Hundreds of clinical trials of potential treatments and vaccines for the "coronavirus 19 disease" (COVID-19) have been set up in record time. This is a remarkable reaction to the global pandemic, but the absence of a global coordination of clinical research efforts raises serious ethical concerns. Some COVID-19 patients might carry the…

Over the past decade, the development of three-dimensional mammalian cell organization--called human organoids--from stem cells has provided a framework for future clinical therapies. As human organoid research progresses, we also need to keep in mind the cross-cultural and ethical dimensions of human organoids research. Our review article aims to…

There is a gap in evidence regarding how research trial closure processes are managed to ensure continuity of HIV care for HIV positive participants following trial closure within low income settings. This research aimed to establish how research staff in Uganda understood and practised post-trial care for HIV positive trial participants. A…

Monitoring of clinical trials is important to ensure adherence to protocol, to safeguard the rights of research participants and to achieve compliance with principles of good clinical practice. Recent regulatory changes in India require Ethics Committees to keep an oversight of ongoing clinical trials including on-site monitoring. In this article,…

This article offers a longitudinal computational-rhetorical analysis of biomedical writing on opioids. Using a corpus of 1,467 articles and essays published in the "New England Journal of Medicine" and the "Journal of the American Medical Association" between 1959 and May 2019, this study evaluates diachronic shifts in (a) the…

Background: Medical research involving human subjects must be evaluated by a research ethics committee (REC) before a study is initiated. However, knowledge of REC decision processes, particularly in relation to evaluating the risk-benefit balance in various study types, appears scant. Methods: The study protocols and records of a Finnish…

Clinical trials in medicine often derive their financial support from the manufacturer of a device or pharmaceutical, but one must view with caution trial designs that allow an interested sponsor to terminate data collection.

The COVID-19 pandemic has brought unprecedented, major challenges to the ethical conduct of research including challenges for the rapid and robust ethical review of biomedical research. The Indian Council of Medical Research's "National Guidelines for Ethics Committees Reviewing Biomedical and Health Research during COVID-19 Pandemic"…

This year the world commemorates the beginning of the tragic USPHS syphilis experiments that occurred in Tuskegee, Alabama from 1932 to 1972. In light of this sobering anniversary, this article will briefly examine four studies: the already mentioned USPHS syphilis studies in Tuskegee, the Nazi Holocaust Experiments and the resulting Doctors'…

This book contains the proceedings of a multidisciplinary workshop convened to explore issues relating to the conduct of medical research on children. In the keynote address, John Holt discusses the right of children to informed consent. The main body of presentations is organized into three categories of concerns: medical imperatives, ethical…