By Nicolas Marty and Kevin Vezirian In 2023, Science reported that as many as nine in ten laboratory animal personnel will experience compassion fatigue at some point in their careers. For a workplace problem of that magnitude, occupational health offers a standard instrument: the hierarchy of controls, which ranks responses to a hazard from most […]
Category: Research Ethics
Will history repeat itself? The Stanford Prison Experiment
By Brianne Helfrich and Mariah Chobany Netflix just announced that they will be re-creating the Stanford Prison Experiment as a reality tv show (titled The New Stanford Prison Experiment) airing this October. The six 45-minute episode series involve 30 participants, and this news has sparked online viral debate and disbelief with many expressing strong concerns […]
Ethics’ forgotten hero – Maurice Pappworth
By Rafael Escandon Every June, I reflect on how Henry Knowles Beecher must have felt – 60 years ago – in the days before his classic, Ethics and Clinical Research (E&CR) was published. From my first reading of it, I thought Beecher’s effort was remarkably brave and have considered him a personal hero ever since. […]
Placebos and ethics in digital therapeutics
By Jacqueline Lutz & Lindsay Ayearst In applied digital health, questions about evidence generation are inseparable from how products are built and whether they ever reach patients. Many scientists working on digital therapeutics are academically trained to run controlled clinical studies, behavioral experiments, or to study specific behavioral intervention mechanisms. That rigor does not disappear […]
When evidence has only one arm: The ethical challenges of single arm trials
By Chiara Mannelli and Giuseppe Traversa Randomized controlled trials (RCTs) have long been regarded as the “gold standard” for testing new treatments. Yet in recent years, an increasing number of marketing authorizations – especially for cancer drugs – have been based on single arm trials (SATs). In these studies, all patients receive the experimental treatment, […]
Teens on the ethics panel: Why IRBs should hear from young people
By Samuel Asiedu Owusu and Claudia Passos-Ferreira Pediatric research is often designed for children but reviewed without them. When research involves children, adults make the ethical calls. They design the studies, write the consent forms, and sit on the ethics committees that approve them. They don’t always get it right. Listening to children can make […]
Mind for Sale: When Cognitive Function Becomes a Monthly Fee
By Guido Cassinadri In the first episode of the seventh season of Black Mirror, “Common People,” the story follows a couple in which the wife’s life is saved by an experimental therapy (spoiler incoming). The portion of her brain affected by an incurable tumor is replaced with synthetic tissue developed by the company Rivermind. The […]
Opportunities Lie Within Beqvez’s Discontinuation
By Rafael Escandon Pfizer announced, surprisingly, on February 20, that they plan to discontinue commercial availability of Beqvez, their recently approved gene therapy (GT) for Hemophilia B. They also announced, in separate communications in mid and late 2024, their terminations of investments in a partnership for a Hemophilia A GT, and their discontinuation of a […]
The USA’s Food and Drug Administration and informed consent
By Hugh Davies The Food and Drug Administration’s (FDA) initiative Over the last three decades seeking consent of patients or volunteers to join a medical research study has become dominated by an increasingly lengthy, opaque and Participant Information Sheet (PIS), shielding the researcher from liability. The FDA argues that Informed consent documents are often long, […]
Up the creek without a paddle? We can help navigate the consent river in pragmatic cluster randomized trials.
By Cory E. Goldstein, Stephanie N. Dixon, Monica Taljaard, Charles Weijer. As bioethicists and statisticians, we are occasionally invited to consult with a research team planning a pragmatic clinical trial after the research question and a basic outline of objectives and methods have been developed. When the proposed design is a cluster randomized design (in […]