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When the Trial Ends: The Case for Post-Trial Provisions in Clinical Psychedelic Research
The ethical value—and to some scholars, necessity—of providing trial patients with post-trial access (PTA) to an investigational drug has been...
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Redundant trials can be prevented, if the EU clinical trial regulation is applied duly
The problem of wasteful clinical trials has been debated relentlessly in the medical community. To a significant extent, it is attributed to...
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Regulation (EU) on Clinical Trials
The European Union regulated clinical trials long before the most recent regulation entered into force (2014)
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Ethical Evaluations of Clinical Trials in France: Towards European Standardization
In France, any request to carry out research involving human beings is evaluated by two distinct and independent structures: the ANSM (National...
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A comparative ethical analysis of the Egyptian clinical research law
BackgroundIn this study, we examined the ethical implications of Egypt’s new clinical trial law, employing the ethical framework proposed by Emanuel...
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Confidentiality and Privacy in Digital Clinical Trials
In today’s digitalized world, new technologies have been modifying not only the forms of patient care but also clinical research, where handling...
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Clinical Significance of Precision Medicine – Genomics and Pharmacogenomics (PGx)
Precision medicine in the form of Pharmacogenomics (PGx) promises personalized medicine rather than the established “one size fits all” approach to...
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A defense of surgical procedures regulation
Since the advent of drug regulation in 1962, regulatory agencies have been in the practice of using strict standards to test the safety and efficacy...
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Clinical Trials (See Research Ethics; Clinical Research)
Clinical trials are scientific research projects involving human subjects.
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Experimentation in Medicine
This chapter distinguishes three forms of experimentation in medical practice, emerging at different periods of the history of medicine: (1) clinical...
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Chemical Regulation
Every day we are exposed to thousands of chemicals (and other substances) through contact with the food we eat, the medications we take, the consumer...
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The Significance of Professional Codes and Ethical Guidelines in Difficult Clinical Situations
When clinicians face ethical challenges, they may refer to professional codes and ethical guidelines for support. Whether and how professional codes...
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National Regulation on Processing Data for Scientific Research Purposes and Biobanking Activities: Reflections on the Experience in Austria
The application of the latest technologies in biology and medicine has brought them to a qualitatively new level of possibilities. Worldwide,...
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Ethical Relativism and Circumstances of Social and Cultural Contingencies on Informed Consent in the Conduct of Research: Clinical Trials in Nigeria
There have been debates across the globe for a social and culturally sensitive ethics to meditate a catalyst of template for informed consent (IC) in...
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Ethical and procedural issues for applying researcher-driven multi-national paediatric clinical trials in and outside the European Union: the challenging experience of the DEEP project
BackgroundWe describe our experience from a multi-national application of a European Union-funded research-driven paediatric trial (DEEP-2, EudraCT...
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Content and Process in the Brain. Implications for Clinical and Educational Approaches
Subjects may be aware in each moment of the content of a given scene and/or internal state. However, the vivid reality of the scene is a by-product...
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Freedom of Conscience and Medical Assistance in Dying—Clinical Perspective
In Carter v. CanadaCanada (Attorney General), the Supreme CourtSupreme Court of Canada emphasized that a physician’s decision to participate in...
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Normative framework of informed consent in clinical research in Germany, Poland, and Russia
BackgroundBiomedical research nowadays is increasingly carried out in multinational and multicenter settings. Due to disparate national regulations...
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Ethical Considerations for Vaccine Research
Vaccination, meaning induction of immunity through controlled exposure to antigens, has been mainly used as a prophylactic measure, but more recently...
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Community Engagement, Ethics Review, and Regulation
Community engagement is ethically important for many types of research. Given that HCS represent a particularly complex, sometimes unfamiliar, and...