This month's research ethics roundup covers scientists' problems with ClinicalTrials.gov, thoughts from the inventor of CRISPR, the FDA's "Animal Rule," and so-called "parachute science."
A team of Oxford and Mexican researchers want to diversify genomic databases. Can they end 'parachute science,' too?
STAT | Emiliano Rodríguez Mega
An Oxford research project aims to create a large biobank of Mexican data samples as part of a global effort to diversify genetic databases that are still overwhelmingly white. In collaborating with mostly Mexican scientists, the project also demonstrates a move away from "parachute" science, where external—usually wealthy—institutions "drop in" to a poorer region, collect data, and leave. But the international collaborations that need to happen to diversify biobanks, according to STAT, nevertheless "pose uncomfortable questions, such as who owns the data, whom to share it with, and what for."
Her Discovery Changed the World. How Does She Think We Should Use It?
The New York Times | David Marchese
Jennifer Doudna, one of the co-creators of the CRISPR gene-editing technology touted as one of the great breakthroughs of modern science, is interviewed in this piece about questions of the ethics and potential future impacts of the technology. Though the technology is still in its relative infancy, its status as a technique that, per Marchese, "involves touching the fabric of life itself," means it carries substantial ethical questions. "If we can do it, should we be doing it? If we are going to do it, in what circumstances, and who decides?" Doudna asks, and is careful not to rush to any conclusions.
A treatment for monkeypox was approved under the FDA's 'Animal Rule.' Here's what that means
STAT | Andrew Joseph
This STAT piece explores the so-called Animal Rule, an FDA policy that allows a select number of drugs to be approved for use in humans without ever having been tested in them. This may occur when a disease cannot be tested in humans because it is rarely or never seen in humans, or if human trials would be so dangerous as to be unethical. Tpoxx, a drug recently cleared for use amid the rising monkeypox surge, was approved via the Animal Rule to treat smallpox in 2018 (because smallpox is eradicated in humans), but can be used to treat monkeypox via the Expanded Access pathway.
Learn more about how IRBs can help facilitate expanded access for Tpoxx in this IRB Forum thread.
Clinical Trial Registry Errors Undermine Transparency
The Scientist | Catherine Offord
ClinicalTrials.gov, the US federal government’s leading tool in promoting transparency in the conduct and reporting of clinical trials, has no one "routinely monitor individual trial records for veracity," according to Offord. The database relies on the person submitting information to the database to do so truthfully and correctly, which is sometimes not the case; COVID-19 trials examined by The Scientist, for example, showed instances of "wildly inaccurate" starts and end dates, among other data, undermining the platform’s utility as a trustworthy source of trial information.