort is worthwhile, especially if it results in a common moral code that all those involved in the debate are willing to use in negotiating a resolution to their differences. (shrink)

The distinction between clinical research and clinical practice directs how we partition medicine and biomedical science. Reasons for a sharp distinction date historically to the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, especially to its analysis of the “boundaries” between research and practice in the Belmont Report (1978). Belmont presents a segregation model of the research-practice distinction, according to which research and practice form conceptually exclusive sets of activities (...) and interventions. This model is still the standard in federal regulations today. However, the Commission’s deliberations and conclusions about the boundaries are more complicated, nuanced, and instructive than has generally been appreciated. The National Commission did not conclude that practice needs no oversight comparable to the regulation of research. It debated the matter and inclined to the view that the oversight of practice needed to be upgraded, though the Commission stopped short of proposing new regulations for its oversight, largely for prudential political reasons. (shrink)

This paper advances a new criterion of a vulnerable population in research. According to this criterion, there are consent-based and fairness-based reasons for calling a group vulnerable. The criterion is then applied to the case of people with serious illnesses. It is argued that people with serious illnesses meet this criterion for reasons related to consent. Seriously ill people have a susceptibility to “enticing offers” that hold out the prospect of removing or alleviating illness, and this susceptibility reduces their ability (...) to safeguard their own interests. This explains the inclusion of people with serious illnesses in the Belmont Report’s list of populations needing special protections, and supports the claim that vulnerability is the rule, rather than the exception, in biomedical research. (shrink)

In research ethics there is a canon regarding what ethical rules ought to be followed by investigators vis-à-vis their treatment of subjects and a canon regarding what fundamental ethical principles apply to the endeavor. What I aim to demonstrate here is that several of the rules find no support in the principles. This leaves anyone who would insist that we not abandon those rules in the difficult position of needing to establish that we are nevertheless justified in believing in the (...) validity of the rules. I conclude by arguing that this is not likely to be accomplished.The rules I call into question are the rules requiring:– that studies be designed in a scientifically valid way– that risks to subjects be minimized– that subjects be afforded post-trial access to experimental interventions– that inducements paid to subjects not be counted as a benefit to them– that inducements paid to subjects not be ‘undue’– that subjects must remain free to withdraw from the study at any time for any reason without penaltyBoth canons, the canon on principles and the canon on rules, are found in the overlap among ethical pronouncements that are themselves canonical: the Nuremberg Code, the Declaration of Helsinki, the Belmont Report, CIOMS's International Ethical Guidelines for Biomedical Research Involving Human Subjects, and NBAC's 2001 report, Ethical Issues in International Research: Clinical Trials in Developing Countries. (shrink)

The article presents and analyzes different approaches of U.S. bioethicists in comprehending the Nazi medical crimes after 1945. The account is divided into two sections: one dealing with discussions on research ethics and the Nuremberg Code up until the 1970s and the other ranging from the 1970s to the present and highlighting bioethics' engagement with Nazi analogies. The portrayal of different bioethical scholars, institutions, and documents—most notably Henry K. Beecher, Jay Katz, the Belmont Report, the Hastings Center, Arthur (...) L. Caplan, and Robert M. Veatch—provides a nuanced interpretation of the motives that bioethicists held and the strategies that they applied to establish an understanding of the Nazi medical crimes and their relation to contemporary bioethical issues. In this, the different approaches shared a common goal: To integrate the Nazi medical crimes into an ethical framework by means of selective acknowledgments and representation of their history. (shrink)

For decades, the greater part of efforts to improve regulatory frameworks for research ethics has focused on informed consent procedures; their design, codification and regulation. Why is informed consent thought to be so important? Since the publication of the Belmont Report in 1979, the standard response has been that obtaining informed consent is a way of treating individuals as autonomous agents. Despite its political success, the philosophical validity of this Belmont view cannot be taken for granted. If (...) the Belmont view is to be based on a conception of autonomy that generates moral justification, it will either have to be reinterpreted along Kantian lines or coupled with a something like Mill’s conception of individuality. The Kantian interpretation would be a radical reinterpretation of the Belmont view, while the Millian justification is incompatible with the liberal requirement that justification for public policy should be neutral between controversial conceptions of the good. This consequence might be avoided by replacing Mill’s conception of individuality with a procedural conception of autonomy, but I argue that the resulting view would in fact fail to support a non-Kantian, autonomy-based justification of informed consent. These difficulties suggest that insofar as informed consent is justified by respect for persons and considerations of autonomy, as the Belmont report maintained, the justification should be along the lines of Kantian autonomy and not individual autonomy. (shrink)

The Belmont Report’s distinction between research and the practice of accepted therapy has led various authors to suggest that these purportedly distinct activities should be governed by different ethical principles. We consider some of the ethical consequences of attempts to separate the two and conclude that separation fails along ontological, ethical, and epistemological dimensions. Clinical practice and clinical research, as with yin and yang, can be thought of as complementary forces interacting to form a dynamic system in which (...) the whole exceeds the sum of its parts. Just as effective clinical practice cannot exist without clinical research, meaningful clinical research requires the context of clinical practice. We defend this thesis by triangulation, that is, by outlining how multiple investigators have reached this conclusion on the basis of varied theoretical and applied approaches. More confidence can be placed in a result if different methods/viewpoints have led to that result. (shrink)

The Belmont Report begins with the sentence, “It is important to distinguish between biomedical and behavioral research, on the one hand, and the practice of accepted therapy on the other”. Writing an essay in a journal issue devoted to the 40th anniversary of the Belmont Report offers an opportunity not only to examine critically a theme addressed in this remarkable document—the distinction between research and practice—but also to reflect on the role of this theme as a (...) major dimension of my work as a bioethics scholar. Encompassing only 12 pages of text, the Belmont Report is a seminal and rich examination of basic norms defining the ethics of biomedical research. I have read the... (shrink)

Should innovative therapy occur only within a research paradigm and under institutional review board oversight? The health risks from current human embryonic stem cell clinical applications have raised again a fundamental question addressed first in papers submitted to inform the writing of the Belmont Report. Revisiting the thinking underlying the Belmont Report, together with examining changed circumstances since then, leads to a new model for overseeing innovative therapy based on its unique risks and context, important changes (...) since the Belmont Report, and new opportunities for addressing risks through safety and quality systems in health care. (shrink)

Vulnerability is one of the least examined concepts in research ethics. Vulnerability was linked in the Belmont Report to questions of justice in the selection of subjects. Regulations and policy documents regarding the ethical conduct of research have focused on vulnerability in terms of limitations of the capacity to provide informed consent. Other interpretations of vulnerability have emphasized unequal power relationships between politically and economically disadvantaged groups and investigators or sponsors. So many groups are now considered to be (...) vulnerable in the context of research, particularly international research, that the concept has lost force. In addition, classifying groups as vulnerable not only stereotypes them, but also may not reliably protect many individuals from harm. Certain individuals require ongoing protections of the kind already established in law and regulation, but attention must also be focused on characteristics of the research protocol and environment that present ethical challenges. (shrink)

In celebration of the fortieth anniversary of the publication of Beauchamp and Childress’s Principles of Biomedical Ethics, a review is undertaken to compare the lists of principles in various bioethical theories to determine the extent to which the various lists can be reconciled. Included are the single principle theories of utilitarianism, libertarianism, Hippocratism, and the theories of Pellegrino, Engelhardt, The Belmont Report, Beauchamp and Childress, Ross, Veatch, and Gert. We find theories all offering lists of principles numbering from (...) one to ten. Many of the differences can be reconciled, but some critical differences remain. (shrink)

The central thesis of this article is that by anchoring bioethics' core conceptual armamentarium in a four-principled theory emphasizing autonomy and treating justice as a principle of allocation, theorists inadvertently biased 20th-century bioethical scholarship against addressing such subjects as ableism, anti-Black racism, classism, and other forms of discrimination, placing them outside of the scope of bioethics research and scholarship. It is also claimed that these scope limitations can be traced to the displacement of the nascent concept of respect for persons—a (...) concept designed to address classist and racist discrimination—with the morally solipsistic concept of autonomy. (shrink)

BackgroundThe proper and ethical inclusion of PWLHIV and their young children in research is paramount to ensure valid evidence is generated to optimize treatment and care. Little empirical data exists to inform ethical considerations deemed most critical to these populations. Our study aimed to systematically review the empiric literature regarding ethical considerations for research participation of PWLHIV and their young children.MethodsWe conducted this systematic review in partnership with a medical librarian. A search strategy was designed and performed within the following (...) electronic databases: Ovid MEDLINE, Embase and CINAHL. We screened titles and abstracts using the following inclusion criteria: (1) a study population of PWLHIV or children under 5 years of age; and (2) collection of qualitative or quantitative data regarding ethics of research participation. Excluded were reviews, commentaries, policy statements, clinical care-related ethics concerns, abstracts, case studies, or studies unrelated to HIV research. Studies were appraised for quality, data were extracted, and studies were qualitatively analyzed using a principle-based ethical framework within the Belmont Report.ResultsOf the 7470 titles identified, 538 full-text articles were reviewed for eligibility and only three articles met full criteria for inclusion within this review. While we allowed for inclusion of studies involving young children born to mothers with HIV, only articles focused on PWLHIV were identified. Within the results of these studies, four themes emerged: (1) adequacy of informed consent; (2) consideration of paternal involvement; (3) balancing risks; and (4) access to research and treatment. A strength of this review is that it included perspectives of international research investigators, community leaders, and male partners. However, only two studies collected empiric data from PWLHIV regarding their experiences participating in researchConclusionResearchers and funding agencies should be aware of these considerations and appreciate the value of and critical need for formative research to ensure clinical trials involving PWLHIV promote ethical, well-informed research participation and, ultimately, improve care outcomes. More research is needed to create a comprehensive ethical framework for researchers when conducting studies with PWLHIV. (shrink)

A core tenet of research ethics is that risks assumed by research participants are reasonable, balanced, and minimized in relation to benefit to the individual and to society. It is also generally accepted that people who cannot give their own informed consent ought only to be exposed to low risks in research, unless there is a compensating potential for direct benefit.However, there is no consensus on whether individuals should be able to voluntarily consent to high net risk in research—or, in (...) other words, to research that is not justified by direct benefits to the individual and must be justified by benefits to others in society. The Belmont Report—perhaps the most canonical document in research ethics—does not... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Is Bioethics Applied Ethics?Robert M. VeatchBioethics is often referred to as a kind of applied ethics. The term applied ethics can be controversial if it is taken to imply that ethical theory from philosophy or religious ethics has to be the starting point for ethical analysis of some practical field such as medicine or law or politics. The term can be understood as requiring some premises from an ethical (...) theory that are then "applied" to some problem area, as a "top down" way of doing the work of moral reflection in a way that axioms in geometry are applied to present proofs of mathematical claim.The publication of an important work in the history of medical ethics, A History of Medical Ethics, provides an opportunity to reflect more carefully on what applied ethics means. That massive multi-authored volume edited by Robert Baker and Laurence McCullough (2007) is scheduled for publication this fall. With the permission of the Press, we have asked Baker and McCullough to prepare an article-length version of one of the central essays in that work. Their paper challenges the idea that ethical theory should be "applied" to medicine or other fields, putting forth an alternative of the "appropriation" of an ethical theory by the formulation of concepts, principles, moral rules, or other specifications that may turn out to be unique or at least modified for the particular field in question.In this issue of the Kennedy Institute of Ethics Journal, we publish the Baker-McCullough article together with five critical commentaries. We include two medical historians who have a sustained commitment to studying the history of ethics in medicine, two systematic ethicists who have an unusual level of commitment to studying ethics historically, and a physician with unusual sensitivity to the history of medical ethics. Each comments on the Baker-McCullough thesis and offers an alternative view of the link between ethical theory and the field of biomedical ethics.Daniel Fox triggered some of the initial reflection on the history of medical ethics in the 1970s. His work is discussed by Baker and McCullough. Fox is sympathetic with the Baker-McCullough appropriation thesis, viewing their position as complementary to his own, although he [End Page 1] urges more attention to the political aspects of medicine, professional dominance, and professional control of medical resources.Ulf Schmidt, a specialist on the historical aspects of research during the Nazi era, focuses on Baker and McCullough's use of that historical example of the appropriation of medical ethics.The two ethicists who comment both have had many years experience with historical aspects of medical ethics, and both worked on the historically important Belmont Report of the National Commission for the Protection of Human Subjects. Both question whether Baker and McCullough overstate the problem of the relation between application and appropriation. Albert Jonsen, as a member of the National Commission, concentrates on the Belmont Report, showing how he sees the report appropriating philosophical ethics.Tom Beauchamp, who was the primary staff person responsible for the report, provides a somewhat different read on the report and particularly on the role of Kantian ethics in the report's discussion of autonomy. Beauchamp accuses Baker and McCullough of having too narrow an understanding of the meaning of the term "applied," claiming that no people doing medical ethics today would simply apply ethical theory in a deductivist manner.Finally, Jeremy Sugarman, the physician ethicist, is, in a somewhat surprising turn, the cautious defender of the application that Baker and McCullough challenge. Although he ends up sympathetic with the appropriation that implies going beyond straight-forward top-down application, he outlines the value of ethical theory for the practical analysis of ethical problems in fields such as medicine.ReferenceBaker, Robert, and McCullough, Laurence, eds. 2007. A History of Medical Ethics. New York: Cambridge University Press, in press. [End Page 2]Google ScholarCopyright © 2007 Johns Hopkins University Press... (shrink)

Martin Luther King, Jr., quoting the 19th-century clergyman Theodore Parker, claimed that the arc of the moral universe “bends toward justice.” One hopes he is right, perhaps especially at times when history appears to have taken something of a detour. The 40th anniversary of the Belmont Report offers the opportunity to evaluate the arc of research ethics, to assess where it is going and whether it too is bending toward justice.The Belmont Report is the work of (...) the National Commission, which was charged with identifying “the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects.” The Commission first considered the possibility of deriving these... (shrink)

The revised Common Rule adopts the reasonable person standard to guide research disclosure. Some members of the research community contend that the standard is confusing and ill-suited to the research oversight system. Yet the revised rule is not as radical as it might seem. During the 1970s, judges started using the standard to evaluate negligence claims brought by injured patients who said doctors had failed to obtain informed consent to the harmful procedures. In its influential Belmont Report, the (...) National Commission recommended application of a “reasonable volunteer standard” to guide IRBs evaluating research disclosures. Evidence also suggests that IRBs often invoke the reasonable person standard in deliberations about consent forms. But past application of the standard has been informal and uneven. Robust application of the reasonable person standard will require researchers and IRBs to learn more about what ordinary people want and need to know about the studies they are invited to join. Input from people with personal experience as study participants could be particularly useful to this effort. (shrink)