This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration using an integration of public policy, law, and bioethics approaches and employing multiple assessment criteria, including economic, social, safety, and technological. Throughout, assessments employing both the multiple criteria and a method of expert elicitation are combined with the existing literature, case law, and regulations providing an integrative historical case study approach. The goal is to provide useful information from multiple disciplines and perspectives (...) to guide discussions regarding appropriate oversight frameworks for nanobiotechnology applications under the FDA’s purview. (shrink)

Board oversight of community benefit constitutes an ethical imperative for nonprofit health care organizations. By "ethical imperative" we mean a health care organization's duty to fulfill value-based obligations that transcend compliance requirements in order to be consistent with its basic sense of purpose. We consider three points here: the existence of a distinctively ethical imperative for board oversight, the fact that the imperative is organizational in nature, and practical ways to fulfill its obligations. To explain the meaning of (...) ethical imperative, offer analytical clarification, and provide evidence-based guidelines we adopt an organizational ethics paradigm. Because community benefit for tax-exempt .. (shrink)

U.S. approaches to oversight of research and technological products have developed over time in an effort to ensure safety to humans, animals, and the environment and to control use in a social context. In modern times, regulatory and oversight tools have evolved to include diverse approaches such as performance standards, tradable allowances, consultations between government and industry, and pre-market safety and efficacy reviews. The decision whether to impose an oversight system, the oversight elements, the level of (...) oversight, the choice of approach, and its execution can profoundly affect technological development, individual and collective interests, and public confidence in technological products. Oversight is conducted by a range of institutions with various capabilities, cultures, and motives. Avenues for disputing oversight decisions are also important, and some argue that the U.S. operates in an adversarial regulatory culture in which Congress, the media, and stakeholders regularly contest the decisions of federal agencies. (shrink)

The Institute of Medicine has called on health care leaders to transform their health systems into “learning health care systems,” capable of studying and continuously improving their practices. Learning health care systems commit to carrying out numerous kinds of investigations, ranging from clinical effectiveness studies to quality improvement research and implementation science. There has been progress in realizing the IOM's vision, but also many challenges. One of these challenges has been lingering uncertainty about whether the data collection and monitoring central (...) to learning health care systems is actually research and if so, what kind of ethical oversight it should have. This is not a new question. Yet so far, there has been no foundational analysis of the fit between the existing human subjects protection framework in use in the United States and the new kinds of data collection activities that are being, and increasingly will be, undertaken by learning health care systems. Two companion feature articles in this volume, by a team at Johns Hopkins, fill this void. (shrink)

The purpose of an oversight structure or institution is to protect human subjects from research that would pose unacceptable dangers or deny human rights. Review boards provide an independent assessment of research proposals. This additional level of scrutiny is meant to provide an additional level of protection for human subjects. However, oversight of human subject research, as currently carried out in the bureaucratic, rule‐based, clinically‐biased American system, is too cumbersome with regard to online research. In addition, it is (...) not conducive to the training of ethical Internet researchers. Internet research differs from traditional human subject research in many ways, and the oversight rules governing traditional research do not easily relate to the complexities of conducting research online. Online researchers do not oppose the foundational principles of non‐maleficence and autonomy, nor do they reject the ideals of informed consent and confidentiality, nevertheless, they face practical dilemmas in attempting to follow these principles and apply these ideals in the various Internet domains. The current oversight system is ill‐equipped to assist. A conservative response to this problem of fit might entail adjustments to the oversight system that, in the case of the American system, would entail modifications to the Common Rule and Institutional Review Boards. I will argue in this paper, instead, that re‐structuring is needed to allow more oversight authority for Internet researchers. I will utilize Consequentialism and Virtue Ethics in making this case. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 10.2 (2000) 171-174 [Access article in PDF] Bioethics Inside the Beltway The Oversight of Human Gene Transfer Research LeRoy Walters Jesse Gelsinger's death last September in a gene transfer study being conducted at the University of Pennsylvania has helped to spark a national debate. In part, this debate parallels the broader discussion of how human subjects research should be reviewed and regulated in (...) the United States. However, human gene transfer research is one of a handful of biomedical technologies that seem to deserve special attention, at least in the early years of their development.The major participants in the national debate on human gene transfer include the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the National Bioethics Advisory Commission, members of Congress, biotechnology and pharmaceutical companies, disease-oriented advocacy groups, reporters, and academics. At the December 1999 meeting of the NIH Recombinant DNA Advisory Committee (RAC), the protocol that involved Jesse Gelsinger was a central focus of discussion, but other topics emerged as well. One ad hoc panel reviewed adverse events that had occurred in other research protocols using adenovirus vectors, while a second proposed changes in the general system for reporting adverse events to NIH and the RAC.During the first several months of the year 2000, the United States Congress also became involved in the human gene transfer debate. In February, Senator Bill Frist (R-TN) convened a hearing to which Jesse Gelsinger's father, representatives of NIH and FDA, and several other witnesses were invited. At approximately the same time, the House Commerce Committee and its Subcommittee on Oversight and Investigations initiated their own inquiries, asking the Office of Inspector General at the Department of Health and Human Services to review the oversight roles of NIH and FDA. In March and April, the House committee also wrote directly to the NIH Director, the FDA Commissioner, and the President of the University of Pennsylvania, requesting extensive documentation on gene transfer, in general, and the trial in which Jesse Gelsinger was involved, in particular. Congressman Henry Waxman (D-CA) and Senator Edward Kennedy (D-MA) have also raised questions and proposed solutions in multiple letters to the NIH Director and the Secretary of Health and Human Services. [End Page 171]The major general questions that have emerged from this discussion are the following:(1) What kinds of information about adverse events should be reported by researchers or sponsors during the course of human gene transfer trials?(2) To what group or groups should adverse-event information be reported? How often and in what ways should the information be analyzed?(3) Should the information about adverse events remain confidential, or should it be discussed publicly?(4) How can the disclosure and consent process in gene transfer trials be improved?(5) Which federal agency should have primary responsibility for overseeing human gene transfer research, and how can it best fulfill its oversight role?How these questions are answered will have immediate relevance to the field of human gene transfer research as it enters into its next phase. At the same time, the models that are created for this important cutting-edge field also may be useful in other complex or controversial arenas of biomedical research, for example, xenotransplantation or human embryonic stem-cell research. In addition, the lessons learned from this one important area of human subjects research may suggest ways to improve protections for all the volunteers who make clinical research--and medical progress--possible.In the remainder of this article, I will turn from reporting, in as objective a way as possible, on the status of the public policy debate about human gene transfer research to suggesting measures for improving the current oversight system for such research. My initial general recommendation is that we should not expect a single regulatory agency to be solely responsible for a field as large and dynamic as human gene transfer research. Rather, there should be some helpful redundancy or, to change the metaphor, checks and balances in the public oversight of this field. Thus, an... (shrink)

In vitro fertilization using donated oocytes is an important medical technique that provides the only option for some infertile patients to have children. The technique remains ethically contentious, however, and, as a result of this controversy, different oversight approaches have been developed in countries around the world. This paper examines the oversight and practice of oocyte donation in Canada, the United Kingdom and the United States to examine how policy choices have influenced the development and use of this (...) medical technology. Examining per capita utilization of oocyte donation in these three countries provides evidence that supply-side policies—specifically policies affecting the compensation of potential oocyte donors—have substantially influenced the use of this technology. These results should provide useful insight for policymakers developing or revising oocyte donation policies. (shrink)

Researchers and others involved in the research enterprise from 12 African countries met with those working in ethics and oversight in the United States as part of an effort to develop research ethics capacity. Drawing on a wealth of experience among participants, discussions at the meeting revealed five categories of issues that warrant careful attention by those engaged in similar efforts as well as international policymakers and those charged with oversight of research. (1) Principal investigators should build ‘true (...) research teams’ where members of the team are meaningfully involved in decisions regarding the protocol and its implementation. (2)There should be explicit discussion about the ‘standard of care’ at the outset of project planning that includes clarification of the terminology that is being used. (3) While internationally collaborative research may involve populations that have inherent vulnerabilities, it is important to recognize the limitations of host country solutions (such as elaborated consent processes) and look for means to negotiate appropriate protections for those willing to participate. (4) In conducting research involving biological materials it would be prudent to develop material transfer agreements at the outset of the study to clarify expectations and to minimize the likelihood of harm. (5) Those engaged in internationally collaborative research need to be alert to the potential conflicts of interests of host country ethics committees during the approval process and to take measures to manage them if they indeed exist. (shrink)

The conflicts of interest that may arise in relationships between academic researchers and industry continue to prompt controversy. The bulk of attention has focused on financial aspects of these relationships, but conflicts may also arise in the legal obligations that faculty acquire through consulting contracts. However, oversight of faculty members' consulting agreements is far less vigorous than for financial conflicts, creating the potential for faculty to knowingly or unwittingly contract away important rights and freedoms. Increased regulation could prevent this, (...) but it is unclear what forms of oversight universities view as feasible and effective. In this article, we report on a Delphi study to evaluate several approaches for oversight of consulting agreements by medical schools. The panel was comprised of 11 senior administrators with responsibility for oversight of faculty consulting relationships. We found broad agreement among panelists regarding the importance of institutional oversight to protect universities' interests. There was strong support for two specific approaches: providing educational resources to faculty and submitting consulting agreements for institutional review. Notwithstanding the complexities of asserting authority to regulate private consulting agreements between faculty members and companies, medical school administrators reached consensus that several approaches to improving institutional oversight are feasible and useful. (shrink)

: Research involving the dead, especially heart-beating cadavers, may facilitate the testing of potentially revolutionary and life-saving medical treatments. However, to ensure that such research is conducted ethically, it is essential to: (1) identify appropriate standards for this research and (2) assign institutional responsibility and a mechanism for oversight. Protocols for research involving the dead should be reviewed by a special committee and assessed according to nine standards intended to ensure scientific merit, to protect deceased patients and their families, (...) and to promote institutional integrity and responsibility. Federal regulation of research involving the dead will foster appropriate standards and, equally importantly, help establish the acceptability of such research. (shrink)

This article explores two questions: (1) whether portable MRI research might escape regulatory oversight altogether under existing U.S. privacy and research ethical frameworks, leaving research participants without adequate protections, and (2) whether existing regulatory frameworks, when they do apply, can guard society’s broader interest in ensuring that portable MRI research pursues socially beneficial, ethically sound aims that minimize the potential for externalities affecting nonparticipating individuals and groups, who might be stigmatized or otherwise harmed even if they decline participation in (...) the research. (shrink)

We examine whether the current regulatory regime instituted in South Korea and the United States would have prevented Hwang’s potential transgressions in oocyte procurement for somatic cell nuclear transfer, we compare the general aspects and oversight framework of the Bioethics and Biosafety Act in South Korea and the US National Academies’ Guidelines for Human Embryonic Stem Cell Research, and apply the relevant provisions and recommendations to each transgression. We conclude that the Act would institute centralized oversight under governmental (...) auspices while the Guidelines recommend politically-independent, decentralized oversight bodies including a special review body for human embryonic stem cell research at an institutional level and that the Guidelines would have provided more vigorous protection for the women who had undergone oocyte procurement for Hwang’s research than the Act. We also suggest additional regulations to protect those who provide oocytes for research in South Korea. (shrink)

Institutional review boards distinguish health care quality improvement and health care quality improvement research based primarily on the rigor of the methods used and the purported generalizability of the knowledge gained. Neither of these criteria holds up upon scrutiny. Rather, this apparently false dichotomy may foster under-protection of participants in QI projects and over-protection of participants within QIR.

High degrees of uncertainty and a lack of effective therapeutic treatments have characterized the COVID-19 pandemic and the provision of drug products outside research settings has been controversial. International guidelines for providing patients with experimental interventions to treat infectious diseases outside of clinical trials exist but it is unclear if or how they should apply in settings where clinical trials and research are strongly regulated. We propose the Professional Oversight of Emergency-Use Interventions and Monitoring System as an alternative pathway (...) based on guidance developed for the ethical provision of experimental interventions to treat COVID-19 in Singapore. We support our proposal with justifications that establish moral duties for physicians to record outcomes data and for institutions to establish monitoring systems for reporting information on safety and effectiveness to the relevant authorities. Institutions also have a duty to support generation of evidence for what constitutes good clinical practice and so should ensure the unproven intervention is made the subject of research studies that can contribute to generalizable knowledge as soon as practical and that physicians remain committed to supporting learning health systems. We outline key differences between POEIMS and other pathways for the provision of experimental interventions in public health emergencies. (shrink)

Clinical gene transfer research has both a unique history and a complex and layered system of research oversight, featuring a unique review body, the Recombinant DNA Advisory Committee. This paper briefly describes the process of decision-making about clinical GTR, considers whether the questions, problems, and issues raised in clinical GTR are unique, and concludes by examining whether the RAC's oversight is a useful model that should be reproduced for other similar areas of clinical research.Clinical GTR is governed by (...) the same oversight system as most clinical trials, with a significant addition: the RAC. Like other research with human subjects, GTR, if it is affiliated with a federally funded institution, must be approved by an institutional review board whose activities are governed by the common rule, that is, the federal regulations for protection of human subjects in research. Like other research intended to produce a drug, device, or biologic to be marketed in the United States, GTR is also overseen by the Food and Drug Administration. (shrink)

Oversight of human gene transfer research presents an important model with potential application to oversight of nanobiology research on human participants. Gene therapy oversight adds centralized federal review at the National Institutes of Health's Office of Biotechnology Activities and its Recombinant DNA Advisory Committee to standard oversight of human subjects research at the researcher's institution and at the federal level by the Office for Human Research Protections. The Food and Drug Administration's Center for Biologics Evaluation and (...) Research oversees human gene transfer research in parallel, including approval of protocols and regulation of products. This article traces the evolution of this dual oversight system; describes how the system is already addressing nanobiotechnology in gene transfer: evaluates gene therapy oversight based on public opinion, the literature, and preliminary expert elicitation; and offers lessons of the gene therapy oversight experience for oversight of nanobiotechnology. (shrink)

In spite of many and varied concerns that the processes of institutional ethical review are flawed, cumbersome, and in need of reform, these processes do provide effective protection in certain sit...

The emergence of nanotechnology, and specifically nanobiotechnology, raises major oversight challenges. In the United States, government, industry, and researchers are debating what oversight approaches are most appropriate. Among the federal agencies already embroiled in discussion of oversight approaches are the Food and Drug Administration , Environmental Protection Agency , Department of Agriculture , Occupational Safety and Health Administration , and National Institutes of Health . All can learn from assessment of the successes and failures of past (...) class='Hi'>oversight efforts aimed at emerging technologies. This article reports on work funded by the National Science Foundation aimed at learning the lessons of past oversight efforts. The article offers insights that emerge from comparing five oversight case studies that examine oversight of genetically engineered organisms in the food supply, pharmaceuticals, medical devices, chemicals in the workplace, and gene therapy. Using quantitative and qualitative analysis, the authors present a new way of evaluating oversight. (shrink)

We show that the respective oversights in the von Neumann's general theorem against all hidden variable theories and Bell's theorem against their local-realistic counterparts are homologous. When latter oversight is rectified, the bounds on the CHSH correlator work out to be ±2√2 instead of ±2.

The ethics research community has all but ignored issues of oversight ethics – the vices and virtues of overseers. This study develops a conceptual framework for exploring the ethics of oversight and provides insights into the design of codes of ethics for oversight institutions and for overseers. Analysis of business licensing in Israel reveals prospective and retrospective oversight ethics problems at the levels of national and local policy and implementation: Overseers failed to act on knowledge of (...) breaches of business licensing stipulations and took action known to be slow and ineffective; policymakers neglected their duty to enact significant policy change in an oversight system that was clearly not working. Partially as a result of these oversight failures, over one third of Israeli businesses are unlicensed, 23 people were killed in the collapse of an unlicensed banquet hall, 2 major fires erupted in the same shopping mall, and a fire in a fertilizer warehouse very nearly became a mega-disaster. (shrink)

Medical research saves lives--yet all too often, it is thwarted by a review system supposed to safeguard patients that instead creates needless delays and expense. Institutional Review Boards, which exist at every hospital and medical school that conducts medical research, have ended up imposing such complex, draconian conditions that research is frequently damaged, delayed, and distorted. This is why medical miracles like the COVID-19 vaccines, which were developed at warp speed, are far too rare. Instead, medical research in countless areas (...) is kept at a horse-and-buggy pace. The result: unnecessary suffering and avoidable deaths. From Oversight to Overkill vividly recounts the story behind this crisis, one that remains unknown to the general public. Family physician and ethicist Simon Whitney shows how the IRB system was launched in response to scandals like the notorious Tuskegee syphilis study--and how, in recent decades, this well-intentioned program has become increasingly bureaucratic, convoluted, and stifling. Readers will learn how vital breakthroughs in treating conditions from kidney stones to heart attacks and premature birth have been delayed by IRB red tape, forcing doctors and patients to settle for less-effective treatments. They'll see how ill-informed demands from Congressional leaders that regulators "get tough" on scientists have caused respected research institutions to be shut down-with no benefit to the public. And they'll learn about a balanced, common-sense approach to reforming the system that can free scientists from pointless wheel-spinning while still protecting the public from the risks of unethical or careless experimentation. Until now, the debate about the IRB system's failures has been confined to specialty journals in medicine, law, and ethics. From Oversight to Overkill will finally alert citizens about this little-known crisis with America's medical research system-and what can be done about it. (shrink)

In qualitative interviews with a diverse group of experts, the vast majority believed unregulated researchers should seek out independent oversight. Reasons included the need for objectivity, protecting app users from research risks, and consistency in standards for the ethical conduct of research. Concerns included burdening minimal risk research and limitations in current systems of oversight. Literature and analysis supports the use of IRBs even when not required by regulations, and the need for evidence-based improvements in IRB processes.

Human oversight has become a key mechanism for the governance of artificial intelligence (“AI”). Human overseers are supposed to increase the accuracy and safety of AI systems, uphold human values, and build trust in the technology. Empirical research suggests, however, that humans are not reliable in fulfilling their oversight tasks. They may be lacking in competence or be harmfully incentivised. This creates a challenge for human oversight to be effective. In addressing this challenge, this article aims to (...) make three contributions. First, it surveys the emerging laws of oversight, most importantly the European Union’s Artificial Intelligence Act (“AIA”). It will be shown that while the AIA is concerned with the competence of human overseers, it does not provide much guidance on how to achieve effective oversight and leaves oversight obligations for AI developers underdefined. Second, this article presents a novel taxonomy of human oversight roles, differentiated along whether human intervention is constitutive to, or corrective of a decision made or supported by an AI. The taxonomy allows to propose suggestions for improving effectiveness tailored to the type of oversight in question. Third, drawing on scholarship within democratic theory, this article formulates six normative principles which institutionalise distrust in human oversight of AI. The institutionalisation of distrust has historically been practised in democratic governance. Applied for the first time to AI governance, the principles anticipate the fallibility of human overseers and seek to mitigate them at the level of institutional design. They aim to directly increase the trustworthiness of human oversight and to indirectly inspire well-placed trust in AI governance. (shrink)

Research and business investment in emerging nanotechnologies is leading to a diverse range of new substances and products. As workers are faced with handling new materials, often with novel properties, the robustness of current workplace health and safety regulatory frameworks is being brought into question. Here, 12 characteristics of the U.S. occupational safety regulatory framework identified by Choi and Ramachandran are considered in the context of emerging nanotechnologies. The assessment suggests that, as the number of new materials entering the workplace (...) continues to increase, OSHA will need to develop flexible approaches to identifying and reducing potential risks. Relying on conventional approaches in the face of unconventional challenges will increase the probability of otherwise avoidable heath impacts. If the potential for engineered nanomaterials to cause harm is to be understood and managed, the agency will need to look at new approaches to generating, sharing, and using information. (shrink)

Since the announcement and establishment of the Oversight Board (OB) by the technology company Meta as an independent institution reviewing Facebook and Instagram’s content moderation decisions, the OB has been subjected to scholarly scrutiny ranging from praise to criticism. However, there is currently no overarching framework for understanding the OB’s various strengths and weaknesses. Consequently, this article analyses, organises, and supplements academic literature, news articles, and Meta and OB documents to understand the OB’s strengths and weaknesses and how it (...) can be improved. Significant strengths include its ability to enhance the transparency of content moderation decisions and processes, to effect reform indirectly through policy recommendations, and its assertiveness in interpreting its jurisdiction and overruling Meta. Significant weaknesses include its limited jurisdiction, limited impact, Meta’s control over the OB’s precedent, and its lack of diversity. The analysis of a recent OB case in Ethiopia shows these strengths and weaknesses in practice. The OB’s relationship with Meta and governments will lead to challenges and opportunities shaping its future development. Reforms to the OB should improve the OB’s control over its precedent, apply OB precedent to currently disputed cases, and clarify the standards for invoking OB precedent. Finally, these reforms provide the foundation for an additional improvement to address the OB’s institutional weaknesses, by involving users in determining whether the OB’s precedent should be applied to decide current content moderation disputes. (shrink)

ABSTRACTAn influential view in recent philosophy of punishment is that the apparatus of criminal justice should be geared at least in part to state censure of wrongdoing. I argue that if it were to be so geared, such an apparatus would make ambitious claims to authority, and that the legitimacy of the relevant state would then depend on whether those claims can be vindicated. This paper looks first at what kind of authority is being claimed by this apparatus. The criminal (...) law, I argue, cannot merely be thought of as claiming a right to rule and to be obeyed. Rather, its authority is better understood as the authority of moral oversight: a power to alter, at will, citizens’ liability to answer for their compliance with—and to be officially censured for their failure to comply with—a designated set of pre-existing moral 7reasons. The paper then looks at whether a state could realistically be expected to possess such authority—that is, whether a state that claims to have such a power could ever be legitimate. (shrink)

We provide additional information relevant to our previous publication on the quality of reports of investigations of research integrity by academic institutions. Despite concerns being raised about ethical oversight of research published by a group of researchers, each of the four institutional investigations failed to determine and/or report whether ethics committee approval was obtained for the majority of publications assessed.

In lieu of an abstract, here is a brief excerpt of the content:Future Directions for Oversight of Stem Cell Research in the United StatesCynthia B. Cohen (bio) and Mary A. Majumder (bio)Human pluripotent stem cell research, meaning research into cells that can multiply indefinitely and differentiate into almost all the cells of the body, has become a minefield in which science, ethics, and politics have collided over the last decade in the United States. President Barack Obama entered this highly (...) charged territory when he indicated during his campaign that once in office he would issue an executive order expanding federally funded human embryonic stem cell (hESC) research and introduce rigorous oversight of it (Obama 2008a & b). Candidate Obama stated that he would require that the hESC lines involved were derived with donor consent from early embryos that otherwise would be discarded following in vitro fertilization (IVF) treatment. However, in contrast with the policy of President George W. Bush, he would do so without regard to the date of their derivation. He added that he would call upon the director of the National Institutes of Health (NIH) to develop guidelines for federally funded hESC and other pluripotent stem cell research that would draw from the guidelines developed in 2005 by the National Academies of Science (NAS) for privately funded research (National Research Council 2005).A similar policy was written into the 2008 version of the Stem Cell Research Enhancement Act, which reiterates the policy enunciated in earlier versions of this bill, passed twice by the Congress but vetoed by President Bush each time (House of Representatives, 110th Congress 2008).1 Depending on how one reads the 2008 version of the act, it could also apply in certain respects to hESC research that is not federally funded. We proceed on the assumption that the act applies at least to federally funded stem cell research. Therefore, it appears that the president or the Congress, or both, will approve of an expanded policy of federal funding of hESC research, as well as other forms of human pluripotent stem cell research. [End Page 79]This policy would make the guidelines developed by a committee appointed by NAS, a prestigious private body of American scientists and related experts, the primary basis for the development of new federal guidelines for oversight of hESC research in the United States. This would have certain advantages in that those familiar with the relevant scientific issues are likely to address them accurately and stem cell investigators are apt to accept restrictions on their research written by fellow scientists and ethics and policy experts whom they perceive as strong supporters of stem cell research. However, it also would have certain disadvantages. Chief among these is that the NAS committee appointed to write guidelines for this research, in its concern to see stem cell science move forward after a period in which many scientists and others maintained that it had been unduly restricted, might have overlooked or deferred consideration of some pressing ethical and policy issues. We maintain that this is the case—although we also maintain that the NAS guidelines provide a responsible foundation for developing NIH guidelines for stem cell research. Consequently, we propose that an NIH task force charged by the director of NIH with writing new guidelines for hESC and other stem cell research should revise and expand the NAS guidelines in ways that we propose below, as well as others that it considers necessary, and make it obligatory for those seeking federal funding of such research to follow these new guidelines.We highlight certain areas in which an ethical case can be made for strengthening the existing NAS guidelines and certain areas in which more fundamental ethical reflection—and building on that, additional guideline/policy development—seems warranted. Among the sections of the NAS guidelines that need clarification and reworking, we include those regarding consent to embryo donation, which provide one of their central focuses, and the development of human-nonhuman chimeras, which they address relatively briefly. In addition, we maintain that new guidelines need to be written to address the nascent ethical and policy issues raised by the possibility that human gametes will be induced from pluripotent stem cells in the next few years and that... (shrink)

This article is the lead piece in a special report that presents the results of a bioethical investigation into chimeric research, which involves the insertion of human cells into nonhuman animals and nonhuman animal embryos, including into their brains. Rapid scientific developments in this field may advance knowledge and could lead to new therapies for humans. They also reveal the conceptual, ethical, and procedural limitations of existing ethics guidance for human‐nonhuman chimeric research. Led by bioethics researchers working closely with an (...) interdisciplinary work group, the investigation focused on generating conceptual clarity and identifying improvements to governance approaches, with the goal of helping scholars, funders, scientists, institutional leaders, and oversight bodies (embryonic stem cell research oversight [ESCRO] committees and institutional animal care and use committees [IACUCs]) deliver principled and trustworthy oversight of this area of science. The article, which focuses on human‐nonhuman animal chimeric research that is stem cell based, identifies key ethical issues in and offers ten recommendations regarding the ethics and oversight of this research. Turning from bioethics’ previous focus on human‐centered questions about the ethics of “humanization” and this research's potential impact on concepts like human dignity, this article emphasizes the importance of nonhuman animal welfare concerns in chimeric research and argues for less‐siloed governance and oversight and more‐comprehensive public communication. (shrink)

Dewey's critique of nationalism is primarily a critique of the ambitions of great powers. He was unaware of the aspirations of small nations, and his critique has less relevance for small-nation nationalism. In fact, as a communitarian, he should have been a supporter. But he also believed that science and technology are pushing mankind towards unity. The ideal society is to be cosmopolitan, democratic and secular, with everyone relying on the scientific method for beliefs. An American nationalist, he believed in (...) America's special link with democracy, in her mission to lead mankind, and saw America as a model of cosmopolitanism. However, he never made clear whether he saw America as a melting pot forming a new nation or as a mosaic. As a result, the status of nationality in the cosmopolitan humanity of the future remains unclear. (shrink)

The history of human subjects research and controversial procedures in relation to it has helped form the field of bioethics. Ethically questionable elements may be identified during research design, research implementation, management at the study site, or actions by a study’s investigator or other staff. Post-approval monitoring (PAM) may prevent violations from occurring or enable their identification at an early stage. In U.S.-initiated human subjects research taking place in resource-constrained countries with limited development of research regulatory structures, arranging a site (...) visit from a U.S. research ethics committee (REC) becomes difficult, thus creating a potential barrier to regulatory oversight by the parent REC. However, this barrier may be overcome through the use of digital technologies, since much of the world has at least remote access to the Internet. Empirical research is needed to pilot test the use of these technologies for research oversight to ensure the protection of human subjects taking part in research worldwide. (shrink)

When scientific research collides with social values, science's right to self-governance becomes an issue of paramount concern. In this article, I develop an account of scientific autonomy within a framework of public oversight. I argue that scientific autonomy is justified because it promotes the progress of science, which benefits society, but that restrictions on autonomy can also be justified to prevent harm to people, society, or the environment, and to encourage beneficial research. I also distinguish between different ways of (...) limiting scientific autonomy, and I argue that government involvement in scientific decision-making should usually occur through policies that control the process of science, rather than policies that control the content of science. (shrink)

New discoveries are improving the odds of human cells surviving in host animals, prompting regulatory and funding agencies to issue calls for additional layers of ethical oversight for certain types of human–animal chimeras. Of interest are research proposals involving chimeric animals with humanized brains. But what is motivating the demand for additional oversight? I locate two, not obviously compatible, motivations, each of which provides the justificatory basis for paying special attention to different sets of human–animal chimeras. Surprisingly, the (...) sets of animals that actually get flagged for special scrutiny by research and funding guidelines do not correlate with either of the sets of animals that arise when we think about what is motivating additional oversight. What this shows is that existing research policies and funding guidelines are disconnected from their motivation: the rationale for flagging certain types of human–animal chimeras as requiring special oversight is ignored in execution. (shrink)

Addressed here are addressing and the address of the here and the there: the direction and indirection of words, whether written or spoken in prayer; but also of pictures, one of them sent to Derrida, one of them an icon presumably destined from God, and a third, the one reproduced on the cover of The Post Card from Socrates to Freud and Beyond, that attends to the difficulty of locating the threshold between the to and the from, perhaps a secular (...) version of the problem of grace—unless that is not a problem but an aporia, wherever the threshold between these has its place. The chance of oversight, επισκoπη, is addressed, and the words Derrida addressed to his friends from the grave. (shrink)

A general case about the insights and oversights of molecular genetics is argued for by considering two specific cases: the first concerns the bearing of molecular genetics on Mendelian genetics, and the second concerns the bearing of molecular genetics on the replicability of the genetic material. As in the first case, it is argued that Mendel's law of segregation cannot be explained wholly in terms of molecular genetics--the law demands evolutionary scrutiny as well. In the second case, it is argued (...) that an account of the replicability of the genetic material in terms of molecular genetics is not entirely independent of evolutionary considerations, in the sense that it raises further evolutionary questions. The limitations of the molecular-genetic approach in these cases point to the limitations of that approach in general. (shrink)

Urban communities experiencing marginalization often disproportionately bear the risks and burdens of research and are left out of research ethics governance processes. To address this, many communities have created place-based and community-led research ethics governance initiatives to ensure that community voice is included in discussions surrounding research conduct. Place-based strategies in the Vancouver Downtown Eastside, the Bronx, and the Philadelphia Promise Zone successfully mobilize community perspectives in research ethics, filling in a significant gap in our current system of institutional research (...) ethics review and oversight. These cases demonstrate that place-based research ethics governance has the potential to account for the community-level risks posed by research projects and to ensure communities receive more felt benefits. Place-based communities sidestep simplistic notions of identity based on single shared features and make space for intersectional analyses and diverse community viewpoints to be considered. Such communities have a unique claim to expertise given their shared experience of place, which grants them the ability to see problematic assumptions embedded in scientific projects as well as community-level concerns within research. Despite this, many marginalized communities are excluded from current research ethics oversight processes. This exclusion demands critical examination and a way forward to facilitate the integration of place-based community oversight strategies within research ethics governance. (shrink)

This paper reviews the paper by Kuzma, Najmaie, and Larson that looks at what can be learned from the experience with genetically engineered organisms for oversight of emerging technologies more generally. That paper identifies key attributes of a good oversight system: promoting innovation, ensuring safety, identifying benefits, assessing costs, and doing so all while building public confidence. In commenting on that analysis, this paper suggests that looking at “oversight” in three phases — research and development, regulatory review, (...) and market acceptance — can help to determine when certain of these attributes should take precedence over others and how to structure remedies when an error occurs. The result is an approach that is precautionary with respect to research and development, prudent and open to public input in the regulatory review stage, and purposefully persuasive once market acceptability is at stake, with remedies that are risk-containing in the first phase, risk-managing in the second, and risk-assuaging in the third. Combining the key attributes with the idea of three phases can help attune oversight to society's needs. (shrink)

Background. Africa has seen an increase in the number of health research projects being conducted on the continent, particularly clinical trials. Ideally, this should be accompanied by a commensurate improvement in research ethics review capacity to competently provide the much-required research ethics oversight. Unfortunately, this is not the case in many African countries, which are still grappling with weak research ethics oversight capacity, not only at national level but also at institutional level. Objectives. To describe the proposal by (...) Kenya’s national research ethics regulatory authority, the National Commission for Science Technology and Innovation (NACOSTI), to build the capacity of its National Scientific and Ethics Committee (NSEC), tasked with providing the required research ethics oversight in the country. Methods. This is the proposal submitted by NACOSTI to the European and Developing Countries Clinical Trials Partnership for funding of a project entitled ‘Strengthening Research Ethics and Oversight in Kenya’ (STReK). It describes the activities involved to strengthen the NSEC to provide the required research ethics in the country, and to build the research ethics capacity of research ethics committees (RECs) it has accredited, through training and mentorship programmes, to enable them to efficiently review research proposals. Results. Proposed activities of the project are presented. Implementation of the activities described is ongoing. Conclusion. Lessons learnt in this regard may be of benefit to other research ethics regulatory authorities in resource-constrained countries aiming to strengthen their research ethics oversight capacity. (shrink)

A proposed state administrative rule would have required medical ethicists to approve certain aspects of gender-affirming care. The authors argue the proposed rule lacked appropriate justification compared to other instances of state-mandated ethics oversight and would undermine trust, raise practical challenges, and send harmful messages to society, patients, and providers.