This week’s Research Ethics Roundup covers ClinicalTrials.gov reporting, animal researchers scrambling to deal with paused research, funders’ responses to COVID-19, and a novel form of being that challenges the computer-animal barrier.
Lost opportunities from FDA, NIH inaction when sponsors fail to report clinical trial results
ClinicalTrials.gov functions as a repository where trial results are presented in a standardized manner, benefiting the advancement of science and offering some empirical support for regulatory decision making. However, it is estimated that up to one third of applicable trial results are missing from the database. Despite a ruling in March of this year requiring the FDA and NIH to mandate the reporting of missing data, the authors of this STAT piece remain unconvinced that the agencies will fully enforce the reporting requirement.
“When a trial sponsor fails to post results on ClinicalTrials.gov, as required by the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA and NIH are authorized to impose penalties…. Yet despite widespread noncompliance, these agencies have never imposed a single fine, withheld a single grant, or imposed any other penalty on a noncompliant trial sponsor.”
Bring Home The Tarantulas? As Research Halts, Scientists Face Difficult Decisions
Scientists are making some unusual arrangements to care for the creatures they study, as lockdowns force labs to temporarily shut their doors. For some, this means bringing home tarantulas, scorpions, and mantises. For others, it means putting field research on ice. As shutdowns drag on, students and scientists wonder what the future holds for their research.
“So when the university gave the go ahead to bring home animals that were not at risk of escaping into the wild and harming the environment, Waters brought the zoo home with him.”
How research funders are tackling coronavirus disruption
Much grant-funded research has been put on hold as labs and universities close in the wake of COVID-19. Researchers are worried about whether they will be able to meet deadlines and pay lab staff, and whether a potential economic downturn will reduce overall funding availability. Major funders around the world are instituting varying levels of accommodation, from extending deadlines to allowing for reallocation of funding to adjust to new remote workflows.
“The increasingly likely prospect of a long-term economic downturn also means science funding could face longer-term impacts, says Mark Harrison, research director at the Borneo Nature Foundation, which conducts ecological research in Indonesia. That could reduce the amount of funding from direct donations as well as government and charitable grants, says Harrison.”
Meet the Xenobots, Virtual Creatures Brought to Life
Scientists working in a lab at Tufts University have developed programmable organisms derived from embryonic frog cells. These microorganisms might one day be used to sweep up microplastics in the ocean or deliver drugs within human bodies. Before that, however, we need to answer important ethical questions that arise at the intersection of machine and animal.
“At the lab, Dr. Levin and Dr. Blackiston emphasized that they are more interested in using xenobots as experimental tools to uncover basic biological principles, and philosophical ones, too. ‘People will ask: is it a robot, is it a machine, is it an animal?’ Dr. Levin said. ‘What this is really telling us is that we need to have better definitions of all these things.’”