By Susan Bull, Euzebiusz Jamrozik, Ariella Binik, Michael Parker Vaccine development processes typically take ten to twenty years. The exceptional pace of COVID-19 vaccine research has resulted in early human trials being commenced with vaccine candidates. Calls have been made to conduct controlled human infection studies (CHIs), also known as challenge studies, with SARS-CoV-2 to […]
Category: Research Ethics
Ethical oversight during COVID-19: rewriting the norms of research ethics review?
By Anna Chiumento and Lucy Frith One consequence of physical distancing in response to the COVID-19 pandemic has been the rapid suspension or adaptation of ongoing research activity. This presents an opportunity for the research ethics community and researchers to promote ethical oversight that integrates the situated and informed judgement of researchers, rebalancing away from […]
Is Research Ethics Committee review of most clinical trials fundamentally broken?
By Mark Yarborough Imagine that you suffered from a fatal neurodegenerative disorder like Alzheimers or ALS, or that you had a serious chronic condition like hypertension or heart disease. Imagine further that you were asked to participate in a clinical trial related to your disease. Finally, imagine that the person recruiting you into the trial […]
We need a framework for the ethics of secondary epidemic vaccine trials
By Joshua Teperowski Monrad Introduction In the 21st century, few medical innovations have been as intensely anticipated as an effective vaccine for COVID-19. The pipeline of candidates now includes more than a hundred potential products, as governments, pharmaceutical companies, and researchers engage in an unprecedented effort to combat the worst pandemic of a century. This […]
Experiment on identical siblings separated at birth: Ethical implications for researchers, universities and archives today
By Adam Kelmenson, MS & Robert Klitzman, MD The 2018 film Three Identical Strangers brought wide media and public attention to a previously little-known 1960’s psychological study. The researchers had secretly separated several sets of twins and one set of triplets into adoptive families, and then studied them for decades without disclosing to the […]
What happens when a healthcare institution becomes a research subject?
By Jan Piasecki and Vilius Dranseika. Consider a hospital manager who works in a large hospital employing hundreds of medical professionals and receiving thousands of patients every day. When she is approached by a group of researchers, she faces a difficult decision. On the one hand, she and the staff of her hospital are committed […]
Allocating scarce biospecimens
By Leah Pierson, Sophia Gibert, and Joseph Millum Clinical researchers frequently collect samples of blood, skin, and other bodily tissues from their patient-participants and have samples left over when their research is complete. These biospecimens are often in high demand from other scientists who want them for their own research. How should such collections of […]
Do you, and should you, own your clinical data?
By Angela Ballantyne Rhetoric of ‘ownership’ is increasingly important to debates about the ethical management of clinical data. But the precise meaning of “ownership” remains opaque. A dominant refrain in the media and some bioethics literature is that patients own their health data: “There is broad agreement that it is individuals who should not only […]
Risks, Benefits, and Taking Participants’ Values Seriously: The Case of HIV Cure Research
By Robert Steel The introduction and refinement of highly effective antiretroviral treatments has transformed HIV into a manageable chronic condition. Nonetheless, treatment is lifelong, burdening people living with HIV and health systems. So there is interest in a cure. But cure trials can be risky and the medical benefit of potentially being cured is limited […]
Take care when testing manufactured organs on the deceased
By Laura Kimberly, Brendan Parent Every article about the organ transplant crisis starts something like this: In the United States in 2018, over 116,000 individuals were on the waiting list for an organ transplant. Yet of those on the waiting list, only 36,000 (31%) received a much-needed transplant to treat their end-stage organ failure, and […]