Research Ethics Roundup: FDA’s Redactions Challenged, Improving the Immune Systems of Lab Mice, and More

This week’s Research Ethics Roundup focuses on the ethical arguments for conducting Zika research on pregnant women, Public Citizen’s challenge of the Food and Drug Administration’s (FDA’s) redaction policy, and the official investigation on why a phase I trial in France left one dead.

mouseDirty Room-Mates Make Lab Mice More Useful: In this piece for Nature, Sara Reardon reports on a new article showing that lab mice that mingle with “dirty mice” have stronger, more “human-like immune systems.” “Dirty mice” often live in the wild or in pet shops and can be mixed with lab mice to change their immune system.

Public Citizen Sues FDA Over Redacted Advisory Committee Info: In this Regulatory Focus article, Michael Mezher reports on Public Citizen’s lawsuit against the FDA alleging the agency’s redactions prevent the public from seeing the background and professional qualifications of the outside experts that sit on the FDA’s advisory committees. Public Citizen says approximately 90% of the advisory committee members’ CVs posted to the FDA’s website are redacted.

ZikaZika Highlights Need for Research on Pregnant Women: In this op-ed for The Baltimore Sun, Anne Drapkin Lyerly, Carleigh Krubiner, and Ruth Faden argue “the knee-jerk response that research with pregnant women is too complex to contemplate is not acceptable.” They cite to the National Institutes of Health’s H1N1 vaccine study as evidence that research on pregnant women can be conducted in an ethical manner.

Botched French Drug Trial Followed Rules But Lacked ‘Common Sense’: In this article for NPR, Rae Ellen Bichell reviews a new report on how a French drug trial turned deadly. The Temporary Specialist Scientific Committee’s report focused on a series of “missteps” by the trial’s conductors and called for modifications in how clinical trials are run.