1,559 research outputs found
Do we need a culturally transcending bioethics? The example of international collaborative research
No full text
Will a patient preference predictor improve treatment decision making for incapacitated patients?
No full textHow should we regulate risk in biomedical research?:An ethical analysis of recent policy proposals and initiatives
No full textThe existing regulatory framework for research is increasingly attacked for its “one-size-fits-all” approach. Many stakeholders contend that existing regulations formulate the same regulatory requirements for research involving very different levels of risk, and thereby unnecessarily stifle medical progress. To address this criticism, regulators are currently developing more risk-adapted approaches to regulating research. A key feature of these approaches is that they aim to calibrate subject protections, including ethical review and safety monitoring, to the risks that studies pose to participants.Risk-adapted systems of research oversight are ethically appealing because they have the potential to promote research within the constraints of adequate subject protection. However, this potential can only be realized if the complexities surrounding research risk can be addressed. The present paper offers the first systematic overview and ethical analysis of how European and U.S. regulators approach the development of more risk-adapted regulations. The analysis finds that so-called stratified approaches are ethically preferable because they specify risk categories with corresponding subject protections, and thereby reduce unwarranted variation in how research participants are protected in different studies. But the recent proposals for stratifying risk and subject protections raise various ethical concerns, for example regarding the accuracy of risk categories. Building on this analysis, the paper develops recommendations for future policy
Risk and risk-benefit evaluations in biomedical research
No full textOne of the fundamental ethical concerns about biomedical research is that it exposes participants to risks for the benefit of others. Therefore, a key ethical requirement for biomedical research studies is that they have an acceptable risk-benefit profile. Yet, despite widespread endorsement of this requirement, how it should be implemented remains controversial. The present paper critically reviews recent debates about risk and risk-benefit evaluations in biomedical research. It traces the history of risk-benefit evaluations in research, which were traditionally conceived of as an extension of the risk-benefit assessment occurring in clinical care. From there, the paper presents and evaluates the four existing ethical frameworks for risk-benefit evaluations: the component analysis, the integrative approach, the agreement principle, and the net risks test. It is argued that the net risks test is superior to the alternative approaches, but fails to offer guidance for evaluating the ethical acceptability of risks that participants incur for research purposes only. This leaves two of the fundamental problems of risk-benefit evaluations in research inadequately addressed, namely, (1) how to weigh the risks to the individual research participant against the potential social value of the knowledge to be gained from a study and (2) how to set upper limits of acceptable research risk. Discussions about the ‘‘minimal’’ risk threshold in research with participants who cannot consent, such as children or patients with dementia, go some way to specifying upper risk limits in this study context. However, these discussions apply only to a small portion of research studies. The paper ends by highlighting several important questions that future research will need to address
- …
