The Covid-19 pandemic has significantly affected the practice of clinical research. Researchers and IRBs have felt an urgency to respond more quickly than usual, aware that lives are at stake.

My partner and I are thinking a lot about this question. Moderna and Pfizer trials are running in our community–at the children’s hospital where I work as a clinical ethicist. The Pfizer trial began enrollment of 5-to-11-year-olds. My almost 4-year-old kid would be in the next cohort.

Multiple candidate vaccines for coronavirus are being evaluated scientifically in a process of unprecedented speed, and thousands of individuals around the world have volunteered to participate in placebo-controlled phase III field trials. If, or when, one of these candidate vaccines is proved to be safe and effective and receives an emergency use authorization by the Food and Drug Administration, will it continue to be ethical to enroll participants in other coronavirus trials that randomize half of them to a placebo?

Volunteering for a Covid-19 vaccine trial satisfied my altruistic goals and harmonizes with my Hindu beliefs. But I am troubled that a drug company is going to profit from my altruism and my religious obligations.

There is little doubt about the urgent need for Covid-19 treatment. But premature publication of definitive recommendations based on inappropriate conclusions grounded in scant, hastily-acquired data serve only at best to confuse and at worst mislead at a time when tensions are high and need for help is great.

Double-blind randomized clinical trials are the gold standard for answering the scientific question of whether a drug produces any effect, positive or negative, in Covid-19 patients. But is rational for a patient to choose to try a drug such as chloroquine for Covid-19 outside of a trial? Some patients may correctly hold that they have little to lose.

The bioethics and legal communities must come together to find ways to move with the same ease of the scientific research community--to transcend the geopolitical borders and jurisdictional concerns that make international regulation so difficult.

Neither one of us expected to be talking about Hannah Arendt at the Vatican. We had been invited to give talks at the Pontifical Academy of Sciences on the scientific and ethical challenges posed by personalized medicine. Walking across the cobblestones of St. Peter’s Square we began to discuss how society regulates biomedical research. Are institutional review boards capable of dealing with innovations like personalized medicine? Are they too bound by regulations? Can they ask larger questions of meaning when simply following the rules won't suffice? And most worrisome, has their bureaucratic function caused them to mistake regulatory compliance for ethical reflection?

A preliminary investigation by Guangdong Province in China of He Jiankui, the scientist who created the world’s first gene-edited babies, found that “He had intentionally dodged supervision, raised funds and organized researchers on his own to carry out the human embryo gene-editing intended for ...

In their single-minded venture of “producing” (shengchan, in their own word) the world’s first gene-edited babies, He Jiankui and his associates have posed numerous and daunting ethical challenges to China and the world. They can be mapped or identified through these four categories: