Determining whether a research risk meets or exceeds a regulatory standard of risk acceptability is difficult. Recently a framework called the systematic evaluation of research risks (SERR) has been proposed as a method of comparing research risks with predetermined standards of acceptability. SERR purports to offer a systematic and largely determinate (definite) way to compare risks and say whether a specific research risk falls below or above an acknowledged standard of acceptable risk. Here the authors review some philosophical problems with (...) this framework, which they take to be representative of determinate approaches to risk comparison, and conclude that it should not be used in a stand-alone or determinate fashion. Instead, the authors suggest that a deliberative approach may be a more viable candidate for future development. Such an approach could be informed by methods such as SERR without being rigidly bound to them. (shrink)

In recent years, we have seen a new concern with ethics training for research and development professionals. Although ethics training has become more common, the effectiveness of the training being provided is open to question. In the present effort, a new ethics training course was developed that stresses the importance of the strategies people apply to make sense of ethical problems. The effectiveness of this training was assessed in a sample of 59 doctoral students working in the biological and social (...) sciences using a pre-post design with follow-up and a series of ethical decision-making measures serving as the outcome variable. Results showed not only that this training led to sizable gains in ethical decision making but also that these gains were maintained over time. The implications of these findings for ethics training in the sciences are discussed. (shrink)

The application of artificial intelligence and machine learning technologies in healthcare have immense potential to improve the care of patients. While there are some emerging practices surro...

Risk takes center stage in ethical debates over nanomedical technologies. Yet concepts of risk may hold different meanings, and they are embedded within particular political, economic, and social contexts. This article discusses framings of risk in debates over medical innovations such as nanomedicine, and draws attention to organizational and institutional forms of risk which are less visible in bioethical policy debates. While significant, possibly unique risks may exist in specific nano-based products, risk may also arise from the very processes and (...) procedures that develop, test, and oversee any novel technology. This supports recommendations to coordinate efforts through an interagency Working Group and a Secretary-level Advisory Committee to provide flexibility and sensitivity to emerging issues of concern. (shrink)

Risk is the most often cited reason for ethical concern about any medical science or technology, particularly those new technologies that are not yet well understood, or create unfamiliar conditions. In fact, while risk and risk-benefit analyses are but one aspect of ethical oversight, ethical review and risk assessment are sometimes taken to mean the same thing. This is not surprising, since both the Common Rule and Food and Drug Administration foreground procedures for minimizing risk for human subjects and require (...) local IRBs to engage in some sort of risk-benefit analysis in decisions to approve or deny proposed research. Existing ethical review and oversight practices are based on the presumption that risk can be clearly identified within the planned activities of the protocol, that metrics can reasonably accurately predict potential hazards, and that mitigation measures can be taken to deal with unintended, harmful, or catastrophic events. (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)

DeMarco and colleagues present a compelling method of dealing with medical risks for which there is equipoise which might be implicated in a given research protocol. This commentary examines how the proposed model should inform the disclosure of other, non-medical risks. Since equipoise is a fairly unclear notion for non-medical risks (since there is little sense of professional uncertainty regarding these risks), this could lead to the inclusion of nearly unlimited non-medical risks. To account for these risks more reasonably, I (...) will argue that a strong participant-researcher relationship is vital to determine if there are any particular non-medical risks that might be uncertainly implicated in a given research program. (shrink)

Safe-by-Design is an approach to engineering that aims to integrate the value of safety in the design and development of new technologies. It does so by integrating knowledge of potential dangers in the design process and developing methods to design undesirable effects out of the innovation. Recent discussions have highlighted several challenges in conceptualizing safety and integrating the value into the design process. Therefore, some have argued to design for the _responsibility_ for safety, instead of for safety itself. However, this (...) idea has not been developed further. In this article, we develop an approach to Safe-by-Design, grounded in care ethics, which builds on the idea of designing for responsibility and can deal with the complexity that is inherent to the conceptualization of safety. We describe five ways in which care ethics contributes to the conceptualization of Safe-by-Design: (1) It suggests the development of ‘circles of care’ in which stakeholders share the responsibility for safety; (2) it recognizes the importance of considering safety as something that is situated in the surroundings of a technology, instead of as a property of the technology itself; (3) it acknowledges that achieving safety is labour that requires an ongoing commitment; (4) it emphasizes that the way in which we relate to technology impacts its safety; and (5) it recognizes the role of emotions in assessing safety. All these elements combined lead to a broader understanding of safety and a philosophically more substantial and practically more appealing conceptualization of Safe-by-Design. (shrink)

The exploitation of participants is a significant problem in biomedical research, especially in the developing world. However, there is a gap between this problem and the theoretical literature on exploitation. This thesis will attempt to bridge it, considering Wertheimer and Sample’s theories. Whereas Wertheimer holds that exploitation is merely an unjust distribution of the “social surplus” arising from a transaction, Sample, whose approach this thesis endorses, construes exploitation as a lack of respect for a person’s true value. This thesis will (...) show that codes of ethics with legal force take a Wertheimerian approach, and that the aspirational codes, which insist that research respond to local health priorities, are more Samplian. Finally, it will argue that the current system of research funding and oversight cannot guarantee that research is responsive to the needs of the developing world and thus fails to prevent exploitation. (shrink)