Research Ethics Roundup: New Setback for Marijuana Research, Genetic Testing Companies’ Security Concerns, Chimera Research and Review Boards, and the European Medicines Agency’s Attempt to Decrease Risks in “First-In-Human” Studies

This week’s Research Ethics Roundup highlights the research implications of the Drug Enforcement Administration (DEA) decision to keep marijuana a Schedule 1 drug, public concern about hackers and stored genetic information, one bioethics professor’s take on the National Institutes of Health’s proposed policy for funding chimera research, and the European Medicines Agency’s response to a French clinical trial that left one man dead.

bush varietal marijuana leaves on a black background in a coffeeshop top view

DEA Decision Keeps Major Restrictions in Place on Marijuana Research: In this STAT article, reporter Andrew Joseph discusses how the DEA’s decision to continue to classify marijuana as a Schedule 1 drug may hamper research into its effects. Currently, scientists researching Schedule 1 drugs “have to gain DEA approval and often upgrade the security protocols in their labs, expensive and time-consuming hurdles.”

What Can a Hacker Do with Your Genetic Information?: Kaleigh Rogers of Motherboard writes about security concerns with genetic testing companies’ storage of data. However, experts point out “while a massive hack might be able to execute a data dump of genetic information, unless the hacker was also able to connect that information to individuals…it wouldn’t be particularly useful.”

Embryologist transferring egg to special culture media in petri dish

The Chimera Quandary: Is it Ethical to Create Hybrid Embryos?: In this NPR article, Ray Suarez spoke with a Case Western Reserve University bioethics professor about the National Institutes of Health’s proposed policy for funding chimera research. Professor Insoo Hyun said, “Review boards do have a track record and a history of overseeing both 100 percent human embryo research and also animal research. So they’ll have to find some chimeric approach, if you will, to this area. And so I think this is a work in progress.”

Europe Overhauls Rules for ‘First-In-Human’ Trials in Wake of French Disaster: Hinnerk Feldwisch-Drentrup reports for Science that the European Medicines Agency (EMA) recently put forth a paper on “improv[ing] strategies to identify and reduce risks in ‘first-in-human’ (FIH) studies on healthy volunteers.” The EMA issued the paper in response to a phase I French clinical trial that left one dead. One critic argued “FIH studies should never be designed to test tolerance…but should be used to understand the pharmacology of the drug in humans, especially in relation to the information available from animals.” The EMA is accepting feedback on the paper until September 30.