This article describes our efforts to screen and enrol clinical trial participants conscientiously in the COVID-19 pandemic setting. We present the standard screening and enrolment process prior to, and our process of adapting to, the pandemic. Our goal was to develop a way to screen and enrol people for clinical trials that was both equitable and…

Progress in precision medicine is being achieved through the design of clinical trials that use genetic biomarkers to guide stratification of patients and assignation to treatment or control groups. Genetic analysis of biomarkers is, therefore, essential to complete their objectives, and this involves the study of biological samples from donor…

As the burden of misconduct in medical research is increasingly recognised, questions have been raised about how best to address this problem. Whilst there are existing mechanisms for the investigation and management of misconduct in medical literature, they are inadequate to deal with the magnitude of the problem. Journal editors and publishers…

Stem cell therapy, a cutting-edge technology, aims to replace damaged cells with healthy ones. Stem cells possess the remarkable ability to multiply and differentiate into various cell types, making them ideal candidates for regenerative medicine. This therapy holds promise for treating a wide range of conditions and injuries. In this review, I…

To reduce the global burden of the COVID-19 pandemic, there is an urgent need to develop a safe vaccine. Vaccine development usually takes many years as it goes through several different phases. To hasten COVID-19 vaccine development, it has been suggested that the final stage could be replaced with a human challenge trial (HCT). Volunteers would…

Clinical trials must address a number of laws, regulations, and other sources of requirements when communicating privacy and confidentiality protections to potential participants. This article outlines relevant requirements from Common Rule regulations, Food and Drug Administration regulations, Health Insurance Portability and Accountability Act…

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…

Incidental findings in research with human participants may have implications for a person's present health or future health outcomes. Current guidelines focus on methods for handling and reporting incidental findings from biological test data but incidental findings might also arise from non-biological tests. This article presents three examples…

In this essay, I suggest that a slightly modified version of Freedman's formulation of the clinical equipoise requirement is justified. I begin this essay with a brief discussion of the equipoise requirement. In the second and third sections, I discuss several objections to the clinical equipoise requirement as well as two attempts to justify the…

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,…

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"…

On the day that Henrietta Lacks died, researcher Dr. George Gey excitedly appeared on national television. He held a vial of her cells in his hand for the entire world to see and stated, "It is possible that, from a fundamental study such as this, we will be able to learn a way by which cancer can be completely wiped out." Once separated…

These are interesting days in the scientific, social, and political debates about human embryonic stem cell research. Pluripotent stem cells--cells that can, in principle, give rise to the body's full range of cell types--were previously derivable only from human embryos that were destroyed in the process. Now, a variety of somatic cell types can…

Many people suffer from chronic diseases and problems due to injury from accidents or ailments. Some problems, such as measles and cancer, can be cured or put into remission with time, medicine, or treatments. Other ailments, such as high blood pressure, failing kidneys, and cystic fibrosis, cannot be cured and require continuous use of…