Institutional review boards and investigators are used to talking about risks of harm. Both low risks of great harm and high risks of small harm must be disclosed to prospective subjects and should be explained and categorized in ways that help potential subjects to understand and weigh them appropriately. Everyone on an IRB has probably spent time at meetings arguing over whether a three-page bulleted list of risk description is helpful or overkill for prospective subjects. Yet only a small fraction (...) of all the time and attention lavished on risk disclosure has been devoted to discussing whether and when potential benefit to subjects can reasonably be claimed and, if so, how it should be described in the consent form and process.Traditionally, IRBs and regulators have worked to ensure that clear lines can be drawn between research that, by definition, carries no potential for direct benefit — because it uses healthy volunteers or because it is not foreseeably focused on the development of treatments — and research that does have the development of effective treatments as its goal. (shrink)

The Covid‐19 pandemic has concentrated bioethics attention on the “lifeboat ethics” of rationing and fair allocation of scarce medical resources, such as testing, intensive care unit beds, and ventilators. This focus drives ethics resources away from persistent and systemic problems—in particular, the structural injustices that give rise to health disparities affecting disadvantaged communities of color. Bioethics, long allied with academic medicine and highly attentive to individual decision‐making, has largely neglected its responsibility to address these difficult “upstream” issues. It is time (...) to broaden our teaching, research, and practice to match the breadth of the field in order to help address these significant societal inequities and unmet health needs. (shrink)

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

The three important target articles make a strong case for regarding racism as a public health crisis. Each calls for advocacy by the bi...

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)

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)

At the time of this writing, a widely publicized, waived-consent trial is underway. Sponsored by Northfield Laboratories, Inc. (Evanston, IL) the trial is intended to evaluate the emergency use of PolyHeme®, an oxygen-carrying resuscitative fluid that might prevent deaths from uncontrolled bleeding. The protocol allows patients in hemorrhagic shock to be randomized between PolyHeme® and saline in the field and, still without consent, randomized between PolyHeme® and blood after arrival at an emergency department. The Federal regulations that govern the waiver (...) of consent restrict its applicability to circumstances where proven, satisfactory treatments are unavailable. Blood - the standard treatment for hemorrhagic shock - is not available in ambulances but is available in hospitals. The authors argue that the in-hospital stage of the study fails to meet ethical and regulatory standards. (shrink)

Informed consent in clinical research is widely regarded as broken, but essential nonetheless. The most recent attempt to reform it comes as part of the first revisions to the Common Rule since it became truly “common” in 1991. This change, the addition of a “key information” requirement for most consent forms, is intended to support and promote a reasoned decision-making process by potential subjects. The key information requirement is both promising and problematic. It is promising because it encourages clarity and (...) honesty about research participation, creativity in information disclosure, and mutual learning through the investigator-subject relationship. It is problematic because those goals — which have remained aspirational since the beginning — may be difficult to achieve in what has become an excessively compliance-oriented regulatory regime. (shrink)

On September 8, 2015, the Department of Health and Human Services issued a Notice of Proposed Rule Making to revise the Federal Policy for the Protection of Human Subjects, widely known as the “Common Rule.” The NPRM proposes several changes to the current system, including a dramatic shift in the approach to secondary research using biospecimens and data. Under the current rules, it is relatively easy to use biospecimens and data for secondary research. This approach systematically facilitates secondary research with (...) biospecimens and data, maximizing the capacity for substantial public benefit. However, it has been criticized as insufficiently protective of the privacy and autonomy interests of biospecimen and data sources. Thus, the NPRM proposes a more restrictive regime, although more so for biospecimens than data. Both the status quo and the NPRM's proposal are critically flawed. (shrink)

Giving up the increasingly troubled distinction between “experiment” and “treatment” would make it easier to focus on informed consent and harder to beg questions about uncertainty and shared decisionmaking in medicine.

In March 1996, the General Accounting Office issued the report Scientific Research: Continued Vigilance Critical to Protecting Human Subjects. It stated that “an inherent conflict of interest exists when physician-researchers include their patients in research protocols. If the physicians do not clearly distinguish between research and treatment in their attempt to inform subjects, the possible benefits of a study can be overemphasized and the risks minimized.” The report also acknowledged that “the line between research and treatment is not always clear (...) to clinicians. Controversy exists regarding whether certain medical procedures should be categorized as research.”This problem currently plagues gene transfer research. A few months prior to the GAO report, an ad hoc committee appointed by National Institutes of Health Director Harold Varmus expressed similar concerns in its assessment of NIH investment in research on gene therapy. (shrink)

The principle of informed consent is so firmly established in bioethics and biomedicine that the term was soon bowdlerized in common practice, such that engaging in the informed decision-making process with patients or research subjects is now often called “consenting” them. This evolution, from the original concept to the rather questionable coinage that makes consent a verb, reveals not only a loss of rhetorical precision but also a fundamental shift in the potential meaning, value, and implementation of the informed consent (...) process. Too often, the sharing of information has been replaced by the mere acquisition of agreement with the authority ostensibly offering a choice.Scholars of informed consent agree that its salience and its legitimacy derive from a fiduciary duty to inform, in order to respect, protect, and promote autonomous decision making by those to whom the duty is owed. (shrink)

In much the same way that genomic technologies are changing the complexion of biomedical research, the issues they generate are changing the agenda of IRBs and research ethics. Many of the biggest challenges facing traditional research ethics today — privacy and confidentiality of research subjects; ownership, control, and sharing of research data; return of results and incidental findings; the relevance of group interests and harms; the scope of informed consent; and the relative importance of the therapeutic misconception — have become (...) important policy issues over the last 20 years because of the ways they have been magnified by genomic research efforts. Research that examines the ethical, legal, and social implications of human genomics research has become a burgeoning international field of scholarship over the last 20 years, thanks in part to its support first by the genome research funding bodies in the U.S. and then by national science agencies in other countries. (shrink)

One of my favorite bioethics quotes is nearing 50 years old:Let us not forget that progress is an optional goal, not an unconditional commitment, and that its tempo in particular, compulsive as it may become, has nothing sacred about it. Let us also remember that a slower progress in the conquest of disease would not threaten society, grievous as it is to those who have to deplore that their particular disease be not yet conquered, but that society would indeed be (...) threatened by the erosion of those moral values whose loss, possibly caused by too ruthless a pursuit of scientific progress, would make its most dazzling triumphs not worth having.Despite its age, this invocation seems to me increasingly relevant as time... (shrink)

First-in-human research has several characteristics that require special attention with respect to ethics and human subjects protections. At least some nanomedical technologies may also have characteristics that merit special attention in clinical research, as other papers in this symposium show. This paper considers how to address these characteristics in the consent form and process for FIH nanomedicine research, focusing principally on experimental nanotherapeutic interventions but also considering nanodiagnostic interventions.It is essential, as a starting point, to recognize that the consent form (...) and process are by no means the primary protectors of human subjects. Instead, consideration of the form and content of informed consent becomes relevant only after a clinical trial has been reviewed and deemed scientifically and ethically acceptable.Two convergent types of challenges to informed consent are posed by nanomedicine FIH research. First, some issues appear generally applicable to FIH research, but have specific nanomedicine implications. (shrink)

Biodefense and emerging infectious disease animal research aims to avoid or ameliorate human disease, suffering, and death arising, or potentially arising, from natural outbreaks or intentional deployment of some of the world’s most dreaded pathogens. Top priority research goals include finding vaccines to prevent, diagnostic tools to detect, and medicines for smallpox, plague, ebola, anthrax, tularemia, and viral hemorrhagic fevers, among many other pathogens (National Institute of Allergy and Infectious Diseases [NIAID] priority pathogens). To this end, increased funding for conducting (...) research, developing research facilities, and purchasing (stockpiling) developed vaccines, diagnostic tools, and therapeutics .. (shrink)

At the time of this writing, a widely publicized, waived-consent trial is underway. Sponsored by Northfield Laboratories, Inc. (Evanston, IL) the trial is intended to evaluate the emergency use of PolyHeme®, an oxygen-carrying resuscitative fluid that might prevent deaths from uncontrolled bleeding. The protocol allows patients in hemorrhagic shock to be randomized between PolyHeme® and saline in the field and, still without consent, randomized between PolyHeme® and blood after arrival at an emergency department. The Federal regulations that govern the waiver (...) of consent restrict its applicability to circumstances where proven, satisfactory treatments are unavailable. Blood—the standard treatment for hemorrhagic shock—is not available in ambulances but is available in hospitals. The authors argue that the in-hospital stage of the study fails to meet ethical and regulatory standards. (shrink)

ABSTRACT:Good science fiction can be a successful vehicle for portraying justice. Science fiction can stimulate moral imagination in much the same way as the most effective justice theories, connecting the world in which we live with a range of alternative futures deliberately and creatively made plausible. A selective examination of classic and recent science fiction stories and novels provides contextual framing for considering questions of climate justice, virtuous personal action in the face of structural injustice, and the problem of what (...) justice means when some people are regarded as “other.” By connecting compelling images of individual responsibility with the complex challenges posed by striving for social justice, science fiction can also help render justice work appealing and achievable—an essential step that is reinforced in closing by a brief set of maxims. (shrink)

ABSTRACT:Bioethics needs to expand its vision. We must examine and interrogate the social and structural barriers that help traditionally privileged communities maintain minoritized groups as inherently inferior "others." Justice requires the field to look beyond the walls of hospitals, clinics, and medical academia to address and ameliorate the structural injustices that give rise to health disparities long before differential access to health services becomes an issue for underserved patients. Doing so means engaging in challenging multidisciplinary collaborations in order to understand (...) the sociohistorical complexities of health and illness, appreciate the factors that contribute to shaming and blaming those "others" who are not "us," and work to lessen the discomfort with uncertainty that impedes equity. All of this necessary work takes bioethics well beyond the well-trodden pathways of our usual scholarship and practice. But we simply have to reach higher to do health justice. (shrink)

_Bioethics, Public Moral Argument, and Social Responsibility_ explores the role of democratically oriented argument in promoting public understanding and discussion of the benefits and burdens of biotechnological progress. The contributors examine moral and policy controversies surrounding biomedical technologies and their place in American society, beginning with an examination of discourse and moral authority in democracy, and addressing a set of issues that include: dignity in health care; the social responsibilities of scientists, journalists, and scholars; and the language of genetics and (...) moral responsibility. (shrink)

Bioethics needs an expanded moral vision. It is now time for bioethics to take full account of the problems of health disparities and structural injustice that are made newly urgent by the COVID-19 pandemic and the effects of climate change. Nancy M. P. King, Gail E. Henderson, and Larry R. Churchill make the case for a more social understanding and application of justice, a deeper humility in assessing expertise in bioethics consulting, a broader and more relevant research agenda, and greater (...) appreciation of the profound health implications of global warming. (shrink)

_341_ _Objectives: _In patients with multivessel disease both the detection of the culprit lesion and the exact allocation are important preconditions for sufficient treatment and improved outcome. In a vessel based approach the combination of quantitative coronary angiography and fractional flow reserve measured by a pressure wire should be advantageous compared to myocardial SPECT, as morphological and functional information is delivered simultaneously. Therefore our aim was to evaluate MS in the detection and allocation of hemodynamically significant stenoses obtained by the (...) combined gold standard QCA plus FFR in patients with multivessel disease. _Methods: _FFR and QCA of 95 vessels in 80 patients have been evaluated. Hemodynamically significant target lesions were defined as intermediate stenoses between 50 and 75% with an FFR. (shrink)

Historian James H. Jones published the first edition of Bad Blood, the definitive history of the Tuskegee Syphilis Experiment, in 1981. Its clear-eyed examination of that research and its implications remains a bioethics classic, and the 30-year anniversary of its publication served as the impetus for the reexamination of research ethics that this symposium presents. Recent revelations about the United States Public Health Service study that infected mental patients and prisoners in Guatemala with syphilis in the late 1940s in order (...) to determine the efficacy of treatment represent only one of the many attestations to the persistence of ongoing, critical, and underaddressed issues in research ethics that Bad Blood first explored. Those issues include, but are not limited to: the complex and contested matters of the value of a given research question, the validity of the clinical trial designed to address it, and the priorities of science. (shrink)

The intrusive state has long viewed women as fetal containers. The Dobbs decision goes further, essentially causing women to vanish when fetuses are abstracted from their relationships to pregnant persons. The ways in which women are first controlled and then made invisible are clearly connected with the move from obedience to omission that has historically affected black Americans. When personal decisionmaking and participation in democracy are regarded as threats, those threatened restrict decisional freedom and political power, deepening structural injustices relating (...) to sex, race, and poverty. Fear of Dobbs has health effects on conditions unrelated to pregnancy and connects with erasures of human value that are not health-related. We reaffirm solidarity as a countering influence. Taking account of the richly relational context in which issues like abortion and political representation arise should lead to better, more meaningful policies, making so many people impossible to unsee. (shrink)

Medical teams care for severely premature infants under conditions of emergency and uncertainty that make parental involvement very difficult. Parents can be invited into a decisional relationship with the team that enables them to assess more fully the meaning of their child's illness.

In Shaping Our Selves, Erik Parens offers both a personal history of bioethics and a cleverly clarifying lens to train on disputes in bioethics about emerging technologies. The question for readers is whether this lens, as useful as it is, leaves too much outside our field of vision. Parens, born in 1957, comes from the first wave of bioethics scholars—those of us who still mostly happened into bioethics as a field, before it was sufficiently well-established to be identified as a (...) career pathway. Bioethics enjoys a fascinating diversity of origin stories, and Parens’s is no exception. He began his studies at the University of Chicago’s pan-disciplinary Committee on Social Thought, one of a handful.. (shrink)

Hastings Center Report, Volume 52, Issue 3, Page 3-3, May–June 2022.