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 […]
Category: Research Ethics
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 […]
Expanding the mind and rights of patients with implantable BCIs
By Guido Cassinadri and Marcello Ienca Implantable brain-computer interfaces (iBCI) are implantable systems that record quantitative neural data and use them to deliver various responses such as therapeutic, diagnostic, or preventive interventions. BCIs have been used inter alia to predict seizures in epileptic patients by monitoring their neural data and either delivering electrical stimulation or […]
Interdisciplinary collaboration to identify and address ethical issues arising from the development of irreversible, high risk medical treatments
By Alex Harris & Frederic Gilbert. There are increasing numbers of clinical trials assessing high risk, irreversible treatments. While a clinical trial aims to assess the safety and efficacy of a clinical intervention, participants enrolled in trials of high risk, irreversible treatments may be left with significant ongoing or emerging burdens after exiting the trial. […]
Confronting ableism: Reflections on the ethical failings of academic health research
By Joanne Hunt and Charlotte Blease. Health research, much like healthcare, is often plagued by persistent ableism. These two issues are likely connected. Disabled people across the globe experience a multitude of institutional, physical and attitudinal barriers to healthcare. Beyond inaccessible clinical environments and equipment, people with disabilities are confronted with clinical ambivalence, discriminatory attitudes […]
“Ethics first” reform for medical research in China: from reactive to proactive
By Jingyi Xu, Zhongxuan Liu, Jiayou Shi, Yue Wang. The 2018 CRISPR-babies incident, involving the controversial editing of human genomes, significantly impacted China’s approach to the ethics governance in medical research. The event underscored the need for a shift from a reactive, post hoc framework to a more proactive and anticipatory model. As a global […]
Should the public health response to Nipah virus disease be like that of COVID-19?
By Tara Hurst, Tess Johnson, Euzebiusz Jamrozik, Phaikyeong Cheah and Michael Parker. Nipah virus made the international news recently for an outbreak in Kerala, India. This bat-borne virus has occurred seasonally in Bangladesh since the first outbreaks were identified in Malaysia and Singapore in 1998-1999 (Figure 1). The course of Nipah virus disease may be […]
Research by any other name: The case of MEURI
By G. Owen Schaefer. Sorting and categorization is a classic and sometimes entertaining parlor game. Is a taco a sandwich? Is a couch a chair? Are calculators computers? Other times, though, the stakes are higher, particularly when classification has moral or legal implications – such as the question of whether corporations are people, or whether […]