Research Ethics Roundup: Right to Try 2.0, social media data access, and more

person using laptop with transparent data overlay

This month’s Research Ethics Roundup covers the latest in right-to-try, social media data access, FDA extrapolation of drug indications, return of genetic results, and a lawsuit about USDA inspections.

Right to try 2.0: Advocates want to reduce oversight of ‘n of 1’ therapies
STAT | Nicholas Florko

The latest version of so-called “Right to Try” laws is a successful effort to pass legislation in Arizona called “Right to Try 2.0,” which focuses on experimental treatments for single-patient studies. Like with previous Right to Try laws, critics say they do very little to actually increase patient access to experimental treatments, given FDA’s existing expanded access program. Supporters of the legislation were “unable to point STAT to any doctors who haven’t been able to administer personalized treatments because of FDA regulations.”

Why Researchers Want Broader Access to Social Media Data
Undark | Teresa Carr

Researchers argue that “the stakes have never been higher” in the fight to understand how information—particularly mis- and disinformation—travels online, and are frustrated by social media companies’ reticence to allow access to platform data. Much existing research on social media data is done in collaboration with those platform companies, undermining the independence of the work: “Always, always, always you are at the whim of the platforms,” one researcher said. The current legal framework prioritizes user privacy, rather than research, though there are a handful of current legislative efforts that may be shifting that balance.

Study: Extrapolation of drug indications from study populations by FDA is ‘common’
RAPS | Jeff Craven

A recent study found that, from 2015-17, FDA “extrapolated indications for 21 drugs a total of 23 times,” meaning that the agency approved a drug for use for an indication not supported by data from the relevant pivotal trials. The study authors argued that, while indication extrapolation is not problematic per se, it suggests the need for further research that often does not occur.

How a South African community’s request for its genetic data raises questions about ethical and equitable research
The Conversation | Dana Al-Hindi and Brenna Henn

Researchers who work with the Khoe-San peoples of South Africa write about the ethics challenges in fulfilling one of the Khoe-San’s most common requests during participation: return of genetic test results. The Khoe-San are “considered the most genetically diverse human populations currently known,” making them a common subject of genetic research, much of which the authors of this piece describe as exploitive or extractive. Returning genetic results to this population comes with challenges that include communicating complex data in a useful way, and potentially fraught reactions to unexpected information derived from the genetic testing.

Lawsuit Alleges USDA Secretly Relaxed Animal Welfare Inspections
The Scientist | Dan Robitzski

A lawsuit filed by a Harvard Law School clinic alleges that the USDA has not been fulfilling its obligations to fully inspect research facilities, and so is in violation of the Animal Welfare Act. The suit alleges that the USDA has passed on performing a full inspection of some facilities that already receive AAALAC accreditation, a move which suggests “the agency is trying to find a cheaper way, a more efficient way to do inspections,” but which critics say is insufficiently rigorous and transparent.