Medical Research on Human Subjects and RECs in the Netherlands

Author(s):  
Jessica Wright ◽  
Bert Gordijn
2020 ◽  
pp. medethics-2019-106034
Author(s):  
Robert C Hughes

Many ethicists maintain that medical research on human subjects that presents no prospect of direct medical benefit must have a prospect of social benefit to be ethical. Payment is not the sort of benefit that justifies exposing subjects to risk. Alan Wertheimer has raised a serious challenge to this view, pointing out that in industry, social value is not considered necessary to make dangerous jobs ethical. This article argues that Wertheimer was correct to think that the ethics of hazard pay should be the same in medical research and in business. Nevertheless, a qualified social benefit requirement should apply in both fields. For a study or a job with significant net physical risk to be ethical, it must have social value beyond the satisfaction of ordinary preferences, including the preference for money. The requirement derives from a non-absolutist version of the doctrine of double effect. If a risky study or a dangerous job has no distinctive social value, and hazard pay is subjects' or workers’ only reason to undergo risks, the very fact that they undergo risk is intended as a means to a financial end. Inviting people to enrol in such a study or to take such a job wrongfully treats people as mere means. By contrast, if a study or a job has social value, people can participate with a primary end other than money, even if they accept compensation. Researchers or employers do not intend but merely foresee risks to subjects or workers.


Author(s):  
Corinna Wagner

Issues around the body have tended to be seen as the concerns of medical materialists and utilitarians, but rarely medievalists. This perception is reflected in the fact that the body only features occasionally in scholarship on Victorian medievalism. However, this chapter makes the claim that medievalists were deeply invested in issues of health and death, as well as anatomy and other branches of medicine. Moreover, medievalists often evoked the past in support of views about the ethics and care of the body that were surprisingly comparable to that of their supposed sworn enemies, materialists and utilitarians. There is a strain of thought, and an aesthetics, that runs through Victorian culture, which could be called ‘materialist medievalism’. I argue that the view of a bifurcated Victorian society has obscured how often opinions between seemingly incompatible thinkers overlapped on aesthetic, philosophical, and ‘condition of England’ questions that focused on the body. It is my hope that this reconsideration will help us better understand the Victorian foundations of our modern concerns with surveillance, medical research on human subjects, health and well-being in urban environments, and memorialization and care of the dead.


2021 ◽  
Author(s):  
Antonio Sandu

We will discuss (…) the need for ethics in times of crisis. Many people consider ethics and bioethics and the call for principles to be bureaucratic obstacles to obtaining a rapid response from the population, for example, to achieve vaccines in record time, to immunize the population, to establish unpopular but necessary measures, such as closing borders and non-compliance with fundamental principles of the European Union, establishing public policies aimed at herd immunity or, conversely, closing most activities considered essential in the economy, to ensure social distancing and self-isolation of the population. These measures are understood as derogations from ethics or bioethics when targeting medical research on human subjects performed faster than required by standard procedure, or the implementation of innovative therapeutic practices that have not previously been studied by clinical trials to certify that there are no known side effects.


1983 ◽  
Vol 92 (3) ◽  
pp. 577
Author(s):  
William J. Curran ◽  
Robert J. Levine

2008 ◽  
Vol 15 (2) ◽  
pp. 145-151 ◽  
Author(s):  

AbstractIn The Netherlands medical research with minors is regulated in the Medical Research Involving Human Subjects Act. During the legislation process in the Houses of Parliament in the 1990s the issue of non-therapeutic research with minors and incapacitated subjects was heavily debated. Stringent regulations were formulated for this type of research and the Act became operational in December 1999. In order to implement the Clinical Trial Directive 2001/20/EG, the Act was modified on several issues. However, the Act was not modified on the issue of non-therapeutic research with minors and incapacitated subjects. As a result at present the Dutch law is more restrictive on non-therapeutic research with minors than the EU Directive. Currently, discussion is ongoing to adapt the Dutch law in order to harmonize it with the EU Directive.


Bioethics ◽  
2013 ◽  
Vol 28 (6) ◽  
pp. 284-292 ◽  
Author(s):  
Mark Sheehan ◽  
Vernon Marti ◽  
Tony Roberts

1999 ◽  
Vol 15 (suppl 1) ◽  
pp. S7-S13 ◽  
Author(s):  
John Harris

In this paper I discuss the application of the principles of medical ethics and of medical research to the case of children and others whose consent to treatment and to research is problematic. Public health depends substantially on the possibility of ongoing research into all conditions which affect the health of the people. Constraints on this research are therefore a public health issue. Moreover and more importantly the possibility of predictive testing and indeed of screening for health-relevant conditions is an important public health tool, and limitations on the use of this tool are of great significance to public health medicine. Having considered the particular problems created by research and predictive testing on children for late-onset conditions I go on to discuss research on those whose consent is problematic more generally. I conclude with radical recommendations for the reform of The Declaration of Helsinki and of the International Ethics Guidelines for Biomedical Research Involving Human Subjects, prepared by the Council for International Organizations of Medical Sciences (CIOMS).


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