22
Apr2014

Did you catch the blood moon and the first lunar eclipse of the year? We hope so, but now it’s time to turn your gaze from the sky to the screen and catch up on what’s been going on in the field of research ethics!

In Landmark Vote, EU Passes New Clinical Trial Regulation, Including Data Transparency Measures: On April 2, 2014, the European Parliament passed new rules that require pharmaceutical companies to make public the results of clinical trials. The vote repeals Directive 2001/20/EC, the clinical trials directive (CTD), and replaces it with an amended rule. The new rule contains hundreds of changes from the original CTD, the most significant of which are the clinical data transparency measures that require companies to publish a detailed summary of findings in a publicly accessible database as well as release all study data at the time of a drug’s approval.

Crowdsourcing Medical Decisions: Ethicists Worry Josh Hardy Case May Set Bad Precedent: Social media supporters of Josh Hardy, a dying seven-year old, pressured a biotech company into giving him an experimental medication to treat an infection he contracted after a bone marrow transplant, although similar requests were turned down by the company. This situation highlights the ethical dilemmas that doctors, companies, and regulators face in the era of online social networking.

How Mouse Studies Lead Medical Research Down Dead Ends: Drugs based on poorly constructed studies are making it fairly far along the pathway toward approval before being proven ineffective or unsafe. Journalist Richard Harris examines how this happens and considers improvements in the drug development process in this piece for NPR.

NIH Puts Squeeze on Chimpanzee Living Space: To confirm a 2011 recommendation from an advisory committee, which critics cited as costly and difficult to implement, NIH solicited input from experts on animal care and commissioned a literature review in order to determine the minimum space density for captive chimpanzees. The agency concluded that the minimum living space for captive research chimpanzees is 250 square feet per animal, one-fourth of the area recommended by the advisory committee.

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