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Personalized and long-term electronic informed consent in clinical research: stakeholder views
BackgroundThe landscape of clinical research has evolved over the past decade. With technological advances, the practice of using electronic informed...
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Challenges and proposed solutions in making clinical research on COVID-19 ethical: a status quo analysis across German research ethics committees
BackgroundIn the course of the COVID-19 pandemic, the biomedical research community’s attempt to focus the attention on fighting COVID-19, led to...
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The CORBEL matrix on informed consent in clinical studies: a multidisciplinary approach of Research Infrastructures Building Enduring Life-science Services
BackgroundInformed consent forms for clinical research are several and variable at international, national and local levels. According to the...
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Develo** a Framework for Self-regulatory Governance in Healthcare AI Research: Insights from South Korea
This paper elucidates and rationalizes the ethical governance system for healthcare AI research, as outlined in the ‘Research Ethics Guidelines for...
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Unproven Stem Cell-Based Interventions: Addressing Patients’ Unmet Needs or Causing Patient Harms?
Stem cells and regenerative medicine have been hyped over the past two decades as a cure for hundreds of diseases and disabilities. However, the...
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Data privacy protection in scientific publications: process implementation at a pharmaceutical company
BackgroundSharing anonymized/de-identified clinical trial data and publishing research outcomes in scientific journals, or presenting them at...
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Rare Disease Research
We address ethical issues in the field of rare diseases (RDs) focusing on four aspects that are relevant for research and translation into clinical...
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Assessment of the appropriateness of the i-CONSENT guidelines recommendations for improving understanding of the informed consent process in clinical studies
BackgroundThe H2020 i-CONSENT project has developed a set of guidelines that offer ethical recommendations and practical tools aimed at making the...
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Research Ethics and Research Ethics Committees in Europe
In Europe, the topics of “research ethics” and “ethics committees” are becoming increasingly present in publications, university seminars, public...
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Institutional Review Board (IRB): US Perspectives
The institutional review board (IRB) is a federally mandated group instituted by the U.S. government to protect the rights and welfare of human...
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Ethics and the marketing authorization of pharmaceuticals: what happens to ethical issues discovered post-trial and pre-marketing authorization?
BackgroundIn the EU, clinical assessors, rapporteurs and the Committee for Medicinal Products for Human Use are obliged to assess the ethical aspects...
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Boundaries Between Research, Surveillance and Monitored Emergency Use
Responses to outbreaks, epidemics and pandemics involves a heterogeneous set of activities that aim to address threats to public health. In addition...
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The Babel of Drugs: On the Consequences of Evidential Pluralism in Pharmaceutical Regulation and Regulatory Data Journeys
Throughout the last century, pharmaceutical regulators all over the world have used various methods to test medical treatments. From 1962 until 2016,...
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Regulatory, scientific, and ethical issues arising from institutional activity in one of the 90 Italian Research Ethics Committees
BackgroundThis paper highlights the issues that one of the 90 Italian Research Ethics Committees (RECs) might encounter during the approval phase of...
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Bioethical Decision-Making About Somatic Cell Genome Editing: Sickle-Cell Disease as a Case Study
Somatic cell genome editing (SCGE) now allows exquisitely precise and targeted non-heritable changes to be made to human DNA. While SCGE has many...
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On the Normative Foundations of Pharmaceutical Regulation
I argue that behind the 1962 Food and Drug Administration Act we find a combination of two normative principles: a liberal argument for the...
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The Place of Digital and Artificial Intelligence in Medical Research
Advances in the performance of computers and new algorithms now make it possible to manage and analyze faster and more data (big data, data sciences,...
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Urban people’s preferences for life-sustaining treatment or artificial nutrition and hydration in advance decisions
BackgroundThe Patient Right to Autonomy Act (PRAA), implemented in Taiwan in 2019, enables the creation of advance decisions (AD) through advance...
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MAI: A Very Short History and the State of the Art
This chapter gives a short overview of the history of MAI and describes its crucial contemporary applications. The aim is not to give a complete list...
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Therapeutic Genome Editing
Efforts to cure single gene disorders by replacing the responsible genes using stem cell transplantation and gene transfer have been pursued for...